[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31399-31400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14429]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5670]
Abbreviated New Drug Application Submissions--Amendments to
Abbreviated New Drug Applications Under the Generic Drug User Fee Act;
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 to Abbreviated New Drug Applications Under
GDUFA.'' This guidance finalizes the October 2017 draft guidance for
industry ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance is intended to explain to
applicants how the review goals established as part of the Generic Drug
User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to
amendments to either abbreviated new drug applications (ANDAs) or prior
approval supplements (PASs) submitted to FDA under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment
classifications and categories and explains how amendment submissions
may affect an application's review goal dates. The guidance also
describes how FDA will review amendments submitted to ANDAs and PASs
received prior to October 1, 2017, the effective date to implement the
GDUFA II review goals.
DATES: The announcement of the guidance is published in the Federal
Register on July 5, 2018.
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-2017-D-5670 for ``ANDA Submissions--Amendments to Abbreviated New
Drug Applications Under GDUFA.'' 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 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-
[[Page 31400]]
402-7930, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``ANDA Submissions--Amendments to Abbreviated New Drug
Applications Under GDUFA.'' This guidance finalizes the October 2017
draft guidance for industry ``ANDA Submissions--Amendments to
Abbreviated New Drug Applications Under GDUFA.'' This guidance is
intended to assist applicants preparing to submit amendments to ANDAs
or to PASs to FDA under section 505(j) of the FD&C Act (21 U.S.C.
355(j)) by explaining how the review goals established as part of GDUFA
II apply to these submissions. In accordance with the GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022 (GDUFA II Commitment Letter: https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/ucm525234.pdf), FDA agreed to
certain review goals and procedures for the review of amendments
pending as of or received on or after the GDUFA II effective date.
The GDUFA II Commitment Letter reflects significant changes in the
classification of and review goals for amendments to ANDAs and PASs
under the Generic Drug User Fee Amendments of 2012 (GDUFA I). Under
GDUFA I, amendments were classified into a complex Tier system based on
the following factors: (1) Whether the amendment was solicited
(submitted in response to a complete response letter) or unsolicited
(submitted on the applicant's own initiative); (2) whether the
amendment was major or minor; the number of amendments submitted to the
ANDA or PAS; and (3) whether an inspection was necessary to support the
information contained in the amendment.
GDUFA II simplified the amendment review goals and no longer
subjects them to a Tier system; however, review goals are still
dependent on several factors. In general, under GDUFA II, amendments
will be designated as either standard or priority; will be classified
as major or minor, and will receive a goal date based on the factors
discussed in the draft guidance, including whether a preapproval
inspection is needed. This guidance supersedes the December 2001
guidance for industry ``Major, Minor, and Telephone Amendments to
Abbreviated New Drug Applications'' and the July 2014 draft guidance
for industry ``ANDA Submissions--Amendments and Easily Correctable
Deficiencies Under GDUFA,'' both of which will be withdrawn. This
guidance finalizes the October 2017 draft guidance for industry ``ANDA
Submissions--Amendments to Abbreviated New Drug Applications Under
GDUFA.'' The final guidance contains clarifications to the draft
guidance of the same title that published in October 2017.
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 to
Abbreviated New Drug Applications Under GDUFA.'' 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 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 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 314.96 have been approved under
OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14429 Filed 7-3-18; 8:45 am]
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