[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Drug Applications; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``ANDA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DATES: Submit either electronic or written comments on the draft
guidance by April 2, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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, [email protected].
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]
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