Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 9249 

TABLE 2.—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

FDA Center No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Center for Food Safety and Applied 

Nutrition 1,794 5 8,970 2 17,940 

Total 14,853 24,272 39,333 

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

The burden estimates were averaged 

based on the approximate number of 

requests for certificates the agency 

received over the past 3 years. The 

burden estimate for the Center for Drug 

Evaluation and Research was increased 

to reflect a more accurate average 

number of requests for certificates. 

Dated: February 23, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4457 Filed 3–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0308] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENDEAVOR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ENDEAVOR 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 

medical device. 

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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. 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 (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 medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B). 

FDA recently approved for marketing 

the medical device, ENDEAVOR 

(Zotarolimus-Eluting Coronary Stent 

System). ENDEAVOR is indicated for 

improving coronary luminal diameter in 

patients with ischemic heart disease due 

to de novo lesions of length ≤27 

millimeters (mm) in native coronary 

arteries with reference vessel diameters 

of ≥2.5 mm to ≤3.5 mm. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for ENDEAVOR (U.S. Patent 

No. 5,624,411) from Medtronic, 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 

June 19, 2008, FDA advised the Patent 

and Trademark Office that this medical 

device had undergone a regulatory 

review period and that the approval of 

ENDEAVOR 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 

ENDEAVOR is 1,507 days. Of this time, 

1,068 days occurred during the testing 

phase of the regulatory review period, 

while 439 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

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

360j(g)) involving this device became 

effective: December 19, 2003. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) required under section 

520(g) of the act for human tests to begin 

became effective was December 19, 

2003. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the Federal 

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

360e): November 20, 2006. The 

applicant claims November 16, 2006, as 

the date the premarket approval 

application (PMA) for ENDEAVOR 

(PMA P060033) was initially submitted. 

However, FDA records indicate that 

PMA P060033 was submitted on 

November 20, 2006. 

3. The date the application was 

approved: February 1, 2008. FDA has 

verified the applicant’s claim that PMA 

P060033 was approved on February 1, 

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 application for patent extension, 

this applicant seeks 954 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

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9250 Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by May 4, 2009. 

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 

August 31, 2009. 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: February 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–4374 Filed 3–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0095] 

Draft Guidance for Industry on the 

Clinical Pharmacology Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Clinical 

Pharmacology Section of Labeling for 

Human Prescription Drug and Biological 

Products—Content and Format.’’ This 

draft guidance is one of a series of 

guidance documents intended to assist 

applicants in complying with new FDA 

regulations on the content and format of 

labeling for human prescription drug 

and biological products. The draft 

guidance describes the recommended 

information to include in the Clinical 

pharmacology section of labeling that 

pertains to the safe and effective use of 

human prescription drug and biological 

products. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 1, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send two self-addressed 

adhesive labels to assist the office in 

processing your requests. Submit 

written comments on the draft guidance 

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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Paul Hepp, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 1270, 

Silver Spring, MD 20993–0002, 

301–796–1538; or 

Lei Zhang, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3106, 

Silver Spring, MD 20993–0002, 

301–796–1635; or 

Stephen M. Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17),Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 24, 

2006 (71 FR 3922), FDA published a 

final rule entitled ‘‘Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and Biological 

Products,’’ to revise the agency’s 

previous regulations on labeling 

(effective June 30, 2006). The new FDA 

regulations are designed to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use, 

thereby increasing the extent to which 

practitioners rely on labeling for 

prescribing decisions. Among other 

things, the new FDA regulations require 

that the Clinical pharmacology section 

of the labeling contain the following 

subsections: Mechanism of action, 

Pharmacodynamics, and 

Pharmacokinetics(§ 201.57(c)(13)(i) (21 

CFR 201.57(c)(13)(i)). 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Clinical Pharmacology Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ The draft guidance is intended 

to assist applicants in producing the 

Clinical pharmacology section of 

labeling for human prescription drug 

and biological products that is 

consistent, understandable, organized, 

clinically useful, and in compliance 

with the new requirements of 

§ 201.57(c)(13)(i). The ultimate goal of 

the guidance is to optimize patient drug 

therapy. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the content and format of the clinical 

pharmacology section of labeling for 

human prescription drug and biological 

products. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

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. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

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