constitutes an amendment containing significant data or other
information.
    We also do not believe that it is necessary to include provisions
on ``minor'' amendments to ANDAs in Sec.  314.96. The ANDA amendments
guidance states that, except for those amendments that are classified
as ``major'' or ``telephone,'' amendments will be designated as
``minor,'' and the guidance provides examples of minor amendments
(e.g., deficiencies in a drug master file, problems regarding good
manufacturing practices). (According to the guidance, an amendment can
be classified as a ``telephone'' amendment at the agency's discretion
if the amendment would otherwise be classified as ``minor'' but the
deficiencies are of a limited number or complexity (e.g., a need for
clarification of data already submitted, a request for a postapproval
commitment).) The guidance states that we attempt to review minor
amendments within 30 to 60 days but notes that we cannot review all of
these amendments within 60 days. We believe that the comment's proposed
definition of minor amendment is not appropriate for the reasons we
stated for not adopting the proposed definition of major amendment. In
addition, we decline to adopt the specific provisions on minor
amendments suggested by the comment. The regulations in previous Sec.
314.94 on amendments to pending ANDAs did not address minor amendments
and did not parallel the provisions in Sec.  314.60 on NDA amendments.
Because ANDA amendments often differ in subject matter from NDA
amendments, we do not believe it is necessary that the provisions on
the content and timing of ANDA amendments match those for NDA
amendments. We believe that the ANDA amendments guidance provides
adequate information to ANDA applicants on minor amendments, and we do
not find it necessary to codify our policy in the regulations at this
time.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs 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 final rule is not a significant regulatory action under the
Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because our economic analysis and comments submitted
in response to the proposed rule show that the provisions of this final
rule either codify existing practice or bring about changes that impose
no significant burdens, the agency certifies 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 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 $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

A. Impact of the Final Rule

    As described in sections II and III of this document, the final
rule makes the following changes: (1) For NDAs and ANDAs, replaces the
two types of action letters currently used (approvable and not
approvable letters) with complete response letters; (2) for BLAs,
incorporates into the regulations an existing policy on complete
response letters; (3) incorporates into the regulations the terminology
and procedures used in the user fee performance goals regarding NDA
resubmissions; and (4) revises regulations governing extension of the
initial review cycle in response to major amendments to unapproved
applications, supplements, and resubmissions. For NDAs (with respect to
resubmissions and amendments) and BLAs, the final rule codifies current
agency practices. For ANDAs, the final rule revises regulations to be
consistent with current practice or, where appropriate, with the
provisions governing NDAs. The most significant impact of the final
rule is on efficacy supplements to approved NDAs and on

resubmissions of applications and efficacy supplements. The impact of
specific provisions of the final rule on NDAs, ANDAs, efficacy
supplements, manufacturing supplements, and resubmissions is described
in greater detail in the following paragraphs.
1. Complete Response Letter
    We are amending our regulations to replace approvable and not
approvable letters with complete response letters. Both approvable and
not approvable letters indicated that an NDA or ANDA was not approvable
in its current form, and that changes were necessary or that we
required additional information. A complete response letter describes
the deficiencies in an NDA or ANDA and, when possible, recommends
actions that the applicant might take to place the application in
condition for approval. In the past, some drug manufacturers expressed
concern that a not approvable letter sent an unintended message that a
marketing application would never be approved, which could adversely
affect a company's ability to raise capital. Thus, in addition to
allowing us to meet our commitments under the user fee performance
goals, this regulatory change addresses industry comments by adopting a
more neutral mechanism to convey that an NDA or ANDA cannot be approved
in its current form. (We had already adopted a policy of issuing
complete response letters for BLAs, and the final rule simply codifies
this policy.) Because this regulatory change is primarily
administrative in nature and is being made in response to the user fee
performance goals, it is expected to have little or no economic impact.
2. Resubmissions
    We also are making regulatory changes to implement the user fee
performance goals and to codify new terminology associated with the
resubmission of drug marketing applications. A Class 2 resubmission--
incorporating major changes or a significant amount of additional
data--would start a new 6-month review cycle, whereas a Class 1
resubmission--incorporating minor changes or a limited amount of
additional data--would begin a new 2-month review cycle. These changes
will codify agency practices regarding NDA resubmissions in place since
1998.
    We are applying the Class 1 and Class 2 provisions to resubmissions
of efficacy supplements as well. We agreed to make this policy change
in PDUFA III because efficacy supplements, like original NDAs, contain
varying amounts of data requiring different review times. We began to
implement this change in October 2002. The application of the Class 1
and Class 2 provisions to resubmissions of efficacy supplements
represents a regulatory change because under PDUFA II, all
resubmissions of efficacy supplements would start a new 6-month review
cycle. Under the final rule, a Class 1 resubmission of an efficacy
supplement will extend the review cycle by only 2 months, rather than 6
months as occurred under PDUFA II. Review times for Class 2 efficacy
supplement resubmissions will be largely unaffected by this change.
Based on data from 1996 to 2000 (the most recent 5-year period for
which complete data were available), an average of 16 efficacy
supplements (approximately 40 percent) resubmitted annually would be
reviewed in 2 months rather than the current 6 months. The final rule
generally maintains current agency practice with respect to the review
of other types of NDA supplements, i.e., for chemistry, manufacturing,
or labeling changes. For ANDA resubmissions, the rule codifies the
current practice of 6-month review.
3. Amendments to Unapproved Drug Marketing Applications
    We also are revising our regulations on extending the initial
review cycle following the submission of an amendment to an unapproved
drug marketing application. The previous regulations stated that, for
unapproved NDAs and efficacy supplements, submission of a major
amendment extended the review cycle for the amount of time necessary to
review the new information but not by more than 180 days. The final
rule generally extends the review cycle by 3 months if a major
amendment to an application, efficacy supplement, or resubmission of an
application or efficacy supplement is submitted within 3 months of the
end of the initial review cycle. (The final rule states that we may
defer review until a subsequent review cycle.) If a major amendment is
submitted more than 3 months before the end of the initial review
cycle, the review cycle will not be extended (but FDA, in its
discretion, may review the amendment during the initial review cycle or
defer it until the subsequent review cycle). These changes codify the
practice for NDAs that has been in place since 1998. However, we have
only recently begun to apply this policy to efficacy supplements.
Before October 2002, under the user fee performance goals, we did not
extend the review cycle for a major amendment to an efficacy
supplement. Therefore, as with the change regarding resubmissions of
efficacy supplements, we believe that it is appropriate to treat the
change regarding amendments to unapproved efficacy supplements as a
regulatory change for purposes of this analysis.
    These provisions of the final rule might slightly increase review
times for efficacy supplements for which at least one major amendment
was received within 3 months of the end of the initial review cycle.
Based on data from 1996 to 2000, these regulatory changes could affect
as many as 11 percent of all efficacy supplements filed, or an average
of 15 per year. The effect of this change is dependent on the timing of
future filings and the number of instances in which we exercise our
review discretion.
    The final rule also codifies our practice of extending the initial
review cycle for a manufacturing supplement by 2 months when a major
amendment is submitted within 2 months of the end of the initial review
cycle. As with major amendments to efficacy supplements, before October
2002, we did not extend the review cycle for a major amendment for a
manufacturing supplement, so we are treating this codification as a
regulatory change.
    This change regarding manufacturing supplements might slightly
increase review times for these supplements for which at least one
major amendment was received within 2 months of the end of the initial
review cycle. Based on data from 1996 to 2000, this regulatory change
could affect as many as 6 percent of all manufacturing supplements
filed, or an average of 76 per year. The effect of this change is
dependent on the timing of future filings and the number of instances
in which we exercise our review discretion.
    With respect to amendments to ANDAs, the changes to the regulations
codify our current approach.

B. Summary of Impacts

    Based on the preceding analysis, the changes to provisions
governing resubmissions could result in reduced review times for up to
40 percent of efficacy supplements resubmitted annually. However, the
provisions governing major amendments could slightly increase review
times for up to 11 percent of efficacy supplements and 6 percent of
manufacturing supplements (for which at least one major amendment was
received during the initial review cycle) filed annually. The full
impact of this rule would be affected by the number of future
submissions and the extent to which we exercise our discretion to defer
review until the next cycle. ANDAs will not be

significantly affected by the changes to regulations.

C. Comments

    We received one comment on the analysis of economic impacts in the
proposed rule. The comment noted that we did not perform a cost-benefit
analysis because the proposed rule was not expected to cause
expenditure of $100 million or more. The comment stated that this would
be a concern only if the rule brought about negative implications, but
the comment stated that, if anything, the rule will bring economic
enhancement. The comment maintained that: (1) More meaningful and
direct communications will allow companies to market drugs and vaccines
better; (2) the time to marketing might be shortened; and (3) more
efficient application procedures will help companies optimize their
earnings goals.
    We agree with the comment that the rule will not have a negative
economic impact on applicants seeking approval of drug and biological
products.

D. Conclusion

    Because this final rule generally amends previous regulations
governing applications for approval to market new drugs and generic
drugs to reflect user fee terminology and performance goals that have
already been incorporated into FDA policies (except with respect to
complete response letters, as noted above), we certify that the rule
will not have a significant economic impact on a substantial number of
small entities. Therefore, no further analysis is required under the
Regulatory Flexibility Act.

V. Environmental Impact

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

VI. Paperwork Reduction Act of 1995

    This final rule does not contain new information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). The final rule substitutes complete response letters
for approvable and not approvable letters (in previous Sec. Sec.
314.110 and 314.120, respectively) when we take action on marketing
applications. The final rule retains the provisions requiring the
recipient of the action letter (a complete response letter under the
final rule) to amend the application (i.e., resubmit it), withdraw it,
or ask us to provide an opportunity for a hearing on whether there are
grounds for denying approval of the application. The final rule also
revises the regulations (Sec. Sec.  314.60, 314.96, 314.110, and
314.120) on extending the review cycle due to the submission of
amendments before we issue an action letter and due to resubmissions,
but does not change the information required in such amendments and
resubmissions. OMB already has approved the information collection
discussed earlier concerning responses to action letters under OMB
control number 0910-0001, which expires on May 31, 2011.
    The final rule also establishes regulations on the issuance of
complete response letters to biologics license applicants and
supplement applicants. The final rule codifies current agency practice
on the issuance of complete response letters to these applicants and on
applicant actions in response to these letters (resubmission or
withdrawal of the application or supplement). OMB has already approved
the information collection concerning responses to complete response
letters for BLAs and BLA supplements under OMB control number 0910-
0338, which expires on June 30, 2010.
    We conclude that this final rule contains no new collection of
information. Therefore, OMB clearance under the PRA is not required.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has 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 have concluded 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.

List of Subjects

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 314

    Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 600

    Biologics, Reporting and recordkeeping requirements.

21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
312, 314, 600, and 601 are amended as follows:

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

0
1. The authority citation for 21 CFR part 312 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 371,
381, 382, 383, 393; 42 U.S.C. 262.

0
2. Section 312.84 is amended in paragraph (c) by revising the first
sentence to read as follows:

Sec.  312.84   Risk-benefit analysis in review of marketing
applications for drugs to treat life-threatening and severely-
debilitating illnesses.

* * * * *
    (c) If FDA concludes that the data presented are not sufficient for
marketing approval, FDA will issue a complete response letter under
Sec.  314.110 of this chapter or the biological product licensing
procedures. * * *
* * * * *

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

0
3. The authority citation for 21 CFR part 314 is revised to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a,
356b, 356c, 371, 374, 379e.

0
4. Section 314.3 is amended in paragraph (b) by removing the
definitions for ``Approvable letter'' and ``Not approvable letter'' and
by adding the following definitions in alphabetical order:

Sec.  314.3   Definitions

* * * * *
    (b) * * *
    Class 1 resubmission means the resubmission of an application or
efficacy supplement, following receipt of a complete response letter,
that

contains one or more of the following: Final printed labeling, draft
labeling, certain safety updates, stability updates to support
provisional or final dating periods, commitments to perform
postmarketing studies (including proposals for such studies), assay
validation data, final release testing on the last lots used to support
approval, minor reanalyses of previously submitted data, and other
comparatively minor information.
    Class 2 resubmission means the resubmission of an application or
efficacy supplement, following receipt of a complete response letter,
that includes any item not specified in the definition of ``Class 1
resubmission,'' including any item that would require presentation to
an advisory committee.
    Complete response letter means a written communication to an
applicant from FDA usually describing all of the deficiencies that the
agency has identified in an application or abbreviated application that
must be satisfactorily addressed before it can be approved.
* * * * *
    Efficacy supplement means a supplement to an approved application
proposing to make one or more related changes from among the following
changes to product labeling:
    (1) Add or modify an indication or claim;
    (2) Revise the dose or dose regimen;
    (3) Provide for a new route of administration;
    (4) Make a comparative efficacy claim naming another drug product;
    (5) Significantly alter the intended patient population;
    (6) Change the marketing status from prescription to over-the-
counter use;
    (7) Provide for, or provide evidence of effectiveness necessary
for, the traditional approval of a product originally approved under
subpart H of part 314; or
    (8) Incorporate other information based on at least one adequate
and well-controlled clinical study.
* * * * *
    Original application means a pending application for which FDA has
never issued a complete response letter or approval letter, or an
application that was submitted again after FDA had refused to file it
or after it was withdrawn without being approved.
* * * * *
    Resubmission means submission by the applicant of all materials
needed to fully address all deficiencies identified in the complete
response letter. An application or abbreviated application for which
FDA issued a complete response letter, but which was withdrawn before
approval and later submitted again, is not a resubmission.
* * * * *

Sec.  314.50   [Amended]

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5. Section 314.50 is amended in paragraph (d)(5)(vi)(b) in the fourth
sentence by removing the phrase ``following receipt of an approvable
letter'' and by adding in its place the phrase ``in a resubmission
following receipt of a complete response letter''.

0
6. Section 314.60 is amended as follows:
    a. By revising the section heading;
    b. By revising paragraph (a);
    c. By redesignating paragraphs (b) and (c) as paragraphs (c) and
(d), respectively;
    d. By adding new paragraph (b); and
    e. By revising newly redesignated paragraphs (c)(1)(iii) and
(c)(1)(iv), and the first sentence of paragraph (c)(2), to read as
follows:

Sec.  314.60   Amendments to an unapproved application, supplement, or
resubmission.

    (a) FDA generally assumes that when an original application,
supplement to an approved application, or resubmission of an
application or supplement is submitted to the agency for review, the
applicant believes that the agency can approve the application,
supplement, or resubmission as submitted. However, the applicant may
submit an amendment to an application that has been filed under Sec.
314.101 but is not yet approved.
    (b)(1) Submission of a major amendment to an original application,
efficacy supplement, or resubmission of an application or efficacy
supplement within 3 months of the end of the initial review cycle
constitutes an agreement by the applicant under section 505(c) of the
act to extend the initial review cycle by 3 months. (For references to
a resubmission of an application or efficacy supplement in paragraph
(b) of this section, the timeframe for reviewing the resubmission is
the ``review cycle'' rather than the ``initial review cycle.'') FDA may
instead defer review of the amendment until the subsequent review
cycle. If the agency extends the initial review cycle for an original
application, efficacy supplement, or resubmission under this paragraph,
the division responsible for reviewing the application, supplement, or
resubmission will notify the applicant of the extension. The initial
review cycle for an original application, efficacy supplement, or
resubmission of an application or efficacy supplement may be extended
only once due to submission of a major amendment. FDA may, at its
discretion, review any subsequent major amendment during the initial
review cycle (as extended) or defer review until the subsequent review
cycle.
    (2) Submission of a major amendment to an original application,
efficacy supplement, or resubmission of an application or efficacy
supplement more than 3 months before the end of the initial review
cycle will not extend the cycle. FDA may, at its discretion, review
such an amendment during the initial review cycle or defer review until
the subsequent review cycle.
    (3) Submission of an amendment to an original application, efficacy
supplement, or resubmission of an application or efficacy supplement
that is not a major amendment will not extend the initial review cycle.
FDA may, at its discretion, review such an amendment during the initial
review cycle or defer review until the subsequent review cycle.
    (4) Submission of a major amendment to a manufacturing supplement
within 2 months of the end of the initial review cycle constitutes an
agreement by the applicant under section 505(c) of the act to extend
the initial review cycle by 2 months. FDA may instead defer review of
the amendment until the subsequent review cycle. If the agency extends
the initial review cycle for a manufacturing supplement under this
paragraph, the division responsible for reviewing the supplement will
notify the applicant of the extension. The initial review cycle for a
manufacturing supplement may be extended only once due to submission of
a major amendment. FDA may, at its discretion, review any subsequent
major amendment during the initial review cycle (as extended) or defer
review until the subsequent review cycle.
    (5) Submission of an amendment to a supplement other than an
efficacy or manufacturing supplement will not extend the initial review
cycle. FDA may, at its discretion, review such an amendment during the
initial review cycle or defer review until the subsequent review cycle.
    (6) A major amendment may not include data to support an indication
or claim that was not included in the original application, supplement,
or resubmission, but it may include data to support a minor
modification of an indication or claim that was included in the
original application, supplement, or resubmission.
    (7) When FDA defers review of an amendment until the subsequent
review cycle, the agency will notify the applicant of the deferral in
the complete response letter sent to the applicant under Sec.  314.110
of this part.

    (c)(1) * * *
    (iii) The applicant has not obtained a right of reference to the
investigation described in paragraph (c)(1)(ii) of this section; and
    (iv) The report of the investigation described in paragraph
(c)(1)(ii) of this section would be essential to the approval of the
unapproved application.
    (2) The submission of an amendment described in paragraph (c)(1) of
this section will cause the unapproved application to be deemed to be
withdrawn by the applicant under Sec.  314.65 on the date of receipt by
FDA of the amendment. * * *
* * * * *

0
7. Section 314.65 is amended by revising the second sentence to read as
follows:

Sec.  314.65   Withdrawal by the applicant of an unapproved
application.

    * * * If, by the time it receives such notice, the agency has
identified any deficiencies in the application, we will list such
deficiencies in the letter we send the applicant acknowledging the
withdrawal. * * *

Sec.  314.71   [Amended]

0
8. Section 314.71 is amended in paragraph (c) by adding the phrase
``except as specified otherwise in this part'' at the end of the
sentence.

0
9. Section 314.96 is amended by revising paragraph (a)(2) and by
removing paragraph (a)(3) to read as follows:

Sec.  314.96   Amendments to an unapproved abbreviated application.

    (a) * * *
    (2) Submission of an amendment containing significant data or
information before the end of the initial review cycle constitutes an
agreement between FDA and the applicant to extend the initial review
cycle only for the time necessary to review the significant data or
information and for no more than 180 days.
* * * * *

0
10. Section 314.100 is revised to read as follows:

Sec.  314.100   Timeframes for reviewing applications and abbreviated
applications.

    (a) Except as provided in paragraph (c) of this section, within 180
days of receipt of an application for a new drug under section 505(b)
of the act or an abbreviated application for a new drug under section
505(j) of the act, FDA will review it and send the applicant either an
approval letter under Sec.  314.105 or a complete response letter under
Sec.  314.110. This 180-day period is called the ``initial review
cycle.''
    (b) At any time before approval, an applicant may withdraw an
application under Sec.  314.65 or an abbreviated application under
Sec.  314.99 and later submit it again for consideration.
    (c) The initial review cycle may be adjusted by mutual agreement
between FDA and an applicant or as provided in Sec. Sec.  314.60 and
314.96, as the result of a major amendment.

0
11. Section 314.101 is amended by revising paragraph (f)(1)(ii) and by
revising the last sentence of paragraph (f)(2) to read as follows:

Sec.  314.101   Filing an application and receiving an abbreviated new
drug application.

* * * * *
    (f)(1) * * *
    (ii) Issue a notice of opportunity for a hearing if the applicant
asked FDA to provide it an opportunity for a hearing on an application
in response to a complete response letter.
    (2) * * * If FDA disapproves the abbreviated new drug application,
FDA will issue a notice of opportunity for hearing if the applicant
asked FDA to provide it an opportunity for a hearing on an abbreviated
new drug application in response to a complete response letter.
* * * * *

0
12. Section 314.102 is amended in the last sentence in paragraph (b) by
removing the phrase ``an action'' and adding in its place the phrase
``a complete response'' and by revising paragraph (d) to read as
follows:

Sec.  314.102   Communications between FDA and applicants.

* * * * *
    (d) End-of-review conference. At the conclusion of FDA's review of
an NDA as designated by the issuance of a complete response letter, FDA
will provide the applicant with an opportunity to meet with agency
reviewing officials. The purpose of the meeting will be to discuss what
further steps need to be taken by the applicant before the application
can be approved. Requests for such meetings must be directed to the
director of the division responsible for reviewing the application.
* * * * *

Sec.  314.103   [Amended]

    13. Section 314.103 is amended in paragraph (c)(1) in the first
sentence by removing the phrase ``an approvable or not approvable'' and
adding in its place the phrase ``a complete response'' and by removing
the phrase ``or Sec.  314.120, respectively''.

Sec.  314.105   [Amended]

0
14. Section 314.105 is amended in paragraph (b) in the first sentence
by removing the phrase ``(rather than an approvable letter under Sec.
314.110)''.

0
15. Section 314.107 is amended by adding a new sentence at the
beginning of paragraph (b)(3)(v) to read as follows:

Sec.  314.107   Effective date of approval of a 505(b)(2) application
or abbreviated new drug application under section 505(j) of the act.

* * * * *
    (b) * * *
    (3) * * *
    (v) FDA will issue a tentative approval letter when tentative
approval is appropriate in accordance with paragraph (b)(3) of this
section. * * *
* * * * *

0
16. Section 314.110 is revised to read as follows:

Sec.  314.110   Complete response letter to the applicant.

    (a) Complete response letter. FDA will send the applicant a
complete response letter if the agency determines that we will not
approve the application or abbreviated application in its present form
for one or more of the reasons given in Sec.  314.125 or Sec.  314.127,
respectively.
    (1) Description of specific deficiencies. A complete response
letter will describe all of the specific deficiencies that the agency
has identified in an application or abbreviated application, except as
stated in paragraph (a)(3) of this section.
    (2) Complete review of data. A complete response letter reflects
FDA's complete review of the data submitted in an original application
or abbreviated application (or, where appropriate, a resubmission) and
any amendments that the agency has reviewed. The complete response
letter will identify any amendments that the agency has not yet
reviewed.
    (3) Inadequate data. If FDA determines, after an application is
filed or an abbreviated application is received, that the data
submitted are inadequate to support approval, the agency might issue a
complete response letter without first conducting required inspections
and/or reviewing proposed product labeling.
    (4) Recommendation of actions for approval. When possible, a
complete response letter will recommend actions that the applicant
might take to place the application or abbreviated application in
condition for approval.
    (b) Applicant actions. After receiving a complete response letter,
the applicant must take one of following actions:

    (1) Resubmission. Resubmit the application or abbreviated
application, addressing all deficiencies identified in the complete
response letter.
    (i) A resubmission of an application or efficacy supplement that
FDA classifies as a Class 1 resubmission constitutes an agreement by
the applicant to start a new 2-month review cycle beginning on the date
FDA receives the resubmission.
    (ii) A resubmission of an application or efficacy supplement that
FDA classifies as a Class 2 resubmission constitutes an agreement by
the applicant to start a new 6-month review cycle beginning on the date
FDA receives the resubmission.
    (iii) A resubmission of an NDA supplement other than an efficacy
supplement constitutes an agreement by the applicant to start a new
review cycle the same length as the initial review cycle for the
supplement (excluding any extension due to a major amendment of the
initial supplement), beginning on the date FDA receives the
resubmission.
    (iv) A major resubmission of an abbreviated application constitutes
an agreement by the applicant to start a new 6-month review cycle
beginning on the date FDA receives the resubmission.
    (v) A minor resubmission of an abbreviated application constitutes
an agreement by the applicant to start a new review cycle beginning on
the date FDA receives the resubmission.
    (2) Withdrawal. Withdraw the application or abbreviated
application. A decision to withdraw an application or abbreviated
application is without prejudice to a subsequent submission.
    (3) Request opportunity for hearing. Ask the agency to provide the
applicant an opportunity for a hearing on the question of whether there
are grounds for denying approval of the application or abbreviated
application under section 505(d) or (j)(4) of the act, respectively.
The applicant must submit the request to the Associate Director for
Policy, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Within 60 days of the date of the request for an opportunity for a
hearing, or within a different time period to which FDA and the
applicant agree, the agency will either approve the application or
abbreviated application under Sec.  314.105, or refuse to approve the
application under Sec.  314.125 or abbreviated application under Sec.
314.127 and give the applicant written notice of an opportunity for a
hearing under Sec.  314.200 and section 505(c)(1)(B) or (j)(5)(c) of
the act on the question of whether there are grounds for denying
approval of the application or abbreviated application under section
505(d) or (j)(4) of the act, respectively.
    (c) Failure to take action. (1) An applicant agrees to extend the
review period under section 505(c)(1) or (j)(5)(A) of the act until it
takes any of the actions listed in paragraph (b) of this section. For
an application or abbreviated application, FDA may consider an
applicant's failure to take any of such actions within 1 year after
issuance of a complete response letter to be a request by the applicant
to withdraw the application, unless the applicant has requested an
extension of time in which to resubmit the application. FDA will grant
any reasonable request for such an extension. FDA may consider an
applicant's failure to resubmit the application within the extended
time period or to request an additional extension to be a request by
the applicant to withdraw the application.
    (2) If FDA considers an applicant's failure to take action in
accordance with paragraph (c)(1) of this section to be a request to
withdraw the application, the agency will notify the applicant in
writing. The applicant will have 30 days from the date of the
notification to explain why the application should not be withdrawn and
to request an extension of time in which to resubmit the application.
FDA will grant any reasonable request for an extension. If the
applicant does not respond to the notification within 30 days, the
application will be deemed to be withdrawn.

Sec.  314.120   [Removed and Reserved]

0
17. Section 314.120 is removed and reserved.

Sec.  314.125   [Amended]

    18. Section 314.125 is amended in paragraph (a)(1) by removing the
phrase ``an approvable or a not approvable'' and adding in its place
the phrase ``a complete response'', and by removing the phrase ``or
Sec.  314.120''.

Sec.  314.430   [Amended]

    19. Section 314.430 is amended in paragraph (b) in the first
sentence by removing the phrase ``approvable letter is sent to the
applicant under Sec.  314.110'' and adding in its place the phrase
``approval letter is sent to the applicant under Sec.  314.105 or
tentative approval letter is sent to the applicant under Sec.
314.107''; and by removing the last sentence.

0
20. Section 314.440 is amended as follows:
    a. In paragraph (a)(1) by removing the phrase ``Document and
Records Section'' and by adding in its place the phrase ``Central
Document Room'';
    b. In paragraph (a)(3) by removing the phrase ``or Sec.  314.120'';
    c. In the introductory text of paragraph (b) by removing the phrase
``or Sec.  314.120''; and
    d. By revising paragraph (a)(2) to read as follows:

Sec.  314.440   Addresses for applications and abbreviated
applications.

    (a) * * *
    (2) Except as provided in paragraph (a)(4) of this section, an
abbreviated application under Sec.  314.94, and amendments,
supplements, and resubmissions should be directed to the Office of
Generic Drugs (HFD-600), Center for Drug Evaluation and Research, Food
and Drug Administration, Metro Park North II, 7500 Standish Place, rm.
150, Rockville, MD 20855. This includes items sent by parcel post or
overnight courier service. Correspondence not associated with an
abbreviated application should be addressed specifically to the
intended office or division and to the person as follows: Office of
Generic Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, Attn: [insert name of person], Metro Park North II,
HFD-[insert mail code of office or division], 7500 Standish Place, rm.
150, Rockville, MD 20855. The mail code for the Office of Generic Drugs
is HFD-600, the mail codes for the Divisions of Chemistry I, II, and
III are HFD-620, HFD-640, and HFD-630, respectively, and the mail code
for the Division of Bioequivalence is HFD-650.
* * * * *

PART 600--BIOLOGICAL PRODUCTS: GENERAL

0
21. The authority citation for 21 CFR part 600 continues to read as
follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371,
374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

0
22. Section 600.3 is amended by adding new paragraphs (ll) and (mm) to
read as follows:

Sec.  600.3  Definitions.

* * * * *
    (ll) Complete response letter means a written communication to an
applicant from FDA usually describing all of the deficiencies that the
agency has identified in a biologics license application or supplement
that must be satisfactorily addressed before it can be approved.
    (mm) Resubmission means a submission by the biologics license
applicant or supplement applicant of all

materials needed to fully address all deficiencies identified in the
complete response letter. A biologics license application or supplement
for which FDA issued a complete response letter, but which was
withdrawn before approval and later submitted again, is not a
resubmission.

PART 601--LICENSING

0
23. The authority citation for 21 CFR part 601 continues to read as
follows:

    Authority:  15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec. 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note).

Sec.  601.3  [Added]

0
24. Section 601.3 is added to subpart A to read as follows:

Sec.  601.3  Complete response letter to the applicant.

    (a) Complete response letter. The Food and Drug Administration will
send the biologics license applicant or supplement applicant a complete
response letter if the agency determines that it will not approve the
biologics license application or supplement in its present form.
    (1) Description of specific deficiencies. A complete response
letter will describe all of the deficiencies that the agency has
identified in a biologics license application or supplement, except as
stated in paragraph (a)(2) of this section.
    (2) Inadequate data. If FDA determines, after a biologics license
application or supplement is filed, that the data submitted are
inadequate to support approval, the agency might issue a complete
response letter without first conducting required inspections, testing
submitted product lots, and/or reviewing proposed product labeling.
    (3) Recommendation of actions for approval. When possible, a
complete response letter will recommend actions that the applicant
might take to place its biologics license application or supplement in
condition for approval.
    (b) Applicant actions. After receiving a complete response letter,
the biologics license applicant or supplement applicant must take
either of the following actions:
    (1) Resubmission. Resubmit the application or supplement,
addressing all deficiencies identified in the complete response letter.
    (2) Withdrawal. Withdraw the application or supplement. A decision
to withdraw the application or supplement is without prejudice to a
subsequent submission.
    (c) Failure to take action. (1) FDA may consider a biologics
license applicant or supplement applicant's failure to either resubmit
or withdraw the application or supplement within 1 year after issuance
of a complete response letter to be a request by the applicant to
withdraw the application or supplement, unless the applicant has
requested an extension of time in which to resubmit the application or
supplement. FDA will grant any reasonable request for such an
extension. FDA may consider an applicant's failure to resubmit the
application or supplement within the extended time period or request an
additional extension to be a request by the applicant to withdraw the
application.
    (2) If FDA considers an applicant's failure to take action in
accordance with paragraph (c)(1) of this section to be a request to
withdraw the application, the agency will notify the applicant in
writing. The applicant will have 30 days from the date of the
notification to explain why the application or supplement should not be
withdrawn and to request an extension of time in which to resubmit the
application or supplement. FDA will grant any reasonable request for an
extension. If the applicant does not respond to the notification within
30 days, the application or supplement will be deemed to be withdrawn.

    Dated: June 26, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15608 Filed 7-9-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52682-52684]
[FR Doc No: 2016-18881]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9950-42-OA]

Request for Nominations for a Science Advisory Board Panel To
Review Risk and Technology Review Screening Methods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The EPA Science Advisory Board (SAB) Staff Office requests
public nominations of scientific experts to form a Panel to review the
draft EPA report entitled ``Screening Methodologies to Support Risk and
Technology Reviews (RTR).'' This draft report describes newly developed
screening methods designed to assess the risk to public health and the
environment that would remain after stationary sources of hazardous air
pollutants come into compliance with the EPA's Maximum Available
Control Technologies (MACT) standards.

DATES: Nominations should be submitted by August 30, 2016 per the
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact the Designated Federal Officer. Nominators unable to submit
nominations electronically as described below may contact the
Designated Federal Officer for assistance. General information
concerning the EPA SAB can be found at the EPA SAB Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    Background: The SAB (42 U.S.C. 4365) is a chartered Federal
Advisory Committee that provides independent scientific and technical
peer review, advice, and recommendations to the EPA Administrator on
the technical basis for EPA actions. As a Federal Advisory Committee,
the SAB conducts business in accordance with the Federal Advisory
Committee Act (FACA) (5 U.S.C. App. 2) and related regulations. The SAB
RTR Methods Review Panel will provide advice through the chartered SAB
on scientific and technical issues related to assessing risks to public
health and the

environment from hazardous air pollutants. The SAB and this Panel will
comply with the provisions of FACA and all appropriate SAB Staff Office
procedural policies.
    EPA's Office of Air and Radiation (OAR) has prepared a draft report
entitled ``Screening Methodologies to Support Risk and Technology
Reviews (RTR): A Case Study Analysis.'' The Clean Air Act (CAA)
establishes a two-stage regulatory process for addressing emissions of
hazardous air pollutants (HAPs) from stationary sources. In the first
stage, the CAA requires the EPA to develop technology-based standards,
known as Maximum Achievable Control Technology (MACT) standards, for
categories of industrial sources. In the second stage, the EPA must
review each MACT standard at least every eight years and revise them as
necessary, taking into account developments in practices, processes and
control technologies. EPA must also conduct an assessment of the health
and environmental risks that remain after stationary sources come into
compliance with the MACT standards. Periodically, the SAB is asked to
review the methods that OAR uses to estimate risks as these methods
evolve or as new methods are developed. Thus, OAR has requested the SAB
to review EPA's draft report that describes newly enhanced screening
methods designed to estimate the potential risks to public health and
the environment that would remain after stationary sources of HAPs come
into compliance with EPA's MACT standards. These include screening
methods to estimate the potential for multi-pathway risks (e.g.,
ingestion, inhalation) from persistent and bioaccumulative HAPs,
screening methods to estimate potential environmental risks, and recent
enhancements to the EPA's inhalation risk assessment methodology. The
SAB Staff Office is forming an expert panel, the SAB RTR Methods Review
Panel, under the auspices of the Chartered SAB to conduct this review.
    Technical Contact for EPA's draft report: For information
concerning the draft report ``Screening Methodologies to Support Risk
and Technology Reviews (RTR): A Case Study Analysis'' please contact
Dr. Michael Stewart by email at<EMAIL_ADDRESS>or phone (919)
541-7524.
    Request for Nominations: The SAB Staff Office is seeking
nominations of nationally and internationally recognized scientists
with demonstrated expertise in the following disciplines: Human health
risk assessment, ecological risk assessment, exposure assessment,
toxicology, ecology, aquatic toxicology, air toxics, and dispersion
modeling. Additional information about this advisory activity is
available on the SAB Web site at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/RTR%20Screening%20Methods%20Review?OpenDocument. Questions regarding
this advisory activity should be directed to Dr. Suhair Shallal,
Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice
mail at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, or via email at
<EMAIL_ADDRESS>    Process and Deadline for Submitting Nominations: Any interested
person or organization may nominate qualified individuals in the areas
of expertise described above for possible service on the SAB RTR
Methods Review Panel identified in this notice. Individuals may self-
nominate. Nominations should be submitted in electronic format
(preferred over hard copy) following the instructions for ``Nominating
Experts to Advisory Panels and Ad Hoc Committees Being Formed,''
provided on the SAB Web site (see the ``Nomination of Experts'' link
under ``Current Activities'' at http://www.epa.gov/sab). To receive
full consideration, nominations should include all of the information
requested below.
    EPA's SAB Staff Office requests contact information about the
person making the nomination; contact information about the nominee;
the disciplinary and specific areas of expertise of the nominee; the
nominee's resume or curriculum vitae; sources of recent grant and/or
contract support; and a biographical sketch of the nominee indicating
current position, educational background, research activities, and
recent service on other national advisory committees or national
professional organizations.
    Persons having questions about the nomination procedures, or who
are unable to submit nominations through the SAB Web site, should
contact Dr. Shallal as indicated above in this notice. Nominations
should be submitted in time to arrive no later than August 30, 2016.
EPA values and welcomes diversity. In an effort to obtain nominations
of diverse candidates, EPA encourages nominations of women and men of
all racial and ethnic groups.
    The EPA SAB Staff Office will acknowledge receipt of nominations.
The names and biosketches of qualified nominees identified by
respondents to this Federal Register notice, and additional experts
identified by the SAB Staff Office, will be posted in a List of
Candidates for the panel on the SAB Web site at http://www.epa.gov/sab.
Public comments on the List of Candidates will be accepted for 21 days.
The public will be requested to provide relevant information or other
documentation on nominees that the SAB Staff Office should consider in
evaluating candidates.
    For the EPA SAB Staff Office a balanced review panel includes
candidates who possess the necessary domains of knowledge, the relevant
scientific perspectives (which, among other factors, can be influenced
by work history and affiliation), and the collective breadth of
experience to adequately address the charge. In forming the expert
panel, the SAB Staff Office will consider public comments on the Lists
of Candidates, information provided by the candidates themselves, and
background information independently gathered by the SAB Staff Office.
Selection criteria to be used for panel membership include: (a)
Scientific and/or technical expertise, knowledge, and experience
(primary factors); (b) availability and willingness to serve; (c)
absence of financial conflicts of interest; (d) absence of an
appearance of a loss of impartiality; (e) skills working in committees,
subcommittees and advisory panels; and, (f) for the panel as a whole,
diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial
conflicts of interest will include a review of the ``Confidential
Financial Disclosure Form for Environmental Protection Agency Special
Government Employees'' (EPA Form 3110-48). This confidential form
allows government officials to determine whether there is a statutory
conflict between a person's public responsibilities (which include
membership on an EPA federal advisory committee) and private interests
and activities, or the appearance of a loss of impartiality, as defined
by federal regulation. The form may be viewed and downloaded from the
following URL address http://yosemite.epa.gov/sab/sabproduct.nsf/Web/ethics?OpenDocument.
    The approved policy under which the EPA SAB Office selects members
for subcommittees and review panels is described in the following
document: Overview of the Panel Formation Process at the Environmental
Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is
posted on the SAB Web site at https://yosemite.epa.gov/sab/
sabproduct.nsf/WebFiles/OverviewPanelForm/$File/ec02010.pdf.

    Dated: August 3, 2016.
Thomas H. Brennan,
 Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2016-18881 Filed 8-8-16; 8:45 am]
BILLING CODE 6560-50-P


CONTACT REPORT From: Vince Hellwig Date of Contact: August 12, 2002 Company/ Agency: Permitting, CARB Person Contacted: Bruce Nixon Subject: Mag Tape RR   Intermag, Inc.

CONTACT SUMMARY: I had a return call today from Bruce Nixon, Permitting, CARB about Intermag, Inc., 4910 Raley Boulevard, Sacramento, CA 95838. Bruce said that Intermag closed all operations and went out of business " a number of years ago." Therefore, we can drop Intermag from our source list.


[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Proposed Rules]
[Pages 68029-68030]
[FR Doc No: 2020-23225]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0127; FRL-10015-74-Region 3]

Air Plan Approval; Maryland; Ozone Interprecursor Trading Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
State of Maryland. This revision pertains to the expansion in the use
of Emission Reduction Credits (ERCs) when new or modified major
stationary sources of ozone precursors are required to obtain emission
offsets within the State of Maryland. This action is being taken under
the Clean Air Act (CAA).

DATES: Written comments must be received on or before November 27,
2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2020-0127 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Cynthia Stahl, Permits Branch (3AD10),
Air & Radiation Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. The telephone
number is<PHONE_NUMBER>. Ms. Stahl can also be reached via electronic
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 31, 2020, the State of Maryland
submitted a revision to its SIP to allow the use of interprecursor
trading (IPT) within the state to satisfy the emission offset
requirements for new or modified major stationary sources under the New
Source Review (NSR) program pertaining to ground level ozone. Volatile
Organic Compound (VOC) and Nitrogen Oxide (NOX) are ozone
precursor pollutants. The Maryland SIP revisions would allow for new or
modified major stationary sources seeking emission offsets to obtain
either VOC or NOX offsets provided that these are obtained
within Maryland and in an area designated with the same or greater
stringency as the area in which the new or modified source is located.

I. Background

    The revision consists of amendments to Code of Maryland Regulations
(COMAR) 26.11.17, Nonattainment Provisions for Major New Sources and
Major Modifications, Sections .01, Definitions, and .04, Creating
Emission Reduction Credits, Air Quality. The revision is applicable to
major new sources and major modifications of sources whose potential
VOC and/or NOX emissions trigger the emission offset
requirements under COMAR 26.11.17. Maryland contains the Baltimore
Ozone Nonattainment area but is also entirely within the Ozone
Transport Region (OTR). The Clean Air Act requires that areas within
the OTR must meet ozone nonattainment area requirements that would
apply if they were classified as moderate ozone nonattainment areas.
For both of these types of ozone nonattainment areas, in accordance
with current requirements, sources would need to offset each ton of VOC
or NOX with more than one ton of ERCs. This greater than
one-for-one offset requirement would continue to apply under the
Maryland IPT program.
    On December 6, 2018, EPA finalized its ozone implementation rule
pertaining to the 2015 Ozone NAAQS (83 FR 62998). With this rule, among
other provisions, EPA described a discretionary IPT program that would
allow any new or modified major stationary source located in an ozone
nonattainment area to satisfy the nonattainment NSR emission offset
requirements for ozone with emission reductions from VOC or
NOX, interchangeably. These requirements are codified at 40
CFR 51.165(a)(11). Under this program, the IPT ratio, substantiated by
EPA approved air quality modeling, is required to be established to
ensure that an equivalent or greater air quality benefit is obtained to
achieve reasonable further progress toward attainment of the ozone
standard for the designated ozone nonattainment area.

II. Summary of SIP Revision and EPA Analysis

    Maryland's revision to COMAR <IP_ADDRESS> adds the definition for
interprecursor trading, which includes a reference to the new COMAR
<IP_ADDRESS> regulation. Maryland's revision to COMAR <IP_ADDRESS>
pertains to its Nonattainment New Source Review (NNSR) program, which
requires that facilities obtain ERCs. COMAR <IP_ADDRESS> requires that
the facilities seeking the option of IPT must meet the current
requirements for ERCs including those pertaining to location,
determination of the amount of ERCs needed for the new source via the
baseline to actual emissions calculations, and eligibility determined
by the date of creation of the ERCs. COMAR <IP_ADDRESS> further
specifies that the IPT ratio must be determined by an approved EPA air
quality modeling methodology and the IPT ratio cannot be less than the
emission offset ratio specified in COMAR <IP_ADDRESS>B(3). The approving
authority for the interprecursor trade is the Maryland Department of
the Environment and such approval is granted on a case-by-case and a
permit specific basis.
    EPA has reviewed the Maryland revisions to COMAR <IP_ADDRESS> and
.04 and determined that they meet the EPA 2015 ozone implementation
final rule published in the Federal Register at 83 FR 62998, December
6, 2018.

III. Proposed Action

    EPA's review of this material indicates the Maryland amendments to
COMAR <IP_ADDRESS> and .04, Air Quality: Nonattainment Provisions for
Major New Sources and Major Modifications pertaining to

interprecursor trading meets the requirements at 40 CFR 51.165(a)(11).
EPA is proposing to approve the Maryland Department of the
Environment's SIP revision to add the definition of interprecursor
trading to COMAR <IP_ADDRESS> and to add the requirements for the IPT
program through COMAR <IP_ADDRESS>. EPA is proposing to approve
Maryland's NNSR IPT program, which was submitted on January 31, 2020.
EPA is soliciting public comments on the issues discussed in this
document. These comments will be considered before taking final action.

IV. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference COMAR <IP_ADDRESS>, effective on April 9, 2018, and COMAR
<IP_ADDRESS>, effective on December 30, 2019 described in Sections II
and III of this preamble. EPA has made, and will continue to make,
these materials generally available through https://www.regulations.gov
and at the EPA Region III Office (please contact the person identified
in the FOR FURTHER INFORMATION CONTACT section of this preamble for
more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because it is not a significant regulatory
action under Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking, addressing the ozone
interprecursor trading requirements in Maryland, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the State, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: October 9, 2020.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2020-23225 Filed 10-26-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)]
[Rules and Regulations]
[Pages 20825-20829]
[FR Doc No: 2017-09029]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]
RIN 0910-ZA48

Food Labeling; Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments; Extension of
Compliance Date; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; extension of compliance date; request for
comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
compliance date for the final rule requiring disclosure of certain
nutrition information for standard menu items in certain restaurants
and retail food establishments. In the Federal Register of December 30,
2016, we stated that the compliance date for the final rule would be
May 5, 2017. We are extending the compliance date to May 7, 2018. We
are taking this action to enable us to consider how we might further
reduce the regulatory burden or increase

flexibility while continuing to achieve our regulatory objectives, in
keeping with the Administration's policies.

DATES: Compliance date: As of May 4, 2017, the compliance date for
covered establishments set out in the final rule published December 1,
2014 (79 FR 71156), and extended in final rules published on July 10,
2015 (80 FR 39675) and December 30, 2016 (81 FR 96364), is further
extended. Covered establishments must comply with the rule published
December 1, 2014 (79 FR 71156), by May 7, 2018.
    Comment date: Submit either electronic or written comments
regarding this compliance date extension, implementation of the
December 2014 final rule, and the various topics flagged in the
SUPPLEMENTARY INFORMATION section of this document, by July 3, 2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 3, 2017. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-F-0172 for ``Food Labeling; Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments;
Extension of Compliance Date; Request for Comments.'' Received
comments, those filed in a timely manner (see DATES), will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Division of Dockets Management. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, 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: Felicia B. Billingslea, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71156), we
published a final rule requiring disclosure of certain nutrition
information for standard menu items in certain restaurants and retail
food establishments. The final rule, which is now codified at Sec.
101.11 (21 CFR 101.11), implements provisions of section 403(q)(5)(H)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H))
and:
     Defines terms, including terms that describe criteria for
determining whether an establishment is subject to the rule;
     establishes which foods are subject to the nutrition
labeling requirements and which foods are not subject to these
requirements;
     requires that calories for standard menu items be declared
on menus and menu boards that list such foods for sale;
     requires that calories for standard menu items that are
self-service or on display be declared on signs adjacent to such foods;
     requires that written nutrition information for standard
menu items be available to consumers who ask to see it;
     requires, on menus and menu boards, a succinct statement
concerning suggested daily caloric intake (succinct statement),
designed to help the public understand the significance of the calorie
declarations;
     requires, on menus and menu boards, a statement regarding
the availability of the written nutrition information (statement of
availability);
     establishes requirements for determination of nutrient
content of standard menu items;
     establishes requirements for substantiation of nutrient
content

determined for standard menu items, including requirements for records
that a covered establishment must make available to FDA within a
reasonable period of time upon request; and
     establishes terms and conditions under which restaurants
and similar retail food establishments not otherwise subject to the
rule could elect to be subject to the requirements by registering with
FDA.
    In the preamble to the final rule (79 FR 71156 at 71239 through
71241), we stated that the rule would be effective on December 1, 2015,
and also provided a compliance date of December 1, 2015, for covered
establishments. The final rule (at Sec.  101.11(a)) defines ``covered
establishment'' as a restaurant or similar retail food establishment
that is a part of a chain with 20 or more locations doing business
under the same name (regardless of the type of ownership, e.g.,
individual franchises) and offering for sale substantially the same
menu items, as well as a restaurant or similar retail food
establishment that is voluntarily registered to be covered under Sec.
101.11(d).

II. Extension of the Compliance Date and Request for Comments

    In the Federal Register of July 10, 2015 (80 FR 39675), in response
to requests from affected entities, we announced our decision to extend
the compliance date for the final rule to December 1, 2016.
    On December 18, 2015, the President signed the Consolidated
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of that law
states that none of the funds made available under the Consolidated
Appropriations Act may be used to implement, administer, or enforce the
final rule entitled ``Food Labeling; Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments''
until the later of December 1, 2016 or 1 year after the date we publish
a Level 1 guidance with respect to nutrition labeling of standard menu
items in restaurants and similar retail food establishments.
    In the Federal Register of May 5, 2016 (81 FR 27067), we announced
the availability of the Level 1 guidance document and stated that
enforcement of the final rule published December 1, 2014, would
commence on May 5, 2017 (81 FR 27067 at 27068). In the Federal Register
of December 30, 2016 (81 FR 96364), we confirmed that the compliance
date would be May 5, 2017.
    This interim final rule extends the compliance date to May 7, 2018.
We are taking this action consistent with Executive Orders 13777,
13771, and 13563, as well as in response to the diverse and complex set
of stakeholders affected by the rule and continued, numerous, and
fundamental questions they raise regarding the final rule and its
implementation. The continued, fundamental questions and concerns with
the final rule suggest that critical implementation issues, including
some related to scope, may not have been fully understood and the
agency does not want to proceed if we do not have all of the relevant
facts on these matters. Retailers with many different and diverse
business models have raised concerns about how the rule lacks
flexibility to permit them to provide meaningful nutrition information
to consumers given their type of business and different operations.
Moreover, we continue to receive many questions about calorie
disclosure signage for self-service foods, including buffets and grab-
and-go foods. We do not want to proceed with a rule that might turn out
to be too inflexible to support innovation in delivering information to
consumers. In addition, we have received questions regarding how to
distinguish a menu, which requires the posting of calorie information,
from advertisements and other marketing pieces, which do not require
calorie information. Many of these menu questions are complex and have
highlighted for the agency the need for further consideration and
clarification. How to address the natural calorie variations for foods
has also been raised by stakeholders as an issue that needs additional
guidance and clarity. Finally, some entities with certain business
models have stated that they continue to have questions about what
provisions of the final rule are applicable to them. We believe
questions like this still need to be addressed.
    The previous extensions, as well as Congressional concern regarding
implementation expressed through letters and appropriations law, are a
reflection of the challenge in implementing this rule for a diverse
industry of approximately 298,600 covered establishments, organized
under 2,130 chains, that we estimated to be covered by the 2014 final
rule. Executive Order 13777, ``Enforcing the Regulatory Reform Agenda''
(82 FR 12285, March 1, 2017), sets forth a policy to alleviate
unnecessary regulatory burdens. Given the principles and policies set
forth in these executive orders, particularly with respect to reducing
burdens, reducing costs, maintaining flexibility, and improving
effectiveness, we have decided to extend the compliance date to May 7,
2018. The additional time will allow us to consider what opportunities
there may be to address these fundamental and complex questions and
reduce the cost and enhance the flexibility of these requirements
beyond those reflected in the final rule. Given our decision to
reconsider the rule consistent with these Executive Orders, it would
not make sense to require establishments covered by our final rule to
come into compliance with the rule (for which compliance is not yet
required), as well as incur additional ongoing costs to maintain or
update compliance, when these requirements may change as a result of
our reconsideration of the rule. We solicit comment on the extension of
the compliance date.
    To assist us in our review, we invite interested parties to submit
comments on how we might further reduce the regulatory burden or
increase flexibility while continuing to achieve our regulatory
objectives to provide consumers with nutrition information so that they
can make informed choices for themselves and their families. In
particular, and in light of the issues we have noted above, we are
interested in hearing about approaches to reduce the regulatory burden
or increase flexibility with respect to:
    (1) Calorie disclosure signage for self-service foods, including
buffets and grab-and-go foods;
    (2) methods for providing calorie disclosure information other than
on the menu itself, including how different kinds of retailers might
use different methods; and
    (3) criteria for distinguishing between menus and other information
presented to the consumer. (See ADDRESSES for instructions on
submitting comments.) These questions have been identified by
stakeholders as among the fundamental issues that continue to pose
significant implementation challenges. As of April 7, 2017, we have
received five requests for an extension of the compliance period, which
we will add to the docket. In addition, on April 5, 2017, a request to
stay the effective date was submitted to FDA (see Docket No. FDA-2017-
P-2164); this request is currently under consideration.
    To the extent that 5 U.S.C. 553 applies to this extension of the
compliance date, the action is exempt from notice and comment because
it constitutes a rule of procedure under 5 U.S.C. 553(b)(A).
Alternatively, to the extent that the notice-and-comment and delayed
effective date requirements set forth in 5 U.S.C. 553 applies to this
action, the implementation of this action without opportunity for
public comment, effective immediately upon publication today in the
Federal Register, is based

on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Given
the imminence of the compliance date (May 5, 2017), and the fact that,
as discussed above, a number of regulated establishments continue to
raise numerous, complex questions about applicability of the menu
labeling requirements and about how to implement them, we have decided
that providing an opportunity for public comment would be impracticable
and contrary to the public interest. This is because providing
immediate notice to covered establishments of the additional time to
come into compliance allows for more efficient planning and accounting
for implementation of requirements, thus reducing regulatory burden and
costs on affected entities. In addition, providing immediate notice
that there will be additional time to comply is necessary so that
affected entities can avoid incurring immediate costs and efficiently
plan and account for implementation of the requirements by the imminent
compliance date. Good cause exists to delay the compliance date without
comment and effective immediately. In accordance with 21 CFR
10.40(e)(1), however, we note that interested parties may provide
comment on the compliance date extension, including whether it should
be modified or revoked. In addition, interested parties may submit
comments on how we might further reduce the regulatory burden or
increase flexibility while continuing to achieve our regulatory
objectives with respect to providing consumers with nutrition
information so that they can make informed choices for themselves and
their families. In addition, as we have done throughout this complex
rulemaking process, we will continue to work with stakeholders as we go
forward.

III. Economic Analysis of Impacts

    We have examined the impacts of the interim 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 new regulations shall ``be
offset by the elimination of existing costs associated with at least
two prior regulations.'' We have developed an Economic Analysis of
Impacts that assesses the impacts of the interim final rule, including
cost savings to industry and foregone benefits to consumers. We
estimate at least one type of impact in at least one year to be greater
than $100 million. Thus, we believe that this interim final rule is an
economically 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 this rule reduces the burden on covered
establishments by further extending the compliance date for the ``Food
Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and
Similar Retail Food Establishments'' final rule (79 FR 71156, December
1, 2014 (final rule); 80 FR 39675, July 10, 2015 (extending the
compliance date to December 1, 2016); 81 FR 96364, December 30, 2016
(clarifying extension of the compliance date to May 5, 2017)), we
certify the interim 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 $148
million, using the most current (2016) Implicit Price Deflator for the
Gross Domestic Product. This interim final rule would not result in an
expenditure by industry in any year that meets or exceeds this amount.
    This interim final rule extends the compliance date to May 7, 2018,
for the final rule requiring disclosure of certain nutrition
information for standard menu items in certain restaurants and similar
retail food establishments. The principal benefit of this interim final
rule will be the reduction in costs to covered establishments
associated with extending the compliance date by one year. The total
annualized benefit (i.e., cost savings) of this interim final rule,
using a 3-percent discount rate over 20 years, would be from $2 to $6
million; with a 7-percent discount rate, the annualized benefit would
be $3 to $8 million. The principal cost of this interim final rule will
be the reduction in benefits to consumers associated with extending the
compliance date by one year. The total annualized cost (i.e., foregone
benefits) of this interim final rule, using a 3-percent discount rate
over 20 years, would be from $5 to $15 million; with a 7-percent
discount rate, the annualized cost would be $6 to $19 million.
Extending the compliance date of the ``Food Labeling: Nutrition
Labeling of Standard Menu Items in Restaurants and Similar Retail Food
Establishments'' final rule by one year reduces the annualized net
benefits (discounted at 3 percent) approximately 1 percent, from $506
million to $501 million. While average annualized net benefits decrease
by $5 million, they are still positive. We recognize that there may be
additional costs and benefits to both consumers and covered
establishments that we do not have the data to quantify here. We are
presenting the estimated benefits and costs of the menu labeling final
rule, which takes effect according to the dates in this interim final
rule. These quantitative estimates reflect an assumed baseline in which
the menu labeling regulation eventually goes fully into effect. If
statutory or other changes that are separate from FDA rulemaking were
to impact full implementation, the quantitative benefits estimates
would be lower and the quantitative cost estimates higher than shown
here. We invite comment on both this Regulatory Impact Analysis and the
Regulatory Impact Analysis for the December 2014 final rule.
    The full analysis of economic impacts is available in the docket
for this interim final rule (Ref. 1) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IV. Paperwork Reduction Act

    This interim final 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.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) 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.

VI. Reference

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically

at https://www.regulations.gov. FDA has verified the Web site
addresses, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.

1. FDA, interim economic impact analysis for ``Food Labeling;
Nutrition Labeling of Standard Menu Items in Restaurants and Similar
Retail Food Establishments; Extension of Compliance Date; Request
for Comment,'' April 2017. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

    Dated: May 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09029 Filed 5-1-17; 4:15 pm]
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