[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Pages 37069-37070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11943]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0861]


Cover Letter Attachments for Controlled Correspondence and 
Abbreviated New Drug Application Submissions; 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 final guidance for industry entitled ``Cover 
Letter Attachments for Controlled Correspondence and ANDA 
Submissions.'' This guidance is intended to assist prospective 
applicants, applicants, and holders of abbreviated new drug 
applications (ANDAs) with optional attachments that can be used when 
preparing cover letters that accompany controlled correspondence, 
original ANDAs, amendments to ANDAs, and supplements to approved ANDAs 
submitted to FDA. This guidance finalizes the draft guidance of the 
same title issued on December 13, 2021.

DATES: The announcement of the guidance is published in the Federal 
Register on June 6, 2023.

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-2021-D-0861 for ``Cover Letter Attachments for Controlled 
Correspondence and ANDA Submissions.'' 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

[[Page 37070]]

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: Jonathan Hughes, Office of Generic 
Drugs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Rm. 1668, Silver Spring, MD 
20993-0002, 240-702-3970, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Cover Letter Attachments for Controlled Correspondence and 
ANDA Submissions.'' This guidance is intended to assist prospective 
applicants, applicants, and holders of ANDAs with optional attachments 
that can be used when preparing cover letters that accompany controlled 
correspondence, original ANDAs, amendments to ANDAs, and supplements to 
approved ANDAs submitted to FDA.
    A cover letter is generally included with controlled correspondence 
to the Office of Generic Drugs and submissions to an ANDA file. While a 
cover letter is not required content for an ANDA, the cover letter is a 
part of the electronic common technical document hierarchy and is 
included in Module 1 of an ANDA submission.
    The cover letter provides an overview of the submission and helps 
FDA ensure that the submission is properly triaged and assigned to the 
appropriate assessors. In an effort to ensure that submissions are 
effectively managed by FDA and acted upon within the performance review 
goal dates reflected in the Generic Drug User Fee Amendments (GDUFA) 
Reauthorization Performance Goals and Program Enhancements Fiscal Years 
2023-2027 commitment letter (GDUFA III Commitment Letter),\1\ FDA has 
developed cover letter attachments to accompany, not replace, 
applicants' cover letters for common submissions, including controlled 
correspondence, original ANDAs, and amendments to ANDAs, as well as 
supplements to approved ANDAs. These cover letter attachments have been 
designed as a checklist to reflect common types of information 
applicants are expected to address in their cover letters. The 
attachments are intended both to serve as a useful guide to help 
applicants prepare their cover letters and to assist FDA in the triage 
and management of submissions.
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    \1\ Available at: https://www.fda.gov/media/153631/download.
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    This guidance finalizes the draft guidance entitled ``Cover Letter 
Attachments for Controlled Correspondence and ANDA Submissions'' issued 
on December 13, 2021 (86 FR 70849). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft to the final guidance include clarifying that use of the cover 
letter attachments are voluntary; defining several terms that may have 
been ambiguous (e.g., ``administrative general correspondence'' and 
``approved citizen petitions''); and adding updated information on 
labeling carve-outs and requests for reconsideration. In addition, 
editorial changes were made to improve clarity, such as adding lines to 
denote where information should be filled in by the applicant and minor 
reformatting of the attachments in the appendices.
    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 ``Cover Letter Attachments for Controlled 
Correspondence and ANDA Submissions.'' 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 part 314 (including subpart C) for to the 
content and format of ANDAs, including original ANDAs, amendments to 
ANDAs, and supplements to approved ANDAs, submitted by applicants and 
approved by FDA have been approved under OMB control number 0910-0001. 
The collections of information for Form FDA 356h (NDA and ANDA cover 
letter) have been approved under OMB control number 0910-0338.
    Applicants submit to FDA controlled correspondence along with cover 
letters related to generic drug development and FDA approval. The 
collections of information for such submissions have been approved 
under OMB control number 0910-0797. The collections of information in 
21 CFR part 11 for electronic records and electronic signatures have 
been approved under OMB control number 0910-0303. The collections of 
information in 21 CFR part 211 about the manufacture of the drug have 
been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the final 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: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11943 Filed 6-5-23; 8:45 am]
BILLING CODE 4164-01-P