[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33309-33310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0008]


Guidance for Industry on Citizen Petitions and Petitions for Stay 
of Action Subject to Section 505(q) of the Federal Food, Drug, and 
Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a 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.'' The Food and Drug 
Administration Amendments Act (FDAAA) added new provisions to the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) addressing the 
Agency's treatment of certain citizen petitions and petitions for stay 
of agency action (collectively, petitions), as well as related 
applications. The guidance describes how FDA will determine if the new 
provisions apply to a particular petition and how FDA will determine if 
a petition would delay approval of a pending abbreviated new drug 
application (ANDA) or 505(b)(2) application. The guidance also 
describes how FDA will interpret the requirements that such petitions 
include a certification and that supplemental information or comments 
to such petitions include a verification. The guidance also 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.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kimberly K. Thomas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6223, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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.'' In the 
Federal Register of January 21, 2009 (74 FR 3611), FDA announced the 
availability of a draft version of this guidance and provided 
interested parties an opportunity to submit comments. As described in 
the January 21, 2009, Federal Register notice, the guidance provides 
information regarding FDA's current thinking on interpreting section 
914 of Title IX of FDAAA (Pub. L. 110-85). Section 914 of FDAAA added 
new section 505(q) to the FD&C Act (21 U.S.C. 355(q)) and governs 
certain citizen petitions and petitions for stay of Agency action that 
request that FDA take any form of action related to a pending 
application submitted under section 505(b)(2) or 505(j) of the FD&C 
Act. 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 includes 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.
    The Agency has carefully reviewed and considered the comments it 
received in response to the draft guidance in developing this final 
version of the guidance. The Agency has added information in sections 
III.C and III.D of the guidance to further explain how FDA will apply 
the certification

[[Page 33310]]

and verification requirements of section 505(q) and has also made 
revisions to clarify aspects of the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on citizen petitions and petitions for stay 
of action that are subject to section 505(q) of the FD&C Act. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act (44 U.S.C. 3501-3520). The collections of 
information in this guidance were approved under OMB control number 
0910-0679. This guidance also refers to previously approved collections 
of information found in FDA regulations and approved under OMB control 
number 0910-0183 (21 CFR 10.20, 10.30, and 10.35) and OMB control 
number 0910-0001 (21 CFR 314.54, 314.94, and 314.102).

III. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14058 Filed 6-7-11; 8:45 am]
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