of the FD&C Act, FDA regulations, and the authorized SIP, the SIP
Sponsor should not need to immediately stop importation of all drugs
under the SIP. One comment asserts that identification of an
illegitimate product in the SIP should be grounds for automatic,
temporary suspension and potential full revocation of the SIP. One
comment notes that if identification of illegitimate product introduced
by a SIP were to lead to automatic revocation of the SIP's
authorization, it could have the counterproductive result of making
trading partners less inclined to identify and report the illegitimate
product.
    (Response 61) As discussed in the NPRM, under certain circumstances
set forth in section 804(g) of the FD&C Act, FDA is required to suspend
importation. Section 804(g) of the FD&C Act provides that the Secretary
must require that importations of a specific prescription drug or
importations by a specific Importer under section 804(b) be immediately
suspended on discovery of a pattern of importation of that specific
prescription drug or by that specific Importer of drugs that are
counterfeit or in violation of any requirement under section 804, until
an investigation is completed and the Secretary determines that the
public is adequately protected from counterfeit and violative
prescription drugs being imported under section 804(b). In some
circumstances, as described in the NPRM, FDA may suspend a SIP in whole
or in part or FDA may revoke authorization of a SIP, in whole or in
part. To ensure that FDA has current relevant information about SIP
participants, we have revised the rule to require a SIP Sponsor to
inform FDA of any new applicable criminal conviction, violation of law,
or disciplinary action.
    (Comment 62) Several comments ask FDA to limit requirements that
they characterize as duplicative or redundant, citing adverse event
reports, individual case safety reports (ICSRs),

and recall requirements. In addition, one comment suggests that
patients might not know whom to contact regarding an adverse event or a
question about medication.
    (Response 62) FDA declines to make substantive changes in response
to these comments. We have made some minor revisions from the
provisions in the NPRM for clarity. For example, in one instance we
have revised the wording to align with existing comparable requirements
in 21 CFR 314.80 (under Sec.  251.18(d)(9), an Importer must
``develop'' written procedures to meet their obligations under that
subpart because this encompasses the requirement to ``maintain'' and
``follow'' such written procedures), but such clarifications do not
change FDA's interpretation of the scope of existing responsibilities
under Sec.  314.80 or other existing safety reporting requirements.
    We do not believe the reporting requirements in the final rule are
duplicative or redundant. The rule requires an Importer to establish
and maintain records and submit to FDA and the manufacturer reports of
all adverse events associated with the use of the drug products it
imports under section 804 of the FD&C Act and this final rule. An ICSR
is a description of an adverse event related to an individual patient
or subject. The final rule outlines when and how an Importer must
submit ICSRs for domestic adverse events, and follow up reports, to FDA
and the manufacturer. As described in the NPRM (84 FR 70796 at 70821),
these reports will aid the manufacturer in its pharmacovigilance
efforts, and it will provide FDA with information that may be relevant
to its review of SIP Proposals and Pre-Import Requests as well as to
its oversight of drugs imported under section 804 of the FD&C Act and
section 804 in general. In the event of a recall, Importers must, upon
request by FDA, provide to FDA the transaction history, information,
and statement, as those terms are defined in section 581(25), (26), and
(27) of the FD&C Act, for the recalled drugs. We have clarified in the
final rule that, in the event of a recall, Foreign Sellers must also
provide certain transaction information to FDA upon request.
    (Comment 63) Several comments assert that it is inappropriate to
establish ``medication error'' reporting requirements only for SIPs.
    (Response 63) We have decided not to establish medication error
reporting requirements for SIPs at this time, before establishing such
requirements for prescription drugs generally, and have revised the
final rule to remove requirements related to reporting medication
errors. FDA might at a later time consider whether it should establish
medication error reporting requirements for SIPs.
    (Comment 64) Several comments request clarification regarding
recall responsibilities. One comment says that the timeframe for
adverse event reporting could lead to significant delays in recalls.
    (Response 64) The rule requires that each SIP proposal include a
recall plan that explains how the SIP Sponsor will obtain additional
recall or market withdrawal information, such as by obtaining recall
information from an Importer, and how the SIP Sponsor will ensure that
recall or market withdrawal information is shared among the SIP
Sponsor, the Foreign Seller, the Importer, and FDA, and provided to the
manufacturer. In addition, the rule requires that each SIP must have a
written recall plan that describes the procedures to perform a recall
of the product and specifies who will be responsible for performing the
procedures. The recall plan must cover recalls mandated or requested by
FDA and recalls initiated by the SIP Sponsor, as well as recalls in
Canada or the United States initiated by a drug's manufacturer that
implicate a drug imported under a SIP, with which the Foreign Seller or
Importer must cooperate. If FDA or any participant in a SIP determines
that a recall is warranted, the SIP Sponsor must effectuate the recall
in accordance with its written recall plan. We have revised the rule to
clarify an Importer's and a Foreign Seller's responsibilities in a
recall. We do not believe that the timeframes for adverse event
reporting, which are consistent with other FDA requirements for adverse
event reporting, would lead to significant delays in effectuating a
recall.
    (Comment 65) One comment suggests that allowing section 804-
imported drugs to coexist on the market with manufacturers' drugs would
introduce confusion to real-world data (RWD) collection and bias real-
world evidence (RWE) analyses.
    (Response 65) The comment assumes that an eligible prescription
drug will have quality concerns that could not be accounted for in RWD
sources and RWE analysis. However, an eligible prescription drug would
need to meet the conditions in an FDA-approved NDA or ANDA, including
quality specifications. In addition, there may be ways of
distinguishing eligible prescription drugs imported under section 804
of the FD&C Act in RWD sources, for example, by NDC.

F. Certification

    (Comment 66) Several comments address the certification that is
required under section 804(l) of the FD&C Act. One comment argues that
the certification cannot become null and void for any reason once it is
made. Instead, the comment argues that the proper way to address
problematic importations is to adopt a proposed new codified provision
that would give the Secretary the authority to order the cessation of a
particular SIP under certain specified circumstances.
    (Response 66) As stated in the NPRM (84 FR 70796 at 70803), the
Secretary's certification rests on the authorities and requirements
outlined in the regulation issued to implement section 804. If any one
of those provisions is invalidated, certification would become null and
void because it was based on an understanding regarding how section 804
would be implemented that, under this scenario, would be factually
incorrect and legally invalid. We decline to add the codified provision
proposed in the comment because this final rule includes Sec.  251.7,
also included in the proposed rule, which provides FDA the authority to
suspend or revoke a SIP under the circumstances set forth in that
section or Sec.  251.18.
    (Comment 67) Several comments assert that the NPRM contained no
assessment of whether importation under section 804 of the FD&C Act
would result in a significant reduction in the cost of covered products
to the American consumer and that section 804(l) requires factual
findings on cost savings before the certification can be made.
    (Response 67) We disagree. For section 804 to become effective,
subsection (l) requires the Secretary to certify that the
implementation of this section will pose no additional risk to the
public's health and safety, and result in a significant reduction in
the cost of covered products to the American consumer. Through this
final rule, implementation of section 804(b) through (h) will result in
a significant reduction in the cost of covered products to the American
consumer. In particular, Sec.  251.3(e)(9), as revised, requires the
SIP Sponsor's importation plan to explain, in a manner sufficiently
detailed to allow for a meaningful evaluation, how the Sponsor will
ensure that the SIP will result in a significant reduction in the cost
to the American consumer; and Sec.  251.7(c) provides that FDA may
revoke the authorization of a SIP if, among other reasons, the Agency
determines that continued implementation of the SIP will not

result in a significant reduction in the cost of drugs covered by the
SIP to the American consumer. Together, these provisions will ensure
that there is a meaningful assessment of whether drugs imported under a
particular SIP will result, and are resulting, in a significant
reduction in the cost of covered products to the American consumer,
which, in turn, allows the Secretary to make the cost-related finding
for the certification under section 804(l).
    (Comment 68) One comment contends that the Secretary is
impermissibly relying on States and Indian Tribes to support his
certification decision under section 804(l) because such reliance on
third parties to make the certification findings is contrary to the
plain language of section 804 of the FD&C Act. The comment further
contends that this rule would effectively subdelegate HHS's fact-
finding role to SIP Sponsors and cites U.S. Telecom Ass'n v. FCC, 359
F.3d 554 (DC Cir. 2004) for the proposition that delegating fact-
finding to the states is unlawful absent congressional authorization.
    (Response 68) In conjunction with this final rule, the Secretary is
certifying that implementation of section 804(b)-(h) will pose no
additional risk to the public's health and safety, and result in a
significant reduction in the cost of covered products to the American
consumer. The final rule is designed to ensure that FDA and other
components of HHS receive the necessary information to ensure this
certification applies to a particular SIP. Ultimately, it will be the
Secretary, acting through FDA, who will find that a particular SIP
proposal meets the certification requirements based on the information
received as part of the proposal. We note that it is a prohibited act
under section 301(aa) of the FD&C Act to import a prescription drug in
violation of section 804, falsify any record required to be maintained
or provided to the Secretary under such section, or violate the
regulations issued under such section. Accordingly, unless the
Secretary has reason not to do so, he may consider the information he
receives pursuant to this final rule and FDA's evaluation of such
information to ensure that a SIP will pose no additional risk to the
public's health and safety, and result in a significant reduction in
the cost of covered products to the American consumer. The Secretary
has not delegated the certification decision or any other finding to
the states or any other third party. Consequently, the comment's
reference to U.S. Telecom Ass'n v. FCC is inapposite because in that
case the court considered, in relevant part, whether a federal agency
delegated its authority to make certain determinations to a state.
    (Comment 69) One comment argues that in order to make the
certification under section 804(l), the Secretary must find that
implementation of all of section 804 will pose no additional risk to
the public's health and safety, and result in a significant reduction
in the cost of covered products to the American consumer. The comment
argues that if the Secretary cannot make this finding with regard to
section 804(j), then the certification cannot be made solely with
regard to section 804(b)-(h) of the FD&C Act. The comment cites Vermont
v. Leavitt, 405 F. Supp. 2d 466 (D. Vt. 2006), in which the court
stated that interpreting section 804(l)(1) to apply to only section
804(b)-(h) is ``a convoluted and implausible interpretation'' and ``is
undermined by the fact that Congress used the term `subsection' in
other provisions of section [804].'' The comment also cites Montgomery
County. v. Leavitt, 445 F.Supp.2d 505, 508 (D. Md. 2006) to support the
assertion that FDA has concluded that the certification requirement in
section 804 applies to the entire section and does not authorize a
specific waiver for a discrete state pilot program.
    (Response 69) We disagree that a certification under section 804(l)
must cover all of section 804 of the FD&C Act. In general, section 804
contains two importation pathways: (1) Commercial importation of drugs
from Canada under subsections (b)-(h), and (2) personal importation
under subsection (j). Each importation pathway must be certified by the
Secretary under section 804(l) to be effective. However, section 804
does not explicitly require a certification to cover both pathways. In
stating that this section only becomes effective if the implementation
of the section meets the certification criteria, section 804(l)
accomplishes two objectives: (1) Ensuring that any provision in section
804 does not take effect unless the Secretary certifies that
implementation of the provision would meet the certification criteria;
and (2) providing for the possibility that implementation could take
different forms, including implementing section 804 in a way that only
pertains to the commercial importation pathway or the personal
importation pathway.
    The court's decision in Vermont v. Leavitt does not support the
comment's assertion. In that case, the state of Vermont argued that the
personal importation provisions in section 804(j) of the FD&C Act could
be implemented without a certification because the certification
provision in section 804(l) only applies to the commercial importation
pathway outlined in section 804(b)-(h). The court found this
interpretation implausible. We agree with the court's decision that for
any provision in section 804 to be in effect, it must be covered by a
certification from the Secretary in accordance with section 804(l). The
court did not also hold that any certification under section 804(l)
must cover all of section 804. In fact, the court expressly did not
reach this decision. See Vermont v. Leavitt, 405 F. Supp. 2d at 479.
    Similarly, in Montgomery County. v. Leavitt, the plaintiff argued
that the certification requirement in section 804(l) of the FD&C Act
did not apply to all of section 804, and that FDA could authorize a
specific waiver for the proposed importation program before any
certification is made. The court held that the certification provision
applies to all of section 804 and, therefore, FDA's denial of the
county's waiver request for its proposed importation program was
mandated by Federal law because no certification had yet been made.
Again, we agree with the court's decision that the certification
provision applies to all of the provisions of section 804; accordingly,
there must be a certification in place for the commercial importation
pathway, the personal importation pathway, or both pathways, prior to
implementation of such pathway(s).
    (Comment 70) One comment argues that the certification under
section 804(l) of the FD&C Act can only be made broadly and not with
regard to only specific approved SIPs because section 804 contemplates
a broad certification finding before the section goes into effect. In
support of this argument, the comment states that: (1) Section 804 does
not provide that certification can be based on state-specific plans for
only certain state residents, and if that was the Congressional intent,
it could have been so limited; (2) the certification provision refers
to the American consumer, not specific American consumers under
particular plans; and (3) section 804 permits the opening of the closed
U.S. drug distribution system that protects patients from counterfeit
and substandard drugs. In addition, the comment cites Montgomery County
v. Leavitt and a letter from FDA to Montgomery County to support the
proposition that the certification provision in section 804 does not
authorize a specific waiver for a discrete state pilot program. The
comment also cites to a government brief filed in the Vermont v.
Leavitt litigation that it argues is inconsistent with the Agency's
position on this issue in this final rule.

    (Response 70) The Secretary's certification is based on the
requirements and safeguards in this final rule. Through this
implementation, the certification can be made because importation of
drugs under section 804(b)-(h) of the FD&C Act will not increase the
risk to the public's health and safety, and will lead to a significant
reduction in the cost of covered products to the American consumer.
Although the certification provision in section 804(l) does not
expressly address the review of sponsored plans for importation, there
is nothing in the provision that precludes the Secretary from basing
the certification on an implementing regulation that ensures any
importations made under section 804 meet appropriate standards,
including a requirement that importation plans be sponsored by certain
entities and reviewed and authorized by the Secretary. In fact, the
certification provision contemplates that the Secretary will base his
decision on certain requirements or other policies established by him
because the provision asks whether implementation of section 804 will
lead to the findings necessary to make the certification.
    With regard to the argument that because the certification
provision refers to the American consumer, the certification must be
broad, it is not clear what is meant by the term broad. We do not
believe that reference to the American consumer means that before a
certification can be made, there must be a finding that all American
consumers will benefit from a significant reduction in the cost of
covered products. In any case, the Secretary's certification does not
limit the number of American consumers who could benefit from
importation of drugs under section 804. A SIP or combination of SIPs
could be broad in scope and provide significant cost savings to
numerous Americans.
    It is not clear how the argument that section 804 opens the closed
U.S. distribution system supports the assertion that the certification
in section 804(l) of the FD&C Act must be broad. In any case, this
final rule does not open the closed U.S. distribution system; instead,
it expands it. The SIP Sponsor must demonstrate, among other things,
how it will ensure that the supply chain in the SIP is secure, as
required by Sec.  251.3(e)(11).
    The references to Montgomery County v. Leavitt and the letter from
FDA to Montgomery County mentioned in that decision do not support this
comment's arguments. The court's decision and the cited letter from FDA
refer to the ability of FDA to authorize a specific waiver for a
discrete state pilot program in the absence of a certification under
section 804(l). This case, along with the decision in Vermont v.
Leavitt, agreed with FDA's position and found that such a program could
not be authorized before the Secretary makes the required certification
under section 804(l) of the FD&C Act.
    As noted in the comment, the government's brief in the Vermont v.
Leavitt litigation (Federal Defendants' Motion to Dismiss Plaintiffs'
Complaint and Memorandum in Support) stated that section 804(l) asks
the Secretary to certify whether the law should be effective for all
Americans, not just those in one particular state. Similar statements
were made in the government's brief in the Montgomery County v. Leavitt
litigation. In contrast, as stated above, the Secretary's certification
and this final rule do not limit the number of American consumers who
could benefit from importation of drugs under section 804 of the FD&C
Act. All states can participate under the rule and, as noted elsewhere,
pharmacists or wholesalers may, under certain circumstances, be able to
sponsor a SIP without the cosponsorship of a State or Indian Tribe. The
involvement of a sponsor does not limit the scope of imports; instead
it is meant to provide additional oversight to ensure that any such
imports are safe.
    As stated above, although section 804(l) does not expressly address
importation plans that are submitted to the Secretary for review and
overseen by sponsors, it does not preclude them either. Instead, the
certification provision asks whether implementation of section 804 will
pose no additional risk to the public's health and safety, and result
in a significant reduction in the cost of covered products to the
American consumer. Section 804(l), itself, does not impose any
requirements on how implementation of section 804 of the FD&C Act would
be done in order to enable those findings under the certification. This
rule is designed to ensure that any authorized SIP poses no additional
risk to the public's health and safety and results in a significant
reduction in the cost of covered products to the American consumer, in
accordance with the Secretary's certification.
    (Comment 71) One comment notes that the proposed rule cites section
804 of the FD&C Act as part of the legal authority for the rule, and
that section 804 is not in effect until the Secretary makes the
certification required under section 804(l). The comment argues that
the proposed rule must be withdrawn because it was issued without an
effective statutory basis.
    (Response 71) In accordance with the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)), the proposed rule includes reference to the
legal authorities under which it was proposed. As noted by the comment,
the referenced legal authorities in the proposed rule include section
804 of the FD&C Act. At the proposed rule stage, the rule is proposed
to be issued under one or more legal authorities. The proposed rule
does not have legal effect at the time it is issued; therefore, the
cited legal authorities do not necessarily need to be in effect at that
time. The Secretary is making the required certification under section
804(l) concurrent with this final rule. Therefore, section 804 is in
effect as a legal authority for this final rule. Furthermore, the
certification requirement was included in section 804 so that the
section would not be implemented before a certification is made. We do
not believe that Congress intended for the provision to preclude the
issuance of a proposed rule proposing how the section could be
implemented in a manner that meets the basis for a certification, once
that certification is made. Moreover, under the comment's reasoning,
section 804(l) effectively repeals by implication the notice and
comment provision of the APA. The Court has consistently noted that
repeal by implication is disfavored. See Morton v. Mancari, 417 U.S.
535, 549-550 (1974).
    (Comment 72) One comment contends that the certification required
under section 804(l) of the FD&C Act is a rule within the meaning of
the APA and is not subject to any exception from notice and comment
requirements in that act. The comment argues that the notice and
comment requirements were not met because the public did not have
access to the information the Secretary relied on to make the
certification and, therefore, could not meaningfully comment on it. The
comment goes on to state that FDA should withdraw the proposed rule,
place in the public record any basis the Secretary has for
certification, and allow the public to comment.
    (Response 72) A rule, as defined in the APA, 5 U.S.C. 551(4), is
the whole or a part of an agency statement of general or particular
applicability and future effect designed to implement, interpret, or
prescribe law or policy or describing the organization, procedure, or
practice requirements of an agency and includes the approval or
prescription for the future of rates, wages, corporate or financial
structures or reorganizations thereof, prices, facilities, appliances,
services or

allowances therefor or of valuations, costs, or accounting, or
practices bearing on any of the foregoing. We do not agree that the
certification under section 804(l) of the FD&C Act is a rule that must
undergo notice and comment rulemaking in accordance with the APA. The
certification is a finding that functions as a procedural step that
does not itself affect the rights or interests of outside parties. Cf.
Batterton v. Marshall, 648 F.2d 694, 707-08 (D.C. Cir. 1980). In
accordance with section 804(l), the certification is made to Congress.
While the certification made by the Secretary leads to section 804(b)-
(h) becoming effective, the only consequence of making section 804(b)-
(h) effective is that, per section 804(b), the Agency can issue a
regulation that was subject to the very process requested by the
commenter (notice and comment rulemaking). Thus, the certification has
no independent effect on outside parties that warrants notice and
comment under section 553 of the APA. Moreover, because this rulemaking
constitutes the basis for the certification, the certification is
effectively undergoing notice and comment in the context of the
rulemaking, and any additional notice and comment process for the
certification would be duplicative. We also note that, even if the
certification were an agency action under the APA, it is more in the
nature of a declaratory order that clarifies FDA's position on the
matters presented in section 804. See 5 U.S.C. 554(e) (``the agency,
with like effect as in the case of other orders, and in its sound
discretion, may issue a declaratory order to terminate a controversy or
remove uncertainty''); Wilson v. A.H. Belo Corp., 87 F.3d 393, 397 (9th
Cir. 1996) (upholding a declaratory order that was issued sua sponte,
in the absence of any parties before the Agency); Time Warner Entm't
Co., L.P. v. FCC, 240 F.3d 1126, 1141 (2001) (an agency has ``very
broad discretion whether to proceed by way of adjudication or
rulemaking''). Finally, unlike other provisions of section 804, section
804(l) does not direct the Secretary to implement the provision by
issuing a regulation. The lack of such direction indicates that
Congress did not intend for the notice and comment requirements to
apply.
    In any case, we do not agree that the public did not have an
opportunity to meaningfully comment on the Secretary's certification.
As stated above, the public did have an opportunity to comment on the
certification in that it had an opportunity to comment on the rule,
which constitutes the basis for the certification. Section 804(l)
states that section 804 of the FD&C Act will become effective only if
the Secretary certifies to Congress that the implementation of this
section will pose no additional risk to the public's health and safety
and result in a significant reduction in the cost of covered products
to the American consumer. The Secretary is making this certification on
the basis of this final rule, which contains provisions and safeguards
to ensure that any SIP that is authorized by FDA will be consistent
with the certification. As stated in response to Comment 67,
implementation of section 804(b)-(h) through this rule will result in a
significant reduction in the cost of covered products to the American
consumer because it requires, among other things, that the SIP
Sponsor's importation plan explain, in a manner sufficiently detailed
to allow for a meaningful evaluation, how the Sponsor will ensure that
the SIP will result in a significant reduction in the cost to the
American consumer. Other provisions of this rule ensure that a SIP will
not pose an additional risk to the public's health and safety. The
Agency sought and received comments on the proposed rule and is issuing
this final rule after considering these comments. Because the
certification relies on this final rule, the public had an opportunity
to meaningfully comment on it.

G. FD&C Act Requirements

    (Comment 73) One comment says that the proposed rule would not
ensure that each prescription drug imported under section 804 complies
with sections 501, 502, and 505 of the FD&C Act, as is required by
section 804(c)(1) of FD&C Act. The comment says that as a result FDA
will be required to refuse admission to section 804 drugs under section
801(a). The comment says that a drug imported under this rule will be
unapproved because it will differ from the drug approved in the NDA and
ANDA. Manufacturing information, specifically information about the
relabeler and about the relabeling of a section 804 drug, will not be
in the NDA or ANDA of its FDA-approved counterpart, and there will be
certain differences set forth in the rule between the labeling of a
section 804 drug and the labeling in an FDA-approved NDA or ANDA. The
comment says that FDA should apply its procedures for drug approval to
each drug imported under section 804.
    The comment also says that drugs imported under this rule will be
misbranded because their labeling will falsely represent that they are
FDA-approved and because the labeling could lead a consumer to
mistakenly attribute the drug to the drug's manufacturer. Finally, the
comment says that the rule will increase the likelihood that
adulterated drugs will enter the U.S. market.
    (Response 73) We agree with the comment that for drugs imported
under section 804 there will not be ``an approval of an application''
under section 505(a) of the FD&C Act. Section 804 drugs will not
themselves be the subject of an approved NDA or ANDA. They will,
however, meet the requirement in section 804(c)(1) of the FD&C Act that
they ``compl[y] with section 505 (including with respect to being safe
and effective for the intended use of the prescription drug).''
Specifically, FDA interprets compliance with section 505 to mean that
the HPFB-approved drug meets the conditions in an FDA-approved NDA or
ANDA. Before a section 804 drug is imported pursuant to this rule, FDA
must make a determination, on the basis of the Statutory Testing and
information provided by the drug's manufacturer, that the drug meets
the conditions in an approved NDA or ANDA.
    The comment's alternative interpretation, requiring approval of an
application under section 505 of the FD&C Act for drugs imported under
section 804 of the FD&C Act, would render section 804 superfluous. If
an Importer sought and obtained FDA approval of a drug that was
previously only approved for sale in Canada, it would not need to
import the drug under section 804. Instead, it could simply import the
drug under section 801 of the FD&C Act without meeting any of the
additional safeguards imposed under section 804. Thus, it is reasonable
for FDA to interpret ``complies with section 505 (including with
respect to being safe and effective for the intended use of the
prescription drug)'' to mean that the HPFB-approved drug meets the
conditions in an FDA-approved NDA or ANDA, without itself having an
approved NDA or ANDA.
    Section 804 drugs generally will bear the labeling of their FDA-
approved counterparts, with certain exceptions set forth in this rule.
Specifically, the labeling of a section 804 drug may differ from the
approved labeling to the extent that it includes: (1) The section 804
drug's NDC number, which will help with supply chain management and
security, among other things, (2) the name of the Importer, which will
ensure that the persons responsible for the product can be identified,
(3) the labeling statement required by

Sec.  251.13(b)(4)(iv), which will help avoid confusion between
products with the same name, help pharmacists distinguish a section 804
product when selecting the product on the pharmacy shelf, and,
potentially, help with pharmacovigilance, and (4) the SIP's website
address, which will also help avoid confusion by educating pharmacists,
healthcare providers, pharmacy benefit managers, health insurance
issuers and plans, as appropriate, and patients.
    We disagree with the comment's assertion that section 804 drugs
will be misbranded under section 502 of the FD&C Act because they are
not FDA-approved. Section 804(h) of the FD&C Act requires that the
manufacturer of a section 804 drug authorize the Importer to use the
approved labeling for the drug, while section 804(c)(3) provides that
the regulations implementing section 804 must require that safeguards
be in place to ensure that section 804 drugs comply with section 502,
among other provisions. Section 804 would not require that Importers be
authorized to use the approved labeling if doing so would make section
804 drugs misbranded and so not comply with section 502. In addition,
the labeling will not mislead consumers about the manufacturer's role
in the importation of a section 804 drug because of the labeling
statement required by Sec.  251.13(b)(4)(iv), which will make clear
that the drug was imported under a SIP without the manufacturer's
authorization. Likewise, there is not an increased likelihood that
section 804 drugs will be adulterated in violation of section 501 of
the FD&C Act, because of the supply chain security, Statutory Testing,
and other protections in section 804 and this rule. For these reasons,
we disagree with the comment that FDA will be required to refuse
admission to section 804 drugs under section 801(a)(3) of the FD&C Act,
which provides that articles shall be refused admission if, among other
things, they are ``adulterated, misbranded, or in violation of section
505.''

H. First Amendment

    (Comment 74) One comment asserted that the proposed rule, if
finalized, would violate the First Amendment on two grounds: (1) The
manufacturer's attestation and information statement and Statutory
Testing requirements amount to compelled speech and a compelled subsidy
and (2) compelled authorization to use the labeling amounts to
compelled speech and a compelled subsidy. The comment asserts that,
because the speech at issue does not propose any commercial
transaction, strict scrutiny applies and the rule would fail under that
standard. The comment also asserts that the proposed rule would fail to
pass muster under the four-part Central Hudson test applied to
government regulation of commercial speech.
    (Response 74) We disagree with the comment's premise that these
provisions should be understood as speech regulations that implicate
the First Amendment. ``[I]t has never been deemed an abridgment of
freedom of speech . . . to make a course of conduct illegal merely
because the conduct was in part initiated, evidenced, or carried out by
means of language, either spoken, written, or printed.'' Rumsfeld v.
Forum for Academic and Institutional Rights, Inc., 547 U.S. 47, 62
(2006) (citation omitted); see also Nicopure Labs, LLC v. FDA, 944 F.3d
267, 291 (D.C. Cir. 2019) (A ``kernel of expression . . . is not
sufficient to bring the activity within the protection of the First
Amendment.'') (quoting City of Dallas v. Stanglin, 490 U.S. 19, 25
(1989)). The final rule requires manufacturers to engage in the
authentication and quality assurance process for drugs imported under a
SIP. Manufacturers can participate directly, by conducting the
Statutory Testing themselves, or they can facilitate the process by
providing the necessary testing information to the Importer.
Manufacturers must also provide the attestation and information
statement and the executed batch records required by Sec.
251.5(c)(4)(xii), to establish that a section 804 drug meets the
conditions in the FDA-approved NDA or ANDA, including any process-
related or other requirements for which compliance cannot be
established through laboratory testing. Participating in and
facilitating authentication and quality assurance are not fundamentally
expressive activities, even though there is necessarily information
exchanged. Similarly, authorizing the use of FDA-approved labeling
neither restricts a manufacturer's speech nor compels it to express
ideas with which it disagrees.
    A market regulation that ``applies to conduct and is imposed `for
reasons unrelated to the communication of ideas''' does not implicate
the First Amendment and is subject to rational-basis review. Nicopure
Labs, 944 F.3d 267 at 291-92 (quoting Lorillard Tobacco Co. v. Reilly,
533 U.S. 525, 569 (2001)). As described earlier, these provisions
easily survive rational-basis review because they are needed to ensure
that drugs imported under a SIP comply with sections 501, 502, and 505
of the FD&C Act, as required by section 804, in addition to other
provisions, such as section 804(e) of the FD&C Act. The testing
results, attestation and information statement, and executed batch
records are needed to ensure that the drugs are authentic, not
degraded, and are in compliance with established specifications and
standards, and to confirm compliance with any process-related or other
requirements that cannot be established through laboratory testing (84
FR 70796 at 70817-70818). The FDA-approved labeling is necessary to
ensure that prescribers, pharmacists, and patients have the information
they need to prescribe, dispense, and use the drugs appropriately.
Without these provisions, it would not be possible to ensure that drugs
imported under section 804 meet U.S. legal and regulatory requirements
and thus pose no additional risk to the public's health and safety.
    Moreover, compelled-speech cases that are subject to review under
the First Amendment typically involve a requirement that a speaker
``must personally speak the government's message'' or ``host or
accommodate another speaker's message.'' Rumsfeld, 547 U.S. at 63. The
fundamental First Amendment concern in such cases is that the
government will compel the speaker ``to voice ideas with which [it]
disagree[s].'' Janus v. AFSCME, Council 31, 138 S. Ct. 2448, 2464
(2018). That is not the case here, where there is no message being
compelled. Manufacturers are simply being called upon to help with the
process of product authentication, quality control, and product
identification.
    For example, the comment asserts that the regulatory program as set
out in the proposed rule--requiring the manufacturer to make available
its product labeling, to provide an attestation and information
statement and executed batch records, and to either conduct testing or
disclose testing information--would amount to a significant economic
subsidy from the manufacturer to the importer. The comment claims,
citing Janus v. AFSCME, Council 31, that this economic subsidy is
impermissible under the First Amendment unless the government can show
that the compelled subsidy serves a compelling state interest that
cannot be achieved through means significantly less restrictive of
associational freedoms. This caselaw, however, is inapposite. First, as
the comment admits, under this rule, there is no direct monetary
payment from the manufacturer to the importer. Moreover, the Court in
Janus found that the subsidies at issue meant that individuals were
``coerced into betraying their convictions'' by ``endors[ing] ideas
they find

objectionable.'' 138 S. Ct. at 2464. See also United States v. United
Foods, 533 U.S. 405, 410-411 (2001) (finding First Amendment implicated
where producers were required to ``subsidize speech with which they
disagree.'') (emphasis added). By contrast, here, the manufacturer is
not compelled to itself convey any ideas or subsidize the conveyance of
ideas by others.
    While the requirement that a drug's manufacturer authorize an
Importer to use the drug's FDA-approved labeling does not equate to a
requirement that the manufacturer convey or subsidize the conveyance of
an idea, the comment argues that consumers could mistakenly conclude
from the inclusion of a manufacturer's name and trademarks on the
labeling that, among other things, the manufacturer vouches for the
safety, efficacy, and quality of its drug when imported by a SIP. The
comment also argues that consumers could mistakenly assume that a
manufacturer authorized the importation of its drug by the SIP. The
comment contends that such mistakes could occur despite the labeling
statement required by proposed Sec.  251.13(b)(6)(i): ``This drug was
imported from Canada under the [Name of State or Other Governmental
Entity and of Its Co-Sponsors, If Any] Section 804 Importation Program
to reduce its cost to the American consumer.'' To address the concern
that the use of the FDA-approved labeling might create the misleading
impression that the manufacturer is conveying or subsidizing the
conveyance of ideas through the labeling of a section 804 drug, we have
revised Sec.  251.13(b)(4)(iv) to require the following disclosure:
``[This drug was/These drugs were] imported from Canada without the
authorization of [Name of Applicant] under the [Name of SIP Sponsor]
Section 804 Importation Program.'' As explained earlier, we have
determined that it is not necessary to require the addition of the
manufacturer's name and place of business if they do not already appear
on the FDA-approved labeling. We have also determined that it is not
necessary to include the phrase ``to reduce its costs to the American
consumer'' in the labeling statement.
    Even if the First Amendment were implicated, any minimal burdens on
speech are more than adequately justified by the purposes served by
this program. The comment appears to suggest that, because this program
does not regulate communications in the realm of commercial marketing,
neither Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985)
nor Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557
(1980) apply, and instead the requirements of this program should be
analyzed under strict scrutiny. We disagree. The Supreme Court has
applied strict scrutiny in First Amendment cases involving compelled
speech on matters of conscience, and it ``trivializes the freedom
protected'' by those cases to assert that incidental burdens on speech
are subject to the same protections. Rumsfeld, 547 U.S. at 62.
    Accordingly, to the extent a court were to analyze this program
under the First Amendment, it would likely apply, instead of strict
scrutiny, the test for compelled speech established by Zauderer or one
of the other more relaxed frameworks under which courts compare the
burden on speech to the asserted government interest. See S.F. Arts &
Athletics, Inc. v. USOC, 483 U.S. 522, 537 n.16 (1987). Under the
framework set out in Zauderer and its progeny, which describe the test
generally applied to required disclosures of factual and
uncontroversial information related to commercial marketing, the
Government may require disclosures that are justified by a governmental
interest and do not unduly burden protected speech. The provisions at
issue here--attesting that a product meets the conditions in its
approved NDA or ANDA and supplying related information, supplying
testing protocols and executed batch records, and authorizing the use
of labeling--all relate to the conveyance of factual and
uncontroversial information. The government interest is clear.
Prescription drug spending in the United States has increased
dramatically in recent years and is projected to account for an
increasing share of the country's health care spending. This program is
designed to address that problem by allowing for the importation of
lower cost prescription drugs from Canada into the United States. And
there is no burden on protected speech--nothing in any of these
provisions limits manufacturers' ability to speak freely about their
products.
    The comment asserts that the regulations would compel the
manufacturer to provide a false or misleading attestation. We disagree.
The rule does not require a manufacturer to attest to anything that the
manufacturer does not know or cannot attest to truthfully. If, for
example, the drug that the manufacturer manufactures for sale in Canada
does not meet the conditions in the FDA-approved NDA or ANDA, a
manufacturer could not and should not attest that ``but for the fact
that [a drug] bears the HPFB-labeling,'' the drug ``meets the
conditions in the FDA-approved NDA or ANDA.'' This is clarified in the
final rule in Sec.  251.5(d), which states that if the manufacturer
cannot provide the attestation and information statement, it must
notify FDA and the Importer of its inability and articulate with
specificity the reason or reasons for it. In addition, a manufacturer's
attestation and information statement would be as of the date that the
drug in question left the manufacturer's control. A manufacturer could
not and should not attest, for example, that the Foreign Seller held
the manufacturer's drug in compliance with CGMP.
    The program also would be constitutional if reviewed under
intermediate scrutiny. Under the test for restrictions on commercial
speech articulated in Central Hudson, agencies can regulate commercial
speech where the regulation directly advances a substantial Government
interest and is not more extensive than necessary to serve that
interest. Central Hudson does not require that the means chosen by the
Government be the least restrictive means available for addressing an
issue, see Boards of Trustees. v. Fox, 492 U.S. 469, 480 (1989), but
the Supreme Court has in any event observed that required factual
disclosures are less intrusive from a First Amendment perspective than
are restrictions on speech. Zauderer, 471 U.S. at 651. Because the
Government's interest in the goals of this program is substantial and
the regulation is no more extensive than necessary to directly advance
that interest, the rule withstands review under Central Hudson. The
increasing cost of prescription drugs is causing hardship to American
consumers (84 FR 70796 at 70798-70801). The regulation would directly
address this by providing for the importation of lower cost
prescription drugs from Canada to significantly reduce the cost of
covered products to the American consumer, while posing no additional
risk to the public's health and safety. The information that the
manufacturer is required to supply is no more extensive than necessary
to ensure that section 804 drugs are authentic, not degraded, and meet
the conditions in an FDA-approved NDA or ANDA, all of which serves to
ensure that the drugs are safe and effective. Likewise, the FDA-
approved labeling is necessary to ensure that prescribers, pharmacists,
and patients have the information they need to prescribe, dispense, and
use the drugs appropriately. As noted earlier, the required labeling
statement will help avoid potential confusion between

products with the same name and help pharmacists distinguish a section
804 product when selecting the product on the pharmacy shelf (84 FR
70796 at 70819). The labeling statement may also aid in
pharmacovigilance (84 FR 70709 at 70820). Finally, the addition of the
explanation that the drug was imported from Canada without the
manufacturer's authorization will prevent prescribers, pharmacists, or
patients from mistakenly concluding that the manufacturer is conveying
an idea or subsidizing the conveyance of an idea.

I. Fifth Amendment Takings

    (Comment 75) Some comments say that certain provisions in section
804 and this rule would take manufacturers' private property for public
use, entitling manufacturers to just compensation under the Fifth
Amendment of the U.S. Constitution. The comments contend that the
information that manufacturers would be required to disclose to
Importers and qualifying laboratories, including information to be used
to conduct the Statutory Testing, could include confidential commercial
information and trade secrets in which manufacturers have a
constitutionally cognizable property interest. Comments also contend
that the provisions of section 804 of the FD&C Act and this rule that
require manufacturers to authorize Importers to use the FDA-approved
labeling for drugs imported under this rule would effect an
unconstitutional taking if the labeling included trademarks such as
brand names, company names, logos, and the trade dress reflected in the
overall packaging design.
    One comment says that because the statute explicitly provides in
section 804(h) that manufacturers must provide authorization to use the
labeling at no cost, but does not include similar language elsewhere,
section 804 of the FD&C Act must be interpreted to permit manufacturers
to charge Importers for information (such as the attestation and
information statement, the executed batch records, and the Statutory
Testing information) or services (such as conducting Statutory Testing)
that section 804 and this rule require them to provide. The comment
says that this interpretation is necessary to avoid a Fifth Amendment
Takings Clause issue.
    (Response 75) ``The focus of the regulatory takings analysis is on
fundamental fairness--is it fair for the government to impose the cost
of a regulation on private parties rather than on the public as a whole
through public spending?'' (Cienega Gardens v. United States, 503 F.3d
1266, 1278 (Fed. Cir. 2007) (citing Palazzolo v. Rhode Island, 533 U.S.
606, 618 (2001); Penn Central Transp. Co. v. New York City, 438 U.S.
104, 123 (1978)). ``[T]he touchstone of the economic impact question is
proportionality: the size of a liability only weighs in favor of
finding a taking insofar as it is out of proportion to the legitimate
obligations society may impose on individual entities.'' (B&G Constr.
Co. v. Dir., OWCP, 662 F.3d 233, 260 (3d Cir. 2011) (citation and
internal quotations omitted)). Indeed, courts have rejected regulatory
takings claims even where the government's actions ``impose
considerable costs on private actors in the regulated industry.''
(Mobile Relay Assocs. v. FCC, 457 F.3d 1, 12 (D.C. Cir. 2006)). In
addition, as a general rule, the government is not required to pay for
the incidental effects of its laws and regulations. (See Penn Central,
438 U.S. at 124. ``Government hardly could go on if to some extent
values incident to property could not be diminished without paying for
every such change in the general law.'' (Pennsylvania Coal Co. v.
Mahon, 260 U.S. 393, 413 (1922)).
    In this case, the pharmaceutical industry operating in the United
States has benefitted from Federal laws and regulations that allow
manufacturers to recoup the costs of pharmaceutical research and
development and to be rewarded for their investments in it. As
explained in the preamble to the proposed rule, however, the increasing
cost of prescription drugs is placing a heavy burden on American
consumers (84 FR 70796 at 70798-70801). That Congress chose to place an
incidental burden on the pharmaceutical industry to reduce the cost of
prescription drugs does not offend any principle of fundamental
fairness.
    The Supreme Court has explained that a takings analysis involves
``essentially [an] ad hoc, factual inquir[y].'' (See Penn Central, 438
U.S. at 124). A threshold step in that analysis is determining whether
the claimant possesses a property interest protected by the Taking
Clause. (Ruckelshaus v. Monsanto, 467 U.S. 986, 1000 (1984)). The
comments assert that manufacturers have property interests in trade
secrets and trademarks. The Supreme Court found in Ruckelshaus v.
Monsanto (467 U.S. at 1003-04) that in certain circumstances there can
be a property interest in trade secrets for purposes of the Fifth
Amendment's Takings Clause (``the property right [in a trade secret] is
defined by the extent to which the owner of the secret protects his
interest from disclosure to others''). We will assume for purposes of
this discussion that some of the information that manufacturers are
required to disclose under section 804 and this rule would meet the
relevant state law definition of a trade secret. The comments did not
cite, and we have not found, a case in which a court has held that a
manufacturer has a cognizable property interest in a trademark for
purposes of the Fifth Amendment Takings Clause, and courts have found
that other forms of intellectual property, namely copyrights and
patents, do not create cognizable property interests for Takings Clause
purposes (Univ. of Hous. Sys. v. Jim Olive Photography, 580 SW3d 360,
377 (Tex. App. 2019); Christy, Inc. v. U.S., 141 Fed. Cl. 641, 660
(2019). The question arises whether trademarks are more akin to trade
secrets or to copyrights and patents for Fifth Amendment Takings Clause
purposes. We find it unnecessary to answer this question here because,
even if trademarks were private property protected under the Takings
Clause, there has been no taking.
    The Supreme Court has held that two categories of regulatory action
are generally per se takings: (1) When the government ``requires an
owner to suffer a permanent physical invasion of her property;'' and
(2) when regulations ``completely deprive an owner of `all economically
beneficial us[e]' of her property'' (Lingle v. Chevron U.S.A. Inc., 544
U.S. 528, 538 (2005) (quoting Lucas v. S.C. Coastal Council, 505 U.S.
1003, 1019 (1992)). Neither of those circumstances is present here.
    In other circumstances, the Supreme Court has held that ``when a
regulation impedes the use of property without depriving the owner of
all economically beneficial use, a taking still may be found based on
`a complex of factors,' including: (1) The economic impact of the
regulation on the claimant; (2) the extent to which the regulation has
interfered with distinct investment-backed expectations; and (3) the
character of the governmental action'' (Murr v. Wisconsin, 137 S. Ct.
1933, 1943 (2017) (citing Palazzolo v. Rhode Island, 533 U.S. at 617)
(citing Penn Central, 438 U.S. at 124)). The force of any one of these
three Penn Central factors may be ``so overwhelming . . . that it
disposes of the taking question'' (Ruckelshaus, 467 U.S. at 1005).
1. Provision of Trade Secrets and Confidential Commercial Information
    With regard to the first Penn Central factor, the economic impact
of section 804 of the FD&C Act and this regulation on manufacturers, we
note that the government action here is limited. The Supreme Court has
explained that ``where an owner possesses a full `bundle' of property
rights, the

destruction of one `strand' of the bundle is not a taking because the
aggregate must be viewed in its entirety'' (Andrus v. Allard, 444 U.S.
51, 65-66 (1979)). (See also Village of Euclid v. Ambler Realty Co.,
272 U.S. 365, 384 (1926) (75 percent diminution in value insufficient
to prove taking); Hadacheck v. Sebastian, 239 U.S. 394, 405 (1915)
(92.5 percent diminution insufficient to prove taking)). Because
manufacturers will retain the right to exclude everyone except
Importers and qualifying laboratories from the use of their trade
secrets and commercial or financial information that is privileged or
confidential, their trade secrets and commercial or financial
information that is privileged or confidential will retain significant
value. An Importer or qualifying laboratory's use of a manufacturer's
trade secrets or commercial or financial information that is privileged
or confidential will be limited to conducting the Statutory Testing and
establishing that an eligible prescription drug meets the requirements
of the FD&C Act and the rule. Consistent with section 804 of the FD&C
Act, the rule mandates that the trade secrets and commercial or
financial information that is privileged or confidential that the
manufacturer provides be used only for purposes of testing or otherwise
complying with the FD&C Act and the rule. Moreover, the government
action here may be further constrained by the fact that there will be a
limited number of SIPs working with a limited number of Importers and
qualifying laboratories, and by the fact that the SIPs will be time-
limited.
    The economic impact of the rule will also be constrained by the
fact that manufacturers will retain their right to protect their trade
secrets against disclosure (Pharm. Care Mgmt. Ass'n v. Rowe, 307 F.
Supp. 2d 164, 179 (D. Me. 2004) (holding that a ``statute's protection
from further disclosure inoculates it from constitutional infirmity'').
As required by section 804(e)(2) of the FD&C Act, the final rule
mandates in Sec.  251.16(g) that the Importer keep any information that
the manufacturer provides to authenticate a prescription drug being
tested and confirm that the labeling of the prescription drug complies
with labeling requirements under the FD&C Act in strict confidence. The
final rule also requires that any trade secrets or commercial or
financial information that is privileged or confidential that the
manufacturer supplies for the purposes of testing or otherwise
complying with the FD&C Act be kept in strict confidence. Moreover,
manufacturers have the option of conducting the Statutory Testing
themselves, which would obviate the need to disclose the Statutory
Testing information to the Importer. While the manufacturer would still
need to disclose the Statutory Testing information and results to FDA,
FDA would ensure that any trade secrets or confidential commercial
information remain confidential consistent with the law (Full Value
Advisors, LLC v. Securities & Exchange Comm., 633 F.3d 1101, 1110 (D.C.
Cir. 2011) (finding that disclosure to the Securities & Exchange
Commission produced no economic harm because the Commission ensured
that the information remained confidential).
    Turning to the second Penn Central factor--interference with
distinct investment-backed expectations--regulated industry has been on
notice since at least October 28, 2000, when the predecessor to the
current section 804 of the FD&C Act was signed into law as part of the
Medicine Equity and Drug Safety (MEDS) Act of 2000, that they could be
required to disclose information needed for safe importation. Thus,
sponsors of NDAs or ANDAs submitted after that date could not have a
reasonable investment-backed expectation that is inconsistent with
section 804. While a comment points to the fact that prior HHS
Secretaries did not make the section 804(l) certification to Congress,
it would not be reasonable for manufacturers to expect that such a
certification could never be made, especially given the widely-known
developments described in the preamble to the proposed rule, including
the continued rise of prescription drug prices which has raised
concerns among policymakers, healthcare professionals, and American
consumers (84 FR 70796 at 70798-70801). With regard to drugs the
applications for which were submitted before October 28, 2000, it still
would not have been reasonable for manufacturers to expect that a
provision like section 804 would not be enacted. Courts have held that
those who do business in highly regulated fields are on notice that
changes are possible (Maine Educ. Ass'n Benefits Trust v. Cioppa, 695
F.3d 145, 154 (1st Cir. 2012) (finding that ``[g]iven the historically
heavy and continuous regulation of insurance in Maine, the [Plaintiff],
in choosing how and where to allocate its resources, ought to at least
be aware of the heightened possibility that new insurance regulations
might hinder the use or value of its loss information'' (internal
citations omitted)); Connolly v. Pension Ben. Guar. Corp., 475 U.S.
211, 226-227 (1986)). The prescription drug industry is such a highly
regulated field (New York v. Actavis PLC, 787 F.3d 638, 643 (2d Cir.
2015) (describing the pharmaceutical industry as ``complex and highly-
regulated'').
    One comment contends that the protections against disclosure of
certain information in the Federal Trade Secrets Act at 18 U.S.C. 1905,
in sections 301(j) and 505(l) of the FD&C Act, and in FDA's regulations
at 21 CFR 20.61 and 314.430 support manufacturers' expectation that
they would not have to supply the information specified in section 804
and this rule. In Ruckelshaus v. Monsanto, the Supreme Court held that
an explicit guarantee of exclusive use created a reasonable investment-
backed expectation that EPA would not consider the data when evaluating
the application of a subsequent applicant (Ruckelshaus, 467 U.S. at
1011). None of the provisions that the comment cites creates an
explicit or implicit guarantee that section 804 would not be
implemented or that regulations would not be issued requiring
manufacturers to provide testing and other information to Importers. We
note that we have determined that it is not necessary for FDA to
provide Statutory Testing information to Importers, and so we are not
finalizing proposed Sec.  251.16(i), which would have provided that
``FDA may transmit information that the manufacturer is required to
provide to an Importer under this section on the manufacturer's behalf
if the manufacturer has not transmitted such information to the
Importer in a timely fashion and if such information is available to
FDA in the NDA or ANDA.'' Manufacturers that choose not to conduct the
Statutory Testing are required to provide the Statutory Testing
information covered by Sec.  251.16(i) to Importers themselves.
    The Supreme Court has described the final Penn Central factor, the
``character of the governmental action,'' as a way to assess whether
the challenged action ``amounts to a physical invasion or instead
merely affects property interests through `some public program
adjusting the benefits and burdens of economic life to promote the
common good' '' (Lingle, 544 U.S. at 539 (quoting Penn Central, 438
U.S. at 124)). Here, section 804 of the FD&C Act and the rule do not
amount to a physical invasion and they have a legitimate public
purpose, to significantly reduce the cost of covered products to the
American consumer without any additional risk to the public's health
and safety. As noted earlier, the increasing cost of

prescription drugs is placing a heavy burden on American consumers. To
promote the common good, section 804 and the rule would require
manufacturers of certain drugs--those imported under SIPs--to provide
limited information to Importers or qualified laboratories under
limited circumstances. For these reasons, the third factor of the
takings analysis, like the first two factors, compels the conclusion
that neither section 804 nor this rule amounts to a regulatory taking
of manufacturers' property that requires compensation under the Fifth
Amendment.
    We do not agree that section 804 of the FD&C Act is best
interpreted to permit manufacturers to charge Importers for information
(such as the attestation and information statement, the executed batch
records, and the Statutory Testing information) or services (such as
conducting Statutory Testing) that section 804 and this rule require
them to provide. Section 804(h) explicitly requires manufacturers to
authorize Importers to use a drug's approved labeling at no cost. This
does not mean that manufacturers can charge for information or services
that they are required to provide. If manufacturers were permitted to
charge it would directly undermine section 804's cost-reducing goal.
Moreover, interpreting section 804 to permit manufacturers to charge
Importers is not necessary to avoid a Fifth Amendment Takings Clause
issue because, as explained earlier, neither section 804 nor this rule
effects a taking under the Fifth Amendment.
2. Authorization To Use FDA-Approved Labeling
    With regard to the first Penn Central factor, the requirement in
section 804 of the FD&C Act and this regulation that a manufacturer
authorize an Importer to use the FDA-approved labeling for an eligible
prescription drug is likely to have little to no impact on the value of
the manufacturer's trademarks. Trademarks do not have inherent value
(Marshak v. Green, 746 F.2d 927, 929 (2d Cir. 1984)). Their only value
is in the goodwill with which they are associated. Under this rule,
there will be little or no diminution in the goodwill associated with
manufacturers' trademarks because section 804 drugs will meet the
conditions of the relevant FDA-approved NDA or ANDA. In addition, as
discussed earlier, the labeling statement will make it clear that the
section 804 drug was imported without the manufacturer's authorization.
Turning to the second Penn Central factor, a manufacturer could not
have a reasonable investment-backed expectation that it would not have
to authorize an Importer to use its labeling. Such an expectation would
be inconsistent with the current version of section 804. With regard to
drugs developed before December 8, 2003, it still would not have been
reasonable for manufacturers to expect that a provision like section
804(h) requiring that the manufacturer of a section 804 drug authorize
the use of the FDA-approved labeling would not be enacted. Finally, as
explained earlier, the third Penn Central factor also weighs against a
finding that section 804 and this rule effect a regulatory taking,
because significantly reducing the cost of covered products to the
American consumer without any additional risk to the public's health
and safety ``promote[s] the common good'' (Lingle, 544 U.S. at 539
(quoting Penn Central, 438 U.S. at 124)).
    (Comment 76) One comment says that section 804 of the FD&C Act and
this rule violate provisions of the World Trade Organization's
Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS. Specifically, the comment says that section 804 and this rule
violate Article 39 of the TRIPS Agreement by requiring manufacturers to
disclose trade secrets and confidential commercial information and
Article 21 of the TRIPS Agreement by requiring manufacturers to
authorize the use of labeling that could include trademarks.
    (Response 76) We disagree that section 804 of the FD&C Act and this
rule violate the TRIPS Agreement. As a general matter, we note that the
United States is in full compliance with its international obligations
under the TRIPS Agreement. Article 39 of TRIPS provides that member
countries ``shall protect undisclosed information in accordance with
paragraph 2 and data submitted to governments or governmental agencies
in accordance with paragraph 3.'' Under section 804 and this rule,
Importers and qualified laboratories obtain information from
manufacturers under the authority of a statute and implementing
regulation. The final rule provides in Sec.  251.16(g), that
information supplied by the manufacturer to authenticate the
prescription drug being tested and confirm that the labeling of the
prescription drug complies with labeling requirements under the FD&C
Act, and any trade secrets or commercial or financial information that
is privileged or confidential that the manufacturer supplies for the
purposes of testing or otherwise complying with the FD&C Act and this
rule, must be kept in strict confidence and used only for the purposes
of testing or otherwise complying with the FD&C Act and this rule.
    With regard to data submitted to governments or governmental
agencies, as discussed earlier, we have determined that it is not
necessary for FDA to provide Statutory Testing information to
Importers, and so we are not finalizing Sec.  251.16(i) from the
proposed rule, which would have provided that FDA may transmit
information that the manufacturer is required to provide to an Importer
under this section on the manufacturer's behalf if the manufacturer has
not transmitted such information to the Importer in a timely fashion
and if such information is available to FDA in the NDA or ANDA.
    We also disagree that section 804 of the FD&C Act and this rule
violate Article 21 of TRIPS, which states that ``compulsory licensing
of trademarks shall not be permitted.'' The requirement that a
manufacturer of a prescription drug authorize an Importer to use the
drug's FDA-approved labeling does not constitute compulsory licensing
of trademarks. This is at least because the labeling is only used
referentially and does not associate the trademark with the Importer.
As noted above, the United States is in full compliance with its
international obligations under the TRIPS Agreement.

J. Disclosure

    (Comment 77) A comment says that FDA's determination that a drug is
an eligible prescription drug that can be imported by a SIP discloses
trade secrets and confidential commercial information about that drug.
When FDA determines that a drug can be imported, FDA has determined
that, but for the fact that the drug bears the HPFB-approved labeling
when marketed in Canada, it meets the conditions in an FDA-approved NDA
or ANDA. The comment says that the information upon which FDA's
determination is based--whether a drug manufactured for sale in Canada
meets the conditions in an FDA-approved NDA or ANDA--is confidential.
Another comment says that FDA should specify that when a manufacturer
notifies an Importer that it cannot or will not make the Sec.
251.5(c)(4)(xii) attestation, because its drug does not meet the
conditions in an FDA-approved NDA or ANDA or for some other reason,
that is confidential information that the Importer should not be able
to disseminate or use.
    (Response 77) Section 804 of the FD&C Act directs the Secretary to
issue regulations permitting pharmacists and

wholesalers to import from Canada drugs that, among other requirements,
comply with section 505 of the FD&C Act. FDA interprets compliance with
section 505 to mean that the HPFB-approved drug meets the conditions in
an FDA-approved NDA or ANDA. Through its labeling requirements, the
statute also directs that FDA's determination that a Canadian drug
complies with section 505 will be publicly available information, as
reflected, for example, in product labeling.
    The final rule clarifies in Sec.  251.5(d) that if a manufacturer
cannot provide the attestation and information statement, the
manufacturer must notify FDA and the Importer and articulate with
specificity the reason or reasons why it cannot provide the attestation
and information statement. The final rule also requires, in Sec.
251.16(g), that importers keep any trade secrets or commercial or
financial information that is privileged or confidential, that the
manufacturer supplies for the purposes of testing or otherwise
complying with the Federal Food, Drug, and Cosmetic Act and this part,
in strict confidence. We note that manufacturers can choose to mark any
trade secrets or commercial or financial information that is privileged
or confidential that is contained in any of the information that they
are required to provide.
    We do not believe that the fact that the manufacturer cannot or
will not provide the attestation and information statement is likely to
be a trade secret or commercial or financial information that is
privileged or confidential. The reasons that the manufacturer gives for
not providing the attestation and information statement, by contrast,
may be trade secrets or commercial or financial information that is
privileged or confidential, which would mean that the Importer would be
legally obligated to keep them in ``strict confidence'' under Sec.
251.16(g).

K. FDA Authority

    (Comment 78) A comment states that FDA lacks the authority under
section 804 to issue certain provisions regarding manufacturers'
information and manufacturers' participation in the importation of
their drugs by SIPs. The comment states that FDA cannot provide the
Importer with the information contained in an approved NDA or ANDA as
is provided for by proposed Sec.  251.16(i). The comment also states
that FDA cannot require the manufacturer to supply ``testing
methodologies and protocols that the manufacturer has developed'' as
FDA proposed in Sec.  251.16(b). The comment states that FDA lacks the
authority to issue Sec.  251.5(c)(4)(xii), which requires manufacturers
to provide an attestation and information statement that establishes
that the drug proposed for import, but for the fact that it bears the
HPFB-approved labeling, meets the conditions in the FDA-approved NDA or
ANDA. The comment also states that, with regard to Sec.  251.13(a), FDA
lacks the authority to deem the manufacturer to have provided
authorization to use the FDA-approved labeling for the manufacturer's
drug, if the manufacturer does not provide written authorization to the
Importer in a timely fashion. Finally, the comment asks FDA to clarify
that section 804(e) of the FD&C Act, which, the comment states, relates
to testing, not supply chain information, does not give FDA the
authority to issue proposed Sec.  251.14, which requires a manufacturer
to provide an Importer with transaction information.
    (Response 78) We have determined that it is not necessary to
include proposed Sec.  251.16(i) in the final rule. That provision
stated that FDA may transmit information that the manufacturer is
required to provide to an Importer under this section on the
manufacturer's behalf if the manufacturer has not transmitted such
information to the Importer in a timely fashion and if such information
is available to FDA in the NDA or ANDA. Manufacturers are required to
provide the Statutory Testing information covered by Sec.  251.16(i)
themselves. If they fail to do so, they will have committed a
prohibited act under section 301(aa) of the FD&C Act. In addition, as
discussed earlier, violations of section 804(e) of the FD&C Act are
subject to a penalty under section 303(b)(6) of the FD&C Act.
    It is necessary, however, and within FDA's authority under section
804 of the FD&C Act, to issue Sec. Sec.  251.16(b) and (d), which
require that the manufacturer provide the Importer with the information
that the Importer needs to conduct the Statutory Testing. Section
804(b) requires that the Secretary issue regulations permitting the
importation of certain drugs under section 804. Section 804(e)
specifies that these regulations shall require the manufacturer to
provide the Importer with the ``information needed to authenticate the
prescription drug being tested.'' Sections 804(d)(1)(J)(i)(III) and
804(d)(1)(L) specify that the regulations shall require the Importer to
submit to FDA documentation demonstrating that section 804 drugs were
tested ``for authenticity and degradation'' and that the Importer
submit to FDA laboratory records including complete data derived from
all tests necessary to ensure that the prescription drug is in
compliance with established specifications and standards. While
sections 804(d)(1)(J)(i)(III) and 804(d)(1)(L) do not state that the
regulations must require manufacturers to provide the information
needed to conduct these tests, FDA has the authority to require this
under section 804(c)(1), which directs the Secretary to issue
regulations that require that safeguards be in place to ensure that
section 804 drugs comply with section 501, 502, and 505 of the FD&C
Act, and under section 804(c)(3), which directs the Secretary to issue
regulations that contain any additional provisions determined by the
Secretary to be a means to facilitate the importation of prescription
drugs.
    With regard to the manufacturer's attestation and information
statement described in Sec.  251.5(c)(4)(xii), section 804(c)(1) of the
FD&C Act specifies that the regulations must require that safeguards be
in place to ensure that each drug imported under the regulations
complies with the FD&C Act, including sections 501, 502 and 505. It
would not be possible to ensure that each drug imported under the
regulations complies with sections 501, 502, and 505, as required by
section 804(c)(1), without the information from the manufacturer that
is captured in the attestation and information statement. For example,
only the manufacturer knows whether a drug that was originally intended
for the Canadian market was manufactured ``in conformity with current
good manufacturing practice,'' as required by section 501. The comment
notes that another provision, section 804(d)(1)(K), does not state that
the regulations must require the manufacturer to provide the Importer
with the information captured in the attestation and information
statement. Under section 804(d)(1)(K), the regulations under section
804(b) must require the Importer to submit to FDA a certification from
the Importer or the manufacturer that the imported drugs are approved
for marketing in the United States and are not adulterated or
misbranded, and that they meet all the labeling requirements under the
FD&C Act. If the Importer provides the section 804(d)(1)(K)
certification, the Importer will need information from the
manufacturer, including information about how the drug was
manufactured. While section 804(d)(1)(K) does not expressly mandate
that the Secretary require the manufacturer to provide the Importer
with the information it needs for certification, it is implied because
the Importer could not make the

certification without certain information from the manufacturer. In any
case, the Secretary clearly has the authority to do so under section
804(c)(1) and under section 804(c)(3), which authorizes the Secretary
to include regulatory provisions that the Secretary determines to be
appropriate as a safeguard to protect the public health or as a means
to facilitate importation of prescription drugs.
    With regard to Sec.  251.13(a), the comment contends that FDA would
need express statutory authority to deem the manufacturer to have
provided authorization to use the FDA-approved labeling for the
manufacturer's drug, if the manufacturer does not provide such
authorization in a timely fashion. We disagree. While section 804(h) of
the FD&C Act, which requires manufacturers to authorize Importers to
use their drugs' FDA-approved labeling, does not expressly state that
FDA can deem manufacturers to have given their authorization if they
fail to do so in a timeframe that FDA determines is reasonable under
the circumstances, other provisions of section 804 give FDA the
necessary authority. Section 804(c)(1) specifies that the regulations
that the Secretary issues must require that safeguards be in place to
ensure that each drug imported under the regulations complies with the
FD&C Act and section 804(c)(3) directs the Secretary to issue
regulatory provisions that it determines will facilitate importation.
The provision at issue here will help ensure that section 804 drugs
comply with the FD&C Act's labeling requirements and are not
misbranded, and will facilitate importation because it will prevent
manufacturers from causing unwarranted delay by withholding their
authorization to use the FDA-approved labeling.
    With regard to Sec.  251.14(b), which requires the manufacturer to
provide to the Importer a copy of any transaction documents that were
provided from the manufacturer to the Foreign Seller, FDA's authority
to require this derives from section 804(c)(3) and (e) of the FD&C Act.
Under section 804(e)(2)(A)(i), if the Importer does the Statutory
Testing, the manufacturer has to provide certain information, including
``information needed to . . . authenticate the prescription drug being
tested.'' The information needed to authenticate a section 804 drug
includes the transaction documents that the manufacturer provides to
the Importer under Sec.  251.14(b). These documents enable the Importer
and FDA to conduct a cross check of the transaction documents that the
Foreign Seller provides to the Importer under Sec.  251.14(c)(6). This
cross check is valuable supporting evidence of the authenticity of the
drug, helping to ensure that importation under section 804 poses no
additional risk to the public's health and safety.
    Under Sec.  251.14(b), manufacturers must provide the transaction
documents needed for the cross check regardless of whether the Importer
or the manufacturer conducts the Statutory Testing. FDA's authority to
require this when the manufacturer conducts the testing derives from
section 804(c)(3) of the FD&C Act, which provides that the regulations
``shall contain any additional provisions determined by the Secretary
to be appropriate as a safeguard to protect the public health or as a
means to facilitate the importation of prescription drugs.'' As noted
earlier, the cross check of the transaction documents from the sale of
the drug by the manufacturer to the Foreign Seller is a valuable
safeguard that protects the public health by providing evidence of the
drug's authenticity.

L. Procedural Requirements

    (Comment 79) One comment states that the proposed ruled failed to
comply with certain procedural requirements set forth in statute and
Executive orders, including the Regulatory Flexibility Act, the
Unfunded Mandates Reform Act, the E-Government Act of 2002, and
Executive Orders 12866, 13175, 12630, and 13045.
    (Response 79) FDA disagrees with this comment. This rulemaking
adheres to procedural provisions set forth in statutes and Executive
orders. For example, as noted in the Final Regulatory Impact Analysis,
FDA conducted economic analysis under the Unfunded Mandates Reform Act
and the Regulatory Flexibility Act. Further, we do not believe the
final rule establishes a new collection of information under the E-
Government Act of 2002. In addition, the final rule describes FDA's
Economic Analysis of Impacts under Executive Order 12866, the
solicitation of comment from Indian Tribes in accordance with Executive
Order 13175 and from States in accordance with Executive Order 13132,
and FDA considered the applicability of other Executive orders in the
development of the rule.
    (Comment 80) One comment states that former Acting Commissioner
Brett Giroir did not have authority to sign the proposed rule because
he was not the Acting Commissioner on December 18, 2019, which is the
date on which the comment asserts the rule was filed with the Federal
Register.
    (Response 80) This statement is incorrect. Acting Commissioner
Giroir had signing authority for the proposed rule because he served in
the role of Acting Commissioner at the time he signed the rule on
December 11, 2019. The date of filing with the Federal Register is
determined by the time the signed, original, clear and legible copies
of a document are received (1 CFR 18.3(c)).
    (Comment 81) A comment says that under the Administrative Procedure
Act and the Due Process Clause of the U.S. Constitution, NDA or ANDA
holders listed in a SIP Proposal must have an opportunity to comment on
the SIP Proposal before FDA authorizes it. The comment says that a SIP
Proposal is either a rule or an informal adjudication and that, as a
result, authorization should not proceed before NDA or ANDA holders
have the opportunity to seek judicial review. The comment says that
allowing NDA or ANDA holders to comment on SIP Proposals would allow
FDA to receive input on appropriate drugs and conserve resources that
might otherwise be spent on unworkable or dangerous SIP Proposals.
    (Response 81) We disagree with the comment that FDA's authorization
of a SIP Proposal is a rule. Such an authorization would be an order.
Under the Administrative Procedure Act (5 U.S.C. 551(4)), a rule is
defined as ``the whole or a part of an agency statement of general or
particular applicability and future effect designed to implement,
interpret, or prescribe law or policy or describing the organization,
procedure, or practice requirements of an agency.'' An order is the
whole or a part of a final disposition, whether affirmative, negative,
injunctive, or declaratory in form, of an agency in a matter other than
rulemaking but including licensing. 5 U.S.C 551(6). Thus, ``[t]he term
`order' is defined to exclude rules.'' S. Rep. 79-752 at 11 (November
19, 1945). While this final rule interprets and implements section 804
of the FD&C Act, when FDA authorizes a SIP Proposal, it will be
applying this rule.
    We also disagree that the manufacturers that hold the NDAs or ANDAs
of the FDA-approved counterparts of the eligible prescription drugs
that a SIP seeks to import would necessarily be entitled to participate
in FDA's review of the SIP Proposal or to seek judicial review of FDA's
authorization of a SIP Proposal before it proceeds. Under 21 CFR 10.25,
``[a]n interested person may petition the Commissioner [of the FDA] to
issue, amend, or revoke a regulation or order, or to take or refrain
from taking any other form of administrative action.''

Under 21 CFR 10.35, an interested person may also ``request the
Commissioner to stay the effective date of any administrative action.''
FDA's regulations further provide that a final administrative decision
on such a petition or request for a stay is a prerequisite to filing
suit in court (21 CFR 10.45). A manufacturer can follow the procedures
set forth in these regulations to petition FDA with regard to, or seek
a stay of, the authorization of a SIP.
    Finally, we do not believe that FDA's review of a SIP Proposal
would necessarily benefit from input from NDA or ANDA holders. The
comment says that NDA or ANDA holders could offer information such as
that antimicrobial, antiviral, or oncology drugs could have a high
potential for resistance or death if misbranded or adulterated. We do
not think that this is necessary because drugs imported under section
804 of the FD&C Act and this rule will not be any more likely to be
adulterated or misbranded than drugs imported with their manufacturer's
authorization.

M. Technical Amendments

    We are revising Sec.  1.74(a)(2) (21 CFR 1.74(a)(2)) to remove the
reference to a biological product regulated by FDA's Center for Drug
Evaluation and Research (CDER) that is required to have an approved
NDA. In the NPRM, we proposed that information filed in ACE must
include, for a biological product regulated by FDA's CDER that is
required to have an approved new drug application or an approved
biologics license application (BLA), the number of the applicable
application. As revised, the text refers to a biological product
regulated by FDA's CDER that is required to have an approved BLA. This
amendment reflects that after March 23, 2020, a marketing application
for a biological product (that previously could have been submitted
under section 505 of the FD&C Act) must be submitted in a BLA under
section 351 of the PHS Act (see section 7002(e) of the Biologics Price
Competition and Innovation Act of 2009 (BPCI Act), enacted as part of
the Patient Protection and Affordable Care Act (Pub. L. 111-148)). On
March 23, 2020, an approved application for a biological product under
section 505 of the FD&C Act was deemed to be a license for the
biological product (i.e., an approved BLA) under section 351 of the PHS
Act (see section 7002(e)(4)(A) of the BPCI Act; see also section
7002(e)(4)(B) of the BPCI Act). As proposed in the NPRM, we are also
adding Sec.  1.74(b), which sets forth the information that ACE filers
must submit when they file entry in ACE for drugs that are imported or
offered for import under section 804. This information will facilitate
the importation of drugs under section 804 and is a safeguard to ensure
that FDA's review of such importation is as protective of the public's
health and safety as the Agency's review of entries for other drugs. We
have revised the authority citation for part 1 to reflect that fact
that we added Sec.  1.74(b) pursuant to our authority in section
804(c)(3).
    In Sec.  251.9(b), we are including language to clarify that when
Foreign Sellers register with FDA under section 804 of the FD&C Act,
they must submit a unique facility identifier in accordance with the
system specified under section 510 of the FD&C Act (21 U.S.C. 360). We
have made conforming revisions to Sec.  1.74(b)(1) and the definitions
in proposed Sec.  251.2. These revisions align the Foreign Seller
registration requirements under section 804 of the FD&C Act with drug
establishment registration requirements under section 510 of the FD&C
Act.
    The definition of ``eligible prescription drug'' in Sec.  251.2
includes revisions from the definition proposed in the NPRM to clarify
that the drug is currently commercially marketed in the United States.
This revision aligns the definition with the certification requirement
in proposed Sec.  251.19(e). We have made a conforming revision to
proposed Sec.  251.3(d)(6).
    In Sec.  251.14 we clarify, as discussed in the NPRM, that a
Foreign Seller, upon receiving a shipment of eligible prescription
drugs from the manufacturer, must, among other things, maintain records
associating the SSI with the Canadian DIN and all the records it
received from the manufacturer upon receipt of the original shipment
intended for the Canadian market for not less than 6 years.
    We are making a number of changes throughout the rule for clarity
and readability.

VI. Effective/Compliance Date(s)

    This rule is effective November 30, 2020.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.''
This final rule has been designated as a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. This rule does not impose new regulatory requirements on
small entities that do not participate in SIPs, however we cannot
anticipate whether sponsors will contract with small entities to
implement their authorized SIP Proposals or whether, under certain
circumstances, a small pharmacist or wholesaler might become a sponsor.
We also lack information to quantify the total impacts of the final
rule. Because we do not have enough information about the effect of the
final rule on small entities, we are not certifying that the final rule
will not have a significant economic impact on a substantial number of
small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $156
million, using the most current (2019) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount. This final
rule allows commercial importation of certain prescription drugs from
Canada through time-limited SIPs, sponsored by a State or Indian Tribe,
or in certain future circumstances by a pharmacist or wholesale
distributor, with possible cosponsorship by a State, Indian Tribe,
pharmacist, or wholesale distributor. If such programs allow Importers
to leverage drug price differences between the United States and
Canada, they may result in cost savings for U.S. consumers.
    We received a number of comments on the preliminary economic
analysis,

including general comments on the analysis as well as comments on
costs, benefits, distributional effects, international effects, and
effects on small entities. We respond to these comments in the final
economic analysis.
    Costs of the final rule may accrue to the Federal Government, SIP
Sponsors, Importers, and manufacturers of imported eligible
prescription drugs. The Federal Government will incur costs to
implement the final rule and conduct oversight of authorized programs.
SIP sponsors will face costs to prepare proposals, implement approved
programs, and produce records and program reports. Drug manufacturers
will have to provide certain information to Importers if their drugs
are imported into the United States from Canada. SIPs may offer cost
savings to patients, as well as participating wholesale drug
distributors, pharmacies, hospitals, and third-party payers. As drug
distributors realize savings in acquiring imported eligible
prescription drugs and pass some of these savings to consumers and
other payors, it is possible that U.S.-based drug manufacturers may
experience a transfer in U.S. sales revenues to these parties.
    We are unable to estimate the cost savings from this final rule,
because we lack information about the likely size and scope of SIPs,
the specific eligible prescription drugs that may be imported, the
degree to which these imported drugs will be less expensive than non-
imported drugs available in the United States, and which eligible
prescription drugs are produced by U.S.-based drug manufacturers.

                                      Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                       Primary        Low          High    ---------------------------------------
              Category                 estimate     estimate     estimate       Year       Discount      Period                    Notes
                                                                              dollars      rate  %      covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/  ...........  ...........  ...........  ...........            7
     year.                                                                                3
    Annualized Quantified..........  ...........  ...........  ...........  ...........            7
                                                                                3
                                    --------------------------------------------------------------------------------------------------------------------
    Qualitative....................   Potential cost savings to consumers
                                       and third-party payers or entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/  ...........  ...........  ...........  ...........            7
     year.                                                                                3
    Annualized Quantified..........  ...........  ...........  ...........  ...........            7
                                                                                3
                                    --------------------------------------------------------------------------------------------------------------------
    Qualitative....................        Potential costs to Federal
                                      Government, SIP Sponsors, Importers,
                                         and manufacturers of imported
                                       eligible prescription drugs. This
                                        framework does not consider the
                                     potential implications of private and
                                            government insurance and
                                         reimbursement as well as other
                                         purchasers in the supply chain
                                      including hospitals and physicians.
                                        We cannot predict the types and
                                        volumes of eligible prescription
                                     drugs that will be imported under the
                                        final rule, which will influence
                                       these payors. Moreover, the prices
                                       paid by multiple payors, including
                                      those affected by discounts, may be
                                       different, unobservable, or both.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized     ...........  ...........  ...........  ...........            7
     $millions/year.                                                                               3
                                    --------------------------------------------------------------------------------------------------------------------
    From/To........................                  From:
                                                      To:                   ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized       ...........  ...........  ...........  ...........            7
     $millions/year.                                                                               3
                                    --------------------------------------------------------------------------------------------------------------------
    From/To........................      From: U.S. drug manufacturers
                                        To: Importers and U.S. consumers            Not
                                                                            Quantified.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: Potential costs and cost savings to
     States and Indian Tribes from sponsoring SIPs.
    Small Business: Potential costs to drug manufacturers; potential costs
     and cost savings to pharmacists and wholesale distributors.
    Wages:
    Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We lack information about the likely size and scope of SIPs, the
specific prescription drug products that may become eligible for
importation, which eligible prescription drugs are produced by U.S.-
based drug manufacturers, and the degree to which these imported drugs
will be less expensive than non-imported drugs available in the United
States, to estimate the present and annualized values of the costs and
cost savings of the final rule over an infinite

time horizon. Therefore, we exclude the Executive Order 13771 summary
table from this analysis. This is a deregulatory action because the
rule is opening a pathway for legal importation that is not currently
allowed.
    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts, including responses to public comments submitted, is available
in the docket for this final rule (Ref. 6) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.31(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual reporting and recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
    Title: Section 804 Importation Program Proposals--21 CFR part 251.
    Description: The final rule provides that a SIP Sponsor that seeks
to implement a SIP to import eligible prescription drugs from Canada
must submit a proposal that includes, among other things, information
about the SIP Sponsor, cosponsors if any, and the SIP Sponsor's
importation plan including the SIP's compliance plan. In addition, SIP
Sponsors must provide FDA with data and information on the eligible
prescription drugs the SIP imports and on the SIP's cost savings to the
American consumer. Importers have a number of responsibilities related
to submitting a Pre-Import Request; screening eligible prescription
drugs; and arranging for importation, testing, and relabeling.
Manufacturers provide an attestation and information statement, batch
records, transaction information, and information needed to test
eligible prescription drugs for compliance with section 804 of the FD&C
Act and the rule.
    Description of Respondents: Respondents would include SIP Sponsors
(States or Indian Tribes, or in certain future circumstances
pharmacists or wholesale distributors, and any cosponsor(s)); Importers
(pharmacists or wholesaler distributors); and manufacturers of eligible
prescription drugs.
    FDA anticipates submissions will be made in electronic format
through the ESG or to an alternative transmission point identified by
FDA.
    FDA estimates that there will be 10 SIP Sponsors requiring 360
hours each to research, prepare, and administer requirements annually;
10 Pre-Import Requests requiring 24 hours each annually; and 20
manufacturers also requiring 24 hours each annually to participate in
the program. In addition, FDA estimates that a recordkeeping burden of
52 hours will be imposed annually on the 10 SIP Sponsors, and a
recordkeeping burden of 24 hours will be imposed annually on each of
the 10 Importers and the 20 manufacturers. The 20 manufacturers
anticipated to participate in the program will also incur an estimated
burden of 24 hours each for copying and providing records to SIP
Sponsors and Importers of foreign transactions.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Type of information collection      Number of     responses per   Total annual     burden per      Total hours
       activity/respondent          respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
SIP Sponsor Sec.  Sec.   251.3;               10               1              10             392           3,920
 251.8; 251.14--SIP Proposal
 Submission Requirements;
 251.18--Post-Importation
 Requirements; 251.19--Reports
 to FDA.........................
Importer Sec.  Sec.   251.5;                  10               1              10              20             200
 251.12; 251.13; 251.17--Pre-
 Import Request and Importation
 Requirements...................
Manufacturer Sec.   251.16                    20               1              20              28             560
 Laboratory Testing Requirements
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,680
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                Table 3--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Type of information collection      Number of      records per    Total annual     burden per      Total hours
       activity/respondent         recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
SIP Sponsor Sec.   251.8--                    10               1              10              52             520
 Modification or Extension of
 Authorized Importation Programs
Importer Sec.  Sec.   251.14(d)--             10               1              10              24             240
 Supply Chain Security
 Requirements; 251.17--
 Importation Requirements;
 251.18 Post-Importation
 Requirements...................
Manufacturer Sec.   251.14(b)--               20               1              20              24             480
 Supply Chain Security
 Requirements...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                            Table 4--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
 Type of information collection     Number of    disclosures per   Total annual     burden per      Total hours
      activity/respondent          respondents      respondent      disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturer Sec.  Sec.                      20                1              20              24             480
 251.5--Pre-Import Request;
 251.14(b)--Supply Chain
 Security Requirements.........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995. Before the effective date of this
final rule, FDA will publish a notice in the Federal Register
announcing OMB's decision to approve, modify, or disapprove the
information collection provisions in this final rule. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

XII. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov/. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. FDA, 2018, ``FDA Launches Global Operation to Crack Down on
websites Selling Illegal, Potentially Dangerous Drugs; Including
Opioids,'' accessed September 21, 2020, https://www.fda.gov/news-events/press-announcements/fda-launches-global-operation-crack-down-websites-selling-illegal-potentially-dangerous-drugs.
2. FDA, 2020, ``Internet Pharmacy Warning Letters,'' accessed
September 21, 2020, https://www.fda.gov/drugs/drug-supply-chain-integrity/internet-pharmacy-warning-letters.
    3. HHS Task Force on Drug Importation, 2004, Report on
Prescription Drug Importation, accessed September 21, 2020, http://www.safemedicines.org/wp-content/uploads/2018/03/HHS-Report1220.pdf.
    4. Government of Canada, Archived, ``Consultation: Regulations
Amending the Food and Drug Regulations 1447--Good Manufacturing
Practices,'' accessed September 21, 2020, https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/compliance-enforcement/regulations-amending-food-drug-regulations-1447.html.
    5. Government of Canada, Health Canada, ``GMP Drug Establishment
Good Manufacturing Practices Pre-Application Package: Importers,
Distributors and Wholesalers,'' accessed September 21, 2020, https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/gmp-bpf/docs/gmp-package-bpf-eng.pdf.
    6. FDA, Regulatory Impact Analysis: Importation of Prescription
Drugs, https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 251

    Exports, Labeling, Packaging and containers, Prescription drugs,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1 and 251 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 is revised to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384, 384a, 384b, 384d, 387,
387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L.
107-188, 116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885,
3889.

0
2. Revise Sec.  1.74 to read as follows:

Sec.  1.74  Human drugs.

    In addition to the data required to be submitted in Sec.  1.72, an
ACE filer must submit the following information at the time of filing
entry in ACE for drugs, including biological products and eligible
prescription drugs as defined in Sec.  251.2 of this chapter that are
imported or offered for import under section 804 of the Federal Food,
Drug, and Cosmetic Act, intended for human use that are regulated by
the FDA Center for Drug Evaluation and Research.
    (a) For a drug intended for human use that is not an eligible
prescription drug covered under paragraph (b) of this section:
    (1) Registration and listing. The Drug Registration Number and the
Drug Listing Number of the foreign establishment where the human drug
was manufactured, prepared, propagated, compounded, or processed before
being imported or offered for import into the United States is required
to register and list the drug under part 207 of this chapter. For the
purposes of this section, the Drug Registration Number that must be
submitted at the time of entry filing in ACE is the unique

facility identifier of the foreign establishment where the human drug
was manufactured, prepared, propagated, compounded, or processed before
being imported or offered for import into the United States. The unique
facility identifier is the identifier submitted by a registrant in
accordance with the system specified under section 510(b) of the
Federal Food, Drug, and Cosmetic Act. For the purposes of this section,
the Drug Listing Number is the National Drug Code number of the human
drug article being imported or offered for import.
    (2) Drug application number. For a drug intended for human use that
is the subject of an approved application under section 505(b) or
505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the
new drug application or abbreviated new drug application. For a
biological product regulated by the FDA Center for Drug Evaluation and
Research that is required to have an approved biologics license
application, the number of the applicable application.
    (3) Investigational new drug application number. For a drug
intended for human use that is the subject of an investigational new
drug application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act, the number of the investigational new drug application.
    (b) For an eligible prescription drug as defined in Sec.  251.2 of
this chapter that is imported or offered for import under section 804
of the Federal Food, Drug, and Cosmetic Act:
    (1) Registration and listing. The Drug Registration Number and the
Drug Listing Number. For the purposes of this section, the Drug
Registration Number that must be submitted in ACE is the unique
facility identifier submitted by the Foreign Seller registrant under
Sec.  251.9 of this chapter in accordance with the system specified
under section 510 of the Federal Food, Drug, and Cosmetic Act. For the
purposes of this section, the Drug Listing Number is the National Drug
Code number that the Importer will use when relabeling the eligible
prescription drug as required in Sec.  251.13 of this chapter.
    (2) Drug application number. The number of the new drug application
or abbreviated new drug application for the counterpart FDA-approved
drug.
    (3) Lot or control number. The lot or control number assigned by
the manufacturer of the eligible prescription drug.
    (4) FDA Quantity. FDA Quantity, which is the quantity of each
eligible prescription drug in an import line delineated by packaging
level, including the type of package from the largest packaging unit to
the smallest packaging unit; the quantity of each packaging unit; and
the volume and/or weight of each of the smallest of the packaging
units.
    (5) Pre-Import Request number. The Pre-Import Request number
assigned by FDA.

0
3. Add part 251 to read as follows:

PART 251--SECTION 804 IMPORTATION PROGRAM

Subpart A--General Provisions
Sec.
251.1 Scope of the part.
251.2 Definitions.
Subpart B--Section 804 Importation Program Proposals and Pre-Import
Requests
251.3 SIP proposal submission requirements.
251.4 Review and authorization of importation program proposals.
251.5 Pre-Import Request.
251.6 Termination of authorized importation programs.
251.7 Suspension and revocation of authorized importation programs.
251.8 Modification or extension of authorized importation programs.
Subpart C--Certain Requirements for Section 804 Importation Programs
251.9 Registration of Foreign Sellers.
251.10 Reviewing and updating registration information for Foreign
Sellers.
251.11 Official contact and U.S. agent for Foreign Sellers.
251.12 Importer responsibilities.
251.13 Labeling of eligible prescription drugs.
251.14 Supply chain security requirements for eligible prescription
drugs.
251.15 Qualifying laboratory requirements.
251.16 Laboratory testing requirements.
251.17 Importation requirements.
251.18 Post-importation requirements.
251.19 Reports to FDA.
251.20 Severability.
251.21 Consequences for violations.

    Authority: 21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371,
374, 381, 384.

Subpart A--General Provisions

Sec.  251.1  Scope of the part.

    (a) This part sets forth the procedures that Section 804
Importation Program sponsors (SIP Sponsors) must follow when submitting
plans to implement time-limited programs to begin importation of drugs
from Canada under section 804 of the Federal Food, Drug, and Cosmetic
Act. This part also sets forth certain requirements that are necessary
for such programs to be authorized by the Food and Drug Administration
(FDA). Additionally, this part sets forth requirements for eligible
prescription drugs and requirements for entities that engage in
importation of eligible prescription drugs.
    (b) This part includes provisions that exempt eligible prescription
drugs that meet certain requirements from section 502(f)(1) of the
Federal Food, Drug, and Cosmetic Act. This part also includes
provisions that exempt certain transactions involving eligible
prescription drugs from certain requirements in section 582 of the
Federal Food, Drug, and Cosmetic Act.

Sec.  251.2  Definitions.

    The definitions of terms in section 804 of the Federal Food, Drug,
and Cosmetic Act apply to the terms used in this part, if not otherwise
defined in this section. The following definitions apply to this part:
    Active ingredient has the meaning set forth in Sec.  314.3 of this
chapter.
    Adverse event means any untoward medical occurrence associated with
the use of a drug product in humans, whether or not it is considered
related to the drug product. An adverse event can occur in the course
of the use of a drug product; from overdose of a drug product, whether
accidental or intentional; from abuse of a drug product; from
discontinuation of the drug product (e.g., physiological withdrawal);
and it includes any failure of expected pharmacological action.
    Combination product has the meaning set forth in Sec.  3.2(e) of
this chapter.
    Constituent part has the meaning set forth in Sec.  4.2 of this
chapter.
    Disability means a substantial disruption of a person's ability to
conduct normal life functions.
    Eligible prescription drug:
    (1) Means a drug subject to section 503(b) of the Federal Food,
Drug, and Cosmetic Act that has been approved and has received a Notice
of Compliance and a Drug Identification Number (DIN) from the Health
Products and Food Branch of Health Canada (HPFB) and, but for the fact
that it deviates from the required U.S. labeling, also meets the
conditions in an FDA-approved new drug application (NDA) or abbreviated
new drug application (ANDA) for a drug that is currently commercially
marketed in the United States, including those relating to the drug
substance, drug product, production process, quality controls,
equipment, and facilities.
    (2) The term eligible prescription drug does not include:
    (i) A controlled substance (as defined in section 102 of the
Controlled Substances Act (21 U.S.C. 802));

    (ii) A biological product (as defined in section 351(i)(1) of the
Public Health Service Act (42 U.S.C. 262(i)(1)));
    (iii) An infused drug (including a peritoneal dialysis solution);
    (iv) An intravenously injected drug;
    (v) A drug that is inhaled during surgery;
    (vi) An intrathecally or intraocularly injected drug;
    (vii) A drug that is subject to a risk evaluation and mitigation
strategy under section 505-1 of the Federal Food, Drug, and Cosmetic
Act; or
    (viii) A drug that is not a ``product'' for purposes of section 582
as defined in section 581(13) of the Federal Food, Drug, and Cosmetic
Act.
    Entered (or entry) for consumption has the meaning set forth in 19
CFR 141.0a(f).
    Entry means the information or data filed electronically in the
Automated Commercial Environment (ACE) or any other U.S. Customs and
Border Protection (CBP)-authorized electronic data interchange system
to secure the release of imported merchandise from CBP, or the act of
filing that information or data.
    Foreign Seller means an establishment within Canada engaged in the
distribution of an eligible prescription drug that is imported or
offered for importation into the United States. A Foreign Seller must
have an active Drug Establishment License to wholesale drugs by Health
Canada. A Foreign Seller must be registered with provincial regulatory
authorities to distribute HPFB-approved drugs. A Foreign Seller must
not be licensed by a provincial regulatory authority with an
international pharmacy license that allows it to distribute drugs that
are approved by countries other than Canada and that are not HPFB-
approved for distribution in Canada. A Foreign Seller must also be
registered with FDA under section 804 of the Federal Food, Drug, and
Cosmetic Act in accordance with the requirements described in this
part.
    Illegitimate foreign product means a drug purchased by a Foreign
Seller from a manufacturer, and intended for sale to the Importer in
the United States, where the Foreign Seller has credible evidence that
shows that the product:
    (1) Is counterfeit, diverted, or stolen;
    (2) Is intentionally adulterated such that the product would result
in serious adverse health consequences or death to humans;
    (3) Is the subject of a fraudulent transaction; or
    (4) Appears otherwise unfit for distribution such that the product
would be reasonably likely to result in serious adverse health
consequences or death to humans.
    Importer means a pharmacist or wholesaler. An Importer must be a
State-licensed pharmacist, or a State- or FDA-licensed wholesale
distributor, who is the U.S. owner of an eligible prescription drug at
the time of entry into the United States. The Importer's pharmacist
license or wholesale distributor license (if issued by a State and not
FDA) must be issued by a State that is a SIP Sponsor or SIP Co-Sponsor.
An Importer's pharmacist or wholesale distributor license must be in
effect (i.e., not expired) and the Importer's license must be in good
standing with the licensor.
    Individual case safety report (ICSR) means a description of an
adverse event related to an individual patient or subject.
    ICSR attachments means any document related to the adverse event
described in an ICSR, such as medical records, hospital discharge
summaries, or other documentation.
    Life-threatening adverse event means any adverse event that places
the patient, in the view of the initial reporter, at immediate risk of
death from the adverse event as it occurred, i.e., it does not include
an adverse event that, had it occurred in a more severe form, might
have caused death.
    Manufacturer means an applicant, as defined in Sec.  314.3 of this
chapter, or a person who owns or operates an establishment that
manufactures an eligible prescription drug. Manufacturer also means a
holder of a drug master file containing information necessary to
conduct the Statutory Testing, prepare the manufacturer's attestation
and information statement, or otherwise comply with section 804 of the
Federal Food, Drug, and Cosmetic Act or this part.
    Minimum data set for an adverse event means the minimum four
elements required for reporting an ICSR of an adverse event: An
identifiable patient, an identifiable reporter, a suspect drug product,
and an adverse event.
    Pharmacist means a person licensed by a State to practice pharmacy,
including the dispensing and selling of prescription drugs.
    Pre-Import Request means a request made to FDA by an Importer that
must be granted by FDA before the Importer can start importation under
a Section 804 Importation Program.
    Qualifying laboratory means a laboratory in the United States that
has been approved by FDA for the purposes of section 804 of the Federal
Food, Drug, and Cosmetic Act.
    Relabel has the meaning set forth in Sec.  207.1 of this chapter.
    Relabeler has the meaning set forth in Sec.  207.1 of this chapter.