[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Rules and Regulations]
[Page 41127]
From the Federal Register Online via the Government Publishing 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