[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to identify regulations that are outdated, burdensome, inefficient, or 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whether they should be revised, rescinded, or continued without change.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