Document ID: FDA-2017-D-5670-0009
Agency: fda
Document Type: Notice
Title: Abbreviated New Drug Application Submissions—Amendments to
Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry; Availability
Posted Date: 2018-07-05T04:00Z

[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 This guidance finalizes the October 2017 draft guidance for 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]
 BILLING CODE 4164-01-P