Document ID: FDA-2009-D-0008-0016
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Citizen Petitions
and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2017-04-25T04:00Z

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19050-19051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08307]

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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; 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 or we) 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.

DATES: Fax written comments on the collection of information by May 25, 
2017.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0679. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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--OMB Control Number 0910-0679--Extension

    FDA's 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'' 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 Federal Food, 
Drug, and Cosmetic Act (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 abbreviated new drug application (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 Food and Drug Administration Safety and Innovation Act (FDASIA) 
was signed into law on July 9, 2012 (Pub. L. 112-144). 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 in this 
document.
    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 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 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 0910-0191). 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,

[[Page 19051]]

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:
     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, 
505(b)(2) application, or biosimilar biological product application. 
Although the submission of a certification for citizen petitions is 
approved under OMB control number 0910-0191, the certification would be 
broadened under section 505(q) of the FD&C Act and the guidance.
     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, 505(b)(2) application, or biosimilar biological product 
application.
     The verification required under section 505(q)(1)(I) of 
the FD&C Act for comments to citizen petitions.
     The verification required under section 505(q)(1)(I) of 
the FD&C Act for comments to petitions for stay of Agency action.
     The verification required under section 505(q)(1)(I) of 
the FD&C Act for supplements to citizen petitions.
     Supplements to petitions for stay of Agency action.
     The verification required under section 505(q)(1)(I) of 
the FD&C Act for supplements to petitions for stay of Agency action.
     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, 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. While we have not included a burden 
estimate for this provision under the instant information collection, 
it is included under OMB control number 0910-0001 (21 CFR 314.54, 
314.94, and 314.102).
    In the Federal Register of January 10, 2017 (82 FR 2999), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice. Therefore, based on our 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 our 
familiarity with the time needed to prepare a supplement, a 
certification, and a verification, we estimate the burden of this 
collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
   Activity/FD&C Act section       Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Certification for citizen                   38            1.37              52  .5 (30 minutes).              26
 petitions; 505(q)(1)(H).
Certification for petitions                  3               1               3  .5 (30 minutes).             1.5
 for stay of Agency action;
 505(q)(1)(H).
Verification for comments to                12            1.66              20  .5 (30 minutes).              10
 citizen petitions;
 505(q)(1)(I).
Verification for comments to                 1               1               1  .5 (30 minutes).              .5
 petitions for stay of Agency
 action; 505(q)(1)(I).
Verification for supplements                 7            2.29              16  .5 (30 minutes).               8
 to citizen petitions;
 505(q)(1)(I).
Supplements to petitions for                 1               1               1  6...............               6
 stay of Agency action.
Verification for supplements                 1               1               1  .5 (30 minutes).              .5
 to petitions for stay of
 Agency action; 505(q)(1)(I).
Letter withdrawing a petition                3               1               3  .5 (30 minutes).             1.5
 for stay of Agency action.
                               ---------------------------------------------------------------------------------
    Total Hours...............  ..............  ..............  ..............  ................              54
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08307 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P