[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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