82 FR 46066 - Abbreviated New Drug Applications Submissions-Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 190 (October 3, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA.'' This draft guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply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 abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The draft guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II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.

[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46066-46068]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21175]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5670]


Abbreviated New Drug Applications Submissions--Amendments To 
Abbreviated New Drug Applications Under the Generic Drug User Fee Act; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``ANDA 
Submissions--Amendments to Abbreviated New Drug Applications Under 
GDUFA.'' This draft guidance is intended to explain to applicants how

[[Page 46067]]

the review goals established as part of the Generic Drug User Fee 
Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to 
abbreviated new drug applications (ANDAs) and prior approval 
supplements (PASs) to FDA under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act). This draft guidance describes amendment classifications 
and categories and explains how amendment submissions may affect an 
application's review goal dates. The draft 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: Submit either electronic or written comments on the draft 
guidance by December 4, 2017 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.
     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: at: https://www.thefederalregister.org/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 to Abbreviated New Drug 
Applications Under GDUFA.'' This guidance is intended to assist 
applicants preparing to submit amendments to ANDAs or 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, available at: 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:
     Whether the amendment was solicited (submitted in response 
to a complete response letter) or unsolicited (submitted on the 
applicant's own initiative).
     Whether the amendment was major or minor.
     The number of amendments submitted to the ANDA or PAS.
     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

[[Page 46068]]

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. When finalized, this draft guidance 
will replace the December 2001 guidance for industry ``Major, Minor, 
and Telephone Amendments to Abbreviated New Drug Applications.'' This 
draft guidance supersedes the July 2014 draft guidance for industry 
``ANDA Submissions--Amendments and Easily Correctable Deficiencies 
Under GDUFA.''
    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 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 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 (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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21175 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P