Review of General Biologics and Licensing Regulations

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to identify regulations that are outdated, burdensome, inefficient, or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whether they should be revised, rescinded, or continued without change.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regulations that are outdated, burdensome, inefficient, or otherwise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

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