Document ID: FDA-2009-D-0008-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of Federal Food, Drug, and Cosmetic Act
Posted Date: 2010-12-15T05:00Z

[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78249-78251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31380]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by January 
14, 2011.

ADDRESSES: 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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``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.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850. 301-796-3792. E-mail: 
elizabeth.berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
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
    In the Federal Register of January 21, 2009 (74 FR 3611), FDA 
announced the availability of a draft guidance for industry entitled 
``Draft 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'' (FD&C Act). FDA is now in the process of finalizing this 
guidance. In that Federal Register notice, FDA provided the public with 
60 days to comment on the proposed collection of information. FDA 
received no comments pertaining to the information collection in the 
draft guidance.
    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 petitions for 
stay of Agency action are persons who choose to file a petition for an 
administrative stay of action.
    Burden Estimate: Section 505(q)(1)(H) of the FD&C Act requires that 
citizen petitions and petitions for stay of Agency action that are 
subject to section 505(q) include a certification to be considered for 
review by FDA. Section 505(q)(1)(I) of the FD&C Act requires that 
supplemental information or comments to such citizen petitions and 
petitions for stay of Agency action include a verification to be 
accepted for review by FDA. This guidance describes our current 
thinking on the interpretation of these requirements. The guidance sets 
forth the criteria the Agency will use in determining if the provisions 
of section 505(q) apply to a particular citizen petition or petition 
for stay of agency action. One of the criteria for a citizen petition 
or petition for stay of Agency action to be subject to section 505(q) 
of the FD&C Act 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, the guidance 
recommends that all petitioners challenging the approvability of a 
possible ANDA or 505(b)(2) application include the certification 
required in section 505(q)(1)(H) of the FD&C Act and that petitioners 
and commenters submitting supplements or comments, respectively, to a 
citizen petition or petition for stay of action challenging the 
approvability of a possible ANDA or 505(b)(2) application include the 
verification required in section 505(q)(1)(I) of the FD&C Act. The 
guidance also recommends that if a petitioner submits a citizen 
petition or petition for stay of Agency action that is missing the

[[Page 78250]]

required certification but is otherwise within the scope of section 
505(q) of the FD&C Act and the petitioner would like FDA to review the 
citizen petition or petition for stay of Agency action, the petitioner 
should submit a letter withdrawing the deficient petition and submit a 
new petition that contains the required certification.
    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 (21 
CFR 10.20), a citizen petition requesting the Commissioner of Food and 
Drugs (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) (21 CFR 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) (21 CFR 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, petitions for administrative stay of action, 
comments to petitions, supplements to citizen petitions, and letters to 
withdraw a citizen petition, as described previously in this document, 
that are subject to section 505(q) of the FD&C Act and described in the 
guidance.
    Under section 505(q) of the FD&C Act and the guidance, the 
following information would be submitted to FDA but is not currently 
approved by OMB under the PRA:
    1. The certification required under section 505(q)(1)(H) of the 
FD&C Act for citizen petitions that are subject to section 505(q) and/
or that are challenging the approvability of a possible ANDA or 
505(b)(2) application. Although the submission of a certification for 
citizen petitions is approved under OMB Control Number 0910-0183, the 
certification would be broadened under section 505(q) of the FD&C Act 
and the guidance.
    2. The certification required under section 505(q)(1)(H) of the 
FD&C Act for petitions for stay of Agency action that are subject to 
section 505(q) and/or that are challenging the approvability of a 
possible ANDA or 505(b)(2) application.
    3. The verification required under section 505(q)(1)(I) of the FD&C 
Act for comments to citizen petitions.
    4. The verification required under section 505(q)(1)(I) of the FD&C 
Act for comments to petitions for stay of Agency action.
    5. The verification required under section 505(q)(1)(I) of the FD&C 
Act for supplements to citizen petitions.
    6. Supplements to petitions for stay of Agency action.
    7. The verification required under section 505(q)(1)(I) of the FD&C 
Act for supplements to petitions for stay of Agency action.
    8. The letter submitted by a petitioner withdrawing a deficient 
petition for stay of Agency action that is missing the required 
certification but is otherwise within the scope of section 505(q) of 
the FD&C Act.
    Section 505(q)(1)(B) and (C) of the FD&C Act and the guidance state 
that if FDA determines that a delay in approval of an ANDA or 505(b)(2) 
application is necessary based on a petition subject to section 505(q), 
the applicant may submit to the petition docket clarifications or 
additional data to allow FDA to review the petition promptly. This 
information collection is not included in this analysis because it is 
approved under OMB Control Number 0910-0001 (21 CFR 314.54, 314.94, and 
314.102).
    Based on FDA's knowledge of citizen petitions and petitions for 
stay of Agency action subject to section 505(q) of the FD&C Act that 
have been submitted to FDA, as well as the Agency's familiarity with 
the time needed to prepare a supplement, a certification, and a 
verification.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Annual
                                 Number of      frequency per   Total  annual      Hours per       Total hours
                                respondents       response        responses         response
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Certification for citizen                  19            1.32               25              0.5             12.5
 petitions (505(q)(1)(H))...
Certification for petitions                 3            1                   3              0.5              1.5
 for stay of Agency action
 (505(q)(1)(H)).............
Verification for comments to                9            1.33               12              0.5              6.0
 citizen petitions
 (505(q)(1)(I)).............
Verification for comments to                2            1                   2              0.5              1.0
 petitions for stay of
 Agency action
 (505(q)(1)(I)).............
Verification for supplements                7            1.43               10              0.5              5.0
 to citizen petitions
 (505(q)(1)(I)).............
Supplements to petitions for                1            1                   1              6.0              6.0
 stay of Agency action......
Verification for supplements                1            1                   1              0.5              0.5
 to petitions for stay of
 Agency action
 (505(q)(1)(I)).............
Letter withdrawing a                        1            1                   1              0.5              0.5
 petition for stay of Agency
 action.....................
    Total Hours.............  ...............  ..............  ...............  ...............             33
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 78251]]

    Dated: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31380 Filed 12-14-10; 8:45 am]
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