Notice2022-27827
Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability
Primary source
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Published
December 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Controlled Correspondence Related to Generic Drug Development." This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This draft guidance revises the guidance for industry entitled "Controlled Correspondence Related to Generic Drug Development" issued in December 2020.
Full Text
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<title>Federal Register, Volume 87 Issue 245 (Thursday, December 22, 2022)</title>
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[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78691-78693]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27827]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1167]
Controlled Correspondence Related to Generic Drug Development;
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Controlled
Correspondence Related to Generic Drug Development.'' This guidance
provides information
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regarding the process by which generic drug manufacturers and related
industry can submit controlled correspondence to FDA requesting
information related to generic drug development and the Agency's
process for providing communications related to such correspondence.
This guidance also describes the process by which generic drug
manufacturers and related industry can submit requests to clarify
ambiguities in FDA's controlled correspondence response and the
Agency's process for responding to those requests. This draft guidance
revises the guidance for industry entitled ``Controlled Correspondence
Related to Generic Drug Development'' issued in December 2020.
DATES: Submit either electronic or written comments on the draft
guidance by February 21, 2023 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2014-D-1167 for ``Controlled Correspondence Related to Generic Drug
Development.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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: Lisa Bercu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1672, Silver Spring, MD 20993-0002, 240-402-6902.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Controlled Correspondence Related to Generic Drug
Development.'' This guidance provides information regarding the process
by which generic drug manufacturers and related industry can submit to
FDA controlled correspondence requesting information related to generic
drug development and the Agency's process for providing communications
related to such correspondence. This guidance also describes the
process by which generic drug manufacturers and related industry can
submit requests to clarify ambiguities in FDA's controlled
correspondence response and the Agency's process for responding to
those requests. In accordance with the Generic Drug User Fee Amendments
(GDUFA) Reauthorization Performance Goals and Program Enhancements
Fiscal Years 2023-2027 (GDUFA III commitment letter), FDA agreed to
certain review goals and procedures for the review of controlled
correspondence received on or after October 1, 2022.
The GDUFA III commitment letter defines level 1 controlled
correspondence and level 2 controlled correspondence, and the draft
guidance provides additional details and recommendations concerning
what inquiries FDA considers controlled correspondence for the purposes
of meeting the Agency's performance goals under the GDUFA III
commitment letter. In addition, this guidance provides details and
recommendations concerning what information requestors should include
in a controlled correspondence to facilitate FDA's consideration of and
response to a controlled correspondence and what information FDA will
provide in its communications to requestors that have
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submitted controlled correspondence. As described in the GDUFA III
commitment letter, FDA has also agreed to review and respond to
requests to clarify ambiguities in the controlled correspondence
response, and the guidance provides information on how requestors can
submit these requests and the Agency's process for responding to them.
This draft guidance revises the guidance for industry entitled
``Controlled Correspondence Related to Generic Drug Development''
issued in December 2020. When finalized, this updated guidance will
replace the December 2020 guidance. Changes from the 2020 version
include updating the guidance to reflect enhancements in the GDUFA III
commitment letter (e.g., including information on controlled
correspondence that can be submitted during abbreviated new drug
application assessment and after issuance of a complete response letter
or a tentative approval or approval); providing additional
recommendations on requests for information related to inactive
ingredients; and other updates that are intended to clarify FDA's
recommendations to industry.
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 ``Controlled
Correspondence Related to Generic Drug Development.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 312 and 314 have been approved under OMB
control numbers 0910-0014 and 0910-0797, respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27827 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P
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