32480 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product ABLAVAR 

(gadofosveset trisodium). ABLAVAR is 

indicated for use as a contrast agent in 

magnetic resonance angiography to 

evaluate aortoiliac occlusive disease in 

adults with known or suspected 

peripheral vascular disease. Subsequent 

to this approval, the Patent and 

Trademark Office received patent term 

restoration applications for ABLAVAR 

(U.S. Patent Nos. 6,676,929 and 

7,060,250) from Epix Pharmaceuticals, 

Inc., and the Patent and Trademark 

Office requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

September 29, 2009, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of ABLAVAR represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

ABLAVAR is 4,508 days. Of this time, 

2,673 days occurred during the testing 

phase of the regulatory review period, 

while 1,835 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: August 21, 

1996. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on August 21, 1996. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 15, 2003. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) 

21–711 was submitted on December 15, 

2003. 

3. The date the application was 

approved: December 22, 2008. FDA has 

verified the applicant’s claim that NDA 

21–711 was approved on December 22, 

2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 1,806 days of patent 

term extension for U.S. Patent No. 

6,676,929 and 924 days of patent term 

extension for U.S. Patent No. 7,060,250. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by August 9, 2010. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

December 6, 2010. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. 

Comments and petitions may be seen 

in the Division of Dockets Management 

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

through Friday. 

Dated: April 23, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–13655 Filed 6–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Funding Opportunity: Affordable Care 

Act Medicare Beneficiary Outreach and 

Assistance Program Funding for Title 

VI Native American Programs 

Purpose of Notice: Availability of 

funding opportunity announcement. 

Funding Opportunity Title/Program 

Name: Affordable Care Act Medicare 

Beneficiary Outreach and Assistance 

Program Funding for Title VI Native 

American Programs. 

Announcement Type: Initial. 

Funding Opportunity Number: HHS– 

2010–AoA–MI–1022. 

Statutory Authority: The Medicare 

Improvements for Patients and 

Providers Act of 2008—Section 119, 

Public Law 110–275 as amended by the 

Patient Protection and Affordable Care 

Act of 2010 (Affordable Care Act). 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.071. 

Discretionary Projects 

DATES: The deadline date for the 

submission of applications is July 30, 

2010. 

I. Funding Opportunity Description 

AoA will provide a grant of $1,000 to 

each Older Americans Act Title VI 

Native American program awardee. The 

purpose of these grants will be for the 

coordination of at least one community 

announcement and at least one outreach 

event to inform and assist eligible 

Native American elders about the 

benefits available to them through 

Medicare Part D, the Low Income 

Subsidy, the Medicare Savings Program, 

or Medicare prevention benefits and 

screenings. The example of $1,000 per 

event is for illustrative purposes only. 

There is data available from the 

National Association of Area Agencies 

on Aging (n4a) and studies performed 

by the National Council on Aging 

(NCOA) that reflect these costs for 

planning and implementing a 

community event for Medicare Part D 

and LIS outreach activities. 

A detailed description of the funding 

opportunity may be found at http:// 


emcdonald on DSK2BSOYB1PROD with NOTICES
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