[Federal Register Volume 64, Number 85 (Tuesday, May 4, 1999)]
[Notices]
[Pages 23844-23845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Assessment of Preclinical Reproductive Toxicity Data; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss an approach for the integrative assessment of 
preclinical reproductive toxicity findings and other information for 
pharmaceuticals. The purpose of the meeting is to provide information 
on the agency's approach, using several pharmaceutical data sets, and 
to invite members of the public to provide comments on the utility of 
the approach. The agency intends to consider feedback from the meeting 
in the development of guidance for integrative assessments of 
pharmaceutical reproductive risk.

DATES: The public meeting will be held on June 24, 1999, from 9 a.m. to 
4 p.m.

[[Page 23845]]

 Submit registration information by June 11, 1999.

ADDRESSES: The public meeting will be held in the Center for Drug 
Evaluation and Research Advisory Committee Conference Room, 5630 
Fishers Lane, rm. 1066, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Adele S. Seifried, Center for Drug 
Evaluation and Research (HFD-024), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5482.

SUPPLEMENTARY INFORMATION:
    Registration. Although there is no fee, preregistration by June 11, 
1999, is required for all attendees at this meeting. Participation is 
limited to the first 75 registrants outside FDA and is also restricted 
within FDA due to limited meeting space. Persons interested in 
attending the meeting should register via e-mail to 
``[email protected]'' using the registration form on the Center for 
Drug Evaluation and Research home page ``http://www.fda.gov/cder'' or, 
if e-mail is not available, fax their registration information 
(including name, affiliation, address, telephone, fax number, and e-
mail address) to 301-827-6801, ATTN: Kimberly L. Topper. Interested 
persons may also register by mailing the registration information to 
the contact person identified previously.
     Building Location and Admittance. The building at 5630 Fishers 
Lane is the former Social Services Building located next to the 
Parklawn Building. Please use the lower entrance, which faces Parklawn 
Dr. Visitor badges for nonagency participants will be held at the guard 
station at the entrance to the building. Participants will need picture 
identification to pick up their badge.
    Parking. There is no public parking at the building at 5630 Fishers 
Lane. A public parking lot (for a fee) is located on Fishers Lane 
across from the Parklawn building, and additional public parking (for a 
fee) is available at the Twinbrook Metro station located several blocks 
to the west.
    Agenda. An agenda for the public meeting will be available 2 weeks 
before the meeting, via the Internet using the World Wide Web (WWW). 
Connect to the CDER home page at ``http://www.fda.gov/cder'' and go to 
the ``What's Happening'' section.

    Dated: April 28, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-11122 Filed 5-3-99; 8:45 am]
BILLING CODE 4160-01-F