# 62 FR 7390: Regulation of Medical Foods; Extension of Comment Period > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_97-4021 ## Section - **Citation:** 62 FR 7390 - **Heading:** Regulation of Medical Foods; Extension of Comment Period - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Federal Register / Vol. 62 / 62 FR 7390 ## Text 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. 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