Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 106 and 107

[Docket No. 95N-0309]

RIN 0910-AA04

Current Good Manufacturing Practice, Quality Control Procedures,

Quality Factors, Notification Requirements, and Records and Reports,

for the Production of Infant Formula; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

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

December 6, 1996, the comment period on the proposed rule that

published in the Federal Register of July 9, 1996 (61 FR 36154). The

document proposed to revise FDA's infant formula regulations. The

agency is taking this action in response to a request for an extension

of the comment period. This extension is intended to allow interested

persons additional time to submit comments to FDA on the proposed

regulations.

DATES: Written comments by December 6, 1996.

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: Carolyn W. Miles, Center for Food

Safety and Applied Nutrition (HFS-456), 200 C St. SW., Washington, DC

20204, 202-401-9858.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 9, 1996 (61

FR 36154), FDA issued a proposed rule to revise its infant formula

regulations to establish requirements for quality factors and current

good manufacturing practice (CGMP); to amend its requirements on

quality control procedures, notification, and records and reports; to

require that infant formulas contain, and be tested for, certain

nutrients, be tested for any nutrients added by the manufacturer

throughout their shelf life, and be produced under strict

microbiological controls; to require that manufacturers implement the

CGMP and quality control procedure requirements by establishing a

production and in-process control system of their own design; and to

implement certain notification requirements in the Federal Food, Drug,

and Cosmetic Act. Interested persons were given until October 7, 1996,

to comment on the proposed rule.

FDA received a request for an extension of the comment period on

its proposed rule to revise its infant formula regulations. After

careful consideration, FDA has decided to extend the comment period to

December 6, 1996, to allow additional time for the submission of

comments on the proposed revisions to its infant formula regulations.

Interested persons may, on or before December 6, 1996, submit to

Dockets Management Branch (address above) written comments regarding

this proposal. 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.

[[Page 49715]]

Dated: September 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-24224 Filed 9-20-96; 8:45 am]

BILLING CODE 4160-01-F