[Federal Register Volume 68, Number 124 (Friday, June 27, 2003)]
[Proposed Rules]
[Page 38247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16357]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 124 / Friday, June 27, 2003 / 
Proposed Rules  

[[Page 38247]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 106 and 107

[Docket No. 1995N-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 Reopened Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of reopened comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to August 
26, 2003, the comment period, reopened on April 28, 2003, for the 
proposed rule published in the Federal Register of July 9, 1996 (61 FR 
36154). The proposed rule would establish requirements for current good 
manufacturing practice (CGMP) and audits, establish requirements for 
quality factors, and amend quality control procedures, notification, 
and records and reports requirements for infant formula. This action is 
being taken in response to a request for more time to submit comments 
to FDA.

DATES: Submit written or electronic comments on the proposed rule by 
August 26, 2003.

ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:  Shellee Anderson, Center for Food 
Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1491, or e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 1996 (61 FR 36154), FDA proposed 
regulations to revise its infant formula regulations to establish 
requirements for quality factors and CGMP; to amend quality control 
procedure, notification, and records and report requirements for infant 
formulas; to require that infant formulas contain, and be tested for, 
required nutrients and for any nutrient added by the manufacturer 
throughout their shelf life, and that they be produced under strict 
microbiological controls; and 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.
    In the Federal Register of April 28, 2003 (68 FR 22341), FDA 
announced that the time period for public comment would be reopened to 
June 27, 2003. On May 6, 2003, FDA received a request to extend the 
reopened comment period to allow interested persons additional time to 
comment. The requester asserts that the time period of 60 days is 
insufficient to respond fully to FDA's specific requests for comments 
and to allow potential respondents to thoroughly evaluate and address 
the original proposal in light of new issues that have arisen since 
1996.
    FDA believes that an extension of the reopened comment period is 
appropriate, given the variety of issues raised by the proposed rule 
and the April 28, 2003, document. However, because the agency wants to 
move forward on finalizing the rule as quickly as possible, FDA is 
extending the comment period only for an additional 60 days, until 
August 26, 2003. This extension will provide the public with a total of 
120 days to submit comments during the reopened comment period.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the proposal. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket numbers found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: June 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16357 Filed 6-26-03; 8:45 am]
BILLING CODE 4160-01-S