Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 9823 

assess consumer understanding of 

‘‘gluten-free’’ claims on foods that are 

naturally free of gluten, and gauge 

consumer reaction to a product carrying 

a gluten claim concurrently with a 

statement about the amount of gluten 

the product contains. 

The data will be collected over the 

Internet from samples derived from two 

sources: (1) A membership list from a 

celiac disease special interest 

organization and (2) an online consumer 

panel. Participation in the study is 

voluntary. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Questionnaire No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Screener 6,000 1 6,000 0.0055 33 

Pretest 140 1 140 .167 23.38 

Experiment 5,000 1 5,000 .167 835 

Total 891.38 

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

Approximately 6,000 respondents 

will be screened. We estimate that it 

will take a respondent 20 seconds 

(0.0055 hours) to complete the screening 

questions, for a total of 33 hours. A 

pretest will be conducted with 140 

participants; we estimate that it will 

take a respondent 10 minutes (0.167 

hours) to complete the pretest, for a total 

of 23.38 hours. Five thousand adults 

will complete the experiment. We 

estimate that it will take a respondent 

10 minutes (0.167 hours) to complete 

the entire experiment, for a total of 835 

hours. Thus, the total estimated burden 

is 891.38 hours. FDA’s burden estimate 

is based on prior experience with 

consumer experiments that are similar 

to this proposed experiment. 

Dated: February 23, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4766 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0105] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ARRANON 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ARRANON 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.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 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 ARRANON 

(nelarabine). ARRANON is indicated for 

the treatment of patients with T-cell 

acute lymphoblastic leukemia and Tcell lymphoblastic lymphoma whose 

disease has not responded to or has 

relapsed following treatment with at 

least two chemotherapy regimens. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

ARRANON (U.S. Patent No. 5,424,295) 

from,SmithKline Beecham Corp. (DBA 

GlaxoSmithKline), and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated April 28, 2008, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of ARRANON 

represented the first permitted 

commercial marketing or use 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 

ARRANON is 4,163 days. Of this time, 

3,980 days occurred during the testing 

phase of the regulatory review period, 

while 183 days occurred during the 

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9824 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 

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: June 7, 1994. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on June 7, 1994. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: April 29, 2005. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

Arranon (NDA 21–877) was initially 

submitted on April 29, 2005. 

3. The date the application was 

approved: October 28, 2005. FDA has 

verified the applicant’s claim that NDA 

21–877 was approved on October 28, 

2005. 

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 5 years 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 5, 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 

September 2, 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. E9–4770 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, FIRCA and 

GRIP in Behavioral and Social Sciences. 

Date: March 24, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: One Washington Circle Hotel, One 

Washington Circle Conference Room, 

Washington, DC 20037. 

Contact Person: Manana Sukhareva, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3214, 

MSC 7808, Bethesda, MD 20892. 301–435– 

1116, sukharem@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, PAR–08–1 

60: Metabolic Effects Psychotropic 

Medications. 

Date: March 25–26, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Reed A. Graves, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6166, 

MSC 7892, Bethesda, MD 20892. (301) 402– 

6297, gravesr@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Millennium 

Promise Awards: Non-communicable 

Disease. 

Date: March 25, 2009. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Admiral Fell Inn, 888 South 

Broadway, Baltimore, MD 21231. 

Contact Person: Cathy Wedeen, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3213, 

MSC 7808, Bethesda, MD 20892. 301–435– 

1191, wedeenc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, ICBG 

Review. 

Date: March 25–26, 2009. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Dan D. Gerendasy, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5132, 

MSC 7843, Bethesda, MD 20892. 301–594– 

6830, gerendad@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Tools for 

Zebrafish Research. 

Date: March 27, 2009. 

Time: 8 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications, Place: The River Inn, 924 

Twenty-Fifth Street, NW. Conference, 

Washington, DC 20037. 

Contact Person: Neelakanta Ravindranath, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5140, 

MSC 7843, Bethesda, MD 20892. 301–435– 

1034, ravindrn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review, Special Emphasis Panel, Zebrafish 

Genetic Screens. 

Date: March 27, 2009. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The River Inn, 924 Twenty-Fifth 

Street, NW. Conference, Washington, DC 

20037. 

Contact Person: Neelakanta Ravindranath, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5140, 

MSC 7843, Bethesda, MD 20892. 301–435– 

1034, ravindrn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Enzyme 

Specificity Program Project. 

Date: April 1–2, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: David R. Jollie, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4150, 

MSC 7806, Bethesda, MD 20892. (301) 435– 

1722, jollieda@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Epigenomics of Human Health and Disease. 

Date: April 2–3, 2009. 

Time: 8 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Michael K. Schmidt, PhD, 

Scientific Review Officer, Center for 

mstockstill on PROD1PC66 with NOTICES