[Federal Register: September 8, 2000 (Volume 65, Number 175)]
[Notices]
[Page 54534-54535]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se00-83]
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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draft guidance document provides information to sponsors regarding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 The draft guidance document, when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DATES: Submit written comments on the draft guidance to ensure their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INFORMATION section for electronic access to the draft guidance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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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