[Federal Register Volume 63, Number 154 (Tuesday, August 11, 1998)]
[Proposed Rules]
[Pages 42773-42774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21406]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 3, 5, 10, 20, 207, 310, 312, 316, 600, 601, 607, 610, 
640, and 660

[Docket No. 98N-0144]
RIN 0910-AB29


Biological Products Regulated Under Section 351 of the Public 
Health Service Act; Implementation of Biologics License; Elimination of 
Establishment License and Product License; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notice of workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop to present issues related to the agency's proposed rule 
entitled ``Biological Products Regulated Under Section 351 of the 
Public Health Service Act; Implementation of Biologics License; 
Elimination of Establishment License and Product License'' issued 
recently in the Federal Register. The purpose of the public workshop is 
to provide interested persons an opportunity to more clearly understand 
the proposed rule and its effect on industry and the public.
DATES: The public workshop will be held on Wednesday, September 2, 
1998, 9 a.m. to 3 p.m. Submit written comments by October 14, 1998. Fax 
registration information to the contact person by August 21, 1998.
ADDRESSES: The public workshop will be held at the Hyatt Regency Hotel, 
One Bethesda Metro, Bethesda, MD 20814, 301-657-6406. Submit written 
comments to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION: Kathy A. Eberhart, Center for Biologics 
Evaluation and Research (HFM-43), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-1317, FAX 301-827-
3079, e-mail ``[email protected]''.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 31, 1998 (63 
FR 40858), FDA published a proposed rule entitled ``Biological Products 
Regulated Under Section 351 of the Public Health Service Act; 
Implementation of Biologics License; Elimination of Establishment 
License and Product License'' proposing to revise the regulations 
regarding the procedures for

[[Page 42774]]

application for approval to market a biological product regulated under 
section 351 of the Public Health Service Act (42 U.S.C. 262 et seq.). 
Currently, most manufacturers must submit an establishment license 
application (ELA) and a product license application (PLA) when 
requesting approval to market a biological product in interstate 
commerce. Under the proposed regulations, a manufacturer would submit 
to FDA the appropriate establishment and product information in a 
single biologics license application (BLA) in lieu of filing a separate 
ELA and PLA. The BLA is intended to replace the many different ELA and 
PLA forms currently in use. Upon approval of the BLA, a manufacturer 
would receive a single biologics license to market the product in 
interstate commerce.
    Interested persons may submit written comments on the proposed rule 
(63 FR 40858) to the Dockets Management Branch (address above). Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with docket number found 
in brackets in the heading of this document and should be submitted by 
October 14, 1998. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    Registration: Fax registration information (including name, title, 
firm name, address, telephone, and fax number) to the contact person by 
Friday, August 21, 1998. There is no registration fee for the workshop. 
Space is limited, therefore interested parties are encouraged to 
register early.
    If you need special accommodations due to a disability, please 
contact Kathy A. Eberhart at least 7 days in advance.
    Transcripts: Transcripts of the workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the workshop at a cost of 10 cents 
per page.

    Dated: August 5, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21406 Filed 8-10-98; 8:45 am]
BILLING CODE 4160-01-F