International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability, 3471-3472 [2010-1027]
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3471
Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices
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Total burden
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45 CFR 309—Plan ..........................................................................................
Form OCSE 34A ..............................................................................................
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[FR Doc. 2010–963 Filed 1–20–10; 8:45 am]
jlentini on DSKJ8SOYB1PROD with NOTICES
BILLING CODE 4184–01–P
VerDate Nov<24>2008
16:17 Jan 20, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0470]
International Conference on
Harmonisation; Guidance on M3(R2)
Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘M3(R2) Nonclinical Safety Studies for
the Conduct of Human Clinical Trials
and Marketing Authorization for
Pharmaceuticals.’’ The guidance was
prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance, which is a revision of an
existing guidance, discusses the types of
nonclinical studies, their scope and
duration, and their relation to the
conduct of human clinical trials and
marketing authorization for
pharmaceuticals. The guidance is
intended to facilitate the timely conduct
of clinical trials and reduce the
unnecessary use of animals and other
drug development resources.
DATES: Submit written or electronic
comments on agency guidance 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, Rockville, MD
20852–1448. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. Send
two self-addressed adhesive labels to
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
assist the office in processing your
requests.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments on the guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Abigail
Jacobs, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New
Hampshire Ave, Bldg. 22, rm. 6484,
Silver Spring, MD 20993–0002,
301–796–0174; or Martin D. Green,
Center for Biologics Evaluation and
Research (HFM–475), Food and
Drug Administration, 1401
Rockville Pike, suite 200N,
Rockville, MD 20852–1448, 301–
827–3070.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
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
E:\FR\FM\21JAN1.SGM
21JAN1
jlentini on DSKJ8SOYB1PROD with NOTICES
3472
Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices
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 September
3, 2008 (73 FR 51491), FDA published
a notice announcing the availability of
a draft guidance entitled ‘‘M3(R2)
Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals.’’ The notice gave
interested persons an opportunity to
submit comments by October 20, 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 June
2009.
Guidance is provided on the various
nonclinical studies recommended to
support conduct of clinical trials and
marketing. The guidance further
harmonizes the recommendations in a
number of areas and includes a new
section on exploratory clinical trials.
The recommendations should promote
safe and ethical development and
availability of new pharmaceuticals.
The guidance reflects revisions made
in response to comments received on
the draft guidance. The revisions
include more detailed discussions of
some types of nonclinical studies and
editorial changes to provide further
clarification in a number of areas.
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.
VerDate Nov<24>2008
16:17 Jan 20, 2010
Jkt 220001
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments on the guidance. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified 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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: January 15, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–1027 Filed 1–20–10; 8:45 am]
BILLING CODE 4160–01–S
Place: Holiday Inn Chevy Chase, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Gary S. Madonna, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID, National Institutes of Health, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892, 301–496–3528, gm12w@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Planning (R34) Grants and Implementation
(U01) Cooperative Agreements.
Date: February 12, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Hotel—Silver Spring,
8777 Georgia Avenue, Silver Spring, MD
20910.
Contact Person: B. Duane Price, PhD,
Scientific Review Officer, Scientific Review
Program, HHS/NIH/NIAID/DEA, Room 3139,
6700B Rockledge Drive, MSC 7616, Bethesda,
MD 20892, (301) 451–2592,
pricebd@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: January 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–1050 Filed 1–20–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
B Subcommittee.
Date: February 11–12, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
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Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, NIDDK KUHFellowship Review.
Date: February 19, 2010.
Time: 8 a.m. to 5 p.m.
E:\FR\FM\21JAN1.SGM
21JAN1
]]>Agencies
[Federal Register Volume 75, Number 13 (Thursday, January 21, 2010)]
[Notices]
[Pages 3471-3472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1027]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0470]
International Conference on Harmonisation; Guidance on M3(R2)
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies
for the Conduct of Human Clinical Trials and Marketing Authorization
for Pharmaceuticals.'' The guidance was prepared under the auspices of
the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH). The guidance,
which is a revision of an existing guidance, discusses the types of
nonclinical studies, their scope and duration, and their relation to
the conduct of human clinical trials and marketing authorization for
pharmaceuticals. The guidance is intended to facilitate the timely
conduct of clinical trials and reduce the unnecessary use of animals
and other drug development resources.
DATES: Submit written or electronic comments on agency guidance 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, Rockville, MD 20852-1448. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800.
Send two self-addressed adhesive labels to assist the office in
processing your requests.
Submit electronic comments to https://www.regulations.gov. Submit
written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave,
Bldg. 22, rm. 6484, Silver Spring, MD 20993-0002, 301-796-0174; or
Martin D. Green, Center for Biologics Evaluation and Research (HFM-
475), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-3070.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
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
[[Page 3472]]
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 September 3, 2008 (73 FR 51491), FDA
published a notice announcing the availability of a draft guidance
entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human
Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The
notice gave interested persons an opportunity to submit comments by
October 20, 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 June 2009.
Guidance is provided on the various nonclinical studies recommended
to support conduct of clinical trials and marketing. The guidance
further harmonizes the recommendations in a number of areas and
includes a new section on exploratory clinical trials. The
recommendations should promote safe and ethical development and
availability of new pharmaceuticals.
The guidance reflects revisions made in response to comments
received on the draft guidance. The revisions include more detailed
discussions of some types of nonclinical studies and editorial changes
to provide further clarification in a number of areas.
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) electronic or written comments on the guidance. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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: January 15, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1027 Filed 1-20-10; 8:45 am]
BILLING CODE 4160-01-S
