16424 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Notices 

Since this regulation does not impose 

any costs on State or local governments, 

the requirements of Executive Order 

13132 are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program and Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 16, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–6813 Filed 3–22–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0277] 

Draft Guidance for Industry: 

Compliance With Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco To 

Protect Children and Adolescents; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised draft guidance 

for industry entitled ‘‘Draft Guidance for 

Industry: Compliance With Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents.’’ This 

revised draft guidance replaces the 

original draft guidance published in the 

Federal Register of June 9, 2010 (75 FR 

32791). The original draft guidance was 

revised to remove potential ambiguities 

and to address several issues not 

included in the original draft guidance. 

This revised draft guidance is intended 

to help small entities comply with the 

final rule entitled ‘‘Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents.’’ 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 23, 2011. 

ADDRESSES: The draft guidance for 

industry entitled ‘‘Draft Guidance for 

Industry: Compliance with Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents’’ is 

available on the Internet at http://

www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatory

Information/default.htm, or a paper 

copy may be ordered free of charge by 

calling 1–877–287–1373. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Office of Compliance and Enforcement, 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229, 877– 

287–1373, ctpcompliance@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) (Pub. L. 111–31; 123 Stat. 1776) 

was enacted on June 22, 2009, amending 

the Federal Food, Drug, and Cosmetic 

Act and providing FDA with the 

authority to regulate tobacco products. 

Section 102 of the Tobacco Control Act 

requires FDA to publish final 

regulations regarding cigarettes and 

smokeless tobacco, which are identical 

in their provisions to the regulations 

issued by FDA on August 28, 1996 (61 

FR 44396), with certain specified 

exceptions. In the Federal Register of 

March 19, 2010 (75 FR 13225), FDA 

published a final rule entitled 

‘‘Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents.’’ The final regulations 

apply to manufacturers, distributors, 

and retailers who make, distribute, or 

sell cigarettes or smokeless tobacco 

products. 

As of June 22, 2010, these Federal 

regulations, among other things, 

prohibit retailers from selling cigarettes, 

cigarette tobacco, or smokeless tobacco 

to persons under the age of 18, and 

require retailers to verify the age of all 

customers under the age of 27 by 

checking a photographic identification 

that includes the bearer’s date of birth. 

FDA announced the publication of the 

original draft guidance document on 

June 9, 2010 (75 FR 32791). This revised 

draft guidance replaces the original draft 

guidance. The original draft guidance 

was revised to remove potential 

ambiguities and to address several 

issues not included in the original draft 

guidance. This revised draft guidance is 

intended to help small entities comply 

with the final rule entitled ‘‘Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents’’ 

published on March 19, 2010. FDA is 

soliciting comments on the revised draft 

guidance document which replaces the 

original draft guidance document. FDA 

may amend the guidance document 

periodically as a result of comments 

received. 

II. Significance of Guidance 

FDA is issuing this draft guidance 

document consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on ‘‘Compliance with 

Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents.’’ It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatory

Information/default.htm or http:// 

www.regulations.gov. 

Dated: March 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6794 Filed 3–22–11; 8:45 am] 

BILLING CODE P 


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