9822 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices 

FDA received no submissions under 

§ 660.36, however FDA is using the 

estimate of one protocol submission in 

the event one is submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2008, which totaled 

6,314, for the various submission 

requirements of samples and protocols 

for the licensed biological products. The 

rate of final actions is not expected to 

change significantly in the next few 

years. The hours per response are based 

on information provided by industry. 

The burden estimates provided by 

industry ranged from 1 to 5.5 hours. 

Under § 610.2, the hours per response 

are based on the average of these 

estimates and rounded to 3 hours. 

Under the remaining regulations, the 

hours per response are based on the 

higher end of the estimate (rounded to 

5 or 6 hours) since more information is 

generally required to be submitted in 

the other protocols than under § 610.2. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

610.2 65 95.5 6,208 3 18,624 

660.6(b) 2 44 88 5 440 

660.36(a)(2) and (b) 1 1 1 6 6 

660.46(b) 1 17 17 5 85 

Total 69 6,314 19,155 

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

Dated: February 24, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4750 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–2009–N–0083] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Gluten-Free 

Labeling of Food Products 

Experimental Study 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a voluntary consumer study entitled 

‘‘Gluten-Free Labeling of Food Products 

Experimental Study.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by May 5, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Gluten-Free Labeling of Food Products 

Experimental Study 

Under section 903(b)(2) of the Federal 

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

393(b)(2)), FDA is authorized to conduct 

research relating to foods and to 

conduct educational and public 

information programs relating to the 

safety of the nation’s food supply. FDA 

is planning to conduct an experimental 

study about gluten-free labeling of food 

products. The Gluten-Free Labeling of 

Food Products Experimental Study will 

collect information from both 

consumers who have celiac disease or 

gluten intolerance and those who do not 

have either condition. The purpose of 

the study is to gauge perceptions of 

characteristics related to claims of 

‘‘gluten-free’’ and allowed variants (e.g., 

‘‘free of gluten,’’ ‘‘without gluten,’’ ‘‘no 

gluten’’), in addition to other types of 

statements (e.g., ‘‘made in a gluten-free 

facility’’ or ‘‘not made in a facility that 

processes gluten-containing foods’’) on 

the food label. The study will also 

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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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