[Federal Register Volume 65, Number 175 (Friday, September 8, 2000)]
[Notices]
[Pages 54534-54535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23052]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1400]


Draft ``Guidance for Industry: Considerations for Reproductive 
Toxicity Studies for Preventive 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 draft document entitled ``Guidance for Industry: 
Considerations for Reproductive Toxicity Studies for Preventive 
Vaccines for Infectious Disease Indications'' dated August 2000. The 
draft guidance document provides information to sponsors regarding 
assessment of the reproductive toxicity potential of preventive 
vaccines for infectious diseases. The draft guidance document, when 
finalized, is intended to provide sponsors with guidance for the 
conduct of reproductive toxicity studies for preventive vaccines and to 
consider establishing clinical pregnancy registries for preventive 
vaccines indicated for females of childbearing potential and pregnant 
individuals.

DATES: Submit written comments on the draft guidance to ensure their 
adequate consideration in preparation of the final document by December 
7, 2000.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry: Considerations for Reproductive Toxicity Studies for 
Preventive Vaccines for Infectious Disease Indications'' to the Office 
of Communication, Training,

[[Page 54535]]

and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. The document may also be 
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800, or by fax by calling the FAX Information 
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document 
entitled ``Guidance for Industry: Considerations for Reproductive 
Toxicity Studies for Preventive Vaccines for Infectious Disease 
Indications'' dated August 2000. Pre-clinical reproductive toxicity 
studies of vaccines intended for maternal immunization and/or females 
of child bearing age are critical in assessing the potential for the 
developmental toxicity of the product. However, the performance and 
design of pre-clinical reproductive toxicity studies for vaccines to 
support their use in females of childbearing potential and/or for 
maternal immunization have not been addressed in the scientific 
literature. This draft guidance document would provide general and 
specific considerations that should be taken into account in the 
assessment of reproductive toxicity for preventive vaccines, and in 
establishing clinical pregnancy registries for vaccine products post-
licensure. The draft guidance document does not address concerns 
regarding male reproductive toxicity and fertility studies.
    This draft guidance document represents the agency's current 
thinking with regard to the performance and design of pre-clinical 
reproductive toxicity studies for vaccines. 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 requirement of the applicable statute, regulations, or 
both. As with other guidance documents, FDA does not intend this 
document to be all-inclusive and cautions that not all information may 
be applicable to all situations. The document is intended to provide 
information and does not set forth requirements.

II. Comments

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Submit written 
comments to ensure adequate consideration in preparation of the final 
document by December 7, 2000. Two copies of any comments are to be 
submitted, except individuals may submit one copy. Comments should be 
identified with the docket number found in the brackets in the heading 
of this document. A copy of the document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at http://www.fda.gov/cber/guidelines.htm.

    Dated: August 15, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-23052 Filed 9-7-00; 8:45 am]
BILLING CODE 4160-01-F