[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60288-60290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities: Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection in 
the guidance on citizen petitions and petitions for stay of action 
subject to of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by December 2, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the 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.

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--(OMB Control Number 0910-0679)--Extension

    In the Federal Register of June 8, 2011(76 FR 33309), FDA announced 
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 guidance provides 
information regarding FDA's current thinking on interpreting section 
914 of Title IX of the Food and Drug Administration Amendments Act 
(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) (U.S.C. 355(b)(2) or U.S.C. 355(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 abbreviated new drug application (ANDA) or 
a section 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

[[Page 60289]]

include a verification. Finally, the guidance addresses the 
relationship between the review of petitions and pending ANDAs and 
section 505(b)(2) applications for which the Agency has not yet made a 
decision on approvability.
    The Food and Drug Administration Safety and Innovation Act (FDASIA) 
was signed into law on July 9, 2012 (Pub. L. 112-144, 126 Stat. 993). 
Section 1135 of FDASIA amended section 505(q) of the FD&C Act in two 
ways. First, it shortened FDA's deadline from 180 days to 150 days for 
responding to petitions subject to section 505(q) of the FD&C Act. 
Second, it expanded the scope of section 505(q) of the FD&C Act to 
include certain petitions concerning applications submitted under 
section 351(k) of the Public Health Service Act (42 U.S.C. 262), the 
abbreviated pathway for the approval of biosimilar biological products. 
Accordingly, we are now including submissions pertaining to biosimilar 
biological product applications in the information collection burden 
estimates below.
    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. The guidance sets forth the criteria the Agency will use in 
determining if the provisions of section 505(q) of the FD&C Act apply 
to a particular citizen petition or petition for stay of agency action. 
The guidance states that 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 section 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 section 505(b)(2) application, the 
guidance recommends that all petitioners challenging the approvability 
of a possible ANDA or section 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 section 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 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, 
which are subject to section 505(q) of the FD&C Act and described in 
the guidance.
    We are requesting OMB approval for the following collection of 
information submitted to FDA under section 505(q) of the FD&C Act and 
the guidance:
    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, section 
505(b)(2) application, or biosimilar biological product 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, section 505(b)(2) application, or biosimilar biological 
product 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, section 
505(b)(2) application, or biosimilar biological product 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.
    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:

[[Page 60290]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                     Number of
                    Activity                         Number of    responses  per   Total annual       Average  burden per  response        Total hours
                                                    respondents     respondent       responses
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Certification for citizen petitions                           26            1.15              32  0.5 (30 min.)........................             16
 (505(q)(1)(H)).
Certification for petitions for stay of agency                 1            1                  1  0.5 (30 min.)........................               .5
 action (505(q)(1)(H)).
Verification for comments to citizen petitions                 9            1.33              12  0.5 (30 min.)........................              6.0
 (505(q)(1)(I)).
Verification for comments to petitions for stay                1            1                  1  0.5 (30 min.)........................               .5
 of agency action (505(q)(1)(I)).
Verification for supplements to citizen                        7            1.43              10  0.5 (30 min.)........................              5.0
 petitions (505(q)(1)(I)).
Supplements to petitions for stay of agency                    1            1                  1  6....................................              6
 action.
Verification for supplements to petitions for                  1            1                  1  0.5 (30 min.)........................              0.5
 stay of agency action (505(q)(1)(I)).
Letter withdrawing a petition for stay of agency               1            1                  1  0.5 (30 min.)........................              0.5
 action.
                                                 -------------------------------------------------------------------------------------------------------
    Total Hours.................................  ..............  ..............  ..............  .....................................             35
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23886 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P