[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Rules and Regulations]
[Pages 20636-20637]
[FR Doc No: 2021-08059]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0264]
RIN 1625-AA00

Safety Zone; Gulf of Mexico, Port Fouchon, LA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters within a \1/2\ mile radius around a capsized
vessel in the Gulf of Mexico, near Port Fourchon, LA. The temporary
safety zone is needed to protect life and property during emergency
search and rescue and salvage operations surrounding the capsized
vessel. Entry of vessels or persons into this zone and movement of
vessels within this zone is prohibited unless specifically authorized
by the Captain of the Port Marine Safety Unit Houma or a designated
representative.

DATES: This rule is effective without actual notice from 12:01 a.m.
until 11:59 p.m. on April 21, 2021. For the purposes of enforcement,
actual notice will be used from April 14, 2021 through April 20, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0264 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email the Lieutenant Commander Joe Hart, Incident Management
Team, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. A safety zone is
necessary to facilitate search and rescue and salvage operations
surrounding a capsized vessel. Immediate action is needed to respond to
the potential safety hazards associated with recovery operations. We we
must establish this safety zone by April 14, 2021 and and lack
sufficient time to provide a reasonable comment period and then
consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be against the public interest because immediate action
is needed to respond to an ongoing search and rescue and salvage
operations.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Marine Safety Unit Houma (COTP) has
determined that potential hazards associated with the response
operations on April 14, 2021, will be a safety concern for anyone
within a \1/2\ mile radius around the capsized vessel at position 29-
00.000 N, 090-12.000 W. This rule is needed to protect life and
property on the navigable waters while response operation are ongoing.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from April 14, 2021
through April 21, 2021. The safety zone will cover all navigable waters
within half mile radius around position 29-00.000 N, 090-12.000 W in
the Gulf of Mexico, near Port Fouchon, LA. The duration of the zone is
intended to protect life and property on these navigable waters for the
duration of emergency response operations related to the capsized
vessel. No vessel or person will be permitted to enter and move within
the safety zone without obtaining permission from the COTP or a
designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Marine Safety
Unit Houma. Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. They may be
contacted on VHF-FM Channel 16 or 67. Persons and vessels permitted to
enter or to move within this safety zone must transit at their slowest
safe speed and comply with all lawful directions issued by the COTP or
the designated representative. The COTP or a designated representative
will inform the public of the enforcement periods and changes through
Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs),
and/or Marine Safety Information Bulletins (MSIBs) as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the limited scale
of the safety zone and the ease of vessel traffic navigating around
said zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone that will prohibit entry within a \1/2\ mile radius of
vessels and machinery being used by personnel response operations to a
capsized vessel. It is categorically excluded from further review under
paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. A Record of Environmental Consideration supporting this
determination is not required but will be made available in the docket
if necessary. For instructions on locating the docket, see the
ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0264 to read as follows:

Sec.  165.T08-0264  Safety Zone; Gulf of Mexico, Port Fourchon, LA.

    (a) Location. The following area is a safety zone: all navigable
waters within a \1/2\ mile radius of the capsized vessel and emergency
response operations taking place at 29-00.000 N, 090-12.000 W.
    (b) Effective period. This section is effective without actual
notice from 12:01 a.m. until 11:59 p.m. on April 21, 2021. For the
purposes of enforcement, actual notice will be used from April 14, 2021
through April 20, 2021.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into or remaining within this zone is prohibited
unless authorized by the Captain of the Port Marine Safety Unit (COTP)
or designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Marine Safety
Unit Houma.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. They may be
contacted on VHF-FM Channel 16 or 67 or by telephone at<PHONE_NUMBER>.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by COTP or the designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement times and date for this
safety zone through Broadcast Notices to Mariners (BNMs), Local Notices
to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs)
as appropriate.

    Dated: April 14, 2021.
K.J. McCormack,
Commander, U.S. Coast Guard, Acting Captain of the Port Marine Safety
Unit Houma.
[FR Doc. 2021-08059 Filed 4-20-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Notices]
[Pages 59410-59411]
[FR Doc No: 2022-21286]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2232-846]

Duke Energy Carolinas, LLC; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-project use of project lands and water.
    b. Project No: 2232-846.
    c. Date Filed: September 12, 2022.
    d. Applicant: Duke Energy Carolinas, LLC.
    e. Name of Project: Catawba-Wateree Hydroelectric Project.
    f. Location: Lake Hickory in the Oxford Development of the Catawba-
Wateree Hydroelectric Project located in Burke County, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Dennis Whitaker, Duke Energy Carolinas,
LLC, 526 South Church St./EC12Q, Charlotte, North Carolina, 28202;
phone<PHONE_NUMBER>.
    i. FERC Contact: Ms. Joy Kurtz,<PHONE_NUMBER>, [email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: October 26, 2022.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. The first page of any filing should
include docket number P-2232-846. Comments emailed to Commission staff
are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests Commission
approval to grant the City of Hickory (City) permission to use project
lands and water within the project boundary on Lake Hickory for the
operation of the existing Long View Water Intake Facility (Facility).
The City purchased the Facility from the previous owner in 2016, and
since then, has been using the Facility as an emergency back-up for its
primary water intake facility, located outside of the project boundary.
Therefore, the City only operates the Facility in the event that its
primary intake is unavailable due to natural disaster, accidental
spill, or other similar circumstances. When in operation, the maximum
withdrawal rate of the Facility is 2 million gallons per day (MGD). The
City is not proposing to modify the Facility in any way; therefore,
there is no construction associated with the request.
    l. Locations of the Application: The Commission provides all
interested persons an opportunity to view and/or print the contents of
this document via the internet through the Commission's website at
http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number
excluding the last three digits in the docket number field to access
the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or email [email protected], for TTY, call
(202) 502-8659. Agencies may obtain copies of the application directly
from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214,

respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: September 26, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-21286 Filed 9-29-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 29, 2008 (Volume 73, Number 41)]
[Notices]
[Page 11191]
[DOCID:fr29fe08-149]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2008-0009, Notice No. 1]

Establishment of an Emergency Relief Docket for Calendar Year
2008

AGENCY: Federal Railroad Administration (FRA), DOT.

ACTION: Notice of establishment of public docket.

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SUMMARY: On August 30, 2006, FRA published an Interim Final Rule (IFR)
addressing the establishment of emergency relief dockets (ERD) and the
procedures for handling petitions for emergency waivers of safety
regulations. 71 FR 51517. The IFR provided that each year, FRA will
establish an ERD for that year and publish a notice in the Federal
Register identifying the docket number of the ERD for that year. This
Notice announces the establishment of FRA's ERD for the current year
(calendar year 2008). The designated ERD for calendar year 2008 is
docket number FRA-2008-0009.

ADDRESSES: See SUPPLEMENTARY INFORMATION section for further
information regarding submitting petitions and/or comments to Docket
No. FRA-2008-0009.

SUPPLEMENTARY INFORMATION: On August 30, 2006, FRA published an IFR
addressing the establishment of ERD and the procedures for handling
petitions for emergency waivers of safety rules, regulations, or
standards during an emergency situation or event. 71 FR 51517. As noted
in the IFR, FRA's purpose for establishing the ERD and emergency waiver
procedures is to provide an expedited process for FRA to address the
needs of the public and the railroad industry during emergency
situations or events. The IFR added Sec.  211.45 to subpart C of 49 CFR
part 211 (49 CFR 211.45). Section 211.45(b) provides that each calendar
year FRA will establish an ERD in the publicly accessible DOT docket
system and that FRA will publish a notice in the Federal Register
identifying by docket number the ERD for that year. This Notice No. 1
announces that the designated ERD for calendar year 2008 is docket
number FRA-2008-0009.
    As detailed in the IFR, if the FRA Administrator determines that an
emergency event as defined in 49 CFR 211.45(a) has occurred, or that an
imminent threat of such an emergency occurring exists, and public
safety would benefit from providing the railroad industry with
operational relief, the emergency waiver procedures of 49 CFR 211.45
will go into effect. 70 FR 51518. In such an event, the FRA
Administrator will issue a statement in the ERD indicating that the
emergency waiver procedures are in effect and FRA will make every
effort to post the statement on its Web site http://www.fra.dot.gov/.
Any party desiring relief from FRA regulatory requirements as a result
of the emergency situation should submit a petition for emergency
waiver in accordance with 49 CFR 211.45(e) and (f). Specific
instructions for filing petitions for emergency waivers in accordance
with 49 CFR 211.45 are found at 49 CFR 211.45(f). Specific instructions
for filing comments in response to petitions for emergency waivers are
found at 49 CFR 211.45(h).

Privacy

    Anyone is able to search all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review DOT's complete Privacy Act
Statement in the Federal Register published on April 11, 2000 (Volume
665, Number 7, Pages 19477-78). The statement may also be found at
http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on February 25, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. 08-889 Filed 2-28-08; 8:45 am]

BILLING CODE 4910-06-M


[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Proposed Rules]
[Pages 25-34]
[FR Doc No: 2011-33622]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-2011-N-0697]

Amendments to Regulations on Citizen Petitions, Petitions for
Stay of Action, and Submission of Documents to Dockets

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
certain regulations relating to citizen petitions, petitions for stay
of action, and the submission of documents to the Agency. In
particular, the proposed rule would establish new regulations to
implement certain provisions of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), which concern certain citizen petitions and petitions
for stay of action (PSAs) that involve a request for FDA to take any
form of action relating to a pending abbreviated new drug application
(ANDA) or 505(b)(2) application. We are making these changes to
implement provisions of the Food and Drug Administration Amendments Act
of 2007 (FDAAA).

DATES: Submit either electronic or written comments by April 2, 2012.
Submit comments on information collection issues under the Paperwork
Reduction Act of 1995 by February 2, 2012, (see section ``VI. Paperwork
Reduction Act of 1995'' of this document). See section II.E of this
document for the proposed effective date of a final rule based on this
proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0697, by any of the following methods; except that comments on
information collection issues under the Paperwork Reduction Act of 1995
must be submitted to the Office of Regulatory Affairs, Office of
Management and Budget (OMB) (see the ``Paperwork Reduction Act of
1995'' section of this document).

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. FDA-2011-N-0697 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:
    Nicole Mueller, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6312,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Enactment of Section 505(q)

    On September 27, 2007, Congress enacted FDAAA (Pub. L. 110-85).
Section 914 of title IX of FDAAA added new section 505(q) to the FD&C
Act (21 U.S.C. 355(q)). Section 505(q) applies to certain citizen
petitions and PSAs (collectively referred to as petitions) that request
FDA to take any form of action related to a pending application
submitted under section 505(b)(2) or (j) of the FD&C Act (21 U.S.C.
355(b)(2) or (j)). An application submitted under section 505(b)(2) of
the FD&C Act is a type of new drug application (NDA) described in that
subsection and is referred to in this document as a ``505(b)(2)
application.'' An application submitted under section 505(j) is an ANDA
for a generic drug product.
    Section 505(q) governs the manner in which FDA handles certain
citizen petitions and PSAs that ask the Agency to take any form of
action related to pending 505(b)(2) applications or ANDAs. Over the
years, FDA has received numerous petitions asking the Agency not to
approve a particular ANDA or 505(b)(2) application (or classes of these
applications concerning a particular drug product or active ingredient)
unless certain criteria set forth in the petition are met. In many
cases, the petitions have raised scientific and/or legal issues
relating to the standards for approval of an application. Examples
include: Petitions suggesting a particular method for determining the
bioequivalence of a proposed generic product to the reference listed
drug (RLD) and petitions maintaining that a proposed generic product
does not contain the same active ingredient as the RLD. When submitted
early, such as when we are making decisions about the bioequivalence
requirements for a generic drug product or before we have received the
first ANDA or 505(b)(2) application for a drug product, a petition
containing material information can assist us in establishing standards
for these applications. However, when petitions are submitted late in
the review process for challenged applications and do not raise valid
scientific and/or legal issues, they may have the effect of improperly
delaying the approval of an application. By enacting section 505(q),
Congress indicated a desire to ensure that petitions not be used to
improperly delay approval of ANDAs and 505(b)(2) applications.

B. Provisions of Section 505(q) of the FD&C Act

    Section 505(q)(1)(A) of the FD&C Act specifies that FDA must not
delay approval of a pending ANDA or 505(b)(2) application because of
any request to take any form of action relating to the application,
unless the request is in writing and in a citizen petition submitted
under Sec.  10.30 (21 CFR 10.30) or a PSA submitted under Sec.  10.35
(21 CFR 10.35), and the Agency determines, upon reviewing the petition,
that a delay is necessary to protect the public health.
    Section 505(q)(1)(F) of the FD&C Act governs the timeframe for
final Agency action on a petition. Under this provision, FDA must take
final Agency action on a petition not later than 180 days after the
date on which the petition

is submitted. The 180-day period is not to be extended for any reason
including any determination made under section 505(q)(1)(A) regarding
delay of approval of an application (i.e., that delay is necessary to
protect the public health), the submission of comments or supplemental
information, or the consent of the petitioner. In addition, FDA may
deny a petition at any point if it determines that a petition or a
supplement to the petition was submitted with the primary purpose of
delaying the approval of an application and the petition does not on
its face raise valid scientific or regulatory issues (section
505(q)(1)(E) of the FD&C Act). FDA may issue guidance to describe the
factors that will be used to determine whether a petition is submitted
with the primary purpose of delaying the approval of an application
(section 505(q)(1)(E) of the FD&C Act).
    Section 505(q) of the FD&C Act also includes certification and
verification requirements for certain documents. Under section
505(q)(1)(H) of the FD&C Act, FDA may not consider a petition for
review unless the petition is in writing and signed and contains a
certification that is specified in that section. In addition, we may
not accept for review any supplemental information or comments on a
petition unless the submission is in writing and signed and contains a
specific verification (section 505(q)(1)(I) of the FD&C Act).

II. Description of the Proposed Rule

    FDA is proposing to amend our regulations on general administrative
procedures in part 10 (21 CFR part 10) to implement section 505(q) of
the FD&C Act. We are proposing to add new Sec.  10.31, which includes
the following provisions:
     Proposed Sec.  10.31(a) states that Sec.  10.31 would
encompass all citizen petitions and PSAs that request that the Agency
take any action that could, if taken, delay approval of an ANDA or
505(b)(2) application (i.e., petitions and PSAs that are or may be
subject to section 505(q) of the FD&C Act).
     Proposed Sec.  10.31(b) would clarify the date of
submission for petitions submitted under Sec.  10.31.
     Proposed Sec.  10.31(c) and (d) would codify the
certification and verification requirements of section 505(q)(1)(H) and
(I). Although the certification and verification requirements of
section 505(q)(1)(H) and (I) include that the document be signed, we
have not proposed a regulation that explicitly states that submissions
under Sec.  10.31 or Sec.  10.35 must be signed because current Sec.
10.20 requires that all submissions made to the Division of Dockets
Management be signed.
    We are also proposing minor revisions to Sec. Sec.  10.20 and 10.30
to conform with the addition of proposed Sec.  10.31.
    With respect to Sec.  10.35, administrative stay of action, we are
proposing a revision to conform with the implementation of section
505(q). We are also proposing to add new Sec.  10.35(i) to clarify that
a petitioner for a stay of action may supplement, amend, or withdraw a
PSA, similar to the provision for citizen petitions in current Sec.
10.30(g).
    In addition to implementing the provisions in section 505(q) of the
FD&C Act, we are proposing minor technical changes to revise Sec. Sec.
10.30(e)(3) and 10.35(e) to allow the Commissioner of Food and Drugs
(the Commissioner) to dismiss petitions as moot.

A. Submission Date for a Citizen Petition Submitted Under Section
505(q) of the FD&C Act

    Proposed Sec.  10.31(b) would make clear that for a petition that
could be subject to section 505(q) of the FD&C Act and submitted under
proposed Sec.  10.31, the date of submission is the date on which the
petition is received by the Division of Dockets Management. Proposed
Sec.  10.31(b) also states that the petition must be submitted in
accordance with Sec. Sec.  10.20, 10.30, 10.31, and 10.35, the other
relevant regulations regarding citizen petitions and PSAs.
1. Current Regulations Regarding Submission Dates
    We are proposing Sec.  10.31(b) because under current Sec.
10.20(e), the submission date for documents submitted to the Division
of Dockets Management depends on how the document is submitted to FDA.
Current Sec.  10.20(e) states that all submissions to the Division of
Dockets Management will be considered as submitted on the date they are
postmarked or, if delivered in person during regular business hours, on
the date on which they are delivered. The date considerations in
current Sec.  10.20(e) apply unless a provision in part 10, an
applicable Federal Register notice, or an order issued by an
administrative law judge specifically states that the documents must be
received by a specified date. Section 10.20(e) provides as an example
Sec.  10.33(g), which states that a petition for reconsideration will
be considered submitted on the date received.
    Under current Sec.  10.20(e), which applies to all citizen
petitions submitted to the Agency, the computation of time to respond
to a citizen petition would depend on the type of delivery service by
which a document is sent to the Division of Dockets Management
regardless of the date on which it is actually received by the Division
of Dockets Management. Therefore, it is possible for two petitions to
have different submission dates even if they are received by the
Division of Dockets Management on the same day. For example, if
Petition A is sent by U.S. mail, postmarked May 1, 2010, and received
by the Division of Dockets Management on May 5, 2010, the submission
date for Petition A would be considered to be May 1, 2010 (the date of
postmark). If Petition B is sent by courier and hand delivered to the
Division of Dockets Management on May 5, 2010, the submission date for
Petition B would be considered to be May 5, 2010.
    Other part 10 regulations also relate to submission dates:
     Under Sec.  10.35(g), a PSA is considered submitted on the
day it is received by the Division of Dockets Management. Therefore,
under the current regulations, a document's submission date could be
different depending on whether the document is a citizen petition or a
PSA.
     Under Sec.  10.30(e), FDA is required to respond to a
citizen petition within 180 days of receipt of the petition by
approving the petition, denying the petition, or providing a tentative
response indicating why the Agency has been unable to reach a decision;
this 180-day deadline is based on the date of receipt by the Division
of Dockets Management.
2. Submission Date for Petitions Submitted Under Proposed Sec.  10.31
    We believe that it is important to be clear regarding what date a
petition submitted under Sec.  10.31 will be considered to be submitted
because section 505(q)(1)(F) of the FD&C Act imposes a strict deadline
for FDA to respond to a petition. Under section 505(q)(1)(F) of the
FD&C Act, FDA must take final Agency action on a petition subject to
section 505(q) no later than 180 days after the date on which the
petition is submitted. The 180-day period is not to be extended for any
reason, including any determination made under section 505(q)(1)(A) of
the FD&C Act regarding delay of approval of an application, the
submission of comments or supplemental information, or the consent of
the petitioner.
    Accordingly, proposed Sec.  10.31(b) would make clear that the date
of submission for all petitions subject to Sec.  10.31 and submitted in
accordance with Sec. Sec.  10.20, 10.30, 10.31, and 10.35 is the date
on which a petition is received

by the Division of Dockets Management. We are proposing a conforming
change to Sec.  10.20 to clarify that the method of calculating
submission dates described in Sec.  10.20 does not apply to petitions
subject to Sec.  10.31.

B. Certification and Verification

1. Current Regulation on Certification for Citizen Petitions
    Current Sec.  10.30 regulating citizen petitions requires that a
citizen petition contain, among other things, a certification stating
that the citizen petition includes all information and views on which
the citizen petition relies and that it includes data and information
known to the petitioner which are unfavorable to the citizen petition.
Current regulations do not include a certification or verification
requirement for supplements or comments to a citizen petition or
comments to a PSA, and the current requirements are different than
those contained in section 505(q) of the FD&C Act.
2. Certification and Verification Required by Section 505(q) of the
FD&C Act
    Section 505(q)(1)(H) of the FD&C Act requires that any petition
subject to section 505(q) include a specified certification. Section
505(q)(1)(I) of the FD&C Act requires that any comments or supplemental
information submitted to a petition subject to section 505(q) include a
specified verification. We propose to add Sec.  10.31(c) and (d) to our
regulation to include the statutory requirement for the submission of a
certification and/or a verification under section 505(q) and the
precise language of the certification and verification.
3. Proposed Certification Requirement
    Consistent with the specific language provided in section 505(q) of
the FD&C Act, proposed Sec.  10.31(c) provides that FDA will not
consider a petition subject to Sec.  10.31 for review unless the
petition is in writing and contains the following certification: ``I
certify that, to my best knowledge and belief: (a) This petition
includes all information and views upon which the petition relies; (b)
this petition includes representative data and/or information known to
the petitioner which are unfavorable to the petition; and (c) I have
taken reasonable steps to ensure that any representative data and/or
information which are unfavorable to the petition were disclosed to me.
I further certify that the information upon which I have based the
action requested herein first became known to the party on whose behalf
this petition is submitted on or about the following date: ------------
. If I received or expect to receive payments, including cash and other
forms of consideration, to file this information or its contents, I
received or expect to receive those payments from the following persons
or organizations: ------------ . I verify under penalty of perjury that
the foregoing is true and correct as of the date of the submission of
this petition.''
    Proposed Sec.  10.31(c) would require that all petitions that
request that FDA take any form of action that could, if taken, delay
approval of an ANDA or 505(b)(2) application (i.e., petitions that are
subject to Sec.  10.31) contain the complete certification required by
Sec.  10.31(c) to be considered for review by FDA. If the petition does
not contain the complete certification, we will not review the
petition.
4. Proposed Verification Requirement
    Consistent with the specific language in section 505(q) of the FD&C
Act, proposed Sec.  10.31(d) provides that FDA will not accept for
review any supplemental information or comments on a petition subject
to Sec.  10.31 unless the supplemental information or comments are in
writing and contain the following verification: ``I certify that, to my
best knowledge and belief: (a) I have not intentionally delayed
submission of this document or its contents; and (b) the information
upon which I have based the action requested herein first became known
to me on or about ---------------- . If I received or expect to receive
payments, including cash and other forms of consideration, to file this
information or its contents, I received or expect to receive those
payments from the following persons or organizations: ----------------
. I verify under penalty of perjury that the foregoing is true and
correct as of the date of the submission of this document.''
    We are proposing one minor editorial change to the language of the
verification set out in the statute. We propose to change ``I verify
under penalty of perjury that the foregoing is true and correct as of
the date of the submission of this petition'' to ``I verify under
penalty of perjury that the foregoing is true and correct as of the
date of the submission of this document'' (emphasis added). We are
proposing this change because we believe that the statute contained a
technical error when referring to a ``petition'' and that the obvious
congressional intent is that this reference be to the ``document'' in
which the verification would be contained (i.e., supplemental
information or comments on a petition rather than a petition itself).
    Under proposed Sec.  10.31(d), if any supplemental information or
comments that are submitted to a petition subject to Sec.  10.31 do not
include the required verification, FDA would not review the submission.
5. Proposed Requirement That the Certification and Verification Use the
Exact Language in the Regulation
    With the addition of proposed Sec.  10.31(c) and (d), our
regulation would include the precise language of the required
certification and verification. We have found that petitioners
occasionally alter the statutory language of the certification and
verification, thereby potentially changing the meaning intended by
Congress when it enacted section 505(q) of the FD&C Act. To avoid any
alteration of the meaning of the certification and verification, we are
proposing to require that petitioners submit the exact statutory
language of the certification and verification, with the exception
discussed previously in section II.B.4 of this document. Because
section 505(q) of the FD&C Act and proposed Sec.  10.31(c) set forth
the exact words to be used in the certification, we will consider a
certification to be deficient if every word in the petitioner's
certification does not match every word of the certification provided
in proposed Sec.  10.31(c). In other words, the petitioner's
certification must correspond verbatim to the certification in proposed
Sec.  10.31(c). For example, if a certification states ``first became
known to me'' instead of ``first became known to the party on whose
behalf this petition is submitted,'' the certification would be
deficient. We believe this interpretation is required by the statutory
language because section 505(q) of the FD&C Act specifies the exact
text of the certification.
    As with our proposed approach to the certification, we would
consider a verification to be deficient if it does not exactly mirror
the words of the verification under proposed Sec.  10.31(d).
6. Date Includes Month, Day, and Year
    Section 505(q) of the FD&C Act and proposed Sec.  10.31(c) also
require that the petitioner provide in the certification the date on or
about which the information first became known to the party. The
certification in proposed Sec.  10.31(c) includes a blank space for
that information. We interpret the FD&C Act's reference to ``date'' to
mean a month, day, and year. Therefore, we propose to consider a
certification to be deficient if the petitioner has not provided the
month, day, and year on or

about which the information first became known to the party on whose
behalf the petition is submitted. For example, if the petitioner
provides ``May 2010'' as the date in the certification, we would
consider the certification to be deficient. The text of the
certification provided in proposed Sec.  10.31(c) includes a
qualification that the petitioner learned of the information on or
about the following date; therefore, we believe the certification would
accommodate instances in which a petitioner may not know the exact date
on which it became aware of the information.
    Similarly, under proposed Sec.  10.31(d), we are proposing that if
the petitioner or commenter does not provide a month, day, and year in
the verification, FDA will consider the verification to be deficient
and will not review the submission.
7. Multiple Dates and Types of Information
    FDA recognizes that a petition, supplement, or comment could be
based on more than one type of information. Proposed Sec.  10.31(c)(2)
would require a petitioner to provide in the certification an estimated
relevant date for each type of information if different types of
information became known over a period of time. The petitioner must
identify the information associated with the particular date. To the
extent that a petitioner believes that additional clarification is
appropriate, the blank space in the certification that proposed Sec.
10.31(c) designates for the date could accommodate additional
information that the petitioner believes is appropriate to explain the
date that it has identified. This would be done by providing, in each
case in which more than one type of information is relied on, the date
followed by an identification of the information associated with that
date in parentheses. Thus, for example, a petition might include the
following in the space for the date:
    September 21, 1995 (information about bioavailability issues with
the innovator drug);
    November 12, 2009 (publication of a draft bioequivalence guidance
for the drug);
    March 30, 2010 (information that an ANDA had been submitted).
    When adding additional information, the petitioner should ensure
that the words of the certification (except for information added in
the blank space provided) continue to exactly match the words of the
certification as provided by proposed Sec.  10.31(c).
    Similarly, proposed Sec.  10.31(d) would require that the
petitioner or commenter include in the verification each type of
information and supply the date each type of information became known.
The verification in proposed Sec.  10.31(d) includes a blank space that
can accommodate this information.
    Under proposed Sec.  10.31(c) and (d), it is the responsibility of
the person submitting the petition, supplemental information, or
comment to identify each type of information upon which it relies and
to supply a date with respect to each such type of information. The
failure to provide any information relied upon (and the date) in the
certification or verification may result in the failure of FDA to
consider that information in its analysis of the petition and would,
FDA believes, foreclose the petitioner or the person submitting the
supplemental information or comment from relying upon such information
in judicial review of FDA's final decision.
8. Petitions That Would Be Required To Include the 505(q) Certification
    Proposed Sec.  10.31 would apply to all petitions that request an
action that could delay the approval of a possible ANDA or 505(b)(2)
application (proposed Sec.  10.31(a)); therefore, all such petitions
would be required to include the certification proposed in Sec.
10.31(c).
    Because section 505(q)(1)(A) of the FD&C Act specifically
references pending ANDA or 505(b)(2) applications, we interpret section
505(q) to apply only to petitions for which, at the time the petition
is submitted, at least one ANDA or 505(b)(2) application related to the
subject matter of the petition is pending. If there is no related ANDA
or 505(b)(2) application pending at the time that the petition is
submitted, then we will not consider the provisions of section 505(q)
of the FD&C Act to apply to the petition. We believe this
interpretation of section 505(q) of the FD&C Act is appropriate because
if no related ANDA or 505(b)(2) application is pending at the time that
a petition is submitted, the references in section 505(q)(1)(A) to a
pending application and delay of approval by a petition would be
inapplicable. With respect to the actual submission of the
certification and/or verification with a petition, we recognize that
petitioners may not be aware of the existence of a pending ANDA or
505(b)(2) application and, therefore, may not know whether to submit
the appropriate certification and/or verification under section 505(q)
of the FD&C Act. Generally, the existence of an ANDA or a 505(b)(2)
application would not be public information.\1\ Therefore, FDA has
recommended that any petitioner challenging the approvability of an
ANDA or a 505(b)(2) application include the statutory certification to
avoid a situation in which a petition that is subject to section 505(q)
of the FD&C Act is missing the certification and therefore cannot be
reviewed by FDA under the statute. We have stated that in situations
where a petitioner submits such a petition, we recommend that the
petitioner withdraw the original petition and resubmit a petition that
includes the required certification under section 505(q) of the FD&C
Act.
---------------------------------------------------------------------------

    \1\ Although the existence of a pending application generally is
not made public by FDA, a potential petitioner may be aware of the
existence of a pending ANDA or 505(b)(2) application because of: (1)
A paragraph IV patent notification, from the applicant to the NDA
holder and the patent owner, stating that the application has been
submitted and explaining the factual and legal bases for the
applicant's opinion that the patent is invalid or will not be
infringed (see section 505(b)(2)(B) and (j)(2)(B) of the FD&C Act),
(2) a public announcement by the applicant disclosing the submission
of the application, or (3) the tentative approval of an ANDA or
505(b)(2) application made public by FDA or the applicant. In
addition, FDA's Web site identifies drug products for which the
Agency has received an ANDA with a paragraph IV certification.
---------------------------------------------------------------------------

    We have also stated that although we may contact a petitioner to
notify him or her of a missing or deficient certification, it is the
responsibility of the petitioner to ensure that his or her petition
complies with the applicable requirements of section 505(q) of the FD&C
Act as well as all other applicable statutory and regulatory
requirements. Contacting petitioners who have submitted deficient
petitions represents an administrative burden for the Agency. In
addition, we are concerned that our contacting such petitioners could
notify the petitioner and the public that an ANDA or 505(b)(2)
application for a particular drug product is pending.
    By including in proposed Sec.  10.31(a) all petitions that
challenge the approvability of a possible ANDA or 505(b)(2)
application, all such petitions would be required to include the
certification in proposed Sec.  10.31(c). Proposed Sec.  10.31(a) would
eliminate the need for FDA to contact a petitioner to advise him or her
that the petition must include the 505(q) certification or avoid a
delay in dealing with the specific issues contained in a petition
because the petitioner must withdraw and resubmit the petition. In
addition, we propose that any supplement or comments to a petition that
is subject to proposed Sec.  10.31 and that includes the certification
in Sec.  10.31(c) must include the verification in Sec.  10.31(d).

C. Dismiss Petition as Moot

    Although the primary purpose of this rule is to implement section
505(q) of the FD&C Act, we are proposing to add language to Sec.
10.30(e) to allow the Commissioner to dismiss a petition as moot.
Because we are making changes to Sec.  10.30 to implement section
505(q) of the FD&C Act, we believe it would be useful to make this
minor clarifying change to the regulations. This change is technical in
nature and would be applicable to citizen petitions in general,
including those subject to section 505(q) of the FD&C Act. Current
Sec.  10.30(e) could be read to require that the Commissioner respond
to a citizen petition by either granting or denying the requests in the
citizen petition, even when circumstances have rendered the requests in
the petition moot. Current Sec.  10.30(e) does not by its terms
contemplate a situation in which a petition can be dismissed as moot.
    Because changes in law, facts, or circumstances occurring after a
citizen petition is submitted to the Agency can render the requests
contained in a petition moot, we propose to allow the Commissioner to
dismiss a petition as moot in these situations. An example of a moot
petition would be a petition that requests that the Agency remove a
particular drug from the market for safety reasons when, at the time of
the response, the drug has already been removed from the market.
Another example would be where a petitioner requests a change to a
regulation that has been rescinded or withdrawn since the petition was
submitted. In such circumstances, it would be appropriate for the
Commissioner to dismiss the petition as moot rather than to grant or
deny the requests in the petition. This proposed change to our
regulations is intended to clarify that, in addition to our authority
to grant or deny a petition under our current regulations, the Agency
can dismiss citizen petitions as moot in certain circumstances.
    When a citizen petition is dismissed as moot, FDA would respond to
the petitioner in writing just as we would when granting or denying a
petition. We believe, however, that the Agency's justification for
dismissing a petition as moot could be brief in comparison to a
response granting or denying a petition, and thus would require
dedication of fewer Agency resources. FDA's response dismissing a
citizen petition as moot, similar to a response granting or denying a
petition, would constitute final Agency action as to that citizen
petition.

D. Petitions for Stay of Action

    We are proposing a conforming change to Sec.  10.35(b) to clarify
the applicable regulations for PSAs that are subject to section 505(q)
of the FD&C Act. Section 10.35(b) currently states that ``a request for
stay must be submitted in accordance with Sec.  10.20 and in the
following form no later than 30 days after the date of the decision
involved.'' We propose to add language to Sec.  10.35(b) to provide
that petitions for stay subject to Sec.  10.31 must include the
certification provided in Sec.  10.31(c). This proposed revision would
alert petitioners for stays of action that may be subject to section to
505(q) of the FD&C Act that they must also submit the certification in
Sec.  10.31(c).
    Section 505(q)(1)(A) of the FD&C Act states that FDA must not delay
approval of a pending ANDA or 505(b)(2) application because of any
request to take any form of action relating to the application unless
the request is in writing, is a citizen petition submitted under Sec.
10.30 or a PSA submitted under Sec.  10.35, and FDA determines, upon
reviewing the petition, that a delay is necessary to protect the public
health. Section 10.35(d) provides that filing a PSA, citizen petition,
or other type of petition, or taking another type of action as
described in Sec.  10.35(d) will not stay or otherwise delay any
administrative action by the Commissioner unless: (1) The Commissioner
determines that a stay or delay is in the public interest and stays the
action, (2) a statute requires that the matter be stayed, or (3) a
court orders that the matter be stayed. In other words, the mere filing
of any petition, including a petition under section 505(q) of the FD&C
Act, would not stay or otherwise delay administrative action by FDA.
See TMJ Implants, Inc. v. United States HHS, 584 F.3d 1290, 1300 (10th
Cir. 2009). A delay of an administrative action could only occur if FDA
chose to take action in response to a particular submission. We are not
proposing any changes to Sec.  10.35(d) to implement section
505(q)(1)(A) of the FD&C Act because we believe that the provisions of
section 505(q)(1)(A) of the FD&C Act regarding the circumstances in
which FDA would stay or delay an administrative action (e.g., approval
of an ANDA or 505(b)(2)) would be covered by the current language of
Sec.  10.35(d).
    As explained previously in this document with respect to citizen
petitions under Sec.  10.30(e)(3), we are proposing to add a sentence
to Sec.  10.35(e) to allow the Commissioner to dismiss a petition for
stay of action as moot.
    In addition, we are proposing to add Sec.  10.35(i), which would
mirror Sec.  10.30(g) governing citizen petitions and allow a
petitioner who has submitted a PSA to supplement, amend, or withdraw a
PSA without Agency approval and without prejudice, unless the PSA has
been referred for a hearing under 21 CFR parts 12, 13, 14, or 15.
Proposed Sec.  10.35(i) would apply to all PSAs, not just PSAs subject
to section 505(q) of the FD&C Act. We believe that adding this
provision to allow PSAs to be amended, withdrawn, or supplemented is
permitted under the FD&C Act and is appropriate to allow petitioners
submitting PSAs the same procedural rights as petitioners submitting
citizen petitions. By amending this regulation, we are clarifying that
it is permissible to amend, withdraw, or supplement a PSA because the
current regulations are not specific on this point and our current
practice allows a PSA to be amended, withdrawn, or supplemented.
Furthermore, under section 505(q)(1)(I) of the FD&C Act, the
verification statement that applies to citizen petitions and PSAs
refers to supplemental information. Therefore, in drafting this
provision, Congress assumed it was possible to provide a supplement to
a PSA.

E. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this
proposal become effective 60 days after its publication in the Federal
Register. FDA seeks public comment on its proposed 60-day effective
date for any final rule that may issue based on this proposed rule.

III. Legal Authority

    This rule, if finalized, would amend Sec. Sec.  10.20, 10.30, and
10.35 and add new Sec.  10.31 in a manner consistent with the Agency's
current understanding and application of these provisions. FDA is
implementing certain provisions of FDAAA that govern petitions subject
to section 505(q) of the FD&C Act. FDA has authority to issue
regulations for the efficient administration of these provisions under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)).

IV. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) 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.

V. Analysis of Impacts

    FDA has examined the impacts of the final 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 final rule is not a significant
regulatory action under 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 annualized compliance costs to
individual industry members who submit a petition is estimated to be
about $100, 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 any
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

A. Purpose of the Proposed Rule

    Section 505(q) of the FD&C Act concerns the manner in which FDA
handles certain citizen petitions and PSAs that request that the Agency
take some action related to a pending 505(b)(2) application or 505(j)
application (ANDA). Congress was concerned that some petitions may
improperly delay the approval of an application if they are submitted
late in the review process and do not contain valid scientific, legal,
or public health issues. The provisions contained in section 505(q) of
the FD&C Act are self-implementing, and FDA has operated under these
requirements since FDAAA became law in September 2007. This proposed
rule would codify the certification and verification requirements
included in section 505(q) of the FD&C Act extend these requirements to
all petitions challenging the approvability of possible ANDAs and
505(b)(2) applications, as well as those submitting supplements and
comments to these petitions, clarify how FDA determines the date of
submissions for citizen petitions and PSAs subject to section 505(q),
and clarify that a petitioner for a PSA may supplement, amend, or
withdraw a PSA in a manner similar to that provided in the provisions
for citizen petitions. In addition, the proposed rule would allow the
Commissioner to dismiss a citizen petition or PSA as moot in certain
circumstances.

B. Benefits of the Proposed Rule

    Section 505(q) of the FD&C Act was enacted in light of concerns
that some citizen petitions were submitted to delay the approval of
ANDAs or 505(b)(2) applications. With the enactment of FDAAA, FDA is
required to take final action on a 505(q) petition within 180 days of
its receipt. Further, the law requires that an expanded certification
statement be included with petitions, and a verification statement be
included with supplements and comments to petitions. While these
requirements do not specifically preclude anyone from submitting a
petition that may delay approval of an ANDA or 505(b)(2) application,
the requirement that the person submitting the document reveal the date
on which he or she became aware of the information contained in the
petition is presumably intended to reduce this type of behavior.
    The requirements contained in section 505(q) of the FD&C Act have
been in effect for 3 years. FDA received 21 505(q) petitions in fiscal
year (FY) 2008, 31 505(q) petitions in FY 2009, and 20 505(q) petitions
in FY 2010. Over the same period, however, the number of ANDAs and
505(b)(2) applications whose approvals were delayed decreased slightly,
from 2 in FY 2008 to 1 in FY 2009 and 1 in FY 2010. The sample size of
only 3 years is too small to conclusively determine whether the statute
has caused a reduction in the number of petitions that did not include
valid scientific or legal issues whose primary purpose was to delay
approval of an application. The existence of the statutory requirement
that FDA take final action within 180 days of receipt of a 505(q)
petition, consequently reducing delays of approval, may have had this
effect by itself.
    By codifying the certification and verification statements (with a
minor technical change to the verification language), the proposed rule
would reinforce the need for exact wording of both the certification
and verification statements. Further, the proposed rule makes clear
that each of these two statements requires the identification of a
month, day, and year in the place of the date, as opposed to just a
year or a month and year. In addition, the proposed rule would clarify
that each individual type of information requires its own separate
date. By providing additional clarity on the statutory requirements,
this proposed rule would likely reduce the number of deficient 505(q)
petitions. FDA does not have enough information to estimate this
reduction in deficient 505(q) petitions, but believes it will result in
lower administrative costs for both industry and FDA.

C. Costs of the Proposed Rule

1. Industry Labor Costs
    Companies involved in pharmaceutical research and manufacturing
would incur labor costs due to the rule through their administrative
review of the final rule and determination of their compliance
responsibilities. All companies involved in this would incur some labor
costs, regardless of the frequency of their submission of ANDAs or
505(b)(2) applications or citizen petitions to FDA. Census data from
2007 list 763 companies in its pharmaceutical preparation manufacturing
category. FDA estimates that each company will expend about 4 hours to
review the final rule and determine any changes it needs to make to its
internal administrative policies due to this rule. The pharmaceutical
and medicine manufacturing category of the North American Industrial
Classification System (NAICS) lists the hourly wage for a manager in
this category at about $54. A 35-percent adjustment to this figure for
employee benefits results in total hourly compensation costs of about
$73. A one-time 4-hour review for each company would result in
compliance costs of almost $300 per company, and a total of about
$224,000 for the industry. This equates to an annualized cost (over 5
years at a 7-percent discount rate) of about $55,000 for the entire
industry. These estimates may overstate true compliance costs for
review of the rule because companies that are unlikely to submit
citizen petitions on even an occasional basis

may not expend as much labor as those that submit petitions more often.
FDA invites comment on the estimate of 4 hours of labor to review the
final rule and make any adjustment to company policies.
    Additional labor costs of the rule would be incurred due to the new
requirement that all petitioners challenging the approvability of a
possible ANDA or 505(b)(2) application for which an application is not
currently pending at FDA submit the appropriate certification, as well
as the requirement that any supplements or comments to these petitions
include the verification. The implementation of the requirements that
505(q) petitions (concerning the approvability of a pending ANDA or
505(b)(2) application) use the new certification language and that
supplements and comments to these petitions use the verification
language began with the enactment of FDAAA in September 2007 and are
not the subject of the proposed rule. FDA has previously estimated that
the statute would result in about 28 additional certifications with
petitions and 25 additional verifications with supplements or comments
to petitions.
    FDA received a yearly average of 32 petitions that challenged the
approvability of a possible ANDA or 505(b)(2) application since the end
of 2007. This number represents a very small increase over the average
for the previous 4-year period. Of these 32 petitions, on average only
25 were 505(q) petitions. FDA uses the difference between these two
numbers, or about seven petitions per year, as its estimate of the
number of additional petitions that this proposed rule would require to
comply with the 505(q) requirements for certification. FDA estimates
that the additional time needed to prepare the certification language
in the proposed rule at 30 minutes. The majority of this time
represents the additional effort of determining the date on which the
information or data included in the petition became known to the person
submitting the petition. FDA uses the same pharmaceutical and medicine
manufacturing category of the NAICS hourly wage for a manager (adjusted
for benefits) of $73 to calculate this cost. At 30 minutes per
petition, the marginal cost to prepare the additional certification
language for 1 petition is estimated at $37. For the average of seven
additional petitions that would need the additional language, the total
cost to industry is estimated at about $250 annually.
    Additional labor costs would also be incurred for the preparation
of certifications for supplements and comments to petitions that
challenge the approvability of ANDA applications and 505(b)(2)
applications for which there is no pending application at the time of
the supplement or comment submission. FDA previously estimated that it
would receive about 9 verifications for every 10 certifications in the
implementation of the 505(q) provision. Using this ratio, FDA estimates
that this proposed rule would result in the submission of verifications
amounting to 90 percent of the additional certifications that it
received due to this rule. Since FDA estimated that 7 additional
certifications would be submitted due to this rule, FDA estimates that
90 percent of this number, or about 6 verifications, would also be
submitted as a result of this rule. At 30 minutes per petition and the
same adjusted wage rate of $73/hour, the additional cost per
verification is estimated at $37. The additional labor costs for the 6
verifications would total to about $220 per year.
    The provision of the proposed rule that would allow a petitioner
who has submitted a PSA to supplement, amend, or withdraw a PSA without
Agency approval would not impose any marginal costs on industry
members. These practices reflect FDA's current policy. Similarly, the
provision of this proposed rule that clarifies how FDA determines the
submission date for documents received by FDA's Division of Docket
Management is also not expected to impose any costs on industry
members.
    The total one-time costs plus annual costs of this proposed rule
are estimated at about $224,000, with annualized costs (one-time costs
annualized over 5 years at a 7-percent discount rate plus annual costs)
at about $55,000 for the entire industry (see table 1 of this
document). This estimate reflects a one-time $300 per company review
cost for each industry member (annualized over 5 years at a 7-percent
discount rate at about $70), plus an additional $37 labor cost per
certification or verification submitted.

                                       Table 1--Industry Compliance Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Annualized costs
                    Labor cost factors                       One-time costs     Annual costs           \1\
----------------------------------------------------------------------------------------------------------------
Final Rule Review.........................................          $223,600  ................           $55,000
Certification Preparation.................................  ................              $250               250
Verification Preparation..................................  ................               200               200
                                                           -----------------------------------------------------
    Total Costs...........................................  ................  ................            55,450
----------------------------------------------------------------------------------------------------------------
\1\ Annualized costs represent one-time costs amortized over 5 years at a 7-percent discount rate plus annual
  costs. At a 3-percent discount rate, annualized costs are reduced by about $5,400.

2. Costs to the Government
    The costs to government for oversight of this proposed rule would
be low as a review of the language in an additional seven
certifications included with petitions and six verifications included
with supplements or comments to petitions would only require 15 minutes
for each. FDA believes this cost would not be significant, and
emphasizes that the FDA personnel reviewing and responding to citizen
petitions spend the vast majority of the time on the substantive issues
included in the documents.

D. Small Business Impact

    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because of the very low costs that would be incurred
by an individual company submitting a petition or supplement or comment
to a petition, FDA believes that the proposed rule would not have a
significant economic impact on a substantial number of small
manufacturing entities.
    The companies that would be affected by this proposed rule are
classified in two NAICS categories by the Census Bureau. The affected
industries are NAICS 325412--Pharmaceutical Preparation, and NAICS
325414--Biological Products (except diagnostic). The Small Business
Administration

(SBA) defines small entities in the pharmaceutical preparation category
as those with less than 750 employees and defines small entities in the
biological product (except diagnostic) category as those with less than
500 employees. The most recent Census of Manufactures data that offer
the level of detail for establishments at or near the employee size
limits as defined by SBA is from 2002. In both of these establishment
size categories, large majorities of the establishments meet the
criteria as small entities. Even taking into account that many of these
establishments are parts of multi-establishment corporations,
significant numbers of companies would still qualify as small entities.
Preliminary Census data from 2007, though less detailed, show that
significant numbers of establishments continue to have fewer than 100
employees across all of these categories. While FDA expects that most
companies submitting petitions that challenge the approvability of an
ANDA or 505(b)(2) application would be larger than the average-sized
company in their industry, FDA concludes that a substantial number of
companies would still qualify as small entities.
    The cost analysis concluded that the annualized compliance cost of
the proposed rule for a company that submitted one additional
certification as a result of the rule would be just over $100. Because
FDA estimates that only about seven additional certifications will be
submitted due to this rule, it is doubtful that many firms will submit
more than one additional certification or verification annually to
those already required by section 505(q) of the FD&C Act. Using 2002
Census data, the average value of shipments for establishments in these
industries with 1 to 4 employees ranged from $478,000 to $824,000
according the Census of Manufactures. Assuming that such small
operations had to prepare even one additional certification or
verification each year, the costs of the proposed rule would represent,
at most, 0.02 percent of the annual value of shipments. For
establishments with 10 or more employees, the compliance costs would
represent 0.01 percent or less of the value of shipments. As stated
previously, FDA concludes that this proposed rule would not have a
significant economic impact on a substantial number of small entities.

VI. Paperwork Reduction Act

    This proposed rule contains collections of information that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501-3520). ``Collection of information'' includes any
request or requirement that persons obtain, maintain, retain, or report
information to the Agency, or disclose information to a third party or
to the public (44 U.S.C. 3502(3) and 5 CFR 1320.3(c)). The title,
description, and respondent description of the information collection
are shown under this section with an estimate of the annual reporting
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
    FDA invites comments on these topics: (1) Whether the collection of
information is necessary for 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.
    Title: Amendments to Regulations on Citizen Petitions, Petitions
for Stay of Action, and Submission of Documents to Dockets.
    Description of Respondents: Respondents to this collection of
information as it is related to citizen petitions are individuals or
households, State or local governments, not-for-profit institutions,
and businesses or other for-profit institutions or groups. Respondents
to this collection of information as it is related to PSAs are persons
who choose to file a petition for an administrative stay of action.
    Description: FDA is requesting public comment on estimates of
annual submissions from these respondents, as required by section
505(q) of the FD&C Act and described in this proposed rule under Sec.
10.31(c) and (d). Section 10.31(c) of this proposed rule requires that
citizen petitions and PSAs that are subject to section 505(q) include a
certification to be considered for review by FDA. Section 10.31(d)
requires that supplemental information or comments to such citizen
petitions and PSAs include a verification to be accepted for review by
FDA. This proposed rule sets forth the statutory language under section
505(q) requiring the submission of a certification and/or a
verification and the precise language of the certification and
verification. One of the criteria for a citizen petition or PSA to be
subject to section 505(q) is that a related ANDA or 505(b)(2)
application is pending at the time the citizen petition or petition for
stay is submitted. Because petitioners or commenters may not be aware
of the existence of a pending ANDA or 505(b)(2) application, this
proposed rule requires that all petitioners challenging the
approvability of a possible ANDA or 505(b)(2) application include the
certification required in Sec.  10.31(c) of this proposed rule and that
petitioners and commenters submitting supplements or comments,
respectively, to a citizen petition or PSA challenging the
approvability of a possible ANDA or 505(b)(2) application include the
verification required in section Sec.  10.31(d) of this proposed rule.
    FDA currently has OMB approval for the collection of information
entitled ``General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions''
(OMB control number 0910-0183). This collection of information
includes, among other things: (1) The format and procedures by which an
interested person may submit to FDA, in accordance with Sec.  10.20, a
citizen petition requesting the Commissioner to issue, amend, or revoke
a regulation or order, or to take or refrain from taking any other form
of administrative action (Sec.  10.30(b)); (2) the submission of
written comments on a filed citizen petition (Sec.  10.30(d)); (3) the
submission of a supplement or amendment to or a letter to withdraw a
filed citizen petition (Sec.  10.30(g)); (4) the format and procedures
by which an interested person may request, in accordance with Sec.
10.20, the Commissioner to stay the effective date of any
administrative action (Sec.  10.35(b)); and (5) the submission of
written comments on a filed petition for administrative stay of action
(Sec.  10.35(c)). This information collection includes citizen
petitions, PSAs, comments to petitions, supplements to citizen
petitions, and letters to withdraw a citizen petition, as described
previously, that are subject to section 505(q) of the FD&C Act and
described in this proposed regulation.
    OMB recently approved (OMB control number 0910-0679) the
information collection in the guidance for industry entitled ``Citizen
Petitions and Petitions for Stay of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic Act'' (see the information
collection analysis at 75 FR 78249 (December 15, 2010), and the
document announcing the availability of the guidance at 76 FR 33309
(June 8, 2011)).

The guidance describes FDA's interpretation of section 505(q) of the
FD&C Act regarding how the Agency will determine if: (1) The provisions
of section 505(q) addressing the treatment of citizen petitions and
petitions for stay of Agency action (collectively, petitions) apply to
a particular petition and (2) a petition would delay approval of a
pending ANDA or a 505(b)(2) application. The guidance also describes
how FDA will interpret the provisions of section 505(q) requiring that:
(1) A petition include a certification and (2) supplemental information
or comments to a petition include a verification. Finally, the guidance
addresses the relationship between the review of petitions and pending
ANDAs and 505(b)(2) applications for which the Agency has not yet made
a decision on approvability.
    Thus, FDA has OMB approval under the PRA for the information
collection required under section 505(q) of the FD&C Act and described
in the guidance. This information collection is also described in
proposed Sec.  10.31(c) and (d).
    There is, however, one proposed provision that would require the
collection of information that is not already approved by OMB. Under
proposed Sec.  10.35(i), a petitioner may, under certain conditions,
supplement, amend, or withdraw a PSA in writing without Agency approval
and without prejudice to resubmission at any time until the
Commissioner rules on the petition. This proposed provision is
explained in section II of this document. FDA estimates that it will
receive approximately one supplement, amendment, or withdrawal under
proposed Sec.  10.35(i) from approximately one applicant, and that it
will take approximately 0.5 hour to make this submission.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of     Annual frequency    Total annual        Hours per
                                                                   respondents      per response        responses         response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Sec.   10.35(i)......................................                 1                 1                 1               0.5               0.5
                                                               -----------------------------------------------------------------------------------------
    Total Hours...............................................  ................  ................  ................  ................               0.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The information collection provisions of this proposed rule have
been submitted to OMB for review. Interested persons are requested to
fax comments regarding information collection by (see DATES section of
this document) to the Office of Information and Regulatory Affairs,
OMB. To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should reference the title of this proposed rule and include
the FDA docket number found in brackets in the heading of this
document.

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. Request for 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 10

    Administrative practice and procedure, News media.

    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 10 be amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

    1. The authority citation for 21 CFR part 10 continues to read as
follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.

    2. Section 10.20 is amended by revising paragraph (e) to read as
follows:

Sec.  10.20  Submission of documents to Division of Dockets Management;
computation of time; availability for public disclosure.

* * * * *
    (e) Except as provided in Sec.  10.31(b), all submissions to the
Division of Dockets Management will be considered as submitted on the
date they are postmarked or, if delivered in person during regular
business hours, on the date on which they are delivered, unless a
provision in this part, an applicable Federal Register notice, or an
order issued by an administrative law judge specifically states that
the documents must be received by a specified date, e.g., Sec.
10.33(g) relating to a petition for reconsideration, in which case they
will be submitted on the date received.
* * * * *
    3. Section 10.30 is amended as follows:
    a. Revise paragraph (b) introductory text;
    b. Revise the first sentence of paragraph (c);
    c. Revise the second sentence of paragraph (d);
    d. Remove from paragraph (e)(2)(ii) the word ``or'';
    e. Redesignate paragraph (e)(2)(iii) as paragraph (e)(2)(iv);
    f. Add new paragraph (e)(2)(iii); and
    g. Add to paragraph (e)(3) a new sentence after the first sentence.
    The additions and revisions read as follows:

Sec.  10.30  Citizen petition.

* * * * *
    (b) A petition (including any attachments) must be submitted in
accordance with Sec.  10.20 and, if applicable, Sec.  10.31. The
certification requirement in this section does not apply to petitions
subject to the

certification requirement of Sec.  10.31. The petition must be in the
following form:
* * * * *
    (c) A petition that appears to meet the requirements of paragraph
(b) of this section, Sec.  10.20, and, if applicable, Sec.  10.31, will
be filed by the Division of Dockets Management, stamped with the date
of filing, and assigned a docket number. * * *
    (d) * * * The comments are to specify the docket number of the
petition, include, if applicable, the verification under Sec.  10.31,
and may support or oppose the petition in whole or in part.* * *
    (e) * * *
    (2) * * *
    (iii) Dismiss the petition as moot if at any time the Commissioner
determines that changes in law, facts, or circumstances since the date
on which the petition was submitted have rendered the petition moot; or
* * * * *
    (3) * * * If, at any time, the Commissioner determines that changes
in law, facts, or circumstances since the date on which the petition
was submitted have rendered the petition moot, the Commissioner may
dismiss the petition as moot. * * *
* * * * *
    4. Section 10.31 is added to read as follows:

Sec.  10.31  Citizen petitions and petitions for stay of action related
to an abbreviated new drug application or a new drug application.

    (a) Applicability. This section applies to a citizen petition or
petition for stay of action that meets all of the following criteria:
    (1) The petition requests that the Commissioner take any form of
action that could, if taken, delay approval of an abbreviated new drug
application (ANDA) submitted under section 505(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)) or a new drug application
submitted under section 505(b)(2) (a 505(b)(2) application).
    (2) The petition is submitted on or after September 27, 2007.
    (3) The petition is submitted in writing and under Sec.  10.30 (for
citizen petitions) or Sec.  10.35 (for petitions for stay of action).
    (b) Date of submission. A petition subject to this section and
submitted in accordance with Sec. Sec.  10.20, 10.30, 10.31, and 10.35
is regarded as submitted on the date on which the petition is received
by the Division of Dockets Management.
    (c) Certification. (1) FDA will not consider for review a petition
that is subject to this section unless the petition is in writing and
contains the following certification: ``I certify that, to my best
knowledge and belief: (i) This petition includes all information and
views upon which the petition relies; (ii) this petition includes
representative data and/or information known to the petitioner that are
unfavorable to the petition; and (iii) I have taken reasonable steps to
ensure that any representative data and/or information that are
unfavorable to the petition were disclosed to me. I further certify
that the information upon which I have based the action requested
herein first became known to the party on whose behalf this petition is
submitted on or about the following date: ---------------- [in the
blank space, provide the date on which such information first became
known to the person submitting the petition]. If I received or expect
to receive payments, including cash and other forms of consideration,
to file this information or its contents, I received or expect to
receive those payments from the following persons or organizations: --
-------------- [in the blank space, provide the names of such persons
or organizations]. I verify under penalty of perjury that the foregoing
is true and correct as of the date of the submission of this
petition.''
    (2) The certification in paragraph (c)(1) of this section must
contain one or more specific dates (month, day, and year) in the blank
space provided. If different categories of information became known at
different times, the certification must contain each estimated relevant
date. The information associated with a particular date must be
identified.
    (d) Verification. (1) FDA will not accept for review any
supplemental information or comments on a petition that is subject to
this section unless the supplemental information or comments are in
writing and contain the following verification: ``I certify that, to my
best knowledge and belief: (i) I have not intentionally delayed
submission of this document or its contents; and (ii) the information
upon which I have based the action requested herein first became known
to me on or about ---------------- [in the blank space, provide the
date on which such information first became known to the person
submitting the document]. If I received or expect to receive payments,
including cash and other forms of consideration, to file this
information or its contents, I received or expect to receive those
payments from the following persons or organizations: ----------------
[in the blank space, provide the names of such persons or
organizations]. I verify under penalty of perjury that the foregoing is
true and correct as of the date of the submission of this document.''
    (2) The verification in paragraph (d)(1) of this section must
contain one or more specific dates (month, day, and year) in the blank
space provided. If different categories of information became known at
different times, the certification must contain each estimated relevant
date. The information associated with a particular date must be
identified.
    5. Section 10.35 is amended by revising the third sentence of
paragraph (b); by adding to paragraph (e) a new sentence after the
second sentence; and by adding paragraph (i) to read as follows:

Sec.  10.35  Administrative stay of action.

* * * * *
    (b) * * * A request for stay must be submitted in accordance with
Sec.  10.20 and in the following form (except that stays subject to
Sec.  10.31 must include the certification provided in Sec.  10.31(c))
no later than 30 days after the date of the decision involved. * * *
* * * * *
    (e) * * * If, at any time, the Commissioner determines that changes
in law, facts, or circumstances since the date on which the petition
was submitted have rendered the petition moot, the Commissioner may
dismiss the petition as moot. * * *
* * * * *
    (i) A petitioner may supplement, amend, or withdraw a petition for
stay of action in writing without Agency approval and without prejudice
to resubmission at any time until the Commissioner rules on the
petition, provided the resubmission is made in accordance with
paragraph (b) of this section, unless the petition for stay of action
has been referred for a hearing under parts 12, 13, 14, or 15 of this
chapter. After a ruling or referral, a petition for stay of action may
be supplemented, amended, or withdrawn only with the approval of the
Commissioner. The Commissioner may approve withdrawal, with or without
prejudice against resubmission of the petition for stay of action.

    Dated: December 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33622 Filed 12-30-11; 8:45 am]
BILLING CODE 4160-01-P