Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices 61359 

satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information referred to in the 

guidance entitled ‘‘Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees’’ have been 

approved under OMB control number 

0910–0581. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: October 24, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–21332 Filed 10–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Privacy Act of 1974: New System of 

Records 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notification of new system of 

records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act, the 

Health Resources and Services 

Administration (HRSA) is publishing a 

notice of a proposal to add a new system 

of records. The Campus Based Branch 

(CBB) of the Division of Health Careers 

Diversity and Development in the 

Bureau of Health Professions is 

currently utilizing a document 

management system (DMS) that 

dynamically manages its flow of 

documents produced and received. the 

DMS is an intra-office system in which 

documents contained within the system 

are only shared among CBB staff. The 

DMS contains names and other 

personally identifiable information of 

borrowers. 

DATES: HRSA invites interested parties 

to submit comments on the proposed 

New System of Records on or before 

December 10, 2007. HRSA has sent a 

report of a New System of Records to 

Congress and to the Office of 

Management and Budget (OMB) on 

October 18, 2007. The New System of 

Records will be effective 40 days from 

the date submitted to OMB unless 

HRSA comments which would result in 

a contrary determination. 

ADDRESSES: Please address comments to 

Donn Taylor, Health Resources and 

Services Administration, Privacy Act 

Coordinator, 5600 Fishers Lane, Room 

14A–20, Rockville, Maryland 20857; 

Telephone (301) 443–0204. Comments 

received will be available for inspection 

at this same address from 9 a.m. to 3 

p.m., Monday through Friday. this is not 

a toll-free number. 

FOR FURTHER INFORMATION CONTACT: 

Henry Lopez, Director, division of 

Health Careers diversity and 

Development, Bureau of Health 

Professions, 5600 Fisher Lane, Room 8- 

42, Rockville, Maryland 20857; 

Telephone 301–443–1173. This is not a 

toll-free number. 

SUPPLEMENTARY INFORMATION: The 

Health Resources and Services 

Administration proposes to establish a 

New System of Records: ‘‘Campus Based 

Branch Programs Document 

Management System, HHS/HRSA/ 

BHPr.’’ The CBB programs which use 

the DMS are authorized by the following 

sections of the Public Health Service 

Act: Section 721 of the Public Health 

Service Act (42 U.S.C. 292q) the Health 

Professions Student Loan Program; 

Section 724 of the Public Health Service 

Act (42 U.S.C. 292s) the Primary Care 

Loan Program; Section 724 of the Public 

Health Service Act (42 U.S.C. 292t) the 

Loans for Disadvantaged Students 

Program; Section 835 of the Public 

Health Service Act (42 U.S. C. 297a) the 

Nursing Student Loan Program; and 

Section 737 of the Public Health Service 

Act (42 U.S.C. 293a) the Scholarships 

for Disadvantaged Students Program. In 

accordance with their applicable 

regulations, the funds appropriated or 

distributed from these CBB programs are 

monitored by the CBB. The DMS is an 

automated system that enables CBB to 

fulfill its duty in monitoring these 

programs. The DMS contains annual 

operating and performance data from 

educational institutions participating in 

CBB programs, as well as personally 

identifiable information of borrowers. 

Dated: October 12, 2007. 

Elizabeth M. Duke, 

Administrator. 

Report of a New System of Records 

09–15–0069 

SYSTEM NAME: 

Campus Based Branch (CBB) Program 

Document Management System (DMS), 

HHS/HRSA/BHPr. 

SECURITY CLASSIFICATION: 

None 

SYSTEM LOCATION: 

The Division of Health Careers 

Diversity and Development (DHCDD) of 

the Bureau of Health Professions (BHPr), 

Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

Records are located at 5600 Fishers 

Lane, Room 8–42, Rockville, MD 20857. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Student and faculty borrowers who 

participate/participated in CBB loan and 

scholarship programs. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The systems include materials such 

as: 

1. Names, addresses, phone numbers, 

medical records, financial information, 

and social security numbers of 

borrowers. 

2. Annual Operating Reports that 

contain financial information from 

institutions, including aggregate 

amounts of loans disbursed, collected 

and retired. 

3. Performance reports on the 

aggregate number of borrowers, their 

classification in race/ethnicity 

categories, and whether they are 

practicing in primary care. 

4. Contact information of financial aid 

officers that include name, title, school 

address and direct phone number. 

5. Correspondence from the financial 

aid officers regarding issues with 

specific borrowers. The majority of 

these correspondence only indicate the 

borrower’s name and/or amount 

borrowed. 


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61360 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices 

6. Correspondence from borrowers on 

specific issues on CBB programs or the 

school that administers the programs. 

These correspondences may include the 

borrower’s name, address and phone 

number. 

7. Case reports from educational 

institutions on borrowers whom the 

school is claiming an uncollectible debt 

or a total disability write-off. The 

documents contained in these case 

reports may include name, address, 

financial income information, medical 

records and social security numbers. 

8. Any other correspondence or 

documentation related to general or 

specific issues regarding CBB programs 

at institutions or borrowers who 

participate in CBB programs. 

AUTHORITY FOR MAINTENANCE OF SYSTEM: 

Section 721 of the Public Health 

Service Act (42 U.S.C. 292q), Health 

Professions Student Loan; Section 835 

of the Public Health Service Act (42 

U.S.C. 297a), Nursing Student Loan; 

Section 723 of the Public Health Service 

Act (42 U.S.C. 292s), Primary Care Loan; 

Section 724 of the Public Health Service 

Act (42 U.S.C. 292t), Loans for 

Disadvantaged Students; Section 737 of 

the Public Health Service Act (42 U.S.C. 

293a), Scholarships for Disadvantaged 

Students. 

PURPOSE(S): 

The purpose of the DMS system is to 

support the CBB in monitoring its 

programs, in order to ensure the 

efficiency of the factual information in 

reports and documents, and to archive 

the documents for efficient access and 

verification. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES: 

Records maintained in the system 

above, disclosure of which is governed 

by the System of Records Notice for the 

‘‘Campus Based Branch Program 

Document Management System, HHS/ 

HRSA/BHPr’’ may be disclosed to 

others: 

1. HRSA may disclose records to 

Department contractors and 

subcontractors for the purpose of 

assisting CBB in reviewing cases and 

maintaining systems, including 

conducting data analysis for program 

evaluations, compiling managerial and 

statistical reports, and record systems 

processing and refinement. Contractors 

will maintain, and are also required to 

ensure that subcontractors maintain, 

Privacy Act safeguards with respect to 

such records. 

2. Disclosure may be made to a 

Congressional office from the record of 

an individual or institutional 

participant, in response to any inquiry 

from the Congressional office made at 

the request of that individual. 

3. Disclosure may be made to the 

Department of Justice, or to a court or 

other tribunal, from this system of 

records, when (a) HHS, or any 

component thereof; or (b) any HHS 

employee in his or her official capacity; 

or (c) any HHS employee in his or her 

individual capacity where the 

Department of Justice (or HHS, where it 

is authorized to do so) has agreed to 

represent the employee; or (d) the 

United States or any agency thereof, 

where HHS determines that the 

litigation is likely to affect HHS or any 

of its components, is a party to litigation 

or has an interest in such litigation, and 

HHS determines that the use of such 

records by the Department of Justice, the 

court or other tribunal is relevant and 

necessary to the litigation and would 

help in the effective representation of 

the governmental party, provided, 

however, that in such case HHS 

determines that such disclosure is 

compatible with the purpose for which 

the records were collected. 

4. In the event that a system of records 

maintained by this agency to carry out 

its functions indicates a violation or 

potential violation of law, whether civil, 

criminal, or regulatory in nature and 

whether arising by general statute or 

particular program statute, or by 

regulation, rule, or order issued 

pursuant thereto, the relevant records in 

the system of records may be referred to 

the appropriate agency, whether 

Federal, State or local, charged with the 

responsibility of investigating or 

prosecuting such violation or charged 

with enforcing or implementing the 

statute or rule, regulation or order 

issued pursuant thereto. 

5. HRSA may disclose from this 

system of records a delinquent debtor’s 

name, address, Social Security number, 

and other information necessary to 

identify him/her; the amount, status, 

and history of the claim, and the agency 

or program under which the claim 

arose, to the Treasury Department, 

Internal Revenue Service (IRS), to 

request a debtor’s current mailing 

address to locate him/her for purposes 

of collecting a debt. This address may be 

disclosed by HRSA to any school from 

which the defaulted borrower received 

the student loan, for use only by 

officers, employees, or agents of the 

school whose duties relate to the 

collection of health professions or 

nursing student loan funds, to locate the 

defaulted borrower to collect the loan. 

Any school which requests and obtains 

this address information must comply 

with the requirements of HRSA and the 

IRS regarding the safeguarding and 

proper handling of this information. 

STORAGE: 

Records are maintained in the DMS or 

in file folders and/or computer data 

files. 

RETRIEVABILITY: 

Retrieval of data and case files is by 

subject’s name or institution ID. 

SAFEGUARDS: 

1. Authorized users: Access is limited 

to authorized HHS staff in performance 

of their duties. Authorized personnel 

include the contractor/system manager 

and his staff who have responsibilities 

for administering the programs. HRSA 

maintains current lists of authorized 

users. Educational institutions may 

request or access information they 

submitted to CBB. However, they do not 

have access to information submitted by 

other institutions. 

2. Physical safeguards: The DMS is 

housed on a HRSA server behind a 

firewall. The DMS is an intra-office 

system only for the sole use of CBB staff. 

All computer equipment and files and 

hard copy files are stored in areas where 

fire and life safety codes are strictly 

enforced. All automated and nonautomated documents are protected on 

a 24-hour basis. Perimeter security 

includes intrusion alarms, on-site guard 

force, random guard patrol, key/ 

passcard/combination controls, and 

receptionist controlled area. Hard copy 

files are maintained in a file room used 

solely for this purpose with access 

limited by combination lock to 

authorized users identified above. 

Computer files are password protected 

and are accessible only by use of 

computers which are password 

protected. 

3. Procedural safeguards: A password 

is required to access computer files. All 

users of personal information in 

connection with the performance of 

their jobs protect information from 

public view and from unauthorized 

personnel entering an unsupervised 

area. All passwords, keys and/or 

combinations are changed when a 

person leaves or no longer has 

authorized duties. Access to records is 

limited to those authorized personnel 

trained in accordance with the Privacy 

Act and ADP security procedures. The 

safeguards described above were 

established in accordance with DHHS 

chapter 45–13 and supplementary 

chapter PHS hf: 45–13 of the General 

Administration Manual; and the DHHS 

Information Resources Management 

Manual, Part 6, ‘‘ADP Systems 

Security.’’


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices 61361 

RETENTION AND DISPOSAL: 

Records in the DMS are retained for 

at least 6 years after full payment of the 

loan, completion of service obligation, 

or repayment to the Secretary in the 

case of a default. Contact the System 

Manager at the following address for 

further information. 

SYSTEM MANAGERS(S) AND ADDRESS: 

Director, Division of Health Careers 

Diversity and Development, Bureau of 

Health Professions, Health Resources 

and Services Administration, 

Department of Health and Human 

Services, 5600 Fishers Lane, Room 8–

42, Rockville, Maryland 20857. 

NOTIFICATION PROCEDURE: 

Requests concerning whether the 

system contains records about you 

should be made to the Systems 

Manager. 

REQUESTS IN PERSON: 

A subject individual who appears in 

person at a specific location seeking 

access or disclosure of records relating 

to him/her shall provide his/her name, 

current address, Social Security number 

and at least one piece of tangible 

identification such as driver’s license, 

passport, voter registration card, or 

union card. Identification papers with 

current photographs are preferred but 

not required. Additional identification 

may be requested when there is a 

request for access to records which 

contain an apparent discrepancy 

between information contained in the 

records and that provided by the 

individual requesting access to the 

records. Where the subject individual 

has no identification papers, the 

responsible agency official shall require 

that the subject individual certify in 

writing that he/she is the individual 

who he/she claims to be and that he/she 

understands that the knowing and 

willful request or acquisition of a record 

concerning an individual under false 

pretenses is a criminal offense subject to 

a $5,000 fine. 

REQUESTS BY TELEPHONE: 

Because positive identification of the 

caller cannot be established, no requests 

by telephone will be honored. 

REQUESTS BY MAIL: 

A written request must contain the 

name and address of the requester, 

Social Security number or other 

identifying numbers, and his/her 

signature which is either notarized to 

verify his/her identify or includes a 

written certification that the reqeuster is 

a person he/she claims to be and that 

he/she understands that the knowing 

and willful request or acquisition of 

records pertaining to an individual 

under false pretenses is a criminal 

offense subject to a $5,000 fine. 

RECORD ACCESS PROCEDURES: 

Same as notification procedures. 

Requesters should also reasonably 

specify the record contents being 

sought. Individuals may also request an 

accounting of disclosures that may have 

been made of their records, if any. 

CONTESTING RECORD PROCEDURES: 

Any record subject may contest the 

accuracy of information on file at CBB 

by writing to the Director, Division of 

Health Careers Diversity and 

Development, Bureau of Health 

Professions, Health Resources and 

Services Administration, Department of 

Health and Human Services, 5600 

Fishers Lane, Room 8–42, Rockville, 

Maryland 20857. The request should 

contain a reasonable description of the 

record, specify the information being 

contested, the corrective action sought, 

and the reasons for requesting the 

correction, along with supporting 

information to show how the record is 

inaccurate, incomplete, untimely or 

irrelevant. 

RECORD SOURCE CATEGORIES: 

1. Educational institutions 

participating in CBB programs 

2. Financial aid officers administering 

CBB programs 

3. Student borrowers and recipients 

participating in CBB programs 

4. Borrowers submitted for 

uncollectible debt write-offs 

5. Borrowers submitted for total 

disability write-offs 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 07–5379 Filed 10–29–07; 8:45 am] 

BILLING CODE 4165–15–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Reimbursement of Travel and 

Subsistence Expenses Toward Living 

Organ Donation Proposed Eligibility 

Guidelines and Publication of Final 

Program Eligibility Guidelines 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Correction of Web site. 

SUMMARY: The Health Resources and 

Services Administration published a 

notice in the Federal Register of 

October 5, 2007 (FR Doc. E7–19747), on 

pages 57049–57052, regarding response 

to solicitation of comments and 

publication of final program eligibility 

guidelines. 

Correction 

In the Federal Register issue of 

October 5 (FR Doc. E7–19747), on page 

57050, second column, under section V. 

Response to Comment that Overall 

Reimbursement Level Should Exceed 

$6,000, Conclusion, correct the Web site 

to read: http:// 

www.livingdonorassistance.org. 

Dated: October 23, 2007. 

Dennis P. Williams, 

Deputy Administrator. 

[FR Doc. E7–21309 Filed 10–29–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Proposed Project: Participant Feedback 

on Training Under the Cooperative 

Agreement for Mental Health Care 

Provider Education in HIV/AIDS 

Program (OMB No. 0930–0195)—

Revision 

The Substance Abuse and Mental 

Health Services Administration’s 

(SAMHSA) Center for Mental Health 

Services (CMHS) intends to continue to 

conduct a multi-site assessment for the 

Mental Health Care Provider Education 

in HIV/AIDS Program. The education 

programs funded under this cooperative 

agreement are designed to disseminate 

knowledge of the psychological and 

neuropsychiatric sequelae of HIV/AIDS 

to both traditional (e.g., psychiatrists, 

psychologists, nurses, primary care 

physicians, medical students, and social 

workers) and non-traditional (e.g., 

clergy, and alternative health care 

workers) first-line providers of mental 

health services, in particular to 

providers in minority communities. 

The multi-site assessment is designed 

to assess the effectiveness of particular 


sroberts on PROD1PC70 with NOTICES