Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices 9903 

continue and complete updating the 

occupational and environmental 

exposure information as well as medical 

history information for respondents 

enrolled in the Agriculture Health 

Study. This represents a request to 

continue and complete phase III (2005– 

2010) of the study. The primary 

objectives of the study are to determine 

the health effects resulting from 

occupational and environmental 

exposures in the agricultural 

environment. Secondary objectives 

include evaluating biological markers 

that may be associated with agricultural 

exposures and risk of certain types of 

cancer. Questionnaire data will be 

collected by using computer assisted 

telephone interview (CATI) and inperson interview (CAPI) systems for 

telephone screeners and home visit 

interviews, respectively. Some 

respondents will also be asked to 

participate in the collection of 

biospecimens including blood, urine, 

and buccal cells (loose cells from the 

respondent’s mouth). The findings will 

provide valuable information 

concerning the potential link between 

agricultural exposures and cancer and 

other chronic diseases among 

agricultural Health Study cohort 

members, and this information may be 

generalized to the entire agricultural 

community. Frequency of Response: 

One or Three. Affected Public: Private 

Sector, Farms. Type of Respondents: 

Licensed pesticide applicators and their 

spouses. The annual reporting burden is 

as follows: 

ESTIMATES OF HOUR BURDEN

Type of respondent Instrument 

Estimated 

annual 

number of respondents 

Frequency of 

response 

Average time 

per response 

minutes/hour 

Annual burden 

hours 

Private Applicators ............................ CATI Screener ................................. 960 1 5/60 

(0.083) 

80 

Private Applicators ............................ Home Visit CAPI and Biospecimens 

× 1.

310 1 95/60 

(1.5) 

465 

Private Applicators ............................ Home Visit CAPI and Biospecimens 

× 3.

10 3 95/60 

(1.5) 

45 

Private Applicators, Spouses, Commercial Applicators.Introductory Telephone Contact and 

Buccal Cell.

150 1 5/60 

(0.083) 

13 

Total ........................................... 1430 ........................ ........................ 603 

The annualized cost to respondents is 

estimated at $16,153 each year for a 

three-year period. 

There are no capital costs, operating 

costs, and/or maintenance costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Michael Alavanja, 

Dr.P.H, Occupational and 

Environmental Epidemiology Branch, 

Division of Cancer Epidemiology and 

Genetics, National Cancer Institute, 

NIH, Executive Plaza South, Room 8000, 

6120 Executive Blvd., Rockville, MD 

20892, or call 301–496–9093, or e-mail 

your request, including your address to: 

alavanjm@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: February 26, 2010. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–4567 Filed 3–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Service; Provider 

Study 

AGENCY: Administration on Aging, HHS. 

ACTION: Notice. 

SUMMARY: The Administration on Aging 

(AoA) 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, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection requirements relating to Area 

Agency on Aging and Local Service 

Provider Study. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 3, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: 

jennifer.klocinski@aoa.hhs.gov. 

Submit written comments on the 

collection of information to 

Administration on Aging, Office of 

Evaluation, Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Klocinski at 202–357–0146. 

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 request or 

requirements that members of the public 

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9904 Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices 

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, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, AoA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following collection 

of information, AoA invites comments 

on: (1) Whether the proposed collection 

of information is necessary for the 

proper performance of AoA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

AoA’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. 

The Administration on Aging collects 

annual program data at the state level 

and has sponsored studies to collect 

information regarding the Area Agencies 

on Aging. The third component of the 

Aging Network that administers and 

implements OAA programs, the Local 

Service Providers are poorly understood 

and characterized. The purpose of this 

data collection is to better understand 

the relationship between the Area 

Agencies on Aging and the Local 

Service Providers with whom they work 

to provide OAA programs to seniors. 

This data collection focuses on two 

areas: an investigation of the feasibility 

of compiling a national inventory of 

aging services providers; and an 

investigation of how Area Agencies on 

Aging utilize their providers to achieve 

program goals. This information will be 

used by AoA to determine the capacity 

of the provider network to meet the 

needs of the expected increase in the 

percentage of persons 60 years and 

older. The proposed data collection 

tools may be found on the AoA Web site 

at http://www.aoa.gov/AoARoot/ 

Program_Results/ 

Program_Evaluation.aspx. 

AoA estimates the burden of this 

collection of information as follows: 200 

hours 

Dated: March 1, 2010. 

Kathy Greenlee, 

Assistant Secretary for Aging. 

[FR Doc. 2010–4602 Filed 3–3–10; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0205] 

James A. Holland; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying James 

A. Holland’s request for a hearing and 

is issuing an order under the Federal 

Food, Drug, and Cosmetic Act (the act) 

debarring Holland for 5 years from 

providing services in any capacity to a 

person who has an approved or pending 

drug product application. FDA bases 

this order on a finding that Holland was 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval of a drug 

product or otherwise relating to the 

regulation of a drug product under the 

act and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

In determining the appropriateness and 

length of Holland’s debarment period, 

FDA has considered the relevant factors 

listed in the act. Holland has failed to 

file with the agency information and 

analysis sufficient to create a basis for 

a hearing concerning this action. 

DATES: The order is effective March 4, 

2010. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Branch (HFA–305), Food 

and Drug Administration, 12420 

Parklawn Dr., rm. 1–23, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: G. 

Matthew Warren, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–4613. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On April 24, 2007, Holland, formerly 

the head of the oncology program at the 

Stratton Veterans Affairs Medical 

Center, pled guilty to failing to establish 

and maintain a required record under 

section 505(i) of the act (21 U.S.C. 

355(i)) in violation of sections 301(e) of 

the act (21 U.S.C. 331(e)). On March 31, 

2009, the United States District Court 

for the Northern District of New York 

sentenced Holland to 5 years of 

probation for his resulting Federal 

misdemeanor conviction under section 

303(a)(1) of the act (21 U.S.C. 333(a)(1)). 

The basis for this conviction was 

Holland’s failure to establish and 

maintain adequate and accurate case 

histories for the subjects of clinical trials 

he oversaw. 

Holland is subject to debarment based 

on a finding, under section 306(b) of the 

act, (1) that he was convicted of a 

misdemeanor under Federal law for 

conduct relating to the development or 

approval of a drug product or otherwise 

relating to the regulation of a drug 

product under the act and (2) that the 

type of conduct underlying the 

conviction undermines the process for 

the regulation of drugs. Holland’s 

conduct related to the development or 

approval of a drug product in that it 

involved clinical trials designed to 

study the effectiveness of drug products 

for possible approval by FDA. 

By letter dated June 1, 2009, FDA 

served Holland a notice proposing to 

debar him for 5 years from providing 

services in any capacity to a person 

having an approved or pending drug 

product application. By letter dated July 

1, 2009, Holland, through counsel, 

requested a hearing on the proposal. In 

his request for a hearing, Holland does 

not dispute his misdemeanor conviction 

under Federal law, as alleged by FDA. 

However, he asserts that he has 

appealed the conviction to the United 

States Court of Appeals for the Second 

Circuit. 

We reviewed Holland’s request for a 

hearing and find that Holland has not 

created a basis for a hearing because 

hearings will be granted only if there is 

a genuine and substantial issue of fact. 

Hearings will not be granted on issues 

of policy or law, on mere allegations, 

denials, or general descriptions of 

positions and contentions, or on data 

and information insufficient to justify 

the factual determination urged or the 

action requested (see 21 CFR 12.24(b)). 

The Acting Chief Scientist and 

Deputy Commissionerhas considered 

Holland’s arguments and concludes that 

they are unpersuasive and fail to raise 

a genuine and substantial issue of fact 

requiring a hearing. 

II. Arguments 

In support of his hearing request, 

Holland argues that the conviction on 

which FDA bases his proposed 

debarment is currently on appeal. 

However, under 306(b)(2)(B)(i), Holland 

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