[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 2999-3002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00193]


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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; 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 section 505(q) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by March 13, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0008 for ``Citizen Petitions and Petitions for Stay of 
Action Subject to Section 505(q) of the Federal Food, Drug, and 
Cosmetic Act.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets

[[Page 3000]]

Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A12M, 11601 
Landsdown St., North Bethesda, MD 20852, [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

    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 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) (21 U.S.C. 355(b)(2) or 21 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 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 (PHS) 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

[[Page 3001]]

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, 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. This information collection is not 
included in this analysis because it is currently 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
               FD&C Act section                   Number of     frequency per   Total annual               Hours per response               Total hours
                                                 respondents      response        responses
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Certification for citizen petitions                        38            1.37              52  0.5 (30 minutes).........................              26
 (505(q)(1)(H)).
Certification for petitions for stay of                     3               1               3  0.5 (30 minutes).........................             1.5
 Agency action (505(q)(1)(H)).
Verification for comments to citizen                       12            1.66              20  0.5 (30 minutes).........................              10
 petitions (505(q)(1)(I)).
Verification for comments to petitions for                  1               1               1  0.5 (30 minutes).........................              .5
 stay of Agency action (505(q)(1)(I)).
Verification for supplements to citizen                     7            2.29              16  0.5 (30 minutes).........................               8
 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 minutes).........................             0.5
 stay of Agency action (505(q)(1)(I)).
Letter withdrawing a petition for stay of                   3               1               3  0.5 (30 minutes).........................             1.5
 Agency action.
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    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: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00193 Filed 1-9-17; 8:45 am]
 BILLING CODE 4164-01-P