[Federal Register Volume 71, Number 30 (Tuesday, February 14, 2006)]
[Notices]
[Pages 7779-7780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1998]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D-1400]
Guidance for Industry: Considerations for Developmental Toxicity
Studies for Preventive and Therapeutic Vaccines for Infectious Disease
Indications; 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 document entitled ``Guidance for Industry:
Considerations for Developmental Toxicity Studies for Preventive and
Therapeutic Vaccines for Infectious Disease Indications,'' dated
February 2006. The guidance is intended to provide sponsors with
recommendations for the conduct of developmental toxicity studies for
[[Page 7780]]
investigational preventive and therapeutic vaccines for infectious
disease indications. The recommendations pertain to the assessment of
the developmental toxicity potential of preventive and therapeutic
vaccines for infectious diseases indicated for females of childbearing
potential and pregnant individuals. This guidance document finalizes
the draft guidance entitled ``Guidance for Industry: Considerations for
Reproductive Toxicity Studies for Preventive Vaccines for Infectious
Disease Indications,'' dated August 2000.
DATES: 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 http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Astrid Szeto, 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:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Considerations for Developmental Toxicity
Studies for Preventive and Therapeutic Vaccines for Infectious Disease
Indications,'' dated February 2006. The guidance document provides
sponsors with recommendations for the conduct and assessment of
developmental toxicity studies for investigational preventive and
therapeutic vaccines for infectious diseases indicated for women of
childbearing potential and pregnant women.
This guidance document finalizes the draft guidance entitled
``Guidance for Industry: Considerations for Reproductive Toxicity
Studies for Preventive Vaccines for Infectious Disease Indications,''
dated August 2000 (65 FR 54534, September 8, 2000). The guidance was
revised based on public comments submitted to the Division of Dockets
Management on the draft guidance, and on recommendations made by an
expert panel convened at a workshop entitled ``Non-Clinical Safety
Evaluation of Preventive Vaccines: Recent Advances and Regulatory
Considerations'' held December 2 and 3, 2002, Arlington, VA.
The 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. 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
collection of information in this guidance for 21 CFR 601.2 has been
approved under OMB control number 0910-0338.
III. Comments
Interested persons may, at any time, submit written or electronic
comments to the Division of Dockets Management (see ADDRESSES)
regarding this 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 the brackets in the heading of this document. A copy of
the guidance and received comments are available for public examination
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 guidance at
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: February 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1998 Filed 2-13-06; 8:45 am]
BILLING CODE 4160-01-S