Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction, 9412 [2014-03588]

Download as PDF 9412 Federal Register / Vol. 79, No. 33 / Wednesday, February 19, 2014 / Rules and Regulations upgrade UI Benefits and Tax Systems by SWAs using Federal funds. (b) The standard designated in paragraph (a) of this section is effective March 21, 2014. Eric M. Seleznow, Acting Assistant Secretary, Employment and Training Administration. 2. On page 8055, in the second column, ‘‘FDA–1995–N–0036’’ is corrected to read ‘‘FDA–1995–N–0063’’. 3. On page 8058, in the third column, ‘‘FDA–1995–N–0036’’ is corrected to read ‘‘FDA–1995–N–0063’’. [FR Doc. 2014–03496 Filed 2–18–14; 8:45 am] Dated: February 13, 2014. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4510–FN–P [FR Doc. 2014–03588 Filed 2–18–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration 21 CFR Parts 106 and 107 21 CFR Part 800 [Docket No. FDA–1995–N–0063 (formerly 95N–0309)] [Docket No. FDA–1977–N–0222] RIN 0910–AF27 Administrative Detention; Corrections Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction AGENCY: AGENCY: Food and Drug Administration, HHS. Interim final rule; request for comments; correction. ACTION: The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of February 10, 2014. The document revised our infant formula regulations to establish requirements for current good manufacturing practices, including audits; to establish requirements for quality factors; and to amend FDA’s quality control procedures, notification, and record and reporting requirements for infant formula. FDA took the action to improve the protection of infants who consume infant formula products. The document was published with an incorrect docket number. This document corrects that error. DATES: Effective Date: This correction is effective February 19, 2014. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208, Silver Spring, MD 20993, 301–796– 9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2014–02148, appearing on page 7934 in the Federal Register of February 10, 2014 (79 FR 7934), the following corrections are made: 1. On page 7934, ‘‘FDA–1995–N– 0036’’ is corrected to read ‘‘FDA–1995– N–0063’’ each time it appears. ehiers on DSK2VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:22 Feb 18, 2014 Jkt 232001 Food and Drug Administration, HHS. Final rule; correcting amendment. ACTION: The Food and Drug Administration (FDA) published a document in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The document established administrative detention procedures for devices intended for human use believed to be adulterated or misbranded. The document was published with a citation in the first column on page 13240 that subsequently was changed by the Nutrition Labeling and Education Act Amendments of 1993. In addition, the document was published with one typographical error in the first column on page 13241. This document corrects these errors. DATES: This correction is effective February 19, 2014. FOR FURTHER INFORMATION CONTACT: Jan B. Welch, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3412, 301–796– 5776, FAX: 301–847–8136, jan.welch@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is correcting a final rule that appeared in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The final rule established administrative detention procedures for devices intended for human use believed to be adulterated or misbranded. The document was published with a citation to section 201(y) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(y)) (the FD&C Act) in the first column on page 13240 (§ 800.55(g)(1) (21 CFR SUMMARY: PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 800.55(g)(1)) that subsequently was changed to section 201(x) of the FD&C Act by section 3(b) of the Nutrition Labeling and Education Act Amendments of 1993 (Pub. L. 103–80). In addition, the document was published with one typographical error in the first column on page 13241 (§ 800.55(k)(1)) in which the word ‘‘is’’ should have been the word ‘‘in’’. This document updates the statutory reference in § 800.55(g)(1) and corrects the typographical error in § 800.55(k)(1). Publication of this rule constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). This amendment to the regulations provides only a technical change and corrects a nonsubstantive error. FDA therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) that notice and public comment are unnecessary, and under 5 U.S.C. 553(d)(3) that the rule can become effective upon publication. FDA has determined under 21 CFR 25.30(i) that this final rule is of a type that, as a class, does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in § 800.55 have been approved under OMB control number 0910–0114, which expires April 30, 2016. List of Subjects in 21 CFR Part 800 Administrative practice and procedure; Medical devices; Ophthalmic goods and services; Packaging and containers; Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR Part 800 is amended as follows: PART 800—GENERAL 1. The authority citation for 21 CFR Part 800 continues to read as follows: ■ Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 361, 362, 371. 2. In § 800.55, revise paragraph (g)(1) and the first sentence of paragraph (k) to read as follows: ■ § 800.55 Administrative detention. * * * * * (g) Appeal of a detention order. (1) A person who would be entitled to claim E:\FR\FM\19FER1.SGM 19FER1

Agencies

[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Rules and Regulations]
[Page 9412]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03588]


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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: Interim final rule; request for comments; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document that appeared in the Federal Register of February 10, 2014. 
The document revised our infant formula regulations to establish 
requirements for current good manufacturing practices, including 
audits; to establish requirements for quality factors; and to amend 
FDA's quality control procedures, notification, and record and 
reporting requirements for infant formula. FDA took the action to 
improve the protection of infants who consume infant formula products. 
The document was published with an incorrect docket number. This 
document corrects that error.

DATES: Effective Date: This correction is effective February 19, 2014.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208, 
Silver Spring, MD 20993, 301-796-9148.

SUPPLEMENTARY INFORMATION: In FR Doc. 2014-02148, appearing on page 
7934 in the Federal Register of February 10, 2014 (79 FR 7934), the 
following corrections are made:
    1. On page 7934, ``FDA-1995-N-0036'' is corrected to read ``FDA-
1995-N-0063'' each time it appears.
    2. On page 8055, in the second column, ``FDA-1995-N-0036'' is 
corrected to read ``FDA-1995-N-0063''.
    3. On page 8058, in the third column, ``FDA-1995-N-0036'' is 
corrected to read ``FDA-1995-N-0063''.

    Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03588 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P

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