Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 32481 

www.aoa.gov/doingbus/fundopp/ 

fundopp.aspx 

II. Award Information 

1. Funding Instrument Type 

These awards will be made in the 

form of grants to Title VI Native 

American Programs. 

2. Anticipated Total Priority Area 

Funding per Budget Period 

AoA intends to make available, under 

this program announcement, grant 

awards for $1,000 to 246 projects at a 

federal share of approximately $246,000 

total for a project period of 1 year. 

III. Eligibility Criteria and Other 

Requirements 

1. Eligible Applicants 

Only current Older Americans Act 

Title VI Native American Program 

grantees are eligible to apply for this 

funding. 

2. Cost Sharing or Matching 

Cost Sharing does not apply. 

3. DUNS Number 

All grant applicants must obtain a D– 

U–N–S number from Dun and 

Bradstreet. It is a nine-digit 

identification number, which provides 

unique identifiers of single business 

entities. The D–U–N–S number is free 

and easy to obtain from http:// 

www.dnb.com/US/duns_update/. 

4. Intergovernmental Review 

Executive Order 12372, 

Intergovernmental Review of Federal 

Programs, is not applicable to these 

grant applications. 

IV. Application and Submission 

Information 

1. Address to Request Application 

Application kits are available by 

writing to the U.S. Department of Health 

and Human Services, Administration on 

Aging, Office for American Indian, 

Alaskan Native, and Native Hawaiian 

Programs, Washington, DC 20201, 

attention: Yvonne Jackson or by calling 

202–357–3501, or online at http:// 

www.grants.gov. 

2. Address for Application Submission 

Applications may be submitted by 

e-mail to grants.office@aoa.hhs.gov, by 

fax to 202–357–3467 or in hard copy by 

overnight delivery to the U.S. 

Department of Health and Human 

Services, Administration on Aging, 

Office of Grants Management, 

Washington, DC 20201, Attn. Sean 

Lewis. 

3. Submission Dates and Times 

To receive consideration, applications 

must be submitted by 11:59 Eastern time 

by the deadline listed in the ‘‘Dates’’ 

section at the beginning of this Notice. 

V. Responsiveness Criteria 

Does not apply. 

VI. Application Review Information 

Does not apply. 

VII. Agency Contacts 

Direct inquiries regarding 

programmatic issues to U.S. Department 

of Health and Human Services, 

Administration on Aging, Office for 

American Indian, Alaskan Native, and 

Native Hawaiian Programs, Washington, 

DC 20201, attention: Yvonne Jackson or 

by calling 202–357–3501, or by e-mail at 

Yvonne.jackson@aoa.hhs.gov. 

Dated: May 18, 2010. 

Kathy Greenlee, 

Assistant Secretary for Aging. 

[FR Doc. 2010–13651 Filed 6–7–10; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0276] 

Guidance for Industry: Enforcement 

Policy Concerning Rotational Warning 

Plans for Smokeless Tobacco; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Enforcement Policy 

Concerning Rotational Warning Plans 

for Smokeless Tobacco Products.’’ The 

guidance is intended to provide 

information relating to FDA’s 

enforcement policy concerning section 3 

of the Comprehensive Smokeless 

Tobacco Health Education Act 

(Smokeless Tobacco Act), as amended 

by the Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act). This guidance will be 

implemented immediately, but remains 

subject to comment in accordance with 

the agency’s good guidance practices 

(GGPs). 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Enforcement Policy 

Concerning Rotational Warning Plans 

for Smokeless Tobacco Products’’ to the 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a fax number to 

which the guidance may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to 

guidance. 

Submit electronic comments on the 

guidance 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: Gail 

Schmerfeld, Center for Tobacco 

Products, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 240–276– 

1717, e-mail: 

Gail.Schmerfeld@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the President 

signed the Tobacco Control Act (Public 

Law 111–31) into law. The Tobacco 

Control Act grants FDA authority to 

regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect public health generally and to 

reduce tobacco use by minors. Section 

204 of the Tobacco Control Act 

amended section 3 of the Smokeless 

Tobacco Act (15 U.S.C. 4402) to 

prescribe new requirements for health 

warning labels that must appear on 

smokeless tobacco product packages 

and advertising, and to require that 

rotational warning plans for packaging 

and advertising for smokeless tobacco 

products be submitted to FDA, rather 

than to the Federal Trade Commission 

(FTC). 

The new warning labels required by 

section 3 of the Smokeless Tobacco Act 

must begin to rotate in advertising for 

smokeless tobacco products beginning 

on June 22, 2010, and must be 

distributed and displayed on the 

packaging of smokeless tobacco 

products manufactured on or after June 

22, 2010, as set forth in section 3(b)(3) 

of the Smokeless Tobacco Act (section 

204(b) of the Tobacco Control Act and 

section 3(b)(3) of the Smokeless Tobacco 

Act). In addition, on or after July 22, 

2010, manufacturers may not introduce 

any smokeless tobacco product into 


emcdonald on DSK2BSOYB1PROD with NOTICES
32482 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

domestic commerce unless its packaging 

complies with section 3 of the 

Smokeless Tobacco Act (Id.). Among the 

requirements in section 3(b)(3) is that 

the rotation of label statements on 

packaging and advertising for each 

brand of smokeless tobacco must be ‘‘in 

accordance with a plan submitted by the 

tobacco product manufacturer, importer, 

distributor, or retailer’’ to, and approved 

by, FDA (Id.). 

At this time, as an exercise of 

enforcement discretion, FDA does not 

intend to commence or recommend 

enforcement of the requirement that a 

smokeless tobacco manufacturer, 

distributor, importer, or retailer must 

have an FDA-approved rotational 

warning plan, so long as a rotational 

warning plan has been submitted to 

FDA by July 22, 2010. FDA believes that 

allowing additional time for the review 

of rotational warning plans will permit 

an orderly transition of regulatory 

authority from FTC to FDA to review 

and approve rotational warning plans. 

During such transition between June 22, 

2010, and July 22, 2010, affected 

companies may wish to contact FDA to 

discuss the submission of their 

rotational warning plans in order to 

make the subsequent approval process 

more orderly and efficient. FDA intends 

to provide further public notice prior to 

revising or rescinding this enforcement 

policy after the transition from FTC to 

FDA has been accomplished for the 

submission and review of rotational 

warning plans. This enforcement policy 

pertains only to the requirement that 

smokeless tobacco manufacturers, 

distributors, importers, or retailers must 

have an FDA-approved rotational 

warning plan. FDA expects compliance 

with regard to all other requirements of 

section 3 of the Smokeless Tobacco Act, 

including the requirements relating to 

size, formatting, location, and use of 

required warning statements. 

II. Significance of Guidance 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s good guidance 

practices regulations (21 CFR 10.115). 

This guidance 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 statutory provisions that 

take effect June 22, 2010. It is important 

that FDA explain its enforcement policy 

concerning the submission and approval 

of rotational warning plans for 

smokeless tobacco products before that 

date. 

III. Comments 

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 

An electronic version of this guidance 

document is available on the Internet at 

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

www.fda.gov/TobaccoProducts/ 

GuidanceComplianceRegulatory

Information/default.htm. 

Dated: June 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13819 Filed 6–4–10; 4:15 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0247] 

Investigational New Drug Applications; 

Co-development of Investigational 

Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of docket; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is establishing a 

public docket to obtain input on 

methods to co-develop two or more 

distinct investigational drugs intended 

to be used in combination to treat a 

disease or condition. FDA is planning to 

develop guidance for industry and other 

affected parties on the co-development 

of two or more novel drugs intended to 

be used in combination (but not as not 

fixed-dose combinations) and is seeking 

public input to identify the affected 

parties’ information needs concerning 

such co-development. Accordingly, 

FDA is seeking comment on general 

methodologic and regulatory issues that 

arise in various scenarios when codeveloping two or more investigational 

drugs intended to be used in 

combination. FDA is also seeking 

comment on methodologic and 

regulatory issues when co-developing 

two or more investigational drugs 

intended to be used in combination for 

specific therapeutic areas, including 

oncology, anti-infectives, seizure 

disorders, cardiovascular diseases, and 

any other therapeutic category in which 

such co-development is likely to occur. 

DATES: Submit either electronic or 

written comments by September 7, 

2010. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Colleen L. Locicero, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4200, 

Silver Spring, MD 20993–0002, 301– 

796–2270. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is aware of growing interest in 

co-developing two or more distinct, 

novel investigational drugs intended to 

be used in combination to treat a disease 

or condition (but not as fixed-dose 

combinations under 21 CFR 300.50). At 

a September 2009 conference co-hosted 

by the ‘‘Friends of Cancer Research’’ in 

partnership with the Engelberg Center 

for Health Care Reform at the Brookings 

Institution, and supported by the 

American Society for Clinical Oncology 

(ASCO), the American Association for 

Cancer Research (AACR) Susan G. 

Komen for the Cure, and the Lance 

Armstrong Foundation (Brookings 

Conference), which was attended by 

FDA scientists, there was considerable 

interest in approaches to developing 

new oncology therapies intended to be 

used in combination. In addition, on 

April 30, 2010, FDA held a public 

hearing in accordance with part 15 (21 

CFR part 15) devoted, in part, to 

obtaining information about study 

designs and appropriate populations for 

developing two or more novel, directacting antivirals intended to be used in 

combination for the treatment of chronic 

hepatitis C. FDA is also aware of efforts 

to try to develop two or more 

investigational drugs intended to be 

used in combination to treat 

tuberculosis. FDA is further aware of 

general uncertainty about the 

evidentiary requirements and regulatory 

criteria applicable to such codevelopment efforts. Accordingly, FDA 

is planning to develop generally 

applicable guidance (not restricted to 

oncology or any other specific 

therapeutic category) to address 


emcdonald on DSK2BSOYB1PROD with NOTICES