83 FR 49935 - 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Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 192 (October 3, 2018)

Page Range		49935-49936
FR Document		2018-21532

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance revises the guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and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 This draft guidance updates the November 2014 guidance to account for recent regulatory changes and describes a change in FDA's current thinking on what constitutes a 505(q)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.

Federal Register, Volume 83 Issue 192 (Wednesday, October 3, 2018)

[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49935-49936]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-21532]

[[Page 49935]]

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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Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Citizen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 This draft guidance revises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 This draft guidance updates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.thefederalregister.org/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

[[Page 49936]]

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

Document Created: 2018-10-03 02:30:04
Document Modified: 2018-10-03 02:30:04

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		83 FR 49935

83 FR 49935 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 192 (October 3, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration