[Federal Register Volume 89, Number 53 (Monday, March 18, 2024)]
[Notices]
[Pages 19328-19329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05687]



[[Page 19328]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1167]


Controlled Correspondence Related to Generic Drug Development; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final 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 guidance 
finalizes the draft guidance of the same title issued on December 22, 
2022. This guidance replaces the guidance ``Controlled Correspondence 
Related to Generic Drug Development'' issued on December 17, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on March 18, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 this 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 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 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

[[Page 19329]]

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 this 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 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 guidance finalizes the draft guidance for industry entitled 
``Controlled Correspondence Related to Generic Drug Development'' 
issued on December 22, 2022 (87 FR 78691). FDA considered comments 
received on the draft guidance as the guidance was finalized. Changes 
from the draft to the final guidance include updating the guidance to 
clarify the role of a cover letter to a controlled correspondence; 
clarify that authorized agents submitting controlled correspondence 
should include the name of and contact information for the generic drug 
manufacturer or related industry they are representing; and explain 
that FDA intends to alert requestors whether their inquiry is a level 1 
or level 2 controlled correspondence and if FDA changes the level of 
the controlled correspondence (e.g., from level 1 to level 2) during 
substantive review. In addition, editorial changes were made to improve 
clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. The 
previously approved 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. 3501-3521). The collections of information 
in 21 CFR parts 312 and 314 have been approved under OMB control 
numbers 0910-0014 and 0910-0001, respectively. The collections of 
information for controlled correspondence, covered product 
authorizations, and GDUFA III meetings are approved under OMB control 
number 0910-0727. The collections of information for risk evaluation 
and mitigation strategies and medication guides are approved under OMB 
control number 0910-0393. The collections of information for citizen 
petitions are approved under OMB control number 0910-0191. The 
collections of information for premarket approval of drug-device 
combination products as described in the draft guidance for industry 
entitled ``Comparative Analyses and Related Comparative Use Human 
Factors Studies for a Drug-Device Combination Product Submitted in an 
ANDA'' have been approved under OMB control number 0910-0231.

III. Electronic Access

    Persons with access to the internet may obtain the 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: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05687 Filed 3-15-24; 8:45 am]
BILLING CODE 4164-01-P