[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]
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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.
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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