[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78691-78693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Controlled 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

[[Page 78692]]

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 This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by February 21, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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.govinfo.gov/content/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, 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

[[Page 78693]]

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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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


