International Conference on Harmonisation; Guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use; Availability, 33748-33749 [2012-13774]
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33748
Federal Register / Vol. 77, No. 110 / Thursday, June 7, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Annual
frequency of
response
Number of
respondents
Total
annual
responses
Hours per
response
Total
hours
CFR Section
FDA Form No.
Exemptions—803.19 ................................
User Facility Reporting—803.30 and
803.32 ...................................................
User Facility Annual Reporting—803.33
........................
57
4
228
3
684
........................
FDA Form
3419
544
195
9
1
4,896
195
1
1
4,896
195
Importer Reporting, Death and Serious
Injury—803.40 and 803.42 ...................
Manufacturer
Reporting—803.50,
through 803.53 .....................................
Supplemental Reports—803.56 ...............
........................
1
1
1
1
1
........................
........................
1,239
124
243
302
301,077
37,448
1
1
301,077
37,448
Total ..................................................
........................
........................
........................
........................
........................
344,301
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
recordkeepers
Annual
frequency of
recordkeeping
Total
annual records
MDR Procedures—803.17 ...................................................
MDR Files—803.18 ..............................................................
220
30,000
1
1
220
30,000
10
1.5
2,200
45,000
Total ..............................................................................
........................
........................
........................
........................
47,200
21 CFR Section
Hours per
recordkeeper
Total
hours
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
Importer Reporting, Malfunctions—803.40 and 803.42 .......
1
25
25
1
25
Dated: June 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–13832 Filed 6–6–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0178]
International Conference on
Harmonisation; Guidance on S2(R1)
Genotoxicity Testing and Data
Interpretation for Pharmaceuticals
Intended for Human Use; Availability
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘S2(R1) Genotoxicity Testing and Data
Interpretation for Pharmaceuticals
Intended for Human Use’’ (ICH S2(R1)).
This guidance was prepared under the
auspices of the International Conference
SUMMARY:
VerDate Mar<15>2010
17:48 Jun 06, 2012
Jkt 226001
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The ICH S2(R1) combines and replaces
two ICH guidances, ‘‘S2A Specific
Aspects for Regulatory Genotoxicity
Tests for Pharmaceuticals’’ and ‘‘S2B
Genotoxicity: A Standard Battery for
Genotoxicity Testing of
Pharmaceuticals.’’ ICH S2(R1) provides
guidance to drug sponsors on which
tests should be performed to assess
potential genotoxicity of
pharmaceuticals. It also provides
guidance on testing conditions, data
interpretation, and followup strategies if
a positive response is seen in in vitro
assays. This guidance is intended to
provide drug sponsors with
recommendations to ensure that drugs
are appropriately tested for potential to
cause genetic damage and to ensure
efficient development of new drugs.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
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:
Regarding the Guidance
David Jacobson-Kram, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6488,
E:\FR\FM\07JNN1.SGM
07JNN1
Federal Register / Vol. 77, No. 110 / Thursday, June 7, 2012 / Notices
Silver Spring, MD 20993–0002, 301–
796–0175.
Regarding the ICH
Michelle Limoli, Office of
International Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 3506, Silver Spring,
MD 20993–0002, 301–796–4600.
SUPPLEMENTARY INFORMATION:
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory Agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
VerDate Mar<15>2010
17:48 Jun 06, 2012
Jkt 226001
In the Federal Register of March 26,
2008 (73 FR 16024), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘S2(R1)
Genotoxicity Testing and Data
Interpretation for Pharmaceuticals
Intended for Human Use.’’ The notice
gave interested persons an opportunity
to submit comments by May 12, 2008.
After consideration of the comments
received and revisions to the guidance,
a final draft of the guidance was
submitted to the ICH Steering
Committee and endorsed by the three
participating regulatory Agencies in
November 2011.
The purpose of the ICH S2(R1)
revision is to provide guidance on
optimizing the standard genetic
toxicology battery for prediction of
potential human risks, and on
interpreting results, with the goal of
improving risk characterization for
carcinogenic effects that have their basis
in changes in the genetic material. The
revised guidance describes
internationally agreed-upon standards
for followup testing and interpretation
of positive results in vitro and in vivo
in the standard genetic toxicology
battery, including assessment of
nonrelevant findings.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on this topic. 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 mailed
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. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
regulations.gov, https://www.fda.gov/
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
33749
Drugs/GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: June 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–13774 Filed 6–6–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of a Noncompetitive
Supplement and a 7-Month Extension
of the Period of Support for the
Frontier Extended Stay Clinic (FESC)
Cooperative Agreement Recipient—
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Consortium
Health Resources and Services
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Health and Human Services.
ACTION: Notice of a Noncompetitive
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the Period of Support for the Frontier
Extended Stay Clinic (FESC)
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AGENCY:
The Health Resources and
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issuing a non-competitive supplement
and a 7-month extension of the period
of support to the Frontier Extended Stay
Clinic (FESC) Cooperative Agreement
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SUMMARY:
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)]
[Notices]
[Pages 33748-33749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13774]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0178]
International Conference on Harmonisation; Guidance on S2(R1)
Genotoxicity Testing and Data Interpretation for Pharmaceuticals
Intended for Human Use; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``S2(R1) Genotoxicity Testing and
Data Interpretation for Pharmaceuticals Intended for Human Use'' (ICH
S2(R1)). This guidance was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). The ICH S2(R1)
combines and replaces two ICH guidances, ``S2A Specific Aspects for
Regulatory Genotoxicity Tests for Pharmaceuticals'' and ``S2B
Genotoxicity: A Standard Battery for Genotoxicity Testing of
Pharmaceuticals.'' ICH S2(R1) provides guidance to drug sponsors on
which tests should be performed to assess potential genotoxicity of
pharmaceuticals. It also provides guidance on testing conditions, data
interpretation, and followup strategies if a positive response is seen
in in vitro assays. This guidance is intended to provide drug sponsors
with recommendations to ensure that drugs are appropriately tested for
potential to cause genetic damage and to ensure efficient development
of new drugs.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the 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, or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist the office in processing your
requests. The guidance may also be obtained by mail by calling CBER at
1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
Submit electronic comments on the 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:
Regarding the Guidance
David Jacobson-Kram, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6488,
[[Page 33749]]
Silver Spring, MD 20993-0002, 301-796-0175.
Regarding the ICH
Michelle Limoli, Office of International Programs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 3506, Silver
Spring, MD 20993-0002, 301-796-4600.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory Agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
In the Federal Register of March 26, 2008 (73 FR 16024), FDA
published a notice announcing the availability of a draft guidance
entitled ``S2(R1) Genotoxicity Testing and Data Interpretation for
Pharmaceuticals Intended for Human Use.'' The notice gave interested
persons an opportunity to submit comments by May 12, 2008.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
Agencies in November 2011.
The purpose of the ICH S2(R1) revision is to provide guidance on
optimizing the standard genetic toxicology battery for prediction of
potential human risks, and on interpreting results, with the goal of
improving risk characterization for carcinogenic effects that have
their basis in changes in the genetic material. The revised guidance
describes internationally agreed-upon standards for followup testing
and interpretation of positive results in vitro and in vivo in the
standard genetic toxicology battery, including assessment of
nonrelevant findings.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this topic. 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 mailed 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. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: June 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13774 Filed 6-6-12; 8:45 am]
BILLING CODE 4160-01-P
