[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: 94-13466]


[[Page Unknown]]

[Federal Register: June 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 606, 607, 610, 640, and 660

[Docket No. 94N-0080]

 

Review of Regulations for Blood Establishments and Blood Products

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 regulations for blood establishments and blood products 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intended to identify regulations that are outdated, burdensome, 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 general biologics and licensing 
regulations 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: Jean M. Olson or Stephen M. Ripley, 
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 
regulations in 21 CFR parts 606, 607, 640, and 660, as well as the 
portions of 21 CFR part 610 that apply to blood and plasma collection 
establishments and blood and blood products; FDA is requesting public 
comment from interested parties 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whether they should be revised, rescinded, or continued without change.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 blood products and establishments, including, but not limited to, 21 
CFR parts 210 and 211. 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 a review of these regulations to determine whether 
they are unnecessary as the 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 blood and 
blood products by updating the blood regulations. This document 
requests information and comments on these regulations.
    A request for comments on the general biologics and licensing 
regulations in 21 CFR parts 600, 601, and 610 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 document. 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 suggested change, 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. 94-13466 Filed 6-2-94; 8:45 am]
BILLING CODE 4160-01-F