Document ID: FDA-1995-N-0063-0077
Agency: fda
Document Type: Rule
Title: Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
Posted Date: 2014-07-15T04:00Z

[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Rules and Regulations]
[Page 41127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16476]

[[Page 41127]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 106 and 107

[Docket No. FDA-1995-N-0063 (formerly 95N-0309)]
RIN 0910-AF27

Current Good Manufacturing Practices, Quality Control Procedures, 
Quality Factors, Notification Requirements, and Records and Reports, 
for Infant Formula; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is correcting a 
final rule that appeared in the Federal Register of June 10, 2014. The 
final rule revised our infant formula regulations by establishing 
requirements for current good manufacturing practices, including 
audits; establishing requirements for quality factors; and amending our 
quality control procedures, notification, and record and reporting 
requirements for infant formula. We issued the final rule to provide 
greater protection of infants who consume infant formula products. In 
this document, we correct some errors that appeared in the preamble to 
the final rule.

DATES: Effective July 15, 2014.

FOR FURTHER INFORMATION CONTACT: Leila Beker, Office of Nutrition, 
Labeling, and Dietary Supplements (HFS-850), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, 240-402-1451.

SUPPLEMENTARY INFORMATION: In FR Doc. 2014-13384, appearing on page 
33057 in the Federal Register of June 10, 2014 (79 FR 33057), we make 
the following corrections:
    1. On pages 33057-33058, under FOR FURTHER INFORMATION CONTACT the 
contact information is changed to read, ``Leila Beker, Office of 
Nutrition, Labeling, and Dietary Supplements (HFS-850), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-1451.''
    2. On page 33062, in the third column, in Comment 9, 
``45[emsp14][deg]F (F)'' is corrected to read ``45[emsp14][deg]F.''
    3. On page 33063, in the third column, in Comment 13, the preamble 
stated, ``The comment requested that, with regard to the requirements 
of Sec.  106.35, we announce the exercise of enforcement discretion or 
a formal delay for this provision to align with the compliance date for 
eligible infant formulas. Nonetheless, with the exception of the 
compliance date for certain requirements related to quality factors for 
eligible infant formulas, the final rule adopts a compliance date of 
September 8, 2014 to facilitate manufacturer compliance with all 
requirements of this final rule.'' We are correcting this passage to 
read, ``The comment requested that, with regard to the requirements of 
Sec.  106.35, we announce the exercise of enforcement discretion, a 
delayed compliance date, or a formal delay for this provision to align 
with the compliance date for eligible infant formulas.''
    4. On page 33063, in the third column, in the Response to Comment 
13, the preamble stated, ``We therefore decline the request to announce 
the exercise of enforcement discretion, a delayed compliance date, or a 
formal delay for this provision to align with the compliance date for 
eligible infant formulas.'' We are correcting this passage to read, 
``We therefore decline the request to announce the exercise of 
enforcement discretion or a formal delay for this provision to align 
with the compliance date for eligible infant formulas. Nonetheless, 
with the exception of the compliance date for certain requirements 
related to quality factors for eligible infant formulas, the final rule 
adopts a compliance date of September 8, 2014, to facilitate 
manufacturer compliance with all requirements of this final rule.''

    Dated: July 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16476 Filed 7-14-14; 8:45 am]
BILLING CODE 4164-01-P