[Federal Register Volume 62, Number 142 (Thursday, July 24, 1997)] [Notices] [Page 39904] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-19426] Federal Register / Vol. 62, No. 142 / Thursday, July 24, 1997 / Notices [[Page 39904]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 95D-0415] Guidance for Industry: Changes To An Approved Application For Specified Biotechnology and Specified Synthetic Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled, ``Guidance for Industry: Changes To An Approved Application For Specified Biotechnology and Specified Synthetic Biological Products.'' The guidance document is intended to assist manufacturers in determining which reporting mechanism is appropriate for a change to an approved license application under the final rule ``Changes To An Approved Application,'' issued elsewhere in this issue of the Federal Register. In a separate document also published in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, ``Guidance for Industry: Changes To An Approved Application: Biological Products,'' to assist applicants in determining how they should report changes to an approved license application for biologic products other than specified biotechnology and specified synthetic biological products under the final rule. The guidance document announced in this notice revises the draft guidance entitled, ``Draft Guidance; Changes To An Approved Application for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products'' announced in the Federal Register of January 29, 1996 (61 FR 2748). DATES: Written comments may be submitted at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled, ``Guidance for Industry: Changes To An Approved Application For Specified Biotechnology and Specified Synthetic Biological Products'' 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, or Center for Drug Evaluation and Research (HFD-210), Drug Information Branch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 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. Submit written comments on the guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-630), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-3074, or Yuan Yuan Chiu, Center for Drug Evaluation and Research (HFD-800), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-0260. SUPPLEMENTARY INFORMATION: The guidance document announced in this notice represents the agency's current thinking on changes to an approved application for specified biotechnology and specified synthetic biological products listed in 21 CFR 601.2(c), recombinant DNA-derived protein/polypeptide products approved under the Federal Food, Drug, and Cosmetic Act (the act), and complexes or conjugates of a drug with a monoclonal antibody approved under the act. 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. Interested persons may, at any time, submit to the Dockets Management Branch (address above) written comments regarding the guidance document. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the guidance document and received comments are available for public examination in the office above between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the INTERNET may obtain the guidance document by using the World Wide Web (WWW), or bounce-back e-mail. For WWW access, connect to CBER at ``http://www.fda.gov/cber/ cberftp.html''. To receive the guidance document by bounce-back e-mail, send a message to ``[email protected]''. Received comments will be considered in determining whether further revision of the guidance document is warranted. Dated: May 28, 1997. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 97-19426 Filed 7-23-97; 8:45 am] BILLING CODE 4160-01-F