[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]
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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.
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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
