Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 9247 

The purpose of this analysis is to 

facilitate public comment on the 

proposed Decision and Order. This 

analysis is not intended to constitute an 

official interpretation of the Consent 

Agreement and the proposed Decision 

and Order, and does not modify their 

terms in any way. Further, the proposed 

Consent Agreement has been entered 

into for settlement purposes only, and 

does not constitute an admission by 

Respondents that they violated the law 

or that the facts alleged in the complaint 

(other than jurisdictional facts) are true. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E9–4481 Filed 3–2–09: 8:45 am] 

[BILLING CODE 6750–01–S] 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health; Decision To 

Evaluate a Petition To Designate a 

Class of Employees for the Oak Ridge 

Hospital, Oak Ridge, TN, To Be 

Included in the Special Exposure 

Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice as required 

by 42 CFR 83.12(e) of a decision to 

evaluate a petition to designate a class 

of employees for the Oak Ridge 

Hospital, Oak Ridge, Tennessee, to be 

included in the Special Exposure Cohort 

under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000. The initial 

proposed definition for the class being 

evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Oak Ridge Hospital. 

Location: Oak Ridge, Tennessee. 

Job Titles and/or Job Duties: All 

employees. 

Period of Employment: June 30, 1958 

through December 31, 1959. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 513– 

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to 

OCAS@CDC.GOV. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E9–4493 Filed 3–2–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Request for Nominations of 

Candidates To Serve on the Board of 

Scientific Counselors, Coordinating 

Center for Infectious Diseases (BSC, 

CCID) 

CDC is soliciting nominations for 

possible membership on the BSC, CCID. 

This board provides advice and 

guidance to the Secretary, Department 

of Health and Human Services (HHS), 

the Director, CDC, and the Director, 

CCID, concerning strategies and goals 

for the programs and research within 

the national centers; shall conduct peerreview of scientific programs; and 

monitor the overall strategic direction 

and focus of the national centers. The 

board shall also monitor program 

organization and resources for 

infectious disease prevention and 

control. 

Nominations are being sought for 

individuals who have the expertise and 

qualifications necessary to contribute to 

the accomplishment of the board’s 

objectives. Nominees will be selected by 

the Secretary, HHS, or designee, from 

authorities knowledgeable in the fields 

relevant to the issues addressed by the 

CCID and related disciplines, including: 

Epidemiology; microbiology; 

bacteriology; virology; parasitology; 

mycology; immunology; public health; 

entomology; bioterrorism threats; 

clinical medicine; ecology; and from the 

general public. Federal employees will 

not be considered. Members may be 

invited to serve for terms of up to four 

years. 

Consideration is given to 

representation from diverse geographic 

areas, both genders, ethnic and minority 

groups, and the disabled. Nominees 

must be U.S. citizens. 

The following information must be 

submitted for each candidate: Name, 

affiliation, address, telephone number, 

e-mail address, and current curriculum 

vitae. 

Nominations should be accompanied 

with a letter of recommendation stating 

the qualifications of the nominee and 

postmarked by March 20, 2009 to: 

Harriette Lynch, Coordinating Center for 

Infectious Diseases, Office of the 

Director, CDC, 1600 Clifton Road, NE., 

Mailstop E–77, Atlanta, Georgia 30333, 

Telephone (404) 498–2726. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Dated: February 25, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–4475 Filed 3–2–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0606] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export of Food and 

Drug Administration Regulated 

Products: Export Certificates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 2, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0498. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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9248 Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Export of Food and Drug 

Administration Regulated Products: 

Export Certificates (OMB Control 

Number 0910–0498)—Extension 

In April 1996 a law entitled ‘‘The 

FDA Export Reform & Enhancement Act 

of 1996’’ (FDAERA) amended sections 

801(e) and 802 of the act (21 U.S.C. 

381(e) and 382). It was designed to ease 

restrictions on exportation of 

unapproved pharmaceuticals, biologics, 

and devices regulated by FDA. Section 

801(e)(4) of the FDAERA provides that 

persons exporting certain FDA-regulated 

products may request FDA to certify 

that the products meet the requirements 

of 801(e) or 802 or other requirements 

of the act. This section of the law 

requires FDA to issue certification 

within 20 days of receipt of the request 

and to charge firms up to $175.00 for the 

certifications. 

This new section of the act authorizes 

FDA to issue export certificates for 

regulated pharmaceuticals, biologics, 

and devices that are legally marketed in 

the United States, as well as for these 

same products that are not legally 

marketed but are acceptable to the 

importing country, as specified in 

sections 801(e) and 802 of the act. FDA 

has developed five types of certificates 

that satisfy the requirements of section 

801(e)(4)(B) of the act: (1) Certificates to 

Foreign Governments, (2) Certificates of 

Exportability, (3) Certificates of a 

Pharmaceutical Product, (4) NonClinical Research Use Only Certificates, 

and (5) Certificates of Free Sale. Table 

1 of this document lists the different 

certificates and details their use: 

TABLE 1. 

Type of Certificate Use 

‘‘Supplementary Information Certificate to Foreign Government Requests’’ 

‘‘Exporter’s Certification Statement Certificate to Foreign Government’’ 

‘‘Exporter’s Certification Statement Certificate to Foreign Government 

(For Human Tissue Intended for Transplantation)’’ 

For the export of products legally marketed in the United States 

‘‘Supplementary Information Certificate of Exportability Requests’’ 

‘‘Exporter’s Certification Statement Certificate of Exportability’’ 

For the export of products not approved for marketing in the United 

States (unapproved products) that meet the requirements of sections 

801(e) or 802 of the act 

‘‘Supplementary Information Certificate of a Pharmaceutical Product’’ 

‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical 

Product’’ 

Conforms to the format established by the World Health Organization 

and is intended for use by the importing country when the product in 

question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or 

reviewing a license 

‘‘Supplementary Information Non-Clinical Research Use Only Certificate’’ 

‘‘Exporter’s Certification Statement Non-Clinical Research Use Only’’ 

For the export of a non-clinical research use only product, material, or 

component that is not intended for human use which may be marketed in, and legally exported from the United States under the act 

Certificates of Free Sale For food, cosmetic products, and dietary supplements that may be legally marketed in the United States 

FDA will continue to rely on selfcertification by manufacturers for the 

first three types of certificates listed in 

table 1 of this document. Manufacturers 

are requested to self-certify that they are 

in compliance with all applicable 

requirements of the act, not only at the 

time that they submit their request to 

the appropriate center, but also at the 

time that they submit the certification to 

the foreign government. 

The appropriate FDA centers will 

review product information submitted 

by firms in support of their certificate 

and any suspected case of fraud will be 

referred to FDA’s Office of Criminal 

Investigations for follow-up. Making or 

submitting to FDA false statements on 

any documents may constitute 

violations of 18 U.S.C. 1001, with 

penalties including up to $250,000 in 

fines and up to 5 years imprisonment. 

In the Federal Register of December 

17, 2008 (73 FR 76655), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2.—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1

FDA Center No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Center for Biologics Evaluation and 

Research 1,501 1 1,501 1 1,501 

Center for Drug Evaluation and Research 7,046 1 7,046 1 7,046 

Center for Devices and Radiological 

Health 6,091 1 6,091 2 12,182 

Center for Veterinary Medicine 664 1 664 1 664 

mstockstill on PROD1PC66 with NOTICES

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 

mstockstill on PROD1PC66 with NOTICES