Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability, 51811-51814 [2012-20946]
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Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Notices
consider safety and occupational healthrelated grant applications.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Price Connor, Ph.D., Health Scientist,
NIOSH, CDC, 1600 Clifton Road N.E.,
Mailstop E–20, Atlanta, Georgia 30333,
Telephone: (404) 498–2511, Fax: (404)
498–2571.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: August 16, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–21013 Filed 8–24–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Emergency Contingency Fund
for Temporary Assistance for Needy
Families (TANF) Programs OFA–100.
OMB No.: 0970–0366.
Description
On February 17, 2009, the President
signed the American Recovery and
Reinvestment Act of 2009 (Recovery
Act), which establishes the Emergency
Contingency Fund for State TANF
Programs (Emergency Fund) as section
403(c) of the Social Security Act (the
Act). This legislation provides up to $5
billion to help States, Territories, and
Tribes in fiscal year (FY) 2009 and FY
2010 that have an increase in assistance
caseloads and basic assistance
expenditures, or in expenditures related
to short-term benefits or subsidized
employment. The Recovery Act made
additional changes to TANF extending
supplemental grants through FY 2010,
expanding flexibility in the use of TANF
funds carried over from one fiscal year
to the next, and adding a hold-harmless
provision to the caseload reduction
credit for States and Territories serving
more TANF families.
The Emergency Fund is intended to
build upon and renew the principles of
work and responsibility that underlie
successful welfare reform initiatives.
The Emergency Fund provides
resources to States, Territories, and
Tribes to support work and families
during this difficult economic period.
On July 20, 2009 we issued a Program
Instruction accompanied by the
Emergency Fund Request Form (OFA–
100), and instructions for jurisdictions
to complete the OFA–100 to apply for
emergency funds.
Failure to collect this data would
compromise ACF’s ability to monitor
caseload and expenditure data that must
increase in order for jurisdictions to
receive awards under the Emergency
Fund.
Documentation maintenance on
financial reporting for the Emergency
Fund is governed by 45 CFR 92.20 and
45 CFR 92.42.
ACF is planning to extend the
information collection with the
adjustment to the Estimated Annual
Burden shown in the table below. Based
on our projections for a lower Estimated
Annual Burden, we have revised the
Number of Respondents to 6 from its
previous number of 93 and the Number
of Responses per Respondent to 3 from
its previous number of 5. Because the
Number of Respondents and the
Number of Responses per Respondents
have been revised, the Estimated Total
Burden Hours is now 432, down from
its previous number of 11,160.
Respondents
State, Territory, and Tribal agencies
administering the Temporary Assistance
for Needy Families (TANF) Program that
are applying for the Emergency Fund.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
TANF Emergency Fund Request Form, OFA–100 .........................................
6
5
24
432
Estimated Total Annual Burden
Hours: 432.
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Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
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publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–21001 Filed 8–24–12; 8:45 am]
BILLING CODE 4184–01–P
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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 SelfIdentification of Generic Drug
Facilities, Sites, and Organizations;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
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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 selfidentification 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 https://
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
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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 selfidentify 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 selfidentification 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 selfidentification 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 selfidentification 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 selfidentify 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
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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
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Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Notices
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 selfidentification 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 selfidentification 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
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 selfidentify, 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 selfidentification 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
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Hours per
response
Total hours
2,650
1.13
3,000
2.5
7,500
Total ..............................................................................
pmangrum on DSK3VPTVN1PROD with NOTICES
Generic Drug Facility and Site Electronic Self-Identification
(including any revisions to the submission) .....................
........................
........................
........................
........................
7,500
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
1 Sites and organizations that package the FDF of
a human generic drug into the primary container/
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closure system and label the primary container/
closure system are considered to be manufacturers,
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whether or not that packaging is done pursuant to
a contract or by the applicant itself.
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Federal Register / Vol. 77, No. 166 / Monday, August 27, 2012 / Notices
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 https://
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, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 866–405–5367 or 301–796–6707.
SUPPLEMENTARY INFORMATION:
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0880]
Draft Guidance for Industry on Generic
Drug User Fee Amendments of 2012:
Questions and Answers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Generic
Drug User Fee Amendments of 2012:
Questions and Answers.’’ The Generic
Drug User Fee Amendments of 2012
(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 also
requires that generic drug facilities,
sites, and organizations located around
the world provide identification
information annually to FDA. 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.
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
on the draft guidance by October 26,
2012.
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
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
ADDRESSES:
VerDate Mar<15>2010
15:04 Aug 24, 2012
Jkt 226001
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Generic Drug User Fee Amendments of
2012: Questions and Answers.’’ 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 reduce costs to
industry. GDUFA enables FDA to assess
user fees to support critical and
measurable enhancements to FDA’s
generic drugs program.
GDUFA establishes fees for
abbreviated new drug applications
(ANDAs), prior approval supplements
(PASs) to ANDAs, and drug master files
(DMFs), annual facility fees, and a onetime fee for original ANDAs pending
with FDA on October 1, 2012 (backlog
fees). Fees will be incurred for ANDAs
and PASs submitted on or after October
1, 2012. An application fee will also be
incurred the first time a DMF is
referenced in an ANDA or PAS
submitted on or after October 1, 2012.
FDA plans to publish the fee amounts
for ANDAs, PASs, DMFs, and the
backlog fee in the Federal Register on
or before October 31, 2012.
The amount of the annual user fees
for generic drug facilities will be
determined after GDUFA program
launch. Under GDUFA, facilities, sites,
and organizations are first required to
self-identify. Fees will be determined
after the self-identification process has
been completed, providing FDA
information about the number of
facilities that will be required to pay
user fees. These include facilities
manufacturing, or intending to
manufacture, active pharmaceutical
ingredients of human generic drugs and/
or finished dosage form human generic
drugs.
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This draft 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
plans for implementing 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 Agency’s current thinking on
generic drug user fee amendments of
2012. 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 either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. 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, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20944 Filed 8–22–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0882]
Generic Drug User Fee Amendments of
2012; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total annual Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Generic Drug Facility and Site 2,650 1.13 3,000 2.5 7,500
Electronic Self-Identification
(including any revisions to the
submission)....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 7,500
----------------------------------------------------------------------------------------------------------------
\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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
