[Federal Register Volume 62, Number 33 (Wednesday, February 19, 1997)]
[Proposed Rules]
[Page 7390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4021]


=======================================================================
-----------------------------------------------------------------------

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