
[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65660-65661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0881]


Self-Identification of Generic Drug Facilities, Sites, and 
Organizations; 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 guidance for industry entitled ``Self-
Identification of Generic Drug Facilities, Sites, and Organizations.'' 
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) 
was signed into law by the President. GDUFA, designed to speed the 
delivery of safe and effective generic drugs to the public and reduce 
costs to industry, requires that generic drug facilities, sites, and 
organizations around the world provide identification information 
annually to FDA. This guidance is intended to assist industry to meet 
the self-identification requirement. It explains who is required to 
self-identify, what information must be requested, how the information 
should be submitted to FDA, and what the penalty is for failure to 
self-identify.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-0881 for ``Self-Identification of Generic Drug Facilities, 
Sites, and Organizations.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/

[[Page 65661]]

regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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: Andrew LeBoeuf, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 240-402-0503.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Self-Identification of Generic Drug Facilities, Sites, and 
Organizations.'' The guidance announced in this notice finalizes the 
draft guidance of the same name announced in the Federal Register of 
August 27, 2012 (77 FR 51811). Compared to the draft guidance, the 
final guidance clarifies various matters, including that the self-
identification requirements have been implemented, and simplifies the 
instructions for electronic submission of self-identification 
information. FDA received one comment on the draft guidance, which was 
considered as the guidance was finalized.
    On July 9, 2012, GDUFA (Pub. L. 112-144, Title III) was signed into 
law by the President. GDUFA is designed to speed the delivery of safe 
and effective generic drugs to the public and reduce costs to industry. 
GDUFA enables FDA to assess user fees to support critical and 
measurable enhancements to FDA's generic drugs program. GDUFA will also 
significantly improve global supply chain transparency by requiring 
owners of facilities producing generic drug products, active 
pharmaceutical ingredients (API), and certain other sites and 
organizations that support the manufacture or approval of these 
products to electronically self-identify with FDA and update that 
information annually.
    Self-identification is required for two purposes. First, it is 
necessary to determine the universe of facilities required to pay user 
fees. Second, self-identification is a central component of an effort 
to promote global supply chain transparency. The information provided 
through self-identification enables quick, accurate, and reliable 
surveillance of generic drugs and facilitates inspections and 
compliance.
    Most facilities that self-identify are required to pay an annual 
facility user fee. These include facilities manufacturing, or intending 
to manufacture, API of human generic drugs and/or finished dosage form 
(FDF) human generic drugs. Other facilities, sites, and organizations 
must self-identify, but are not required to pay the annual facility 
user fee. These include facilities that solely manufacture positron 
emission tomography drugs, or sites and organizations that only perform 
testing, repackaging, or relabeling operations. Please note that while 
re-packagers are not required to pay user fees, packagers are, in most 
cases, FDF manufacturers and subject to facility fees.
    A separate system for the electronic self-identification of generic 
industry facilities, sites, and organizations was established for 
GDUFA. Entities required to register and list (under section 510 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) or section 351 of 
the Public Health Service Act (42 U.S.C. 262)), and those required to 
self-identify under GDUFA, submit information separately to the 
respective systems. Each system populates its own database to meet 
unique requirements and deadlines. The new GDUFA system uses the same 
platform and technical standards already familiar to manufacturers 
required to register and list.
    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 ``Self-Identification of Generic Drug 
Facilities, Sites, and Organizations.'' 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.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22944 Filed 9-22-16; 8:45 am]
 BILLING CODE 4164-01-P


