28984 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices 

Application 

No. Drug Applicant 

NDA 20–144 TRANSDERM–NITRO (nitroglycerin), 0.1 mg/hour (hr), 0.2 

mg/hr, 

0.4 mg/hr, 0.6 mg/hr, 0.8 mg/hr 

Novartis Pharmaceuticals Corp. 

NDA 20–584 LODINE (etodolac) XL Tablets, 600 mg Wyeth Pharmaceuticals, Inc. 

NDA 21–110 RAPAMUNE (sirolimus) Tablets, 5 mg Wyeth Pharmaceuticals, Inc. 

NDA 50–477 NEBCIN (tobramycin sulfate) Injection, 10 mg/mL Eli Lilly and Co. 

NDA 50–519 NEBCIN (tobramycin sulfate) Injection, 1.2 grams/vial Do. 

ANDA 62–008 NEBCIN (tobramycin sulfate) Injection, 40 mg/mL Do. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. Approved 

ANDAs that refer to the NDAs and 

ANDA listed in this document are 

unaffected by the discontinued 

marketing of the products subject to 

those NDAs and ANDA. Additional 

ANDAs for the products may also be 

approved by the agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

agency will advise ANDA applicants to 

submit such labeling. 

Dated: May 15, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9962 Filed 5–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004E–0319] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BEXTRA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

BEXTRA and is publishing this notice of 

that determination as required by law. 

FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions 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.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–007), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

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 human drug 

product 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 BEXTRA 

(valdecoxib). BEXTRA is indicated for 

relief of the signs and symptoms of 

osteoarthritis and adult rheumatoid 

arthritis and for the treatment of 

primary dysmenorrhea. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for BEXTRA (U.S. Patent 

No. 5,633,272) from G.D. Searle, LLC, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

August 31, 2004, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of BEXTRA 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 

BEXTRA is 1,767 days. Of this time, 

1,462 days occurred during the testing 

phase of the regulatory review period, 

while 305 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: January 16, 

1997. The applicant claims January 15, 

1997, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices 28985 

IND effective date was January 16, 1997, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: January 16, 2001. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

Bextra (NDA 21–341) was initially 

submitted on January 16, 2001. 

3. The date the application was 

approved: November 16, 2001. FDA has 

verified the applicant’s claim that NDA 

21–341 was approved on November 16, 

2001. 

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 application for patent extension, 

this applicant seeks 276 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by July 23, 2007. 

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 

November 19, 2007. 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: May 2, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–9957 Filed 5–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Pretesting of Substance Abuse 

Prevention and Treatment and Mental 

Health Services Communication 

Messages—(OMB No. 0930–0196)— 

Extension 

As the Federal agency responsible for 

developing and disseminating 

authoritative knowledge about 

substance abuse prevention, addiction 

treatment, and mental health services 

and for mobilizing consumer support 

and increasing public understanding to 

overcome the stigma attached to 

addiction and mental illness, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) is 

responsible for development and 

dissemination of a wide range of 

education and information materials for 

both the general public and the 

professional communities. This 

submission is for generic approval and 

will provide for formative and 

qualitative evaluation activities to (1) 

assess audience knowledge, attitudes, 

behavior and other characteristics for 

the planning and development of 

messages, communication strategies and 

public information programs; and (2) 

test these messages, strategies and 

program components in developmental 

form to assess audience comprehension, 

reactions and perceptions. Information 

obtained from testing can then be used 

to improve materials and strategies 

while revisions are still affordable and 

possible. The annual burden associated 

with these activities is summarized 

below. 

Activity No. of 

respondents 

Responses 

respondent 

Hours per 

response Total hours 

Individual In-depth Interviews: 

General Public .......................................................................................... 400 1 .75 300 

Service Providers ..................................................................................... 200 1 .75 150 

Focus Group Interviews: 

General Public .......................................................................................... 3,000 1 1.5 4,500 

Service Providers ..................................................................................... 1,500 1 1.5 2,250 

Telephone Interviews: 

General Public .......................................................................................... 335 1 .08 27 

Service Providers ..................................................................................... 165 1 .08 13 

Self-Administered Questionnaires: 

General Public .......................................................................................... 2,680 1 .25 670 

Service Providers ..................................................................................... 1,320 1 .25 330 

Gatekeeper Reviews: 

General Public .......................................................................................... 1,200 1 .50 600 

Service Providers ..................................................................................... 900 1 .50 450 

Total ................................................................................................... 11,700 ........................ ........................ 9,290 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by June 22, 2007 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 


pwalker on PROD1PC71 with NOTICES