[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Rules and Regulations]
[Page 69543]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2010-N-0560]


Amendments to General Regulations of the Food and Drug 
Administration; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) published a final 
rule in the Federal Register on November 30, 2010, amending certain 
regulations to include tobacco products, where appropriate, in light of 
FDA's authority to regulate these products under the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act). The final 
rule inadvertently deleted an authority citation and language related 
to the definition of ``package.'' We are restoring the inadvertent 
deletions and making a corresponding technical change.

DATES: This rule is effective November 20, 2013.

FOR FURTHER INFORMATION CONTACT: Felicia Billingslea, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-2371.

SUPPLEMENTARY INFORMATION: We are making technical amendments to our 
regulations under 21 CFR part 1.
    In the Federal Register of November 30, 2010 (75 FR 73951), we 
amended certain regulations in part 1 (21 CFR part 1), ``General 
Enforcement Regulations,'' in light of our authority under the Tobacco 
Control Act. The final rule, among other things:
     Revised the authority citation for part 1 by removing a 
reference to section 302 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 332);
     Revised Sec.  1.1(c), ``General,'' by removing the terms 
``package in Sec.  1.20 and of'', and
     Revised Sec.  1.20, ``Presence of mandatory label 
information,'' by removing the terms ``package in Sec.  1.20 and of''.
    The preamble to the final rule explained that the revisions to part 
1 reflected our authority over tobacco products under the Tobacco 
Control Act (75 FR 73951 at 73952). However, the revisions 
inadvertently created one inconsistency (in that other provisions in 
part 1 did, in fact, rely on section 302 of the FD&C Act as part of 
their legal authority) or created confusion over whether the definition 
of ``package'' was limited to the regulations in part 1 or whether it 
also applied to other FDA regulations.
    Therefore, through this rule, we are amending part 1 as follows:
     We are restoring section 302 of the FD&C Act to the 
authority citation for part 1. Because the authority citation is 
expressed in terms of the U.S. Code, the amendment is to insert ``332'' 
in the list of U.S. Code sections.
     We are revising Sec.  1.1(c) to restore the terms 
``package in Sec.  1.20 and of''.
     We are revising Sec.  1.20 to add a cross-reference to 
Sec.  1.1(c).
    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). These 
amendments are merely correcting inadvertent deletions. FDA, therefore, 
for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that 
notice and public comment are unnecessary.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
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 
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as 
follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 352, 355, 360b, 362, 371, 374, 381, 382, 387, 387a, 387c, 393; 
42 U.S.C. 216, 241, 243, 262, 264.


Sec.  1.1  [Amended]

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2. Amend Sec.  1.1 by adding the phrase ``of package in Sec.  1.20 
and'' after the word ``definition'' in the first sentence of paragraph 
(c).


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3. In Sec.  1.20, revise the introductory text to read as follows:


Sec.  1.20  Presence of mandatory label information.

    In the regulations specified in Sec.  1.1(c) of this chapter, the 
term package means any container or wrapping in which any food, drug, 
device, or cosmetic is enclosed for use in the delivery or display of 
such commodities to retail purchasers, but does not include:
* * * * *

    Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27773 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P