Regulation of Medical Foods; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Ch. I

[Docket No. 96N-0364]

RIN 0910-AA20

Regulation of Medical Foods; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment

period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is extending to April

28, 1997, the comment period for the advance notice of proposed

rulemaking for the regulation of medical foods that published in the

Federal Register of November 29, 1996. This action is being taken in

response to several requests from interested persons for an extension

of the comment period on this document.

DATES: Written comments by April 28, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food

Safety and Applied Nutrition (HFS-456), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-4605.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 29, 1996

(61 FR 60661), FDA published an advance notice of proposed rulemaking

for the regulation of medical foods. Interested persons were given

until February 27, 1997, to comment on the advance notice of proposed

rulemaking.

FDA has received requests for an extension of the comment period

from: Manufacturers, a trade organization representing manufacturers of

medical foods, and a professional society representing health care

providers and research scientists. The interested parties stated in

their requests for an extension of the comment period that such an

extension would help ensure that the agency receives comprehensive and

carefully researched information from experts to consider in response

to the notice. After careful consideration of the requests submitted to

the agency, FDA has decided to grant an extension of the comment period

until April 28, 1997.

Interested persons may, on or before April 28, 1997, submit to the

Dockets Management Branch (address above) written comments regarding

this advanced notice of proposed rulemaking. 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. Received comments may be seen in the

office above between 9 a.m. and 4 p.m., Monday through Friday.

This document is issued under sections 4, 5, and 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453, 1454, 1455); sections 201,

301, 402, 403, 404, 405, 409, 411, 412, 501, 502, 503, 505, and 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 343,

344, 345, 348, 350, 350a, 351, 352, 353, 355, 371); and 21 U.S.C.

360ee(b)(3) (section 5(b)(3) of the Orphan Drug Amendments of 1988, as

amended by Pub. L. 100-290).

Dated: February 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-4021 Filed 2-18-97; 8:45 am]

BILLING CODE 4160-01-F