[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70849-70850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26893]


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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 Correspondences and 
Abbreviated New Drug Application Submissions; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Cover 
Letter Attachments for Controlled Correspondences and Abbreviated New 
Drug Application 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 to the 
Office of Generic Drugs (OGD), as well as original ANDAs, amendments to 
ANDAs, and supplements to approved ANDAs submitted to FDA.

DATES: Submit either electronic or written comments on the draft 
guidance by February 11, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2021-D-0861 for ``Cover Letter Attachments for Controlled 
Correspondences 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 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: Nicole Park, Office of Generic Drugs, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Rm. 1725, Silver Spring, MD 20993-0002, 240-
402-7764, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Cover Letter Attachments for Controlled Correspondences 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 to OGD, as well as original ANDAs, amendments to ANDAs, 
and supplements to approved ANDAs submitted to FDA.
    A cover letter is generally included with controlled correspondence 
to OGD 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

[[Page 70850]]

document (eCTD) 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 set by the Generic Drug User Fee Amendments, 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.
    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 ``Cover Letter 
Attachments for Controlled Correspondences 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. 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 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 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26893 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P