38456 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

check, bank draft, or postal money 

order. Your payment can be mailed to: 

Food and Drug Administration, P.O. 

Box 70963, Charlotte, NC 28272–0963. 

If checks are to be sent by a courier 

that requests a street address, the 

courier can deliver the checks to: 

Wachovia Bank, Attn: Food and Drug 

Administration Lockbox 70963, 1525 

West WT Harris Blvd., rm. NC0810, 

Charlotte, NC 28262. (Note: This 

Wachovia Bank address is for courier 

delivery only.) 

Please make sure that the FDA post 

office box number (P.O. Box 70963) is 

written on the check, bank draft, or 

postal money order. 

Wire transfer payment may also be 

used. Please reference your unique user 

fee ID number when completing your 

transfer. The originating financial 

institution usually charges a wire 

transfer fee between $15.00 and $35.00. 

Please ask your financial institution 

about the fee and include it with your 

payment to ensure that your fee is fully 

paid. The account information is as 

follows: New York Federal Reserve 

Bank, US Dept of Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33, 

Beneficiary: FDA, 5600 Fishers Lane, 

Rockville, MD 20857. 

Application fees can also be paid 

online with an electronic check (ACH). 

FDA has partnered with the U.S. 

Department of the Treasury to utilize 

Pay.gov, a Web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA Web site after the 

user fee ID number is generated. 

The tax identification number of the 

Food and Drug Administration is 53– 

0196965. 

B. Establishment and Product Fees 

FDA will issue invoices for 

establishment and product fees for FY 

2010 under the new fee schedule in 

August 2009. Payment will be due on 

October 1, 2009. FDA will issue 

invoices in November 2010 for any 

products and establishments subject to 

fees for FY 2010 that qualify for fees 

after the August 2009 billing. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18457 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Privacy Act of 1974; Report of Altered 

Systems of Records 

AGENCY: Department of Health and 

Human Services (HHS), Health 

Resources and Services Administration 

(HRSA). 

ACTION: Notice of Altered Systems of 

Records (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

the Health Resources and Services 

Administration (HRSA) is proposing to 

alter four existing systems of records 

(SORs) for the reasons indicated below: 

09–15–0002: Records of Patient’s 

Personal Valuables and Monies, HHS/ 

HRSA/BPHC 

HRSA is updating the system 

location, categories of individuals 

covered by the system, storage, 

retrievability, safeguards, retention and 

disposal, system manager, and 

notification procedure. HRSA is also 

adding a new routine use, number 3 

(breach notification language). 

09–15–0003: Contract Physicians and 

Consultants, HHS/HRSA/BPHC 

HRSA is updating the system 

location, categories of individuals 

covered by the system, categories of 

records in the system, authority for 

maintenance of the system, retention 

and disposal, and system manager. 

HRSA is also adding a new routine use, 

number 6 (breach notification language). 

09–15–0007: Patient’s Medical Record 

System Public Health Service 

Hospitals, HHS/HRSA/BPHC 

HRSA is updating the system location 

(Appendix 2—Federal Records Centers), 

categories of individuals covered by the 

system, categories of records in the 

system, authority for maintenance of the 

system, purpose of the system, physical 

safeguards, retention and disposal, 

system manager, and notification 

procedure. HRSA is deleting four 

routine uses, numbers 6 (Bureau of 

Prisons (BP) to report results of 

examination and treatment of patients 

examined and/or treated for and on 

behalf of the BP), 7 (Federal, state or 

private health benefit plans for billing 

purposes), 14 (Disclosure may be made 

to a private firm for the purpose of 

collating, analyzing, aggregating or 

otherwise refining records in this 

system. The contractor is required to 

maintain Privacy Act safeguards with 

respect to such records), and 19 (To 

organizations or individuals with 

agreements to provide photocopying or 

medical record data abstracting services. 

(a) PBS may inform the sexual and/or 

needle-sharing partner(s) of a subject 

individual who is infected with the 

human immunodeficiency virus (HIV) 

of their exposure to HIV, under the 

following circumstances: 

1. The information has been obtained 

in the course of clinical activities at PHS 

facilities carried out by PHS personnel 

or contractors; 

2. The PHS employee or contractor 

has made reasonable efforts to counsel 

and encourage the subject individual to 

provide the information to the 

individual’s sexual or needle-sharing 

partner(s); 

3. The PBS employee or contractor 

determines that the subject individual is 

unlikely to provide the information to 

the sexual or needle-sharing partner(s) 

or that the provision of such 

information cannot reasonably be 

verified; and 

4. The notification of the partner(s) is 

made, whenever possible, by the subject 

individual’s physician or by a 

professional counselor and shall follow 

standard counseling practices. (b) PHS 

may disclose information to State or 

local public health departments, to 

assist in the notification of the subject 

individual’s sexual and/or needlesharing partner(s), or in the verification 

that the subject individual has, notified 

such sexual or needle-sharing partner(s). 

HRSA is also adding one new routine 

use, number 16 (breach notification 

language). 

09–15–0028: Public Health Service 

Clinical Affiliation Trainee Records, 

HHS/HRSA/BPHC 

HRSA is updating the system 

location, authority for maintenance of 

the system, retrievability, safeguards, 

retention and disposal, and system 

manager. HRSA is also deleting one 

routine use, number 2 (to 

representatives of medical/allied health 

training program accreditation of PHS 

Training Programs), and adding a new 

routine use, number 6 (breach 

notification language). 

DATES: HRSA filed an altered system 

report with the Chair of the House 

Committee on Government Reform and 

Oversight, 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 July 

23, 2009. To ensure all parties have 

adequate time in which to comment, the 

altered systems, including the routine 

uses, will become effective 30 days from 


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the publication of the notice or 40 days 

from the date it was submitted to OMB 

and Congress, whichever is later, unless 

HRSA receives comments that require 

alterations to this notice. 

ADDRESSES: Please address comments to 

Associate Administrator, Health 

Resources and Services Administration, 

5600 Fishers Lane, Room 17–105, 

Rockville, Maryland 20857. Comments 

received will be available for inspection 

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

p.m. (Eastern Standard Time Zone), 

Monday through Friday. 

FOR FURTHER INFORMATION CONTACT: 

Renee Painter, Administrative Officer, 

National Hansen’s Disease Program, 

Bureau of Primary Health Care, 1770 

Physician’s Park Drive, Room 113, 

Baton Rouge, Louisiana 70816; 

Telephone (225) 756–3773. This is not 

a toll-free number. 

SUPPLEMENTARY INFORMATION: HRSA’s 

Bureau of Primary Health Care’s 

National Hansen’s Disease Program 

(NHDP) (formerly Gillis W. Long 

Hansen’s Disease Center) relocated from 

Carville, Louisiana, to Baton Rouge, 

Louisiana. The proposed changes to the 

systems of records maintained at the 

NHDP are to update the system location, 

categories of individuals covered by the 

systems, categories of records in the 

systems, authority for maintenance of 

the systems, routine uses, retrievability, 

storage, safeguards, retention and 

disposal, system managers, and 

notification procedures. 

Dated: July 9, 2009. 

Mary K. Wakefield, 

Administrator. 

SYSTEM NUMBER: 

09–15–0002. 

SYSTEM NAME: 

Record of Patients’ Personal Valuables 

and Monies, HHS/HRSA/BPHC. 

SECURITY CLASSIFICATION: 

None. 

SYSTEM LOCATION: 

National Hansen’s Disease Program, 

1770 Physician’s Park Drive, Baton 

Rouge, Louisiana 70816. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Individuals admitted to the National 

Hansen’s Disease Program (NHDP). 

CATEGORIES OF RECORDS IN THE SYSTEM: 

Information regarding personal 

valuables such as watches or rings, and 

monies checked in by the patients for 

safe-keeping. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

Section 321 of the Public Health 

Service Act. 

PURPOSE(S): 

The purpose of the system is to 

provide for the safekeeping of patients’ 

valuables. Records may also be used by 

the HHS Audit Agency for audit 

purposes. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES: 

1. Disclosure may be made to a 

congressional office from the record of 

an individual in response to a verified 

inquiry from the congressional office 

made at the written request of that 

individual. 

2. The Department may disclose 

information from this system of records 

to the Department of Justice, or to a 

court or other tribunal, 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 each case, HHS 

determines that such disclosure is 

compatible with the purpose for which 

the records were collected. 

3. To appropriate Federal agencies 

and Department contractors that have a 

need to know the information for the 

purpose of assisting the Department’s 

efforts to respond to a suspected or 

confirmed breach of the security or 

confidentiality of information 

maintained in this system of records, 

and the information disclosed is 

relevant and necessary for that 

assistance. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

• Storage: Valuables and monies 

(contents verified by the patient and a 

witness) are placed in an envelope by 

the patient. Name, hospital number, and 

list of contents are written on the 

envelope and on flap. It is sealed and 

receipt flap is given to the patient. The 

envelope is then placed in locked 

cabinet or safe. Actions are documented 

in the patient’s medical record. 

• Retrievability: Presentation of 

receipt flap, name, and hospital number. 

Return of valuables is documented in 

the medical record. 

• Safeguards: 

1. Authorized Users: DNHDP 

personnel responsible for the security of 

valuables and monies. 

2. Physical Safeguards: All documents 

are protected during lunch hours and 

nonworking hours in locked file 

cabinets or locked storage areas. 

3. Procedural Safeguards: 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 office. Access to records is 

strictly limited to those staff members 

trained in accordance with the DHHS 

Chapter 45–13 and Chapter PHS.hf: 45– 

13 of the General Administration 

Manual. 

RETENTION AND DISPOSAL: 

Documentation within the medical 

record is retained indefinitely until 

authority to destroy medical records is 

received. 

HOW DESTROYED: 

Incinerator or shredding. 

SYSTEM MANAGER(S) AND ADDRESS: 

Medical Records Coordinator, 

National Hansen’s Disease Program, 

1770 Physician’s Park Drive, Baton 

Rouge, Louisiana 70816. 

NOTIFICATION PROCEDURE: 

Write to the National Hansen’s 

Disease Program, Medical Records 

Coordinator, 1770 Physician’s Park 

Drive, Baton Rouge, Louisiana 70816. 

Individual must provide positive 

identification such as driver’s license, 

passport, voter registration card, union 

card, or a written certification verifying 

his or her identity. Requesters should 

also reasonably specify the record 

contents being sought. 

RECORD ACCESS PROCEDURES: 

Same as notification procedures. 

CONTESTING RECORD PROCEDURES: 

Write to the official at the address 

specified in the notification procedures 

above, and reasonably identify the 

record, specify the information to be 

contested, and state the corrective 

action sought, with supporting 

justification. 

RECORD SOURCE CATEGORIES: 

Patient and admission record. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 


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SYSTEM NUMBER: 

09–15–0003 

SYSTEM NAME: 

Contract Physicians and Consultants, 

HHS/HRSA/BPHC. 

SECURITY CLASSIFICATION: 

None. 

SYSTEM LOCATION: 

National Hansen’s Disease Program, 

1770 Physician’s Park Drive, Baton 

Rouge, Louisiana 70816. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Medical and allied health 

professionals (e.g., physicians, nurses, 

physical therapists, and dentists) who 

have contracted with the National 

Hansen’s Disease Program to provide 

services to beneficiaries. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

Duplicate of original contract and 

personal data qualifications. Original 

contracts developed by the National 

Hansen’s Disease Program. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

Section 320 of the Public Health 

Service Act, as amended (42 U.S.C. 

247e), the National Hansen’s Disease 

Program; section 321 of the Public 

Health Service Act, as amended (42 

U.S.C. 248), Control and Management of 

Hospitals; and section 326 of the Public 

Health Service Act, as amended (42 

U.S.C. 253), Medical services to Coast 

Guard, National Oceanic and 

Atmospheric Administration, and the 

Public Health Service. 

PURPOSE(S): 

To monitor contract negotiations and 

compliance, to review credentials, and 

to collect statistical data required to 

manage the program. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES: 

1. Disclosure may be made to a 

congressional office from the record of 

an individual in response to a verified 

inquiry from the congressional office 

made at the written request of that 

individual. 

2. 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, as a 

routine use, 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. 

3. Where a contract between a 

component of the Department and a 

labor organization recognized under 

E.O. 11491 provides that the agency will 

disclose personal records relevant to the 

organization’s mission, records in this 

system of records may be disclosed to 

such organization. 

4. The Department may disclose 

information from this system of records 

to the Department of Justice, or to a 

court or other tribunal, 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 each case, HHS 

determines that such disclosure is 

compatible with the purpose for which 

the records were collected. 

5. Disclosure may be made to State 

Boards of Medical Examiners and to 

equivalent State licensing boards of 

professional review actions which 

adversely affect the clinical privileges of 

health care professionals who either: 

1. Are or were employed by the 

Federal Government; 

2. Provide or have provided health 

care service under a fee-for-service 

contract with the Federal Government; 

or 

3. Provide or have provided health 

care services on behalf of the Federal 

Government as a volunteer or as a 

visiting fellow. 

Boards of Medical Examiners and 

equivalent State licensing boards are 

required by the Health Care Quality 

Improvement Act of 1986 and by the 

Medicare and Medicaid Patient and 

Program Protection Act of 1987 to report 

this information to the National 

Practitioner Data Bank. 

6. To appropriate Federal agencies 

and Department contractors that have a 

need to know the information for the 

purpose of assisting the Department’s 

efforts to respond to a suspected or 

confirmed breach of the security or 

confidentiality of information 

maintained in this system of records, 

and the information disclosed is 

relevant and necessary for that 

assistance. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

• Storage: File folders. 

• Retrievability: Name and contract 

number. 

• Safeguards: 

1. Authorized Users: HHS medical 

and financial management staff and 

contracting personnel. 

2. Physical Safeguards: All documents 

are protected during lunch hours and 

nonworking hours in locked file 

cabinets or locked storage areas. 

3. Procedural Safeguards: 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 office. Access to records is 

strictly limited to those staff members 

trained in accordance with DHHS 

Chapter 45–13 and Chapter PHS.hf: 45– 

13 of the General Administration 

Manual. 

RETENTION AND DISPOSAL: 

Duplicate contracts: Held 1–3 years 

dependent upon renewal. Destroyed per 

authority General Records Schedule 5 

and 7. 

ORIGINAL CONTRACTS: 

1. Transactions of more than 10,000: 

Destroy 6 years and 3 months after final 

payment. 

2. Transactions of 10,000 or less: 

Destroy 3 years after final payment. 

SYSTEM MANAGER(S) AND ADDRESS: 

Contracting Officer, National 

Hansen’s Disease Program, 1770 

Physician’s Park Drive, Baton Rouge, 

Louisiana 70816. 

NOTIFICATION PROCEDURE: 

To determine if a record exists, write 

to the System Manager at the address 

above. The individual must provide 

positive identification, such as driver’s 

license, passport, voter registration card, 

or written certification verifying his or 

her identity. Requesters should also 

reasonably specify the record contents 

being sought. 

RECORD ACCESS PROCEDURES: 

Same as notification procedures. 

CONTESTING RECORD PROCEDURES: 

Write to the System Manager at the 

address specified above, and reasonably 

identify the record, specify the 


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information to be contested, and state 

the corrective action sought, with 

supporting justification. 

RECORD SOURCE CATEGORIES: 

Medical, allied health professionals 

and dentists. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

SYSTEM NUMBER: 

09–15–0007 

SYSTEM NAME: 

Patients Medical Record System 

Public Health Service Hospitals, HHS/ 

HRSA/BPHC. 

SECURITY CLASSIFICATION: 

None. 

SYSTEM LOCATION: 

See Appendices 1 and 2. A list of sites 

where individually identifiable data is 

currently located is available upon 

request to the System Manager. 

Appendix 1 

A. Public Health Service Facilities: 

Director, Public Health Service Health 

Data Center, 1770 Physicians Park 

Drive, Baton Rouge, Louisiana 70816. 

B. Successor Organizations: Director, 

Johns Hopkins Medical Service, 3100 

Wyman Park Drive, Baltimore, 

Maryland 21211. Administrator, 

Lutheran Medical Center, 2609 Franklin 

Boulevard, Cleveland, Ohio 44114. 

Administrator, Martins Point Health 

Center, 331 Veranda Street, Portland, 

Maine 04103. Director, Pacific Medical 

Center, 1200 12th Avenue South, 

Seattle, Washington 98144. 

Appendix 2—Federal Records Centers 

• Area served: Buffalo, New York 

OutPatient Clinic, San Juan, and Staten 

Island. Central Plains Federal Records 

Center, 200 Space Center Drive, Lee’s 

Summit, Missouri 64064–1182. 

• Area served: Chicago and Detroit. 

Federal Records Center, 7358 S. Pulaski 

Road, Chicago, Illinois 60629–5898. 

• Area served: Cincinnati and Detroit. 

Federal Records Center, 3150 

Springboro Road, Dayton, Ohio 45439– 

1883. 

• Area served: Atlanta, Charleston, 

Jacksonville, Memphis, Miami, Mobile, 

Savannah and Tampa. Federal Records 

Center, 4712 Southpark Boulevard, 

Ellenwood, Georgia 30294. 

• Area served: 090 section of 

Houston, New Orleans, Galveston and 

Nassau Bay. Federal Records Center, 

P.O. Box 6216, Fort Worth, Texas 76115. 

• Area served: 512 section of 

Houston, New Orleans, Galveston/ 

Nassau Bay. Federal Records Center, 

17501 W. 98th Street, Suite 47–48, 

Lenexa, Kansas 66219. 

• Area served: San Diego and San 

Pedro. Federal Records Center, P.O. Box 

6719, 23123 Cajalco Road, Perris, 

California 92570–7298. 

• Area served: Philadelphia and 

Pittsburg. Federal Records Center, 14700 

Townsend Road, Philadelphia, 

Pennsylvania 19154–1096. 

• Area served: San Francisco and 

Honolulu. Federal Records Center, 1000 

Commodore Drive, San Bruno, 

California 94066–2350. 

• Area served: Honolulu and 

Portland, Oregon. Federal Records 

Center, 6125 Sand Point Way, NE., 

Seattle, Washington 98115–7999. 

• Area served: Buffalo, DC, Norfolk, 

Port Arthur, St. Louis Space Park 

Memorial, Seattle, New Orleans, Tampa, 

San Francisco, Galveston, Seattle and 

Maryland. Washington National Records 

Center, 4205 Suitland Road, Suitland, 

Maryland 20746. 

• Area served: Boston, Maine, 

Massachusetts, Kentucky and Indiana. 

Federal Records Center, 380 Trapelo 

Road, Waltham, Massachusetts 02154– 

6399. 

• Area served: Individuals with 

Hansen’s disease, examined and/or 

treated at the National Hansen’s Disease 

Program (formerly Public Health Service 

Hospital), National Hansen’s Disease 

Programs, 1770 Physician’s Park Drive, 

Baton Rouge, Louisiana 70816. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Uniformed and non-uniformed 

individuals treated as inpatients in 

Public Health Service Hospitals. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

Medical examination, diagnostic and 

treatment data; information for proof of 

eligibility; social data such as address 

and birth date; disease registers, such as 

Hansen’s disease and tumor and 

surgical procedure registers; treatment 

logs, medical summaries and 

correspondence (for example, family to 

doctor, doctor to doctor, doctor to 

clinic). 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

Section 320 of the Public Health 

Service Act, as amended (42 U.S.C. 

247e), the National Hansen’s Disease 

Program; and section 326 of the Public 

Health Service Act, as amended (42 

U.S.C. 253), Medical Services to Coast 

Guard, National Oceanic and 

Atmospheric Administration, and 

Public Health Service. 

PURPOSE(S): 

The purposes of this system are: 

1. To serve as a basis for planning 

patient care and for continuity in the 

evaluation of the patient’s condition and 

treatment to furnish documentary 

evidence of the course of the patient’s 

medical evaluation, treatment and 

change in condition during the hospital 

stay, ambulatory care or emergency 

visit, or while being followed in a 

facility-based home care program; 

2. To document communications 

between the responsible practitioner 

and any other health professional’s 

contribution to the patient’s care and 

treatment in order to assist in protecting 

the legal interests of the patient, the 

hospital or clinic, and responsible 

practitioners; 

3. To provide data for use in facility 

management, continuing education, 

Department initiatives, quality 

assurance activities and research at the 

National Hansen’s Disease Program, 

Baton Rouge, Louisiana. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES: 

Disclosure may be made to: 

1. Any community health 

organization, government agency, 

private physician and/or company 

which has requested or arranged for an 

examination, treatment or care of an 

individual. 

2. Army, Navy, Air Force to report 

results of examination or treatment of 

their uniformed service personnel. 

3. Department of Transportation to 

report results of examination/treatment 

of their uniformed services personnel 

found to be suffering from conditions 

that render them hazardous to 

themselves or to others. 

4. Department of Commerce to report 

results of examination/treatment of 

uniformed services and other personnel 

of that agency. 

5. Immigration and Customs 

Enforcements (ICE) to report results of 

examination/treatment of aliens 

examined and treated for and in behalf 

of that agency. 

6. U.S. Department of Labor, Office of 

Workers’ Compensation Programs for 

persons claiming compensation benefits 

due to personal injury while employed 

by the Government. 

7. Organizations such as Joint 

Commission on Accreditation of 

Hospitals for accreditation of hospitals 

and clinics, and American Medical 

Association for accreditation of resident 

training programs. Medical records are 

used to document quality of service by 

health care providers. 

8. Health professions students serving 

an affiliation at the institution and their 

parent education program; students 

provide patient care and use medical 

records in performance of their duties. 

9. Non-agency physicians providing 

continuing care to current and former 


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Public Health Service Beneficiaries, 

laboratories performing tests for the 

continuing care of these patients, and 

successor organizations providing 

health care in former Public Health 

Service hospitals and clinics. 

10. Veterans Administration to assist 

uniformed service personnel, retirees 

and veterans to obtain medical care or 

benefits. 

11. Disclosure may be made to a 

congressional office from the record of 

an individual in response to a verified 

inquiry from the congressional office 

made at the written request of that 

individual. 

12. A record may be disclosed for a 

research purpose, when the Department: 

(a) Has determined that the use or 

disclosure does not violate legal or 

policy limitations under which the 

record was provided, collected, or 

obtained; (b) has determined that the 

research purpose (1) cannot be 

reasonably accomplished unless the 

record is provided in individually 

identifiable form, and (2) warrants the 

risk to the privacy of the individual that 

additional exposure of the record might 

bring; (c) has required the recipient to— 

(1) establish reasonable administrative, 

technical, and physical safeguards to 

prevent unauthorized use or disclosure 

of the record, and (2) remove or destroy 

the information that identifies the 

individual at the earliest time at which 

removal or destruction can be 

accomplished consistent with the 

purpose of the research project, unless 

the recipient has presented adequate 

justification of a research or health 

nature for retaining such information, 

and (3) make no further use or 

disclosure of the record except—(A) in 

emergency circumstances affecting the 

health or safety of any individual, (B) 

for use in another research project, 

under these same conditions, and with 

written authorization of the Department, 

(C) for disclosure to a properly 

identified person for the purpose of an 

audit related to the research project, if 

information that would enable research 

subjects to be identified is removed or 

destroyed at the earliest opportunity 

consistent with the purpose of the audit, 

or (D) when required by law; (d) has 

secured a written statement attesting to 

the recipient’s understanding of, and 

willingness to abide by these provisions. 

13. Organizations deemed qualified 

by the Secretary to carry out quality 

assessment, medical audits or 

utilization review. 

14. Information regarding the 

commission of crimes or the reporting 

or occurrence of communicable 

diseases, tumors, child abuse, births, 

deaths, alcohol or drug abuse, etc. as 

may be required by health providers and 

facilities, by state law, or regulation of 

the department of health or other agency 

of the state or its subdivision in which 

the facility is located. Disclosure may be 

made to organizations as specified by 

the state law or regulation such as birth 

and deaths to vital statistics agencies 

and crimes to law enforcement agencies. 

Disclosure of the contents of records 

which pertain to patient identity, 

diagnosis, prognosis or treatment of 

alcohol or drug abuse is restricted under 

the provisions of the Confidentiality of 

Alcohol and Drug Abuse Patient 

Records Regulations 42 CFR part 2 as 

authorized by 21 U.S.C. 1175 and 42 

U.S.C. 4582, as amended by Public Law 

93–283. To the extent possible, identical 

restrictions are applied to the disclosure 

of the contents of records pertaining to 

individuals with other programs who 

are participating in employee 

counseling programs. 

15. In the event of litigation where the 

defendant is 

a. The Department, any component of 

the Department, or any employee of the 

Department in his or her official 

capacity; 

b. The United States where the 

Department determines that the claim, if 

successful, is likely to directly affect the 

operations of the Department or any of 

its components; or 

c. Any Department employee in his or 

her individual capacity where the 

Justice Department has agreed to 

represent such employee, for example in 

defending a claim against the Public 

Health Service based upon an 

individual’s mental or physical 

condition and alleged to have arisen 

because of activities of the Public Health 

Service in connection with such 

individual. Disclosure may be made to 

the Department of Justice to enable that 

Department to present an effective 

defense, provided that such disclosure 

is compatible with the purpose for 

which the records were collected. 

16. To appropriate Federal agencies 

and Department contractors that have a 

need to know the information for the 

purpose of assisting the Department’s 

efforts to respond to a suspected or 

confirmed breach of the security or 

confidentiality of information 

maintained in this system of records, 

and the information disclosed is 

relevant and necessary for that 

assistance. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

• Storage: File folders, magnetic tape, 

disk or laser optical media, punch cards, 

and microfilm. 

• Retrievability: Indexed by name, 

register number, number control 

register, disease and operation, and 

uniformed services service number 

(which is the Social Security number 

(SSN)). Those records indexed by SSN 

are retrieved in accordance with section 

7(a)(2)(B) of the Privacy Act. 

• Safeguards: 

1. Authorized Users: Health care 

practitioners, and other allied health 

personnel, medical and allied health 

students and administrative personnel 

for determination of eligibility for care 

and facility management; qualified 

research personnel with approved 

protocol; Public Health Service 

Commissioned Personnel Operations 

Division; and Public Health Service 

Claims Officer. 

2. Physical Safeguards: Magnetic 

tapes, discs, other computer equipment 

and other forms of personal data are 

stored in areas where fire and life safety 

codes are strictly enforced. All 

documents are protected during lunch 

hours and nonworking hours in locked 

file cabinets in double-locked storage 

areas. 

3. Procedural Safeguards: A password 

is required to access the terminal and a 

data set name controls the release of 

data only to authorized users. 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 office. Access 

to records is strictly limited to those 

staff members trained in accordance 

with Privacy Act safeguards. The 

contractor is required to maintain 

confidentiality safeguards with respect 

to these records. These safeguards are in 

accordance with DHHS Chapter 45–13 

and supplementary Chapter PHS.hf: 45– 

13 of the General Administration 

Manual, and Part 6 of the DHHS 

Information Resources Management 

Manual. The Memorandums of 

Agreement between the successor 

organizations and the Public Health 

Service require the successor 

organizations to comply with the 

Privacy Act. Public Health Service and 

HHS guidelines have been provided to 

each successor organization. 

RETENTION AND DISPOSAL: 

1. Former Public Health Service 

Hospitals/Clinics: Destroyed 50 years 

after date of last treatment, inactive 

medical records for active duty 

uniformed service personnel and nonuniformed service personnel. 

2. National Hansen’s Disease Program: 

Retained at facility—not transferred to a 

Federal Records Center. Destroyed, as 

appropriate, after 50 years, or when no 


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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38461 

longer needed for research purposes, as 

determined by the project leader or 

principal investigator. 

SYSTEM MANAGER(S) AND ADDRESS: 

Director, Public Health Service Health 

Data Center, National Hansen’s Disease 

Program, 1770 Physician’s Park Drive, 

Baton Rouge, Louisiana 70816. 

NOTIFICATION PROCEDURE: 

To determine the existence of a 

record, write to: Public Health Service 

Health Data Center, National Hansen’s 

Disease Program, 1770 Physician’s Park 

Drive, Baton Rouge, Louisiana 70816. 

If requesting records by mail, a 

written certification verifying identity 

must be provided. If appearing in 

person at the National Hansen’s Disease 

Program, Baton Rouge, Louisiana, 

positive identification such as a driver’s 

license, passport, or voter’s registration 

card must be provided. An individual 

who requests access to a medical/dental 

record shall designate in writing, at the 

time the request is made, a responsible 

representative who will be willing to 

review the record and inform the subject 

individual of its contents. Finally, a 

parent or guardian who requests 

notification of access to a child’s/ 

incompetent person’s record shall 

designate a family physician or other 

health professional (other than a family 

member) to whom the record, if any, 

will be sent. The parent or guardian 

must verify relationship to the child/ 

incompetent person as well as his/her 

own identity. 

RECORD ACCESS PROCEDURES: 

Same as notification procedures. 

Requesters should also reasonably 

specify the record contents being 

sought. 

CONTESTING RECORD PROCEDURES: 

Contact the official at the address 

specified in the notification procedures 

above, and reasonably identify the 

record, specify the information to be 

contested, and state the corrective 

action sought, with supporting 

justification. 

RECORD SOURCE CATEGORIES: 

Individual, health care personnel, 

other hospitals and physicians, 

employers, social agencies, maritime 

unions, shipping companies. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

SYSTEM NUMBER: 

09–15–0028 

SYSTEM NAME: 

Public Health Service Clinical 

Affiliation Trainee Records, HHS/ 

HRSA/BPHC. 

SECURITY CLASSIFICATION: 

None. 

SYSTEM LOCATION: 

National Hansen’s Disease Program, 

1770 Physicians Park Drive, Baton 

Rouge, Louisiana 70816. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

Students in Public Health Service 

training programs or serving clinical 

affiliation in National Hansen’s Disease 

Program. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

Transcripts of past education, 

application for training, training 

program staff and clinical supervisor 

evaluations and progress reports, course 

grades and evidence of completion of 

training requirements. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

Section 320 of the Public Health 

Service Act, as amended (42 U.S.C. 

247e), the National Hansen’s Disease 

Program; and section 327A of the Public 

Health Service Act, as amended (42 

U.S.C. 254), Interdepartmental Work. 

PURPOSE(S): 

To provide communication between 

educational and supervisory staff for 

evaluation of trainees. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES: 

Disclosure may be made: 

To Educational Program staff of 

affiliated college/university to provide 

reports of student trainee’s progress in 

training; 

1. To prospective employers for 

professional reference; 

2. To professional boards or 

associations to certify the student’s 

progress in or completion of training as 

required for professional license, 

registration certification, etc. 

3. To a congressional office from the 

record of an individual in response to a 

verified inquiry from the congressional 

office made at the written request of that 

individual. 

4. The Department of Health and 

Human Services (HHS) may disclose 

information from this system of records 

to the Department of Justice, or to a 

court or other tribunal, 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 each case, HHS 

determines that such disclosure is 

compatible with the purpose for which 

the records were collected. 

5. To appropriate Federal agencies 

and Department contractors that have a 

need to know the information for the 

purpose of assisting the Department’s 

efforts to respond to a suspected or 

confirmed breach of the security or 

confidentiality of information 

maintained in this system of records, 

and the information disclosed is 

relevant and necessary for that 

assistance. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

• Storage: File folders. 

• Retrievability: By year of training 

and alphabetically by last name. 

• Safeguards: 

Æ Authorized Users: Rehabilitation 

and Educational Services Coordinator, 

National Hansen’s Disease Program, 

work and staff supervisors and 

administrative personnel. 

Æ Physical Safeguards: All documents 

are protected during lunch hours and 

nonworking hours in locked file 

cabinets and locked storage areas. 

Æ Procedural Safeguards: 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 office. Access to records is 

strictly limited to those staff members 

trained in accordance with DHHS 

Chapter 45–13 and Chapter PHS.hf: 45– 

13 of the General Administration 

Manual. 

RETENTION AND DISPOSAL: 

Retained 5 years, then destroyed per 

authority of General Records Schedule 

1.29. 

SYSTEM MANAGER(S) AND ADDRESS: 

Rehabilitation and Educational 

Services Coordinator, National Hansen’s 

Disease Program, 1770 Physician’s Park 

Drive, Baton Rouge, Louisiana 70816. 


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38462 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

NOTIFICATION PROCEDURE: 

The individual should contact the 

Director, National Hansen’s Disease 

Program, 1770 Physicians Park Drive, 

Baton Rouge, Louisiana 70816, and 

provide name, date of birth and 

approximate dates of training to allow 

positive identification of the record. 

RECORD ACCESS PROCEDURES: 

Same as notification procedures. 

Requesters should also reasonably 

specify the record contents being 

sought. 

CONTESTING RECORD PROCEDURES: 

Contact the facility mentioned at the 

address specified in the notification 

procedures above, and reasonably 

identify the record, specify the 

information to be contested, and state 

corrective action sought, with 

supporting justification. 

RECORD SOURCE CATEGORIES: 

Individuals, clinical supervisors, 

instructors, training program staff and 

administrative personnel of facility and 

affiliated college/university. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. E9–18439 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0351] 

Seafood Hazard Analysis and Critical 

Control Points Alliance for Education 

and Training (U18) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

intention to receive and consider a 

single source application for the award 

of a cooperative agreement in fiscal year 

2009 (FY09) to the University of Florida 

for the support of the Seafood Hazard 

Analysis and Critical Control Points 

(HACCP) Alliance for Education and 

Training. The goal of the Seafood 

HACCP Alliance for Education and 

Training is to provide partial support, 

periodic clerical assistance, and 

personnel travel to national and 

international events and committee 

meetings. 

DATES: Important dates are as follows: 

1. The application due date is August 

24, 2009. 

2. The anticipated start date is in 

September 2009. 

3. The opening date is August 3, 2009. 

4. The expiration date is August 25, 

2009. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Center Contact: Barbara Kennedy, 

Center for Food Safety and Applied 

Nutrition (HFS–669), 5100 Paint 

Branch Pkwy., College Park, MD 

20740, 301–436–2056, e-mail: 

Barbara.Kennedy@fda.hhs.gov. 

Scientific/Programmatic Contact: 

Stanley Serfling, Center for Food 

Safety and Applied Nutrition (HFS– 

325), 5100 Paint Branch Pkwy., 

College Park, MD 20740, 301–436– 

2320, e-mail: 

stanley.serfling@fda.hhs.gov. 

Grants Management Contact: Camille 

Peake, Division of Acquisition 

Support and Grants (HFA–500), 

Food and Drug Administration , 

5630 Fishers Lane, rm. 2139, 

Rockville, MD 20857, 301–827– 

7175, FAX: 301–827–7101, e-mail: 

Camille.Peake@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at http:// 

www.cfsan.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–09–014 

Catalog of Federal Domestic Assistance 

Number: 93.103 

A. Background 

This FOA issued by the Office of Food 

Safety is soliciting a sole source grant 

application from University of Florida 

that proposes to provide funding in 

support of the Seafood HACCP Alliance 

for Education and Training. The 

Seafood HACCP Alliance remains the 

primary training and educational 

program supporting both regulatory and 

commercial governance of seafood and 

aquaculture product safety in the U.S.A. 

FDA actively participates with the 

Alliance and values their educational 

programs, which are essential and 

consistent with the prevailing federal 

mandates for HACCP education and 

training for commercial interests and 

inspectors in state and federal agencies. 

Our funds will provide partial support, 

periodic clerical assistance, and 

personnel travel to national and 

international events and committee 

meetings. These are pertinent to the 

Alliance Steering Committee objectives: 

Related supplies for communications 

and educational programs, 

telecommunication and computer 

equipment for communications and 

production of educational materials, 

and possible part-time student labor for 

temporary assignments. 

B. Research Objectives 

The Seafood HACCP Alliance remains 

the primary training and educational 

program supporting both regulatory and 

commercial governance of seafood and 

aquaculture product safety in the U.S.A. 

Leadership for the Alliance has been 

anchored in the Florida Sea Grant 

College Program based at the University 

of Florida since its beginning in 1994. 

The Alliance continues to function 

under the structure of a formal Steering 

Committee, which is built on a 

backbone of cooperative extension 

services aligned with representation 

from every pertinent federal agency, i.e., 

the U.S. Department of Agriculture, 

FDA, and the U.S. Department of 

Commerce, and the leading national 

seafood trade associations, i.e., National 

Fisheries Institute and the National 

Food Processors Association (recently 

changed to the Seafood Processors 

Association). This is a large, complex, 

and multifaceted effort that involves 

every pertinent state regulatory agency 

in the nation with protocols established 

through the Association of Food & Drug 

Officials (AFDO) and the six regional 

AFDO affiliates. The protocols include 

standards for approving training 

materials, trainers, and courses, and 

procedures for certifications and records 

for course graduates and evaluations. 

This organizational structure has 

involved every state in the nation and 

every cooperative extension program in 

the respective state universities. The 

Alliance is well recognized across the 

nation and about the world, and their 

educational services are expected. This 

network remains experienced and 

poised for continuing services. 

In addition, FDA will support the 

general management of the Seafood 

HACCP Alliance as positioned in the 

Florida Sea Grant College Program at the 

University of Florida. The activities 

associated with Alliance Steering 

Committee objectives are multifaceted 

and involve numerous individuals 

about the nation working through the 

wide variety of programs. These 

working arrangements have been in 

operation and productive for well over 

10 years. 

This cooperative agreement will 

enable the University of Florida to 

continue and strengthen the valued 

utility and proven impacts of the 

existing Seafood HACCP Alliance for 

Education and Training through 

updates, additions, and new programs 

that address the changes in seafood 


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