Agency Information Collection Activities: Proposed Collection: Comment Request, 19514 [E8-7500-2]
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19514
Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices
Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–7500 Filed 4–9–08; 8:45 am]
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
ved several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. The guidance announced in
this notice finalizes the draft guidance
dated October 30, 2006.
This Level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the agency’s
current thinking on the 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cvm or https://
www.regulations.gov.
Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–7500 Filed 4–9–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
mstockstill on PROD1PC66 with NOTICES
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 514.1(b)(3) have been approved
under OMB control number 0910–0032.
In compliance with the requirement
for opportunity for public comment on
dance for Food and Drug
Administration Reviewers and
Sponsors: Content and Review of
Chemistry, Manufacturing, and Control
Information for Human Gene Therapy
Investigational New Drug Applications;
Availability
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
III. Comments
Submit written requests for single
copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments should be identified with the
docket number found in brackets in the
heading of this document. Received
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for FDA Reviewers and
Sponsors: Content and Review of
Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene
Therapy Investigational New Drug
Applications (INDs),’’ dated April 2008.
The guidance document provides to
sponsors recommendations on the CMC
information to include in an original
IND for human gene therapy. In
addition, the guidance provides
instructions to FDA reviewers about the
information to record and assess as part
of the IND review. The guidance
document announced in this notice
finalizes the draft guidance of the same
title dated November 2004.
VerDate Aug<31>2005
16:48 Apr 09, 2008
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Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Training, and
Manufacturers Assistance (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 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. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for FDA
Reviewers and Sponsors: Content and
Review of Chemistry, Manufacturing,
and Control (CMC) Information for
Human Gene Therapy Investigational
New Drug Applications (INDs),’’ dated
April 2008. The guidance document
provides to sponsors of a human gene
therapy IND recommendations on the
CMC information to include in an
original IND. In addition, the guidance
provides instructions to FDA reviewers
about the information to record and
assess as part of the IND review. This
guidance will help sponsors and FDA
reviewers to assess, given the phase of
the investigation, whether sufficient
information is provided to assure the
proper identification, quality, purity,
and potency of the investigational
product.
In the Federal Register of November
9, 2004 (69 FR 64958), FDA announced
the availability of the draft guidance of
the same title. FDA received several
comments on the draft guidance and
FDA considered those comments when
finalizing the guidance. In addition, we
revised the guidance to clarify its
applicability for sponsors. The guidance
announced in this notice finalizes the
draft guidance dated November 2004.
E:\FR\FM\10APN1.SGM
10APN1
]]>Agencies
[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Page 19514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7500]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on ved several comments on the draft guidance and those
comments were considered as the guidance was finalized. The guidance
announced in this notice finalizes the draft guidance dated October 30,
2006.
This Level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance represents
the agency's current thinking on the 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. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 514.1(b)(3) have been approved
under OMB control number 0910-0032.
III. Comments
Submit written requests for single copies of the guidance to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments should 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/cvm or https://www.regulations.gov.
Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7500 Filed 4-9-08; 8:45 am]
BILLING CODE 4160-01-S
