Document ID: FDA-2018-D-4726-0008
Agency: fda
Document Type: Notice
Title: Abbreviated New Drug Application Submissions—Amendments and Requests for Final Approval To Tentatively Approved Abbreviated New Drug Applications; Guidance for Industry; Availability
Posted Date: 2020-09-29T04:00Z

[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61014-61016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21470]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4726]

Abbreviated New Drug Application Submissions--Amendments and 
Requests for Final Approval To Tentatively Approved Abbreviated New 
Drug Applications; 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 ``ANDA 
Submissions--Amendments and Requests for Final Approval to Tentatively 
Approved ANDAs.'' This guidance is intended to assist applicants in 
preparing and submitting amendments to tentatively approved abbreviated 
new drug applications (ANDAs), including requests for final approval. 
This guidance provides recommendations on the timing and content of 
amendments to tentatively approved ANDAs to facilitate submission in a 
timely fashion to enable final approval on the earliest date on which 
the ANDA may lawfully be approved based on patent and/or exclusivity 
protections (earliest lawful approval date). This guidance finalizes 
the draft guidance of the same title issued on February 1, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on September 29, 2020.

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

[[Page 61015]]

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-2018-D-4726 for ``ANDA Submissions--Amendments and Requests for 
Final Approval to Tentatively Approved ANDAs.'' 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: Elizabeth Giaquinto Friedman, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 
240-402-7930, elizabeth.giaquinto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDA Submissions--Amendments and Requests for Final Approval 
to Tentatively Approved ANDAs.'' This guidance is intended to assist 
applicants in preparing and submitting amendments to tentatively 
approved ANDAs, including requests for final approval. This guidance 
provides recommendations on the timing and content of amendments to 
tentatively approved ANDAs to facilitate submission in a timely fashion 
to enable final approval on the earliest date on which the ANDA may 
lawfully be approved based on patent and/or exclusivity protections 
(earliest lawful approval date).
    If an ANDA meets the substantive requirements for approval but 
cannot be finally approved by FDA because of unexpired patents or 
exclusivities, FDA will tentatively approve the ANDA. Under section 505 
of the Federal Food, Drug, and Cosmetic Act) (21 U.S.C. 355), a drug 
product that is the subject of a tentatively approved ANDA is not an 
approved drug and does not have an effective approval until FDA issues 
an approval after any necessary additional review of the application.
    An ANDA applicant may submit amendments to a tentatively approved 
application that propose changes to the application, request final 
approval, or propose changes and request final approval. As described 
in the guidance, an amendment proposing changes to the application may 
delay FDA's final approval of the ANDA, depending on the timing of 
submission of the amendment and the nature of the changes proposed and 
any related deficiencies identified upon review. The guidance is 
intended to assist applicants in preparing an amendment for submission 
in a timely fashion to enable final approval on the earliest lawful 
approval date. In particular, applicants that wish to request final 
approval should determine whether changes are necessary before 
requesting this final approval, review any changes that have been made 
to their application since the tentative approval was granted, and 
consider the possible review goal dates that may be assigned to the 
request for final approval to request final approval in a timely 
fashion.
    In the Federal Register of February 1, 2019 (84 FR 1164), FDA 
announced the availability of the draft guidance of the same title 
dated January 2019. The draft guidance was posted on FDA's website on 
January 16, 2019, during the lapse in appropriations to provide advance 
notice of the document to the public. The comment period opened upon 
publication in the Federal Register. FDA received five comments on the 
draft guidance and those comments were considered as the guidance was 
finalized. The final guidance contains minor clarifications to the 
draft guidance. The guidance announced in

[[Page 61016]]

this notice finalizes the draft guidance dated January 2019.
    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 ``ANDA Submissions--Amendments and Requests 
for Final Approval to Tentatively Approved ANDAs.'' 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. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: September 22, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21470 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P