[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49935-49936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21532]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Citizen Petitions and Petitions for Stay of Action Subject to 
Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Citizen 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.'' This draft guidance revises 
the 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'' issued in November 2014. This draft guidance updates 
the November 2014 guidance to account for recent regulatory changes and 
describes a change in FDA's current thinking on what constitutes a 
505(q) petition. In addition, FDA is revising this guidance to describe 
some of the considerations FDA will take into account in determining 
whether a petition is submitted with the primary purpose of delaying 
the approval of an application.

DATES: Submit either electronic or written comments on the draft 
guidance by December 3, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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; Draft Guidance for Industry.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kim Thomas, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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.'' This 
draft guidance provides information regarding FDA's current thinking on 
implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 355(q)). Section 505(q) of the FD&C Act 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: (1) Section 505(b)(2) of the FD&C Act 
(referred to in this document as a 505(b)(2) application), (2) 505(j) 
of the FD&C Act (referred to in this document as an abbreviated new 
drug application or ANDA), or (3) a pending application for licensure 
of a biological product as biosimilar or interchangeable that is 
submitted under section 351(k) of the Public Health

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Service Act (42 U.S.C. 262(k), referred to in this document as a 351(k) 
application).
    This draft guidance describes how the Agency determines if: (1) The 
provisions of section 505(q) of the FD&C Act 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, 505(b)(2) application, 
or 351(k) application. This draft guidance also describes how FDA 
implements the provisions of section 505(q) requiring that: (1) A 
petition include a certification and (2) supplemental information or 
comments to a petition include a verification. It also addresses the 
relationship between the review of petitions and pending ANDAs, 
505(b)(2) applications, and 351(k) applications for which the Agency 
has not yet made a decision on approvability.
    This draft guidance revises the 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'' issued in November 
2014. This draft guidance updates the November 2014 guidance to account 
for recent regulatory changes to add Sec.  10.31 (21 CFR 10.31) to 
FDA's regulations and modify 21 CFR 10.30 and 10.35. The revision also 
describes a change in FDA's current thinking on what constitutes a 
505(q) petition. In addition, FDA is revising this guidance to describe 
some of the considerations FDA will take into account in determining 
whether a petition is submitted with the primary purpose of delaying 
the approval of an application under section 505(q)(1)(E) of the FD&C 
Act.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on citizen 
petitions and petitions for stay of action subject to section 505(q) of 
the FD&C Act. It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR 10.20, 10.30, and 10.35 have 
been approved under OMB control number 0910-0191; the collections of 
information in Sec.  10.31 have been approved under OMB control number 
0910-0679; and the collections of information in 21 CFR 314.54, 314.94, 
and 314.102 have been approved under OMB control number 0910-0001. The 
certification and verification statements required under Sec.  10.31(c) 
and (d) are ``public disclosure[s] of information originally supplied 
by the Federal government to the recipient for the purpose of 
disclosure to the public . . .'' (5 CFR 1320.3(c)(2)) and therefore not 
subject to OMB review under the PRA.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21532 Filed 10-2-18; 8:45 am]
 BILLING CODE 4164-01-P