[Federal Register Volume 61, Number 185 (Monday, September 23, 1996)]
[Proposed Rules]
[Pages 49714-49715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24224]


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

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