SS: Vaccine or related product; content and format of chemistry, manufacturing, and controls information and establishment description information; industry guidance,

[Federal Register: January 5, 1999 (Volume 64, Number 2)]

[Notices]

[Page 518-519]

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

[DOCID:fr05ja99-82]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0401]

``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product;'' Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 519]]

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product.'' The guidance document provides guidance to applicants on the content and format of the chemistry, manufacturing and controls (CMC) and establishment description sections of the ``Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use'' (revised Form FDA 356h) for vaccines or related products. This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives and the FDA Modernization Act of 1997, and is intended to reduce unnecessary burdens for industry without diminishing public health protection.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the guidance document entitled ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product'' to the Office of Communication, Training, 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 that office in processing your requests. The guidance 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 guidance document.

Submit written comments on the guidance 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:

1. Background

   FDA is announcing the availability of a guidance document entitled ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product.'' This guidance document is intended to provide guidance to applicants in completing the CMC section and the establishment description information of revised Form FDA 356h. The guidance announced in this notice supersedes the draft guidance entitled ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product'' announced in the Federal Register of June 19, 1998 (63 FR 33686). In the Federal Register of July 8, 1997 (62 FR 36558), FDA announced the availability of Form FDA 356h that will be used as a single harmonized application form for all drug and licensed biological products. Manufacturers may voluntarily begin using this form for vaccines or related products. FDA will announce in the future when manufacturers are required to use this form for all products. Use of the new harmonized Form FDA 356h will allow a biologic product manufacturer to submit one biologics license application instead of two separate applications (product license application and establishment license application). This guidance document represents FDA's current thinking on the content and format of the CMC and establishment description sections of a license application for a vaccine or related product. 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 guidance document to be all-inclusive and cautions that not all information may be applicable to all situations. The guidance document is intended to provide information and does not set forth requirements.

2. Comments

   Interested persons, may at any time, submit to the Dockets Management Branch (address above) written comments regarding this guidance document. 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 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.

3. Electronic Access

   Persons with access to the Internet may obtain the document by using the World Wide Web (WWW). For WWW access, connect to CBER at ``http://www.fda.gov/cber/guidelines.htm''.

   Dated: December 28, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination.

   [FR Doc. 99-30Filed1-4-99; 8:45 am]

   BILLING CODE 4160-01-F