Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction, 41127 [2014-16476]

Download as PDF Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Rules and Regulations 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. 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 °F (F)’’ is corrected to read ‘‘45 °F.’’ 3. On page 33063, in the third column, in Comment 13, the preamble stated, ‘‘The comment requested that, wreier-aviles on DSK5TPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 15:12 Jul 14, 2014 Jkt 232001 with regard to the requirements of § 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 § 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 DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 1 and 301 [TD 9675] RIN 1545–BJ16 IRS Truncated Taxpayer Identification Numbers Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. AGENCY: This document contains final regulations regarding an IRS truncated SUMMARY: PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 41127 taxpayer identification number, or a TTIN. Where not prohibited by the Internal Revenue Code, applicable regulations, other guidance published in the Internal Revenue Bulletin, forms, or instructions, these regulations allow use of a TTIN in lieu of a taxpayer’s social security number (SSN), IRS individual taxpayer identification number (ITIN), IRS adoption taxpayer identification number (ATIN), or employer identification number (EIN) on payee statements and certain other documents. The TTIN displays only the last four digits of a taxpayer identifying number; either asterisks (*) or Xs replace the first five digits of the identifying number. These regulations affect persons that furnish or receive payee statements and other documents that the Internal Revenue Code, regulations, or other published guidance requires to be furnished to another person to the extent that a TTIN may appear in lieu of the SSN, ITIN, ATIN, or EIN of the payee or document recipient. DATES: Effective Date: These regulations are effective on July 15, 2014. Applicability Date: For dates of applicability see §§ 1.6042–4(g), 1.6043– 4(i), 1.6044–5(d), 1.6045–2(i), 1.6045– 3(g), 1.6045–4(s), 1.6045–5(h), 1.6049– 6(e)(5), 1.6050A–1(e), 1.6050E–1(m), 1.6050N–1(e), 1.6050P–1(h), 1.6050S– 1(f), 1.6050S–3(g), and 301.6109–4(c). FOR FURTHER INFORMATION CONTACT: Jacqueline K. Queener, (202) 317–6844 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background This document amends the Income Tax Regulations (26 CFR part 1) and the Procedure and Administration Regulations (26 CFR part 301) to authorize filers of information returns to truncate a payee’s or other person’s nine-digit identifying number on payee statements and certain other documents. The goal of these amendments is to reduce the risk of identity theft that may stem from the inclusion of a taxpayer’s entire identifying number on a payee statement or other document. Concerned about the risks of identity theft, including its effect on tax administration, the IRS established a pilot program allowing filers of information returns who met certain requirements to truncate an individual payee’s identifying number on paper payee statements (Forms 1098, 1099, and 5498) for calendar years 2009 and 2010. See Notice 2009–93, 2009–51 IRB 863. The IRS subsequently extended the pilot program for payee statements for calendar years 2011 and 2012, and modified the program by removing the E:\FR\FM\15JYR1.SGM 15JYR1

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[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.

-----------------------------------------------------------------------

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

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