
[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1164-1166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00680]


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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Drug Applications; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``ANDA 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 lawful approval 
date.

DATES: Submit either electronic or written comments on the draft 
guidance by April 2, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.

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     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.
     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.gpo.gov/fdsys/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.
    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: 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 draft 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 ANDA 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 (FD&C Act) (21 U.S.C. 355), 
a drug product that is the subject of a tentatively approved ANDA is 
not an approved drug and may not be marketed without final Agency 
approval. In addition, under section 301 of the FD&C Act (21 U.S.C. 
331), the introduction or delivery for introduction into interstate 
commerce of such a drug product before the final approval date is 
prohibited.
    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 draft guidance, an amendment may delay FDA's final approval of 
the ANDA until after the earliest lawful ANDA approval date, depending 
on the nature of the changes proposed in the amendment and any related 
deficiencies identified upon review. The draft guidance is intended to 
assist applicants in preparing an amendment for submission in a timely 
fashion to obtain 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.
    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 ``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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These 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. 3501-3520). 
The collection of information for the submission of ANDAs under 21 CFR 
part 314, subpart C has been approved under OMB control number 0910-
0001. In accordance with the PRA, prior to publication of any final 
guidance document, FDA intends to solicit public

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comment and obtain OMB approval for any information collections 
recommended in this guidance that are new or that would represent 
material modifications to those previously approved collections of 
information found in FDA regulations or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: January 11, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00680 Filed 1-31-19; 8:45 am]
BILLING CODE 4164-01-P


