[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Proposed Rules]
[Pages 41434-41438]
[FR Doc No: 2011-17696]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 203

[Docket No. FDA-2011-N-0446]

Removal of Certain Requirements Related to the Prescription Drug
Marketing Act; Opportunity for Public Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to remove
a section of the Prescription Drug Marketing Act (PDMA) regulations
requiring that prior to the completion of any wholesale distribution of
a prescription drug, an unauthorized distributor must provide to the
purchaser ``a statement identifying each prior sale, purchase, or trade
of such drug,'' starting with the manufacturer, and that the
identifying statement (also known as the ``pedigree'') must include
certain information about the drug and each prior sale, purchase, or
trade. This action is being taken in response to longstanding issues,
including an injunction currently in effect, regarding the application
of and compliance with this requirement. FDA is also announcing that it
intends to exercise enforcement discretion with respect to certain
requirements of the regulation while the rulemaking is pending and with
respect to the statutory pedigree requirements of the PDMA, as long as
the pedigree identifies the names and addresses of the last authorized
distributor of record that handled the drug and the associated dates of
transactions involving that last authorized distributor of record and
the drug, as well as the names and addresses of all subsequent
unauthorized distributors that handled the drug and the corresponding
dates of those transactions.

DATES: Submit either electronic or written comments on the proposed
rule by September 12, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0446, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Karen Rothschild, Center for Drug
Evaluation and Research, Food Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The PDMA (Pub. L. 100-293) was enacted on April 22, 1988, and was
modified by the PDA (Pub. L. 102-353) on August 26, 1992. The PDMA, as
modified, amended the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) to establish restrictions and requirements relating to various
aspects of human prescription drug marketing and distribution. The
primary purpose of the PDMA was to increase safeguards to prevent the
introduction and retail sale of substandard, ineffective, and
counterfeit drugs into the U.S. drug supply chain. Among other things,
the PDMA, in section 503(e)(1)(A) of the FD&C Act (21 U.S.C. 353),
requires a wholesale distributor ``who is not the manufacturer or
authorized distributor of record'' to provide drug pedigrees to
purchasers ``identifying each prior sale, purchase or trade of such
drug (including the date of the transaction and the names and addresses
of all parties to the transaction).''
    On August 1, 1988, the Agency issued a letter that provided
guidance on the PDMA for industry pending the issuance of implementing
regulations (the 1988 guidance letter) (see attachment E of FDA's 2001
Report to Congress (http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/PrescriptionDrugMarketingActof1987/UCM203186.pdf)). Among other issues, the 1988 guidance letter discussed
drug pedigrees. The 1988 guidance letter stated that the necessary
identifying information regarding all sales in the chain of
distribution may start with the manufacturer or authorized distributor
of record. As explained in an FDA 2001 Prescription Drug Marketing Act
Report to Congress (2001 Report to Congress) (see http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/PrescriptionDrugMarketingActof1987/UCM203186.pdf), it was the Agency's
understanding at the time that the authorized distributor of record
would be the distributor to whom the manufacturer first sold the drugs,
not just any authorized distributor who happened to purchase the drugs
somewhere along the distribution chain.
    In the Federal Register of March 14, 1994 (59 FR 11842), we issued
a proposed rule related to certain provisions of the PDMA. With respect
to prescription drug pedigrees, the proposed rule provided in relevant
part that the identifying statement for sales by unauthorized
distributors must include ``the business name and address of all
parties to each prior transaction involving the drug, starting with the
manufacturer.'' (59 FR 11865). A final rule was issued in the Federal
Register of December 3, 1999 (64 FR 67720) (the December 1999 final
rule), with an effective date of December 4, 2000. The final rule
contained provisions on prescription drug reimportation; wholesale
distribution of prescription drugs by unauthorized distributors; the
resale of prescription drugs by hospitals, health care entities, and
charitable institutions; and distribution of prescription drug samples.
In the December 1999 final rule, FDA responded to a comment objecting
to the pedigree requirement as proposed because it would require an
unauthorized distributor to provide information about all prior sales,
purchases, or trades of the drug, starting with the manufacturer, even
in cases where the seller from whom the distributor received the drug
was an authorized distributor of record and did not provide any
pedigree for the drug. The comment recommended revising the proposed
rule to require that the pedigree only go back to the last authorized
distributor of record (64 FR 67720 at 67747). FDA declined to revise
the rule, explaining that the statute requires that the pedigree
identify ``each prior sale, purchase, or trade of the drug'' and
``[t]here is no indication in [the] PDMA that Congress intended that
the statement include only those sales, purchases, or trades since the
drug was last handled by an authorized distributor.'' (64 FR 67720 at
67747).
    The December 1999 final rule thus codified Sec.  203.50(a) (21 CFR
203.50(a)), which follows section 503(e)(1)(A) of the FD&C Act,
requiring that, before the completion of any wholesale distribution by
a wholesale distributor of a prescription drug for which the seller is
not a manufacturer or an authorized distributor of record, the seller
must provide to the purchaser a statement (also referred to as a
pedigree) identifying each prior sale, purchase, or trade of the drug.
According to Sec.  203.50(a), the identifying statement must include:
The proprietary and established name of the drug; dosage; container
size; number of containers; the lot or control numbers of the drug
being distributed; the business name and address of all parties to each
prior transaction involving the drug, starting with the manufacturer;
and the date of each previous transaction.
    After publication of the December 1999 final rule, we received many
comments on, and held several meetings to discuss, the implications of
the final regulations regarding, among other things, the pedigree
provisions at Sec.  203.50(a) requiring unauthorized distributors to
provide a pedigree showing all prior sales going back to the
manufacturer. Industry representatives of unauthorized distributors
represented that they could not obtain the required pedigree showing
all prior sales of the drugs they purchase because a large portion of
these drugs are purchased from authorized distributors who are not
required to provide pedigrees and who are unwilling to voluntarily
provide them.\1\ Industry representatives also claimed that
implementation of this requirement could prevent as many as 4,000
smaller, unauthorized distributors from distributing many drugs to
their

customers, putting the unauthorized distributors out of business.\2\
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    \1\ FDA, The Prescription Drug Marketing Act Report to Congress,
2001 (http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/PrescriptionDrugMarketingActof1987/UCM203186.pdf).
    \2\ (See footnote 1 of this document.)
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    In the 2001 Report to Congress, we noted that we would be able to
address some, but not all of the concerns raised by unauthorized
distributors. We stated that we believed that ``the concerns related to
continuing to exempt authorized distributors from the pedigree
requirement and the exact meaning of the phrase `each prior sale' can
be addressed only through statutory remedies.'' \3\
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    \3\ (See footnote 1 of this document.)
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    As a result of these comments, other informal communications that
FDA had with industry, industry associations, and Congress, and the
Agency's consideration of a petition for stay of action received on May
3, 2000, FDA delayed the effective date of several provisions of the
December 1999 final rule until October 1, 2001, and reopened the
administrative record to receive additional comments (65 FR 25639, May
3, 2000). In the Federal Register of March 1, 2001 (66 FR 12850), we
announced our decision to further delay until April 1, 2002, the
applicability of Sec.  203.50, among other provisions. Further delays
of the effective dates followed until December 1, 2006, to give us
additional time to consider whether regulatory changes were appropriate
and, if so, to initiate such changes (67 FR 6645, February 13, 2002; 69
FR 4912, January 23, 2003; 69 FR 8105, February 23, 2004).
    While Sec.  203.50 was stayed, the industry followed the advice
given in the 1988 guidance letter, which, as noted previously, stated
that the pedigree should include ``all necessary identifying
information regarding all sales in the chain of distribution of the
product, starting with the manufacturer or the authorized
distributor.''
    In the Federal Register of June 14, 2006 (71 FR 34249), we
announced that FDA did not intend to further delay the effective date
of certain regulations related to the PDMA, including Sec.  203.50, and
that the regulation would go into effect on December 1, 2006.
    On September 20, 2006, a group of unauthorized wholesalers of
prescription drugs filed a lawsuit against FDA in the U.S. District
Court for the Eastern District of New York, seeking, among other
things, a declaratory judgment that Sec.  203.50(a) erroneously
interprets the statutory requirement for pedigrees (21 U.S.C.
353(e)(1)(A)), and violates the U.S. Constitution's guarantees of equal
protection and due process. (RxUSA Wholesale, Inc. v. Dept. of Health
and Human Servs., 467 F. Supp.2d 285 (E.D.N.Y. 2006)). On November 22,
2006, the plaintiffs moved for a preliminary injunction against
implementation of the regulation, which, as noted previously, was
scheduled to become effective on December 1, 2006. On December 8, 2006,
the district court issued a preliminary injunction enjoining FDA from
implementing Sec.  203.50(a) (467 F.Supp. 2d at 292). The court
concluded that the statute, unlike Sec.  203.50(a), does not
``specifically or expressly require[] unauthorized distributors to
provide pedigree information all the way back to the manufacturer.''
467 F. Supp. 2d at 290 (emphasis in original). The court stated that
``[u]nauthorized distributors would be unable to comply with'' the
December 1999 final rule requirement to ``provide complete pedigree
information for all prior sales up to the manufacturer'' because
unauthorized distributors purchase drugs from authorized distributors
``who do not provide pedigree information.'' (467 F. Supp. 2d at 291).
The district court concluded that plaintiffs had shown a likelihood of
success on the merits of their claim because, in the court's view, the
pedigree regulation undermined the purpose of the statute and was
therefore arbitrary and capricious. (467 F. Supp. 2d at 291). The court
also found that issuance of the preliminary injunction would benefit
the public interest by preserving ``the status quo and the current
practice in the industry.'' (467 F. Supp. 2d at 292).
    The Agency appealed the district court's preliminary injunction
order, but the district court's order was affirmed on July 10, 2008, by
the U.S. Court of Appeals for the Second Circuit. (See RxUSA Wholesale,
Inc., v. Dept. of Health and Human Servs., 285 Fed. Appx. 809 (2d Cir.
2008)). The appellate court explained that the PDMA ``does not
specifically state whether'' a pedigree must ``extend back to the
manufacturer, or whether it must only extend to the last authorized
distributor. The parties offer differing textual interpretations, but
we agree with the district court that for purposes of preliminary
injunction the statute's language does not unambiguously compel one
interpretation over another.'' (285 Fed. Appx. at 811). Moreover, the
second circuit concluded that the district court had not abused its
discretion in determining that the plaintiffs had shown a likelihood of
success on the merits because Sec.  203.50(a) requires unauthorized
distributors to ``provide pedigree information that is currently held
only by authorized distributors'' and the regulation is ``inconsistent
with the position taken by the agency in its original 1988 guidance
letter, and it runs directly counter to the 20-year history of industry
reliance on the FDA's initial position.'' (285 Fed. Appx. at 811).
    The district court's preliminary injunction, as affirmed by the
circuit court, halted FDA's implementation of the requirements of Sec.
203.50(a). Specifically, the order enjoins FDA from implementing the
requirement in Sec.  203.50(a) that a pedigree identify each prior sale
or trade of a drug back to the drug's original manufacturer and the
requirement that specifies the types of information that must be
included in the pedigree, including lot numbers and container sizes.
    Under the district court's order, unauthorized distributors are
only required to provide pedigrees that include information regarding
transactions going back to either the manufacturer or the last
authorized distributor of record that handled the drugs. In addition,
as specified in the FD&C Act, all pedigrees must include the dates of
the listed transactions and the names and addresses of all parties to
those transactions. We recognized that these circumstances resulting
from the court's order could lead to confusion and possible disruptions
or delays in the nation's drug distribution system for wholesale
distributors operating outside of the court's jurisdiction and could
provide an undue advantage to certain wholesaler distributors.
Therefore, we announced that we would exercise enforcement discretion
in a manner consistent with the court's opinion throughout the rest of
the country.

II. Proposed Regulation

    FDA is now proposing to remove Sec.  203.50(a). Over the past 20
years, we have endeavored to ensure that the pedigree requirements in
our regulations are consistent with congressional intent and provide
appropriate accountability to protect our nation's drug supply. We have
made a good faith effort to implement the requirements in Sec.
203.50(a) consistent with the language of the PDMA through public
meetings, Federal Register documents requesting comments, meetings with
the wholesale industry, Members of Congress, and others, a Report to
Congress, and other actions. For the various reasons discussed earlier,
Sec.  203.50(a) has been effective for only a total of 7 days since the
finalization of the rule in 1999. As explained previously, there have
been serious ongoing concerns about the

effect that full implementation of the statutory pedigree requirements,
as codified in Sec.  203.50(a), would have on the nation's drug supply
and on wholesaler distributors. Therefore, in light of the courts'
opinions, we are proposing to remove Sec.  203.50(a).
    By proposing to remove Sec.  203.50(a), we would remove the
requirement in the regulation that the pedigree identify each prior
sale or trade of a drug back to the drug's manufacturer. In addition,
this proposal would remove the requirement in the regulation that the
identifying statement include certain information, such as the
proprietary and established name of the drug, the dosage, container
size, number of containers, the drug's lot or control number(s), the
business name and address of all parties for each prior transaction,
starting with the manufacturer, and the date of each previous
transaction. While the rulemaking to remove the regulation is pending,
we intend to exercise enforcement discretion with respect to all of
these requirements in Sec.  203.50(a).
    We note that even with the removal of Sec.  203.50(a), the pedigree
requirements of section 503(e)(1)(A) of the FD&C Act would still be in
effect. However, with respect to these statutory pedigree requirements,
the Agency intends to exercise enforcement discretion and not initiate
an enforcement action against any wholesalers for failing to provide a
pedigree that goes back to the manufacturer or for failing to include
the specific information listed in the regulation, as long as the
pedigree otherwise identifies the last authorized distributor of record
that handled the drugs and the associated dates of the transactions, as
well as the names and addresses of all unauthorized distributors that
handled the drug after the last authorized distributor, and the
corresponding dates of those transactions.
    In summary, unauthorized distributors need to be aware that their
pedigree(s) must: (1) Include information regarding transactions going
back to either the manufacturer or the last authorized distributor of
record that handled the drugs, consistent with the preliminary
injunction order previously referenced and (2) include the date of the
transaction and the names and addresses of all parties to the
transaction as explicitly required under section 503(e)(1)(A) of the
FD&C Act. Furthermore, while FDA is proposing to remove Sec.  203.50(a)
and intends to exercise enforcement discretion under these described
circumstances with respect to the statutory requirements for a
pedigree, FDA encourages wholesalers to include the drug, dosage,
container size, number of containers, and the drug's lot or control
number(s) in the pedigree as well.
    FDA continues to believe that drug supply chain security is of the
utmost importance and that transparency of transactions and
accountability are essential to further secure our nation's drug
supply. Counterfeit and diverted drugs continue to be found in our drug
supply chain and the action proposed in this document should not be
interpreted to mean that there is not a problem with counterfeit and
diverted drugs. Rather, FDA remains committed to the framework set
forth in the 2004 FDA Counterfeit Drug Task Force Report (Task Force
Report) and subsequent updates to that Task Force Report (http://www.fda.gov/Drugs/DrugSafety/ucm169825.htm) and will continue to move
forward, working with the private and public sectors to improve the
security of the drug supply chain and implement measures to further
protect Americans from counterfeit and diverted drugs. We also will
continue our efforts to implement the pharmaceutical security
provisions contained in section 913 of the Food and Drug Administration
Amendments Act of 2007.
    As stated in the Task Force Report, such measures include
implementation of tracking and tracing, which would help secure the
integrity of the supply chain by providing an accurate electronic
record of transactions in the drug supply chain. Such electronic
records documenting the movement of a drug product from the
manufacturer to the dispenser would be an important step in preventing
counterfeit and diverted drugs from entering the drug supply chain. FDA
will continue to develop standards for the purpose of securing the drug
supply chain against counterfeit, diverted, subpotent, substandard,
adulterated, misbranded, or expired drugs, including standards for the
identification, validation, authentication, and tracking and tracing of
prescription drugs. We are not proposing any new provisions in lieu of
Sec.  203.50(a) at this time.

III. Legal Authority

    FDA is issuing this proposed rule to remove the provisions in Sec.
203.50(a) under its rulemaking authority under section 701(a) of the
FD&C Act (21 U.S.C. 371) and based on those reasons provided in section
II of this document. Specifically, FDA can issue regulations through
its rulemaking authority to establish requirements for section 503(e)
of the FD&C Act. As described in section I of this document, FDA
previously issued a final rule establishing certain requirements for
section 503(e)(1)(a). Similarly, under its rulemaking authority, FDA
can propose to remove those specific requirements that have been
established by regulation. FDA is basing the proposed removal of Sec.
203.50(a) on the grounds described in section II of this document. As
explained earlier, the statutory provisions of section 503(e) of the
FD&C Act, as well as the other provisions of Sec.  203.50 that would
not be removed by this proposed rule, would remain legally effective.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, 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 Agencies 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). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the removal of the specified pedigree
requirements for prescription drug distribution in Sec.  203.50(a)
would not measurably decrease the estimated compliance costs of the
December 1999 final rule, the Agency proposes to certify that the final
rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``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 $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

    The Agency published a final rule on December 3, 1999, codified in
Sec.  203.50(a), that contained certain requirements concerning
prescription drug distribution. Specifically, it required that before
the wholesale distribution of any prescription drug to another
wholesale distributor or retail pharmacy for which the seller is not an
authorized distributor of record, the wholesale distributor must
provide to the purchaser a statement identifying each prior sale,
purchase or trade. Further, it contained a list of specific information
to be contained in the identifying statement. As explained previously,
this regulation is the subject of a preliminary injunction. In the
December 1999 final rule, the Agency estimated that the wholesale
distribution requirements, including the drug identifying (or origin)
statement and a separate distributor list to be provided by
manufacturers, would together impose $258,000 in annual recordkeeping
costs. In making this estimate, the Agency judged that the marginal
costs for the inclusion of the additional information that Sec.
203.50(a) would have required beyond that information that would be
required in the PDMA pedigree provision would be negligible, and did
not increase its cost estimate to reflect this additional effort. The
removal of Sec.  203.50(a), therefore, is expected to reduce compliance
costs by only that negligible amount that the Agency did not separately
estimate for the final rule, as the pedigree provision of the PDMA
still requires its own, slightly less expansive, pedigree provision.
This regulatory action that removes a provision of the December 1999
final rule is expected to reduce the previously estimated annual
compliance costs of $258,000 for this provision by a negligible, but
unquantified, amount.

V. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.30 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.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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, the Agency tentatively concludes that the proposed 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.

VIII. Proposed Effective Date

    The Agency is proposing that any final rule that may issue based
upon this proposed rule become effective upon its publication in the
Federal Register.

IX. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 203

    Labeling, Prescription drugs, Reporting and recordkeeping
requirements, Warehouses.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 203 be amended as follows:

PART 203--PRESCRIPTION DRUG MARKETING

    1. The authority citation for 21 CFR part 203 continues to read as
follows:

    Authority: 21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374,
381.

Sec.  203.50  [Amended]

    2. Section 203.50 is amended by removing and reserving paragraph
(a).

    Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17696 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 13, 2009 (Volume 74, Number 196)]
[Notices]
[Page 52493-52494]
[DOCID:fr13oc09-75]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0484]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Reagents for Detection of Specific Novel
Influenza A Viruses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on guidance on reagents for
detection of specific novel influenza A viruses.

DATES: Submit written or electronic comments on the collection of
information by December 14, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance on Reagents For Detection of Specific Novel Influenza A
Viruses-21 CFR 866.3332-(OMB Control Number 0910-0584)-Extension

    In accordance with section 513 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360c), FDA evaluated an application
for an in vitro diagnostic device for detection of influenza subtype H5
(Asian lineage), commonly known as avian flu. FDA concluded that this
device is properly classified into class II in accordance with 21
U.S.C. 360c(a)(1)(B), because it is a device for which the general
controls by themselves are insufficient to provide reasonable assurance
of the safety and effectiveness of the device, but there is sufficient
information to establish special controls to provide such assurance.
    The statute permits FDA to establish as special controls many
different things, including postmarket surveillance, development and
dissemination of guidance recommendations, and ``other appropriate
actions as the Secretary deems necessary'' (21 U.S.C. 360c(a)(1)(B)).
This information collection is a measure that FDA determined to be
necessary to provide reasonable assurance of safety and effectiveness
of reagents for detection of specific novel influenza A viruses.
    FDA issued an order classifying the H5 (Asian lineage) diagnostic
device into class II on February 3, 2006, establishing the special
controls necessary to provide reasonable assurance of the safety and
effectiveness of that device and similar future devices. The new
classification will be codified in 21 CFR 866.3332, a regulation that
will describe the new classification for reagents for detection of
specific novel influenza A viruses and set forth the special controls
that help to provide a reasonable assurance of the safety and
effectiveness of devices classified under that regulation. The
regulation will refer to the special controls guidance document
entitled ``Class II Special Controls Guidance Document: Reagents for
Detection of Specific Novel Influenza A Viruses,'' which provides
recommendations for measures to help provide a reasonable assurance of
safety and effectiveness for these reagents.
    The guidance document recommends that sponsors obtain and analyze
postmarket data to ensure the continued reliability of their device in
detecting the specific novel influenza A virus that it is intended to
detect, particularly given the propensity for influenza viruses to
mutate and the potential for changes in disease prevalence over time.
As updated sequences for novel influenza A viruses become available
from the World Health Organization, National Institutes of Health, and
other public health entities, sponsors of reagents for detection of
specific novel influenza A viruses will collect this information,
compare them with the primer/probe sequences in their devices, and
incorporate the result of these analyses into their quality management
system, as required by 21 CFR 820.100(a)(1). These analyses will be
evaluated against the device design validation and risk analysis
required by 21 CFR 820.30(g), to determine if any design changes may be
necessary.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section of the Federal Food, Drug, and        No. of        Annual Frequency     Total Annual        Hours per                         Total Operating &
             Cosmetic Act                  Respondents        per Response        Responses           Response         Total Hours     Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
513                                                    10                  2                 20                 10                200             $5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA estimates that 10 respondents will be affected annually. Each
respondent will collect this information twice per year, estimated to
take 10 hours. This results in a total data collection burden of 200
hours (10 x 20= 200). FDA estimates that cost of developing standard
operating procedures for each data collection is $500 (10 hours of work
at $50/hour). This results in a total cost to industry of $5,000 ($500
x 10 respondents).
    The guidance also refers to previously approved information
collections found in FDA regulations. The information collections in 21
CFR part 820 have been approved under OMB control number 0910-0073.

    Dated: October 5, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24544 Filed 10-9-09; 8:45 am]

BILLING CODE 4160-01-S