82 FR 34679 - Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 142 (July 26, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) are designed to speed the delivery of safe and effective generic drugs to the public and to improve the review process for abbreviated new drug applications (ANDAs). This guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. This guidance finalizes the draft guidance originally issued in August 2012 and issued in revised draft form in September 2013.

[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Pages 34679-34680]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15654]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0880]


Generic Drug User Fee Amendments of 2012: Questions and Answers 
Related to Self-Identification of Facilities, Review of Generic Drug 
Submissions, and Inspections and Compliance; 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 the guidance entitled ``Generic Drug User Fee 
Amendments of 2012: Questions and Answers Related to Self-
Identification of Facilities, Review of Generic Drug Submissions, and 
Inspections and Compliance.'' The Generic Drug User Fee Amendments of 
2012 (GDUFA) are designed to speed the delivery of safe and effective 
generic drugs to the public and to improve the review process for 
abbreviated new drug applications (ANDAs). This guidance is intended to 
provide answers to common questions from the generic drug industry and 
other interested parties involved in the development and/or testing of 
generic drug products regarding the requirements and commitments of 
GDUFA. This guidance finalizes the draft guidance originally issued in 
August 2012 and issued in revised draft form in September 2013.

DATES: Submit either electronic or written comments on this guidance at 
any time.

ADDRESSES: You may submit comments 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-2012-D-0880 for ``Generic Drug User Fee Amendments of 2012: 
Questions and Answers Related to Self- Identification of Facilities, 
Review of Generic Drug Submissions, and Inspections and Compliance.'' 
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.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.
    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: Sonia Kim, Center for Drug Evaluation 
and Research, Food and Drug

[[Page 34680]]

Administration, 10001 New Hampshire Ave., Hillandale Building, 4th 
Floor, Silver Spring, MD 20993-0002, 240-402-5118.

SUPPLEMENTARY INFORMATION:

I. Background

    GDUFA (Pub. L. 112-144, Title III) was signed into law by the 
President on July 9, 2012. GDUFA is designed to speed the delivery of 
safe and effective generic drugs to the public and to improve the 
review process for ANDAs. GDUFA enables FDA to assess user fees to 
support critical and measurable enhancements to FDA's generic drugs 
program.
    On August 27, 2012, FDA announced the availability of a draft 
guidance for industry entitled ``Generic Drug User Fee Amendments of 
2012: Questions and Answers'' (77 FR 51814). On September 10, 2013, FDA 
announced the availability of a revised version of this guidance (78 FR 
55261). The comment period on the revised draft guidance ended on 
December 11, 2013 (78 FR 70953). FDA received several comments on the 
draft guidance, and these comments as well as FDA's experience 
implementing GDUFA were considered as the guidance was finalized.
    This guidance is intended to provide answers to common questions 
from generic drug industry participants and other interested parties 
involved in the development and/or testing of generic drug products 
regarding FDA's implementation of GDUFA. This guidance includes three 
categories of questions and answers: Self-identification of facilities, 
sites, and organizations; review of generic drug submissions; and 
inspections and compliance. The draft versions of this guidance also 
addressed the subject of fees. The portion of the draft guidance 
relating to fees was updated and finalized in November 2016 (81 FR 
81774, November 18, 2016).
    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 ``Generic Drug User Fee Amendments of 2012: 
Questions and Answers Related to Self- Identification of Facilities, 
Review of Generic Drug Submissions, and Inspections and Compliance.'' 
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. 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: July 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15654 Filed 7-25-17; 8:45 am]
 BILLING CODE 4164-01-P