
[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Notices]
[Pages 51811-51814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20946]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0881]


Draft Guidance for Industry on Self-Identification of Generic 
Drug Facilities, Sites, and Organizations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Self-
Identification of Generic Drug Facilities, Sites, and

[[Page 51812]]

Organizations.'' On July 9, 2012, the Generic Drug User Fee Amendments 
of 2012 (GDUFA) (Pub. L. 112-144, Title III) 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 as it prepares 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments concerning the 
proposed collection of information by October 26, 2012. Submit either 
electronic or written comments on the draft guidance by October 26, 
2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jaewon Hong, Center for Drug 
Evaluation and Research (HFD-300), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 1-866-405-5367 or 301-796-
6707.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the Generic Drug User Fee Amendments of 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 fund 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 and 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. Once the self-identification process has been completed, FDA will 
determine the fees and publish the amounts in the Federal Register. 
Second, self-identification is a central component of an effort to 
promote global supply chain transparency. The information provided 
through self-identification will enable quick, accurate, and reliable 
surveillance of generic drugs and facilitate inspections and 
compliance.
    This guidance is intended to assist human generic drug facilities, 
sites, and organizations by describing how FDA will implement the self-
identification requirement contained in GDUFA. As required by GDUFA, in 
the coming weeks FDA will issue a self-identification requirement 
notice in the Federal Register. The notice will explain that human 
generic drug facilities, sites, and organizations are required to 
submit identification information electronically to FDA within 60 days. 
The notice will also list the self-identification information that must 
be submitted. FDA is issuing this guidance to assist industry as it 
prepares to meet the self-identification requirement. The guidance 
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.
    To facilitate the implementation of the self-identification 
requirement in GDUFA, FDA is establishing a new system for the 
electronic self-identification of generic industry facilities, sites, 
and organizations. Entities that are required to register and list 
under section 510 of the Federal Food, Drug, and Cosmetic Act or 
section 351 of the Public Health Service Act, and those entities 
required to self-identify under GDUFA, will submit information 
separately to the respective systems. Each system will populate its own 
database to meet unique requirements and deadlines. The new GDUFA 
system will use the same platform and technical standards already 
familiar to manufacturers required to register and list.
    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 Agency's current thinking on self-
identification of generic drug facilities, sites, and organizations. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information that 
they conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on the following topics: (1) 
Whether the proposed information collected is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimated burden of 
the proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the

[[Page 51813]]

respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Under GDUFA, and as described in the draft guidance, electronic 
self-identification will be required by all facilities, sites, and 
organizations involved in the development and manufacturing of generic 
drugs identified or intended to be identified in an approved or pending 
FDA generic drug submission. The electronic self-identification 
requirement applies equally to all domestic and foreign facilities and 
is independent of the obligation to pay user fees.
    Generic drug facilities, sites, and organizations required under 
GDUFA to self-identify include:
    1. Facilities that manufacture, or intend to manufacture, human 
generic drug APIs or FDFs, or both.
    2. Sites and organizations that package the FDF of a human generic 
drug into the primary container/closure system and label the primary 
container/closure system.\1\
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    \1\ Sites and organizations that package the FDF of a human 
generic drug into the primary container/closure system and label the 
primary container/closure system are considered to be manufacturers, 
whether or not that packaging is done pursuant to a contract or by 
the applicant itself.
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    3. Sites that are identified in a generic drug submission and 
pursuant to a contract with the applicant remove the drug from a 
primary container/closure system and subdivide the contents into a 
different primary container/closure system.
    4. Bioequivalence (BE)/bioavailability (BA) sites that are 
identified in a generic drug submission and conduct clinical BE/BA 
testing, bioanalytical testing of samples collected from clinical BE/BA 
testing, and/or in vitro BE testing.
    5. Sites that are identified in a generic drug submission and 
perform testing of one or more attributes or characteristics of the FDF 
or the API pursuant to a contract with the applicant to satisfy a 
current good manufacturing practice (CGMP) testing requirement 
(excludes sites that are testing for research purposes only).
    All of the facilities, sites, and organizations listed above are 
currently required to register and list except for 4.
    FDA is establishing a new system for self-identification of generic 
industry facilities, sites, and organizations. Entities that are 
required to register and list, and those that are required to self-
identify, will submit information to both systems separately. Each 
system will populate its own database to meet unique requirements and 
deadlines. Although separate, both systems are built on a common 
process already familiar to manufacturers required to register and 
list. This will minimize the cost and effort associated with 
compliance.
    FDA will use the same electronic exchange standards and formats for 
self-identification that are used in the Drug Registration and Listing 
System (eDRLS) including XML file formats, which conform to message 
standards for Structured Product Labeling (SPL). Facilities, sites, and 
organizations will be able to generate electronic SPL files in the free 
eSubmitter tool available on FDA's Web site, or other commercially 
available tools, and submit the files through FDA's Electronic 
Submissions Gateway. Facilities, sites, and organizations will be 
required to provide Data Universal Numbering System (D-U-N-S) numbers 
and Facility Establishment Identifiers (FEI) to enable quick and 
accurate identification of registrants as well as facilities, sites, 
and organizations. They will also be required to submit information 
about the registrant, facility, and SPL file. Requested information 
will include:

Document Information--
Type of Document
ID Root
Set ID Root
Version number
Effective Time
Registrant Information--
Name
Registrant D-U-N-S Number
Registrant Contact Information
Establishment (Facility) Information--
Name
Establishment Facility D-U-N-S Number
FEI
Physical address
Type of Business Operations
Establishment (Facility) Contact Information

    FDA estimates that approximately 2,650 facilities, sites, and 
organizations (``number of respondents'' in Table 1) will submit the 
self-identification information set forth above and described in the 
draft guidance, resulting in approximately 3,000 annual submissions 
(``total annual responses'' in Table 1). Although there will be one 
self-identification submission annually by each facility, site, and 
organization, we rounded the estimate upwards to approximately 3,000 to 
account for any revisions to the submissions, if needed. These 
estimates are based on FDA's database of manufacturers in eDRLS and are 
consistent with conversations between the Agency and representatives of 
regulated industry during the generic drug user fee negotiations. We 
also estimate that preparing and submitting this information will take 
approximately 2.5 hours for each facility (``hours per response'' in 
Table 1). We base this estimate on the hour burden estimate for 
submitting drug registration information electronically under eDRLS, as 
approved by OMB under control number 0910-0045. Most facilities, sites, 
and organizations are familiar with the eDRLS process and already have 
the self-identification information available. Entities that are 
required to register would submit this information separately to the 
eDRLS system, as approved by OMB under control number 0910-0045.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
                                     Number of     responses per   Total annual      Hours per      Total hours
                                    respondents     respondent       responses       response
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Generic Drug Facility and Site             2,650            1.13           3,000             2.5           7,500
 Electronic Self-Identification
 (including any revisions to the
 submission)....................
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    Total.......................  ..............  ..............  ..............  ..............           7,500
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.


[[Page 51814]]

IV. Electronic Access

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

    Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20946 Filed 8-22-12; 11:15 am]
BILLING CODE 4160-01-P


