[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]


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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.

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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