[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the draft guidance entitled ``Guidance for Industry: Considerations for 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