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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Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices 9905 

is subject to debarment if FDA finds that 

he ‘‘has been convicted of—* * * a 

misdemeanor under Federal law’’ and 

that ‘‘the type of conduct which served 

as the basis for such conviction 

undermines the process for the 

regulation of drugs.’’ FDA has made both 

findings, and Holland does not dispute 

either finding. Section 306 contains no 

requirement that a conviction be 

finalized on appeal before it subjects an 

individual to debarment. In fact, under 

306(l)(1)(A), ‘‘a person is considered to 

have been convicted of a criminal 

offense—* * * when a judgment of 

conviction has been entered against the 

person * * * regardless of whether 

there is an appeal pending.’’ Moreover, 

under 306(d)(3), Holland may apply to 

FDA to have the debarment order 

withdrawn if his conviction is reversed. 

It is therefore clear from section 306 that 

a pending appeal for a conviction does 

not preclude FDA’s reliance on that 

conviction for debarment. 

III. Findings and Order 

Therefore, the Acting Chief Scientist 

and Deputy Commissioner, under 

section 306(b)(2)(B)(i)(I) of the act and 

under authority delegated to him, finds 

(1) that Holland has been 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 which served as the 

basis for that conviction undermines the 

process for the regulation of drugs. FDA 

has considered the relevant factors 

listed in section 306(c)(3) of the act and 

determined that a debarment of 5 years 

is appropriate. 

As a result of the foregoing findings, 

Holland is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under section 

505, 512, or 802 of the act (21 U.S.C. 

355, 360b, or 382), or under section 351 

of the Public Health Service Act (42 

U.S.C. 262), effective (see DATES) (see 21 

U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) 

and 21 U.S.C. 321(dd)). Any person 

with an approved or pending drug 

product application who knowingly 

uses the services of Holland, in any 

capacity during his period of 

debarment, will be subject to civil 

money penalties. If Holland, during his 

period of debarment, provides services 

in any capacity to a person with an 

approved or pending drug product 

application, he will be subject to civil 

money penalties. In addition, FDA will 

not accept or review any abbreviated 

new drug applications submitted by or 

with the assistance of Holland during 

his period of debarment. 

Any application by Holland for 

termination of debarment under section 

306(d) of the act should be identified 

with Docket No. FDA–2009–N–0205 

and sent to the Dockets Management 

Branch (see ADDRESSES). All such 

submissions are to be filed in four 

copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). Publicly 

available submissions may be seen in 

the Dockets Management Branch 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Publicly available submissions may 

be seen in the Dockets Management 

Branch between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: January 22, 2010. 

Jesse L. Goodman, 

Acting Chief Scientist and Deputy 

Commissioner for Science and Public Health. 

[FR Doc. 2010–4449 Filed 3–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0223] (formerly 

2006D–0383) 

Guidance for Industry: 

Characterization and Qualification of 

Cell Substrates and Other Biological 

Materials Used in the Production of 

Viral Vaccines for Infectious Disease 

Indications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Characterization 

and Qualification of Cell Substrates and 

Other Biological Materials Used in the 

Production of Viral Vaccines for 

Infectious Disease Indications,’’ dated 

February 2010. The guidance document 

provides recommendations to 

manufacturers of viral vaccines for the 

characterization and qualification of cell 

substrates, viral seeds, and other 

biological materials used for the 

production of viral vaccines for human 

use. The guidance announced in this 

notice finalizes the draft guidance 

entitled ‘‘Guidance for Industry: 

Characterization and Qualification of 

Cell Substrates and Other Biological 

Starting Materials Used in the 

Production of Viral Vaccines for the 

Prevention and Treatment of Infectious 

Diseases,’’ dated September 2006, and 

replaces the information specific to viral 

vaccines for the prevention and 

treatment of infectious diseases that the 

agency provided in the 1993 document 

entitled ‘‘Points to Consider in the 

Characterization of Cell Lines Used to 

Produce Biologicals.’’ 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance 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. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic or written 

comments on the guidance. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Paul 

E. Levine, 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 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Characterization and 

Qualification of Cell Substrates and 

Other Biological Materials Used in the 

Production of Viral Vaccines for 

Infectious Disease Indications,’’ dated 

February 2010. The guidance document 

provides manufacturers of viral vaccines 

with recommendations for the 

characterization and qualification of cell 

substrates, viral seeds, and other 

biological materials used for the 

production of viral vaccines for human 

use. The recommendations in the 

guidance may be used to support a 

Biologics License Application or an 

application for an Investigational New 

Drug. 

In the Federal Register of September 

29, 2006 (71 FR 57547), FDA announced 

the availability of the draft guidance 

entitled ‘‘Guidance for Industry: 

Characterization and Qualification of 

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