[Federal Register: February 3, 1999 (Volume 64, Number 22)] [Notices] [Page 5301-5302] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr03fe99-63] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-1224] Guidance for Industry on FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products.'' The guidance considers the quality and quantity of data that may be adequate to add a new use to the prescribing information for a product used in the treatment of cancer. The guidance is part of an agency effort to encourage the submission of supplemental applications for new uses for approved drug and biological products. This guidance is consistent with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), which specifies that the agency will continue its efforts to encourage sponsors to submit supplemental applications for new uses for their products. DATES: Written comments on agency guidance documents are welcome at any time. ADDRESSES: Copies of this guidance for industry are available on the Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http:// www.fda.gov/cber/guidelines.htm''. Submit written requests for single copies of this guidance to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or to the Office of Communication, Training, and Manufacturers Assistance (HFM- 40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments are to be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Robert L. Justice, Center for Drug [[Page 5302]] Evaluation and Research (HFD-150), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2473. SUPPLEMENTARY INFORMATION: In the Federal Register of March 21, 1997 (62 FR 13650), FDA published a draft guidance for industry entitled ``Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products'' as part of efforts to encourage the submission of supplemental applications for drug and biological products. The intent of that draft guidance was to clarify what clinical evidence of effectiveness should be provided in new drug applications and supplemental applications. On that same date, the agency published a draft guidance for industry entitled ``FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products,'' which considered the quality and quantity of data that may be adequate to add a new use to the prescribing information for a product used in the treatment of cancer. These guidances were published as part of agency efforts to expedite the development of new and supplemental uses for drug and biological products. In November 1997, the Modernization Act (Pub. L. 105-111) was signed into law by the President. Section 403 of the Modernization Act specifies that FDA will continue its efforts to encourage sponsors to submit supplemental applications for new uses for their products. Consistent with section 403 of the Modernization Act, the agency has finalized the draft guidances it issued in March 1997. After considering comments submitted by the public, FDA announced the availability, in final form, of the guidance entitled ``Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products'' in the Federal Register of May 15, 1998 (63 FR 27093). This notice announces the availability of the final version of the guidance entitled ``FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products.'' This guidance focuses on the particular information to be provided when submitting an application for the approval of a supplemental new cancer treatment use for a marketed drug or therapeutic biological product. Cancer research often reveals potential new uses for already marketed drugs, and it is important to have new uses approved for inclusion in the product labeling as soon as adequate evidence of product safety and effectiveness for the new use becomes available. Consistent with section 403(c) of the Modernization Act, CDER and CBER have designated key persons who will: (1) Encourage the prompt review of supplemental applications for approved products, and (2) work with sponsors to facilitate the development and submission of data to support supplemental applications. Within CDER, the Associate Director for Medical Policy is fulfilling the requirements of section 403(c) of the Modernization Act by working with sponsors to facilitate the development of supplemental applications. Within the Division of Oncology Drug Products, the Special Assistant to the Division Director is working with sponsors to facilitate the development and submission of data to support supplemental applications for drug products used in cancer treatment. Efforts include: (1) Managing initiatives to seek the views of major groups and of individuals in the cancer research and treatment community, (2) managing and monitoring actions regarding possible labeling revisions, and (3) preparing regular progress reports. Within CBER, supplemental applications are being facilitated by the Deputy Director, Medical, in accordance with section 403(c) of the Modernization Act. Review activities for most oncologic product applications are managed by the Office of Therapeutics Research and Review. The Oncology Branch of the Division of Clinical Trials Design and Analysis will work with sponsors to facilitate the development and submission of data to support supplemental applications for biologics used in cancer treatment. This guidance represents the agency's current thinking on new cancer treatment uses for marketed drug and biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public in any way. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. Dated: January 27, 1999. Jane E. Henney, Commissioner of Food and Drugs. [FR Doc. 99-2562 Filed 2-2-99; 8:45 am] BILLING CODE 4160-01-F