[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
