Biological products: Workshop,

[Federal Register: August 11, 1998 (Volume 63, Number 154)]

[Proposed Rules]

[Page 42773-42774]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11au98-28]

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.

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 ``eberhart@cber.fda.gov''. 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. 98-21406Filed8-10-98; 8:45 am]

BILLING CODE 4160-01-F