Site Specific Stability Data for Drug and Biologic Applications; Public Meeting; Request for Comment

[Federal Register Volume 64, Number 50 (Tuesday, March 16, 1999)]
[Notices]
[Page 13029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0362]


Site Specific Stability Data for Drug and Biologic Applications; 
Public Meeting; Request for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comment.

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SUMMARY:The Food and Drug Administration (FDA) is announcing a public 
meeting on site specific stability data for drug and biologic 
applications. The agency has scheduled the public meeting to discuss 
scientific issues related to a section of the draft guidance entitled 
``Draft Guidance for Industry--Stability Testing of Drug Substances and 
Drug Products.'' Specifically, the agency will discuss the section of 
the draft guidance entitled ``Site-Specific Stability Data for Drug and 
Biologic Applications.'' The agency invites comments on issues related 
to the meeting.

DATES: The public meeting will be held on March 31, 1999, from 9 a.m. 
to 2 p.m. Submit written notices of participation by March 24, 1999. 
Submit written comments on the specific issues of the meeting by June 
14, 1999.
ADDRESSES: The public meeting will be held at the Holiday Inn Bethesda, 
8120 Wisconsin Ave., Bethesda, MD 20814. Submit written notices of 
participation to Kimberly L. Topper or Angie Whitacre (addresses 
below). Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Kimberly L. Topper or Angie Whitacre, 
Center for Drug Evaluation and Research (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, 
or e-mail topperk@cder.fda.gov.
    Interested persons may present data, information, or views, orally 
or in writing, on issues pending before the committee. Written 
submissions may be made to the contact person by March 24, 1999. Oral 
presentations from the public will be scheduled. Time allotted for each 
presentation may be limited. Those persons desiring to make formal oral 
presentations should notify the contact person before March 24, 1999 
(providing name, firm name, address, and telephone number), and submit 
a brief statement of the general nature of the evidence or arguments 
they wish to present, and an indication of the approximate time 
requested to make their presentation.

    Dated: March 9, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-6301 Filed 3-15-99; 8:45 am]
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