[Federal Register Volume 62, Number 43 (Wednesday, March 5, 1997)] [Notices] [Page 10062] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-5311] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 95N-0329] Preclearance of Promotional Labeling; Clarification Agency: Food and Drug Administration, HHS. Action: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that the Center for Biologics Evaluation and Research (CBER) is clarifying its policy regarding the preapproval of promotional labeling for biological products. In the November 1995 report issued by the President and Vice President, ``Reinventing the Regulation of Drugs Made from Biotechnology,'' FDA made a commitment to harmonize immediately CBER's requirements for the preapproval of promotional labeling with those of the Center for Drug Evaluation and Research (CDER) under which a company may submit such information to the agency at the time the company disseminates it. This notice is issued to clarify that FDA has fulfilled the commitment to allow industry to submit promotional labeling to CBER at the time of initial dissemination. Sponsors need not wait for approval from CBER before using promotional labeling. FOR FURTHER INFORMATION CONTACT: Toni M. Stifano, Center for Biologics Evaluation and Research (HFM-202), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-3028. SUPPLEMENTARY INFORMATION: Under CBER's previous policy, as announced in the Federal Register of August 9, 1993 (58 FR 42340) and revised in the Federal Register of August 3, 1994 (59 FR 39570), preapproval by CBER was required for promotional labeling prior to introduction of a new biologic, for 120 days following approval of a new biologic, and for 120 days following approval of a new use for a currently licensed biologic. In the November 1995 report issued by the President and Vice President, ``Reinventing the Regulation of Drugs Made from Biotechnology,'' FDA made a commitment that, effective immediately, CBER would no longer require preapproval of promotional labeling. This approach, it was noted, is consistent with that of CDER. FDA has fulfilled its commitment. In a proposed rule on changes to an approved application, published in the Federal Register of January 29, 1996 (61 FR 2739), FDA took a further step toward harmonizing the two Centers' promotional requirements. Among other things, the proposed rule would amend 21 CFR 601.12 to make CBER requirements for advertisements, as well as promotional labeling, consistent with those of CDER as set forth in 21 CFR 314.81(b)(3)(i). The scope of this notice does not extend to promotional materials for products reviewed under the regulations for accelerated approval (21 CFR part 601, subpart E), which should be submitted to the agency for consideration as required in 21 CFR 601.45. Dated: February 28, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-5311 Filed 3-4-97; 8:45 am] BILLING CODE 4160-01-F