25272 Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 

1Under section 102(a)(3)-(4) of the Family 

Smoking Prevention and Tobacco Control Act (21 

U.S.C. 387a-1(a)(3)-(4)), FDA may amend the final 

rule after issuing a proposed rule for notice and 

comment. 

I. Background 

In the Federal Register of March 19, 

2010 (75 FR 13225), FDA published 

final regulations restricting the sale and 

distribution of cigarettes and smokeless 

tobacco to protect children and 

adolescents. This guidance document 

discusses FDA’s intended enforcement 

policies with respect to two provisions 

of the final regulations restricting the 

sale and distribution of cigarettes and 

smokeless tobacco to protect children 

and adolescents. 

One provision, § 1140.16(a) (21 CFR 

1140.16(a)), specifies that manufacturers 

may not use a trade or brand name of 

a nontobacco product as the trade or 

brand name for a cigarette or smokeless 

tobacco product unless the trade or 

brand name was on both the tobacco 

product and a nontobacco product sold 

in the United States on January 1, 1995. 

FDA is aware of concerns regarding this 

provision and is considering what 

changes, if any, would be appropriate to 

address those concerns.1 While FDA has 

this issue under consideration, it 

intends to exercise its enforcement 

discretion concerning § 1140.16(a) (21 

CFR 1140.16(a)) not to commence 

enforcement actions under this 

provision for the duration of its 

consideration where: 

(1) The trade or brand name of the 

cigarettes or smokeless tobacco product 

was registered, or the product was 

marketed, in the United States on or 

before June 22, 2009; or 

(2) The first marketing or registration 

in the United States of the tobacco 

product occurs before the first 

marketing or registration in the United 

States of the nontobacco product 

bearing the same name; provided, 

however, that the tobacco and 

nontobacco product are not owned, 

manufactured, or distributed by the 

same, related, or affiliated entities 

(including as a licensee). 

The second provision is § 1140.32(a) 

(21 CFR 1140.32(a)). Under this section 

of the final rule, manufacturers, 

distributors, and retailers must use only 

black text on a white background for 

labeling or advertising (with certain 

exceptions). The United States District 

Court for the Western District of 

Kentucky recently issued an order 

permanently enjoining FDA from 

enforcing § 1140.32(a) (formerly 21 CFR 

897.32(a) of the 1996 final rule that 

published in the Federal Register of 

August 28, 1996 (61 FR 44396)) 

(Commonwealth Brands, Inc. v. United 

States, No. 1:09-CV-117-M (W.D. Ky. 

Jan. 4, 2010)). As required by section 

102 of the Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act), the effective date for 

§ 1140.32(a) is June 22, 2010. At this 

time, however, in light of the court’s 

order in Commonwealth Brands, FDA 

intends to exercise its enforcement 

discretion concerning § 1140.32(a) not 

to commence enforcement actions under 

this provision during the pendency of 

the litigation irrespective of whether the 

entity is a party to the pending lawsuit 

or located in the Western District of 

Kentucky. 

FDA intends that the exercise of 

enforcement discretion expressed in this 

guidance document for §§ 1140.16(a) 

and 1140.32(a) begin upon the effective 

date of the final rule (June 22, 2010). In 

accordance with FDA’s GGP regulation 

(§ 10.115 (21 CFR 10.115)), you may 

comment on this guidance at any time. 

The agency will consider your 

comments and determine whether to 

revise the guidance at a later date. 

II. Significance of Guidance 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s GGP regulation 

(§ 10.115). This guidance document is 

being implemented immediately 

without prior public comment under 

§ 10.115(g)(2) because the agency has 

determined that prior public 

participation is not feasible or 

appropriate. This document provides 

guidance on regulations that are 

required by statute (section 102 of the 

Tobacco Control Act); moreover, the 

statute directs that the regulations take 

effect on June 22, 2010 (section 

102(a)(2)(F) of the Tobacco Control Act). 

It is important that FDA explain its 

enforcement policy for these two 

provisions before that date. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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 

An electronic version of the guidance 

document is available on the Internet at 

http://www.regulations.gov and http:// 

www.fda.gov/TobaccoProducts/ 

GuidanceComplianceRegulatory

Information/default.htm. 

Dated: May 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10934 Filed 5–5–10; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Advisory Committee for Women’s 

Services; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given of a meeting of 

the Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Advisory Committee for Women’s 

Services (ACWS) on May 26–27 at 

SAMHSA. 

The meeting is open to the public. It 

will include reports from the SAMHSA 

Administrator and the ACWS Chair, 

Updates from ACWS members, and a 

discussion of SAMHSA’s strategic 

initiatives. 

Attendance by the public will be 

limited to space available. Public 

comments are welcome. The meeting 

can also be accessed via Webstream. To 

obtain the access information, to 

register, to submit written or brief oral 

comments, or to request special 

accommodations for persons with 

disabilities, please register at the 

SAMHSA Committee’s Web site at 

https://nac.samhsa.gov/Registration/ 

meetingsRegistration.aspx or 

communicate with the Designated 

Federal Officer for the ACWS, Ms. 

Nevine Gahed (see contact information 

below). Substantive meeting 

information and a roster of Committee 

members may be obtained either by 

accessing the SAMHSA Committee’s 

Web site at https://nac.samhsa.gov/ 

WomenServices/index.aspx, or by 

contacting Ms. Gahed. The transcript for 

the meeting will be available on the 

SAMHSA Committee’s Web site within 

three weeks after the meeting. 

Committee Name: SAMHSA’s Advisory 

Committee for Women’s Services. 

Date/Time/Type: Wednesday, May 26, 

2010 from 9 a.m. to 5 p.m. EST: OPEN. 

Thursday, May 27, 2010 from 9 a.m. to 12 

noon EST: OPEN. 

Place: 1 Choke Cherry Road, Seneca 

Conference Room, Rockville, Maryland 

20857. 

Contact: Nevine Gahed, Designated Federal 

Officer, SAMHSA Advisory Committee for 

Women’s Services, 1 Choke Cherry Road, 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 25273 

Room 8–1112, Rockville, Maryland 20857, 

Telephone: (240) 276–2331; Fax: (240) 276– 

2220 and E-mail: 

nevine.gahed@samhsa.hhs.gov. 

Toian Vaughn, 

Committee Management Officer, Substance 

Abuse and Mental Health Services 

Administration. 

[FR Doc. 2010–10778 Filed 5–6–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel—NIBIB Training 

SEP. 

Date: July 7–9, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Manana Sukhareva, PhD, 

Scientific Review Officer, National Institute 

of Biomedical Imaging & Bioeng, National 

Institutes of Health, 6707 Democracy 

Boulevard, Suite 959, Bethesda, MD 20892, 

301–451–3397, sukharem@mail.nih.gov. 

Dated: April 30, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10892 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center on Minority and Health 

Disparities; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center on 

Minority Health and Health Disparities 

Special Emphasis Panel, Faith Based R21. 

Date: June 29–July 1, 2010. 

Time: 5 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Prabha L. Atreya, PhD, 

Chief, Office of Scientific Review, National 

Center on Minority Health and Health 

Disparities, 6707 Democracy Boulevard, 

Suite 800, Bethesda, MD 20892, (301) 594– 

8696, atreyapr@mail.nih.gov. 

Dated: April 30, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10889 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, Basis of 

Myocardial Injury in the Elderly. 

Date: May 27, 2010. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Suite 2C212, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Bita Nakhai, PhD, 

Scientific Review Officer, Scientific Review 

Branch, National Institute on Aging, Gateway 

Bldg., 2C212, 7201 Wisconsin Avenue, 

Bethesda, MD 20814. 301–402–7701. 

nakhaib@nia.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: April 29, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10888 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group, Clinical Neuroplasticity and 

Neurotransmitters Study Section. 

Date: June 3–4, 2010. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Melrose Hotel, 2430 

Pennsylvania Avenue, NW., Washington, DC 

20037. 


jlentini on DSKJ8SOYB1PROD with NOTICES