[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13465]
[[Page Unknown]]
[Federal Register: June 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 600, 601, and 610
[Docket No. 94N-0066]
Review of General Biologics and Licensing Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Intent to review regulations; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is conducting a review
of certain general biologics and licensing regulations and is
requesting public comment on these regulations. This review is intended
to identify regulations that are outdated, burdensome, inefficient, or
otherwise unsuitable or unnecessary from a regulatory standpoint and in
need of revision. This review is part of FDA's program to periodically
review existing significant regulations. A request for comments on
certain regulations for blood establishments and blood products will be
published elsewhere in this issue of the Federal Register.
DATES: Written comments by August 17, 1994.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Ann Reed Gaines or Timothy W. Beth,
Center for Biologics Evaluation and Research (HFM-635), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 20, 1994
(59 FR 3043), FDA announced its plan to review significant regulations
pursuant to Executive Order 12866, which requires all Federal agencies
to develop a program for periodically reviewing existing significant
regulations. Under this plan, FDA is conducting a review of the general
biologics and licensing regulations in 21 CFR parts 600, 601, and 610,
and is requesting public comment on these regulations.
FDA is conducting a review of these regulations to determine
whether they should be revised, rescinded, or continued without change.
FDA is also evaluating whether to review other regulations applicable
to biological products. This request for comments is intended to assist
the Center for Biologics Evaluation and Research in identifying
regulations that are outdated, burdensome, inefficient, or otherwise
unsuitable or unnecessary from a regulatory standpoint and in need of
revision to achieve their public health goals more effectively.
Under Executive Order 12866, the Paperwork Reduction Act of 1980
(Pub. L. 96-511), and the Regulatory Flexibility Act (Pub. L. 96-354),
FDA is performing this review of these existing regulations to
determine whether they are unnecessary as a result of changed
circumstances, duplicative, or inappropriately burdensome. This action
is also intended to incorporate the scientific advances in the field,
to introduce, where appropriate, increased flexibility in the
regulations, and to further insure the safety, purity, and potency of
biologics products by updating the regulations. This document requests
public comment on these regulations.
A request for comments on the blood establishments and blood
products regulations in 21 CFR parts 606, 607, 610, 640, and 660 will
be published elsewhere in this issue of the Federal Register.
Interested persons may, on or before August 17, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this request. 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. FDA requests that comments include the following information
in the order shown: (1) The section affected in Title 21 of the CFR;
(2) a description of the change suggested, including, if appropriate,
suggested changes in the text of the regulation; (3) the rationale for
the change or the problem to be addressed by the change; (4) any
related regulations or guidance also affected by the suggested change;
(5) any pertinent background information; and (6) whether the comment
includes attachments. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 26, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-13465 Filed 6-2-94; 8:45 am]
BILLING CODE 4160-01-F
