14280 Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

FDA Center Subject 

No. of 

Focus 

Groups per 

Study 

No. of Focus 

Groups Sessions 

Conducted 

Annually 

No. of 

Participants 

per Group 

Hours of Duration for 

Each Group (Includes 

Screening) 

Total 

Hours 

Center for Drug Evaluation and Research Varies (e.g., direct-to-consumer Rx drug promotion, 

physician labeling of Rx 

drugs, medication guides, 

over-the-counter drug labeling, risk communication) 

10 200 9 1 .58 2,844 

Center for Devices and 

Radiological Health 

Varies (e.g., FDA Seal of Approval, patient labeling, tampons, online sales of medical 

products, latex gloves) 

4 16 9 2 .08 300 

Center for Food Safety 

and Applied Nutrition 

Varies (e.g., food safety, nutrition, dietary supplements, 

and consumer education) 

8 40 9 1 .58 569 

Center for Veterinary 

Medicine 

Varies (e.g., animal nutrition, 

supplements, labeling of animal Rx) 

5 25 9 2 .08 468 

Total 28 286 9 1 .78 4,252 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Annually, FDA projects about 28 

focus group studies using 186 focus 

groups lasting an average of 1.78 hours 

each. FDA has allowed burden for 

unplanned focus groups to be 

completed so as not to restrict the 

agency’s ability to gather information on 

public sentiment for its proposals in its 

regulatory as well as other programs. 

Dated: March 16, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5505 Filed 3–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003E–0252] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; A180 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for A180 

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 

animal 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–7), 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 animal drug 

products, the testing phase begins on 

the earlier date when either a major 

environmental effects test was initiated 

for the drug or when an exemption 

under section 512(j) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

360b(j)) became effective and runs until 

the approval phase begins. The approval 

phase starts with the initial submission 

of an application to market the animal 

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 animal drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(4)(B). 

FDA approved for marketing the 

animal drug product A180 

(danofloxacin mesylate). A180 is 

indicated for treatment of bovine 

respiratory disease associated with 

Mannheimia (Pasteurella) haemolytica 

and Pasteurella multocida in beef cattle. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for A180 

(U.S. Patent No. 4,861,779) from Pfizer, 

Inc., and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

July 16, 2003, FDA advised the Patent 

and Trademark Office that this animal 

drug product had undergone a 

regulatory review period and that the 

approval of A180 represented the first 

permitted commercial marketing or use 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices 14281 

of the product. Shortly 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 

A180 is 5,365 days. Of this time, 5,314 

days occurred during the testing phase 

of the regulatory review period, while 

51 days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 512(j) of the Federal Food, Drug, 

and Cosmetic Act involving this animal 

drug product became effective: January 

14, 1988. The applicant claims January 

20, 1988, as the date the investigational 

new animal drug application (INAD) 

became effective. However, FDA records 

indicate that the date of FDA’s letter 

assigning a number to the INAD was 

January 14, 1988, which is considered to 

be the effective date for the INAD. 

2. The date the application was 

initially submitted with respect to the 

animal drug product under section 

512(b) of the Federal Food, Drug, and 

Cosmetic Act: August 1, 2002. FDA has 

verified the applicant’s claim that the 

new animal drug Application (NADA) 

for A180 (NADA 141–207) was initially 

submitted on August 1, 2002. 

3. The date the application was 

approved: September 20, 2002. The 

applicant claims September 24, 2002, as 

the date NADA 141–207 was approved. 

However, FDA records indicate that the 

date of approval was September 20, 

2002. 

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 1,826 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 May 29, 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 

September 24, 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 are to 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: March 12, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–5504 Filed 3–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0090] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on June 13, 2007, from 8 a.m. to 5 

p.m. 

Addresses: Electronic comments 

should be submitted to http:// 

www.fda.gov/dockets/ecomments. 

Select ‘‘2007N–0090’’ and follow the 

prompts to submit your statement. 

Written comments should be submitted 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, by close of 

business on May 30, 2007. All 

comments will be posted without 

change, including any personal 

information provided. Comments 

received on or before May 30, 2007, will 

be provided to the committee before or 

at the meeting. 

Location: Hilton Silver Spring, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589–

5200. 

Contact Person: Cathy A. Groupe, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

Cathy.Groupe@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512536. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

the efficacy and safety of new drug 

application (NDA) 21–888, proposed 

tradename Zimulti (rimonabant), 20 

milligrams tablets, Sanofi-Aventis, as an 

adjunct to diet and exercise for obesity 

management in patients with a body 

mass index equal to or greater than 30 

kilograms (kg) per square meter, or a 

body mass index equal to or greater than 

27 kg per square meter if accompanied 

by at least one cardiovascular risk 

factor. 

FDA intends to make background 

material available to the public no later 

than 1 business day before the meeting. 

If FDA is unable to post background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 30, 2007. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before May 22, 2007. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak on or before May 21, 

2007. 


sroberts on PROD1PC70 with NOTICES