[Federal Register: May 10, 1999 (Volume 64, Number 89)] [Notices] [Page 25049-25050] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10my99-88] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0512] ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h, `Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use;''' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h, `Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.''' This guidance document is intended to assist applicants in the preparation of the content and format of the chemistry, manufacturing, and controls (CMC) section and the establishment description section of a biologics license application (BLA), revised Form FDA 356h, for human blood and blood components intended for transfusion or for further manufacture. In addition, this guidance document provides assistance for the completion of the BLA. This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives and the Food and Drug Administration Modernization Act of 1997 (Modernization Act), 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 entitled ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h, [[Page 25050]] `Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use''' 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 the 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 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: I. Background FDA is announcing the availability of a document entitled ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h, `Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.''' This guidance document is intended to provide instructions on the completion of the revised Form FDA 356h, including CMC and establishment description sections for human blood and blood components intended for transfusion or for further manufacture. The guidance announced in this notice has been revised based on comments received on the draft guidance entitled ``Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h, `Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use''' announced in the Federal Register of July 10, 1998 (63 FR 37401) and finalizes that draft document. 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, to include blood and blood components. Manufacturers may voluntarily begin using the form for human blood and blood components. FDA will announce in the future when manufacturers are required to use this form for all products. Use of the new harmonized form 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 guidance document represents the agency's current thinking on content and format of the CMC and establishment description information sections of a license application for human blood and blood components intended for transfusion or for further manufacture. 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 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 Interested persons, may at any time, submit written comments to the Dockets Management Branch (address above) 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 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 document using the World Wide Web (WWW). For WWW access, connect to CBER at ``http:// www.fda.gov/cber/guidelines.htm''. Dated: April 30, 1999. William K. Hubbard, Acting Deputy Commissioner for Policy. [FR Doc. 99-11735 Filed 5-7-99; 8:45 am] BILLING CODE 4160-01-F