[Federal Register Volume 63, Number 217 (Tuesday, November 10, 1998)] [Notices] [Pages 63067-63068] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-30094] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0964] Draft ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product;'' Availability
Agency
Food and Drug Administration, HHS.
Action
Notice.
-----------------------------------------------------------------------
Summary
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product.'' The draft guidance document, when finalized, is intended to assist applicants in the preparation of the chemistry, manufacturing, and controls (CMC) section and the establishment description section of a biologics license application (BLA), revised Form FDA 356h, for biological in vitro diagnostic products. This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives and FDA Modernization Act of 1997, and it is intended to reduce unnecessary burdens for industry without diminishing public health protection.
Dates
Written comments may be submitted at any time, however, comments should be submitted by January 11, 1998, to ensure their adequate consideration in preparation of the final document.
Addresses
Submit written requests for single copies of ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product'' to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, 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 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 SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit written comments on the document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For Further Information Contact
Robert A. Yetter, Center for Biologics Evaluation and Research (HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0373.
Supplementary Information
I. Background
FDA is announcing the availability of a draft document entitled ``Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product.'' This draft document, when finalized, is intended to provide general information for the content and format of the CMC section and establishment description section of the BLA for biological in vitro diagnostic products. This draft document is intended for use by those firms which manufacture any licensed in vitro diagnostic product used to screen donor blood, determine donor suitability, test for retroviral infection, or determine transfusion compatibility (e.g., blood grouping and typing reagents). This draft document is not intended to cover those in vitro diagnostic products used to test for endotoxins, such as limulus amebocyte lysate (LAL), or those products for which a premarket application (PMA) or a 510(k) must be submitted. In the Federal Register of July 8, 1997 (62 FR 36558), FDA announced the availability of a new harmonized Form FDA 356h entitled ``Application to
Market a New Drug, Biologic, or an Antibiotic for Human Use.'' The new harmonized form is intended to be used by applicants for all drug and biological products. The new harmonized form, when fully implemented, will allow biological product manufacturers to submit a single application, the BLA, instead of two separate license application submissions, a product license application (PLA), and an establishment license application (ELA). This draft guidance document represents the agency's current thinking on content and format of the CMC information and establishment description information for biological in vitro diagnostic products. 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 requirements of the applicable statute, regulations, or both. As with other guidance documents, FDA does not intend this document to be all inclusive and cautions that not all information may be applicable to all situations. The document is intended to provide information and does not set forth requirements.
II. Comments
This draft document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit written comments to the Dockets Management Branch (address above) regarding the draft guidance document. Written comments may be submitted at any time, however, comments should be submitted January 11, 1998, to ensure their adequate consideration in preparation of the final document. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments and requests for copies should be identified with the docket number found in the 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.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance document by using the World Wide Web (WWW). For WWW access connect to CBER at ``www.fda.gov/cber/guidelines.htm''.
www.fda.gov/cber/guidelines.htmDated: November 2, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-30094 Filed 11-9-98; 8:45 am] BILLING CODE 4160-01-F