Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Notices 1623 

Transitional Grant Areas (TGAs). As a 

component of Part A (previously Title I), 

the purpose of the Minority AIDS 

Initiative (MAI) Supplement is to 

improve access to high quality HIV care 

services and health outcomes for 

individuals in disproportionately 

impacted communities of color who are 

living with HIV disease, including 

African-Americans, Latinos, Native 

Americans, Alaska Natives, Asian 

Americans, Native Hawaiians and 

Pacific Islanders (Section 2693(b)(2)(A) 

of the Public Health Service (PHS) Act). 

Since the purpose of the Part A MAI is 

to expand access to medical, health, and 

social support services for 

disproportionately impacted racial/ 

ethnic minority populations living with 

HIV/AIDS, who are not yet in care, it is 

important that HRSA is able to report on 

minorities served by the Part A MAI. 

The Part A MAI Report is a data 

collection instrument in which grantees 

report on the number and characteristics 

of clients served and services provided. 

The Part A MAI Report, first approved 

for use in March 2006, is designed to 

collect performance data from Part A 

Grantees that will not change, and it has 

two parts: (1) A Web-based data entry 

application that collects standardized 

quantitative and qualitative information, 

and (2) an accompanying narrative 

report. 

Grantees submit two Part A MAI 

Reports annually: Part A MAI Plan 

(Plan) and the Part A MAI Year-End 

Annual Report (Annual Report). The 

Plan and Annual Report components of 

the report are linked to minimize the 

reporting burden, and include dropdown menu responses, fields for 

reporting budget, expenditure and 

aggregated client level data, and openended responses for describing client or 

service-level outcomes. Together the 

Plan and Annual Report components 

collect information from grantees on 

MAI-funded services, expenditure 

patterns, the number and demographics 

of clients served, and client-level 

outcomes. 

The MAI Plan Narrative that 

accompanies the Plan Web-forms 

provides (1) an explanation of the data 

submitted in the Plan Web forms; (2) a 

summary of the Plan, including the plan 

and timeline for disbursing funds, 

monitoring service delivery, and 

implementing any service-related 

capacity development or technical 

assistance activities; and (3) the plan 

and timeline for documenting clientlevel outcome measures. In addition, if 

the EMA/TGA revised any planned 

services, allocation amounts or target 

communities after their grant 

application was submitted, the changes 

must be highlighted and explained. The 

accompanying MAI Annual Report 

Narrative describes (1) progress towards 

achieving specific goals and objectives 

identified in the Grantee’s approved 

MAI Plan for that fiscal year and in 

linking MAI services/activities to Part A 

and other Ryan White HIV/AIDS 

Program services; (2) achievements in 

relation to client-level health outcomes; 

(3) summary of challenges or barriers at 

the provider or grantee levels, the 

strategies and/or action steps 

implemented to address them, and 

lessons learned; and (4) discussion of 

MAI technical assistance needs 

identified by the EMA/TGA. 

This information is needed to monitor 

and assess: (1) Changes in the type and 

amount of HIV/AIDS health care and 

related services being provided to each 

disproportionately impacted community 

of color; (2) the aggregate number of 

persons receiving HIV/AIDS services 

within each racial and ethnic 

community; and (3) the impact of Part 

A MAI-funded services in terms of 

client-level and service-level health 

outcomes. The information also is used 

to plan new technical assistance and 

capacity development activities and 

inform the HRSA policy and program 

management functions. The data 

provided to HRSA does not contain 

individual or personally identifiable 

information. 

The annual estimated response 

burden for grantees is as follows: 

Form 

Estimated 

number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Part A MAI Report ............................................................... 56 2 112 5 hrs 560 

Note: Data collection system enhancements have resulted in a shortened response burden (from 6 to 5 total hours per response) for respondents since the previous OMB approval request. 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857. Written 

comments should be received within 60 

days of this notice. 

Dated: January 6, 2010. 

Sahira Rafiullah, 

Deputy Director, Division of Policy Review 

and Coordination. 

[FR Doc. 2010–364 Filed 1–11–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0305] 

Jason Vale; Denial of Hearing; Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying Jason 

Vale’s request for a hearing and is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (the act) 

permanently debarring Mr. Vale from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on a finding that Mr. Vale was 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

a drug product under the act. Mr. Vale 

has failed to file with the agency 

information and analyses sufficient to 

create a basis for a hearing concerning 

this action. 

DATES: The order is effective January 12, 

2010. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

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: 

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1624 Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Notices 

1There is, however, a split among the Federal 

Circuits with respect to whether a conviction for 

criminal contempt may be treated as a felony. The 

Court of Appeals for the Fifth Circuit has read the 

Supreme Court’s decisions in Frank and Cheff to 

mean that criminal contempt can never be a felony. 

(United States v. Holmes, 822 F.2d 481, 493–94 (5th 

Cir. 1987) (citing those cases for the proposition 

that criminal contempt is neither a misdemeanor 

nor a felony)). The Court of Appeals for the Ninth 

Circuit, however, has relied on the decision in 

Frank to conclude that a conviction of criminal 

contempt may be treated as a felony based on the 

defendant’s sentencing range. (United States v. 

Carpenter, 91 F.3d 1282, 1283–86 (9th Cir. 1996) 

(holding that courts should look to the appropriate 

sentencing guideline range to determine whether a 

particular offense under 18 U.S.C. 401 is a felony); 

see also In re Cohn, 525 F.Supp.2d 1316, 1321 

(S.D.Fla. 2007) (holding that criminal contempt is 

always a Class A felony under 18 U.S.C. 3559(a) 

because the maximum sentence is life in prison)). 

I. Background 

On July 21, 2003, a Federal jury found 

Mr. Vale, formerly the president of 

Christian Brother’s Inc., guilty of three 

counts of criminal contempt in violation 

of 18 U.S.C. 401(3). On June 18, 2004, 

the U.S. District Court for the Eastern 

District of New York sentenced Mr. Vale 

to 63 months in prison on each of the 

three counts, to be served concurrently. 

On January 26, 2006, on remand from 

the Court of Appeals for the Second 

Circuit, the district court reduced the 

sentence to 60 months. 

Mr. Vale is subject to permanent 

debarment based on a finding, under 

section 306(a)(2) of the act (21 U.S.C. 

335a(a)(2)), that he was convicted of a 

felony under Federal law for conduct 

relating to the regulation of a drug 

product. Mr. Vale’s convictions for 

contempt stemmed from his violation of 

consent decrees of preliminary and 

permanent injunction prohibiting him 

from distributing unapproved or 

misbranded drugs, including any drugs 

or other products, containing or 

purporting to contain, Laetrile, ‘‘Vitamin 

B–17,’’ amygdalin, or apricot seeds. The 

evidence introduced at Mr. Vale’s 

criminal contempt trial showed that, in 

violation of the two injunctions, he 

continued to promote and sell 

amygdalin-based products and apricot 

seeds under a different business name. 

Mr. Vale acquired a post office box in 

Arizona under the name ‘‘Praise 

Distributing’’ (Praise), began referring 

former and incoming customers of 

Christian Brothers to a Praise phone 

number for purchase of those products, 

and continued to sell those products to 

his customers through Praise, with the 

assistance of others employed by 

Christian Brothers. Mr. Vale’s 

convictions for criminal contempt under 

18 U.S.C. 401(3) related directly to the 

regulation of drug products under the 

act. By continuing to market amygdalinbased products and apricot seeds, Mr. 

Vale ignored two injunctions, which 

were intended to prevent him from 

violating the requirements for drug 

products in the act. 

By letter dated June 26, 2008, FDA 

served Mr. Vale a notice proposing to 

permanently debar him from providing 

services in any capacity to a person 

having an approved or pending drug 

product application. In a letter dated 

August 13, 2008, Mr. Vale requested a 

hearing on the proposal. In his request 

for a hearing, Mr. Vale acknowledges his 

convictions under Federal law, as 

alleged by FDA. However, he argues that 

his convictions for criminal contempt 

under 18 U.S.C. 401(3) are not felony 

convictions subjecting him to 

permanent debarment under section 

306(a)(2) of the act. 

We reviewed Mr. Vale’s request for a 

hearing and find that Mr. Vale 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 (see 21 

CFR 12.24(b)). 

The Acting Chief Scientist and 

Deputy Commissioner has considered 

Mr. Vale’s arguments and concludes 

that they are unpersuasive and fail to 

raise a genuine and substantial issue of 

fact requiring a hearing. 

II. Argument 

Mr. Vale raises a single legal argument 

in support of his hearing request. Citing 

Frank v. United States, 395 U.S. 147, 

149–52 (1969), he contends that his 

convictions for criminal contempt under 

18 U.S.C. 401(3) may not be 

characterized as felony convictions for 

purposes of section 306(a)(2) of the act 

because criminal contempt is not a 

felony under Federal law. An offense is 

typically a felony if the maximum term 

authorized is more than 1 year. (See 18 

U.S.C. 3559(a)(1)–(5) (categorizing 

offenses as felonies if maximum terms 

of imprisonment are greater than 1 

year); United States v. Wildes, 120 F.3d 

468, 470 (4th Cir. 1997) (relying on 18 

U.S.C. 3559 to conclude that a felony is 

any offense punishable by more than 

one year in prison)). Under 18 U.S.C. 

401, however, there is no specific term 

of imprisonment authorized; a Federal 

court has the power to punish criminal 

contempt by imprisonment ‘‘at its 

discretion.’’ 

In Frank, the U.S. Supreme Court 

addressed whether a particular offense 

under 18 U.S.C. 401 was ‘‘petty’’ or 

‘‘serious’’ for purposes of the criminal 

contemnor’s right to a jury trial under 

the Sixth Amendment. (395 U.S. at 148– 

52.) The Supreme Court acknowledged 

that criminal contempt is a sui generis 

offense (id. at n.5, citing Cheff v. 

Schnackenberg, 384 U.S. 373, 379–80 

(1966)) in that ‘‘a person may be found 

in contempt for a great many different 

types of offenses, ranging from 

disrespect for the court to acts otherwise 

criminal.’’ (Frank, 395 U.S. at 149.) But 

the Court found that ‘‘in prosecutions for 

criminal contempt where no maximum 

penalty is authorized, the severity of the 

penalty actually imposed is the best 

indication of the seriousness of the 

particular offense.’’ (Id.) The Court 

concluded that the particular offense at 

issue was ‘‘petty’’ because the contemnor 

received less than 6 months in prison. 

(Id. at 152) 

In short, the Supreme Court held in 

Frank that, when sentence has been 

imposed, the length of that sentence is 

an appropriate measure for determining 

whether a criminal contempt conviction 

is a petty offense, misdemeanor, or 

felony.1 FDA will therefore look to the 

sentence imposed on Mr. Vale upon his 

conviction to evaluate whether his 

offense under 18 U.S.C. 401(3) was a 

felony. At 5 years for each conviction, 

Mr. Vale’s sentences far exceeded 1 

year, and thus his convictions were 

clearly for felony offenses. Accordingly, 

FDA concludes that all three of his 

convictions of criminal contempt 

subject him to mandatory debarment 

under section 306(a)(2) of the act. 

III. Findings and Order 

Therefore, the Acting Chief Scientist 

and Deputy Commissioner, under 

section 306(a)(2)(B) of the act and under 

authority delegated to him, finds that 

Mr. Vale has been convicted of a felony 

under Federal law for conduct relating 

to the regulation of a drug product 

under the act. 

As a result of the foregoing findings, 

Mr. Vale is permanently debarred 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), (see DATES) (see section 

306(c)(1)(B) and (c)(2)(A)(ii) and section 

201(dd) of the act (21 U.S.C. 321(dd))). 

Any person with an approved or 

pending drug product application who 

knowingly uses the services of Mr. Vale, 

in any capacity during his period of 

debarment, will be subject to civil 

money penalties. If Mr. Vale, during his 

period of debarment, provides services 

in any capacity to a person with an 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Notices 1625 

approved or pending drug product 

application, he will be subject to civil 

money penalties. In addition, FDA will 

not accept or review any ANDAs 

submitted by or with the assistance of 

Mr. Vale during his period of 

debarment. 

Any application by Mr. Vale for 

termination of debarment under section 

306(d)(4) of the act should be identified 

with Docket No. FDA–2008–N–0305 

and sent to the Division of Dockets 

Management (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. 

Dated: January 4, 2010. 

Jesse L. Goodman, 

Acting Chief Scientist and Deputy 

Commissioner for Science and Public Health. 

[FR Doc. 2010–289 Filed 1–11–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Privacy Act of 1974; Report of 

Amended or Altered System; Medical, 

Health and Billing Records System 

AGENCY: Indian Health Service (IHS), 

HHS. 

ACTION: Amendment of One Altered 

Privacy Act System of Records 

(PASOR), 09–17–0001. 

SUMMARY: Pursuant to the provisions of 

the Privacy Act of 1974, as amended, 5 

U.S.C. 552a(e)(4), the IHS has amended 

and is publishing the proposed 

alteration of a system of records, System 

No. 09–17–0001, ‘‘Medical, Health and 

Billing Records.’’ The amended and 

altered system of records is to reflect 

revisions in the Purpose and Routine 

Uses sections, the Notification 

Procedures section and updates to 

Appendix 1 of the PASOR. 

In the Purpose section of the PASOR, 

IHS is altering number seven to allow 

the disclosure of controlled substance 

prescription data and/or protected 

health information (PHI) and personally 

identifiable information (PII) to its 

business associate contractor(s) for 

stated healthcare operations prior to 

transferring to various State Health 

Monitoring Programs and Registries; 

and to disclose data transmission of PHI 

to various health data exchange, 

regional health information and 

e-prescribing networks. 

In the Routine Uses section, routine 

use number thirteen is altered to 

include language that will allow the 

disclosure to various stated healthcare 

operations and health data exchange, 

regional health information and eprescribing networks. 

In the Notification Procedure section 

under Record Access and Contesting 

Record procedures, IHS is referencing 

its various IHS forms with its stated 

purposes to be utilized by the 

requester(s). 

DATES: Effective Dates: IHS filed an 

altered system report with the Chair of 

the House Committee on Oversight and 

Government Reform, the Chair of the 

Senate Committee on Homeland 

Security and Governmental Affairs, and 

the Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) on 

January 12, 2010. To ensure that all 

parties have adequate time in which to 

comment, the altered PASOR will 

become effective 40 days from the 

publication of the notice, or from the 

date the SOR was submitted to OMB 

and the Congress, whichever is later, 

unless IHS receives comments on all 

portions of this notice. 

ADDRESSES: The public should address 

comments to: Mr. William Tibbitts, IHS 

Privacy Act Officer, Division of 

Regulatory Affairs, Office of 

Management Services, 801 Thompson 

Avenue, TMP, Suite 450, Rockville, MD 

20852–1627; call non-toll free (301) 

443–1116; send via facsimile to (301) 

443–9879, or send your e-mail requests, 

comments, and return address to: 

William.Tibbitts@ihs.gov. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Patricia Gowan, IHS Lead Health 

Information Management (HIM) 

Consultant and Area HIM Consultants, 

Office of Health Programs, Phoenix Area 

Office, Two Renaissance Square, Suite 

606, 40 North Central Avenue, Phoenix, 

AZ 85004–4450, Telephone (602) 364– 

5172 or via the Internet at 

Patricia.Gowan@ihs.gov. 

SUPPLEMENTARY INFORMATION: As 

required by the Privacy Act of 1974, as 

amended, 5 U.S.C. 552a(e)(4), this 

document sets forth the amendment of 

the proposed alteration of a system of 

records maintained by the IHS. IHS is 

altering System No. 09–17–0001, 

‘‘Health, Medical and Billing Records,’’ 

for the stated reasons. First, a change to 

the Purpose section number seven will 

further enable IHS to disclose controlled 

substance prescription data to a 

business associate contractor(s) for 

stated healthcare operations prior to 

transferring to various State Health 

Monitoring Programs and Registries; as 

well as to enable IHS to disclose data 

transmission of PHI to various health 

data exchange and/or regional health 

information contractors. Second, a 

change to the Routine Uses section 

number thirteen will enable IHS to 

allow the disclosure of information from 

the record for the various stated 

healthcare operations and Health Data 

Exchange; Regional Health Information; 

and e-prescribing networks. 

Dated: December 29, 2009. 

Yvette Roubideaux, 

Director, Indian Health Service. 

Department of Health and Human 

Services 

Indian Health Service 

System Number: 09–17–0001 

SYSTEM NAME: 

Medical, Health, and Billing Records 

Systems, Health and Human Services/ 

Indian Health Service/Office of Clinical 

and Preventive Services (HHS/IHS/ 

OCPS). 

SECURITY CLASSIFICATION: 

None. 

SYSTEM LOCATION: 

IHS hospitals, health centers, school 

health centers, health stations, field 

clinics, Service Units, IHS Area Offices 

(Appendix 1), and Federal Archives and 

Records Centers (Appendix 2). 

Automated, electronic health and 

computerized records, including but not 

limited to clinical information and 

Patient Care Component (PCC) records, 

are stored in the Resource and Patient 

Management System (RPMS) at the 

National Programs/Office of Information 

Technology (NP/OIT), IHS, located in 

Albuquerque, New Mexico. Records 

may also be located at contractor sites. 

A current list of contractor sites is 

available by writing to the appropriate 

System Manager (Area or Service Unit 

Director/Chief Executive Officer) at the 

address shown in Appendix 1. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Individuals, including both IHS 

beneficiaries and non-beneficiaries, who 

are examined/treated on an inpatient 

and/or outpatient basis by IHS staff and/ 

or contract health care providers 

(including Tribal contractors). 

CATEGORIES OF RECORDS IN THE SYSTEM: 

Note: Records relating to claims by and 

against the HHS are maintained in the 

Privacy Act System of Records (PASOR) 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES