4238 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Privacy Act of 1974; Annual

Publication of Systems of Records

AGENCY: Public Health Service, DHHS.

ACTION: Privacy Act: Annual

republication of notices of revised

systems of records.

SUMMARY: The National Institutes of

Health (NIH) has conducted a

comprehensive review of all Privacy Act

systems of records and is publishing the

resulting revisions. None of the

revisions meet the OMB criteria for a

new or altered system of records

requiring an advance period for public

comment. These changes are in

compliance with Circular A–130,

Appendix 1. The notices republished

below are complete and accurate as of

January 5, 1995.

SUPPLEMENTARY INFORMATION:

The following information

summarizes the current status of

systems of records which had minor

modifications during 1994 and lists all

systems maintained by NIH:

A. System name. The following

systems have been updated to reflect a

change in the name of the system:

09–25–0093, Administration: Administration

Authors, Reviewers and Members of the

Journal of the National Cancer Institute,

HHS/NIH/NCI.

09–25–0105, Administration: Health Records

of Employees, Visiting Scientists, Fellows,

Contractors and Others who Receive

Medical Care Through the Employee

Health Unit, HHS/NIH/ORS.

09–25–0165, National Institutes of Health

Loan Repayment Program, HHS/NIH/OD.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0170, Diabetes Control and

Complications Trial (DCCT) Data System,

HHS/NIH/NIDDK.

09–25–0203, National Institute on Drug

Abuse, Addiction Research Center, Federal

Prisoner and Non-Prisoner Research Files,

HHS/NIH/NIDA.

09–25–0207, Subject—Participants in

Pharmacokinetic Studies on Drugs of

Abuse and on Treatment Medications,

HHS/NIH/NIDA.

09–25–0209, Subject—Participants in Drug

Abuse Research Studies on Drug

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA.

B. System location. The following

systems have been updated to reflect a

change in the system locations or

location address. These changes do not

affect the access by the individual to the

individual’s records.

09–25–0011, Clinical Research: Blood Donor

Records, HHS/NIH/CC.

09–25–0012, Clinical Research: Candidate

Normal Volunteer Records, HHS/NIH/CC.

09–25–0014, Clinical Research: Student

Records, HHS/NIH/CC.

09–25–0042, Clinical Research: National

Institute of Dental Research Patient

Records, HHS/NIH/NIDR.

09–25–0044, Clinical Research: Sensory

Testing Research Program, HHS/NIH/

NIDR.

09–25–0054, Administration: Property

Accounting, HHS/NIH/ORS.

09–25–0099, Clinical Research: Patient

Medical Records, HHS/NIH/CC.

09–25–0102, Administration: Grants

Associates Program Working Files, HHS/

NIH/OER.

09–25–0112, Grants and Cooperative

Agreements: Research, Research Training,

Fellowship and Construction Applications

and Related Awards, HHS/NIH/OD.

09–25–0118, Contracts: Professional Services

Contractors, HHS/NIH/NCI.

09–25–0154, Biomedical Research Records of

Subjects: (1) Cancer Studies of the Division

of Cancer Prevention and Control, HHS/

NIH/NCI; and (2) Women’s Health

Initiative (WHI) Studies, HHS/NIH/OD.

09–25–0165, National Institutes of Health

Loan Repayment Program, HHS/NIH/OD.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0168, Invention, Patent and Licensing

Documents Submitted to the Public Health

Service by its Employees, Grantees,

Fellowship Recipients and Contractors,

HHS/PHS/NIH/OTT.

09–25–0170, Diabetes Control and

Complications Trial (DCCT) Data System,

HHS/NIH/NIDDK.

09–25–0202, Patient Records on PHS

Beneficiaries (1935–1974) and Civilly

Committed Drug Abusers (1967–1976)

Treated at the PHS Hospitals in Fort

Worth, Texas, or Lexington, Kentucky,

HHS/NIH/NIDA.

09–25–0203, National Institute on Drug

Abuse, Addiction Research Center, Federal

Prisoner and Non-Prisoner Research Files,

HHS/NIH/NIDA.

09–25–0209, Subject—Participants in Drug

Abuse Research Studies on Drug

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA.

C. Categories of individuals covered

by the system. The following systems

have been updated to reflect a change in

the categories covered by the system.

This change does not alter the character

or purpose of the system.

09–25–0105, Administration: Health Records

of Employees, Visiting Scientists, Fellows,

Contractors and Others who Receive

Medical Care Through the Employee

Health Unit, HHS/NIH/ORS.

09–25–0154, Biomedical Research Records of

Subjects: (1) Cancer Studies of the Division

of Cancer Prevention and Control, HHS/

NIH/NCI; and (2) Women’s Health

Initiative (WHI) Studies, HHS/NIH/OD.

09–25–0165, National Institutes of Health

Loan Repayment Program, HHS/NIH/OD.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0170, Diabetes Control and

Complications Trial (DCCT) Data System,

HHS/NIH/NIDDK.

09–25–0207, Subject-Participants in

Pharmacokinetic Studies on Drugs of

Abuse and on Treatment Medications,

HHS/NIH/NIDA.

D. Categories of records. The

following systems have been updated to

reflect a change in the categories of

records in the system. This change does

not alter the character or purpose of the

system.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0170, Diabetes Control and

Complications Trial (DCCT) Data System,

HHS/NIH/NIDDK.

E. Authority. The following system

has been updated to reflect a change in

the authority. This change does not alter

the character or purpose of the system.

09–25–0165, National Institutes of Health

Loan Repayment Program, HHS/NIH/OD.

F. Storage. The following systems

have been updated to reflect a change in

system storage practices:

09–25–0026, Clinical Research: Nervous

System Studies, HHS/NIH/NINDS.

09–25–0028, Clinical Research: Patient

Medical Histories, HHS/NIH/NINDS and

HHS/NIH/NIDCD.

09–25–0077, Biological Carcinogenesis

Branch Human Specimen Program, HHS/

NIH/NCI.

09–25–0140, International Activities:

International Scientific Researchers in

Intramural Laboratories at the National

Institutes of Health, HHS/NIH/FIC.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0209, Subject-Participants in Drug

Abuse Research Studies on Drug

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA.

G. Retrieval. The following systems

have been updated to reflect a change in

retrieval practices.

09–25–0140, International Activities:

International Scientific Researchers in

Intramural Laboratories at the National

Institutes of Health, HHS/NIH/FIC.

09–25–0142, Clinical Research: Records of

Subjects in Intramural Research,

Epidemiology, Demography and Biometry

Studies on Aging, HHS/NIH/NIA.

09–25–0203, National Institute on Drug

Abuse, Addiction Research Center, Federal

Prisoner and Non-Prisoner Research Files,

HHS/NIH/NIDA.

09–25–0209, Subject-Participants in Drug

Abuse Research Studies on Drug

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4239

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA.

H. Safeguards. The following systems

have been updated to reflect a change in

safeguard practices.

09–25–0028, Clinical Research: Patient

Medical Histories, HHS/NIH/NINDS and

HHS/NIH/NIDCD.

09–25–0093, Administration: Administration

Authors, Reviewers and Members of the

Journal of the National Cancer Institute,

HHS/NIH/NCI.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0207, Subject-Participants in

Pharmacokinetic Studies on Drugs of

Abuse and on Treatment Medications,

HHS/NIH/NIDA.

09–25–0209, Subject-Participants in Drug

Abuse Research Studies on Drug

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA.

I. Retention and disposal. The

following systems have been updated to

reflect a change in retention and

disposal:

09–25–0152, Biomedical Research: Records

of Subjects in National Institute of Dental

Research Contracted Epidemiological and

Biometric Studies, HHS/NIH/NIDR.

09–25–0207, Subject-Participants in

Pharmacokinetic Studies on Drugs of

Abuse and on Treatment Medications,

HHS/NIH/NIDA.

09–25–0209, Subject-Participants in Drug

Abuse Research Studies on Drug

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA.

09–25–0212, Clinical Research: Neuroscience

Research Center Patient Medical Records,

HHS/NIH/NIMH.

J. System manager(s) and address(es).

The following systems have been

updated to reflect a change in the

system manager or the address of the

system manager. These changes do not

affect the access by the individual to the

individual’s records.

09–25–0001, Clinical Research: Patient

Records, HHS/NIH/NHLBI.

09–25–0005, Administration: Library

Operations and User I.D. File, HHS/NIH/

OD.

09–25–0011, Clinical Research: Blood Donor

Records, HHS/NIH/CC.

09–25–0012, Clinical Research: Candidate

Normal Volunteer Records, HHS/NIH/CC.

09–25–0014, Clinical Research: Student

Records, HHS/NIH/CC.

09–25–0026, Clinical Research: Nervous

System Studies, HHS/NIH/NINDs.

09–25–0028, Clinical Research: Patient

Medical Histories, HHS/NIH/NINDS and

HHS/NIH/NIDCD.

09–25–0042, Clinical Research: National

Institute of Dental Research Patient

Records, HHS/NIH/NIDR.

09–25–0044, Clinical Research: Sensory

Testing Research Program, HHS/NIH/

NIDR.

09–25–0054, Administration: Property

Accounting, HHS/NIH/ORS.

09–25–0078, Administration: Consultant

File, HHS/NIH/NHLBI.

09–25–0093, Administration: Administration

Authors, Reviewers and Members of the

Journal of the National Cancer Institute,

HHS/NIH/NCI.

09–25–0099, Clinical Research: Patient

Medical Records, HHS/NIH/CC.

09–25–0102, Administration: Grants

Associates Program Working Files, HHS/

NIH/OER.

09–25–0106, Administration: Office of the

NIH Director and Institute/Center/Division

Correspondence Records, HHS/NIH/OD.

09–25–0112, Grants and Cooperative

Agreements: Research, Research Training,

Fellowship and Construction Applications

and Related Awards, HHS/NIH/OD.

09–25–0118, Contracts: Professional Services

Contractors, HHS/NIH/NCI.

09–25–0126, Clinical Research: National

Heart, Lung, and Blood Institute

Epidemiological and Biometric Studies,

HHS/NIH/NHLBI.

09–25–0128, Clinical Research: Neural

Prosthesis and Biomedical Engineering

Studies, HHS/NIH/NINDS.

09–25–0129, Clinical Research: Clinical

Research Studies Dealing with Hearing,

Speech, Language and Chemosensory

Disorders, HHS/NIH/NIDCD.

09–25–0140, International Activities:

International Scientific Researchers in

Intramural Laboratories at the National

Institutes of Health, HHS/NIH/FIC.

09–25–0148, Contracted and ContractRelated Research: Records of Subjects in

Clinical, Epidemiological and Biomedical

Studies of the National Institute of

Neurological Disorders and Stroke and the

National Institute on Deafness and Other

Communication Disorders, HHS/NIH/

NINDS and HHS/NIH/NIDCD.

09–25–0152, Biomedical Research: Records

of Subjects in National Institute of Dental

Research Contracted Epidemiological and

Biometric Studies, HHS/NIH/NIDR.

09–25–0153, Biomedical Research: Records

of Subjects in Biomedical and Behavioral

Studies of Child Health and Human

Development, HHS/NIH/NICHD.

09–25–0154, Biomedical Research Records of

Subjects: (1) Cancer Studies of the Division

of Cancer Prevention and Control, HHS/

NIH/NCI; and (2) Women’s Health

Initiative (WHI), Studies, HHS/NIH/OD.

09–25–0156, Records of Participants in

Programs and Respondents in Surveys

Used to Evaluate Programs of the Public

Health Service, HHS/PHS/NIH/OD.

09–25–0161, Administration: NIH Consultant

File, HHS/NIH/DRG.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0168, Invention, Patent and Licensing

Documents Submitted to the Public Health

Service by its Employees, Grantees,

Fellowship Recipients and Contractors,

HHS/PHS/NIH/OTT.

09–25–0170, Diabetes Control and

Complications Trial (DCCT) Data System,

HHS/NIH/NIDDK.

09–25–0202, Patient Records on PHS

Beneficiaries (1935–1974) and Civilly

Committed Drug Abusers (1967–1976)

Treated at the PHS Hospitals in Fort

Worth, Texas, or Lexington, Kentucky,

HHS/NIH/NIDA.

09–25–0203, National Institute on Drug

Abuse, Addiction Research Center, Federal

Prisoner and Non-Prisoner Research Files,

HHS/NIH/NIDA.

09–25–0205, Alcohol, Drug Abuse, and

Mental Health Epidemiologic and

Biometric Research Data, HHS/NIH/

NIAAA, HHS/NIH/NIDA and HHS/NIH/

NIMH.

09–25–0208, Drug Abuse Treatment Outcome

Study (DATOS), HHS/NIH/NIDA.

K. Record access. The following

systems have been updated to reflect a

change in the record access procedures.

09–25–0012, Clinical Research: Candidate

Normal Volunteer Records, HHS/NIH/CC.

09–25–0156, Records of Participants in

Programs and Respondents in Surveys

Used to Evaluate Programs of the Public

Health Service, HHS/PHS/NIH/OD.

L. Notification procedures. The

following systems have been updated to

reflect a change in the office, official,

and/or address to write to in order to

determine whether or not the system

contains a record about the individual.

09–25–0042, Clinical Research: National

Institute of Dental Research Patient

Records, HHS/NIH/NIDR.

09–25–0044, Clinical Research: Sensory

Testing Research Program, HHS/NIH/

NIDR.

09–25–0078, Administration: Consultant

File, HHS/NIH/NHLBI.

09–25–0112, Grants and Cooperative

Agreements: Research, Research Training,

Fellowship and Construction Applications

and Related Awards, HHS/NIH/OD.

09–25–0152, Biomedical Research: Records

of Subjects in National Institute of Dental

Research Contracted Epidemiological and

Biometric Studies, HHS/NIH/NIDR.

09–25–0153, Biomedical Research: Records

of Subjects in Biomedical and Behavioral

Studies of Child Health and Human

Development, HHS/NIH/NICHD.

09–25–0156, Records of Participants in

Programs and Respondents in Surveys

Used To Evaluate Programs of the Public

Health Service, HHS/PHS/NIH/OD.

M. The following systems have been

changed for clarity and editing

purposes.

09–25–0036, Extramural Awards and

Chartered Advisory Committees: IMPAC

(Grant/Contract/Cooperative Agreement/

Chartered Advisory Committee, HHS/NIH/

DRG and HHS/NIH/CMO.

09–25–0093, Administration: Administration

Authors, Reviewers and Members of the

Journal of the National Cancer Institute,

HHS/NIH/NCI.

09–25–0154, Biomedical Research Records of

Subjects: (1) Cancer Studies of the Division

of Cancer Prevention and Control, HHS/

NIH/NCI; and (2) Women’s Health

Initiative (WHI) Studies, HHS/NIH/OD.

4240 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

09–25–0165, National Institutes of Health

Loan Repayment Program, HHS/NIH/OD.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS.

09–25–0168, Invention, Patent and Licensing

Documents Submitted to the Public Health

Service by its Employees, Grantees,

Fellowship Recipients and Contractors,

HHS/PHS/NIH/OTT.

09–25–0170, Diabetes Control and

Complications Trial (DCCT) Data System,

HHS/NIH/NIDDK.

09–25–0207, Subject-Participants in

Pharmacokinetic Studies on Drugs of

Abuse and on Treatment Medications,

HHS/NIH/NIDA.

09–25–0209, Subject-Participants in Drug

Abuse Research Studies on Drug

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA.

09–25–0212, Clinical Research: Neuroscience

Research Center Patient Medical Records,

HHS/NIH/NIMH.

N. Organization name change. There

are no changes in this category.

O. Deleted systems of records. The

following systems of records which

appeared in the December 29, annual

publication are now being deleted

because:

09–25–0100, Clinical Research:

Neuropharmacology Studies, HHS/NIH/

NINDS. The records have been destroyed.

09–25–0151, Administration: Public Health

Service ALERT Records Concerning

Individuals Under Investigation for

Possible Misconduct In Science or Subject

to Sanctions for Such Misconduct, HHS/

PHS/OSR. The system has been officially

transferred to the Office of the Assistant

Secretary for Health (OASH), Office of

Research Integrity (ORI).

The following is a list of active

systems of records maintained by NIH.

Table of Contents.

09–25–0001, Clinical Research: Patient

Records, HHS/NIH/NHLBI, published

Federal Register, Vol. 56, Number 247,

December 24, 1991.

09–25–0005, Administration: Library

Operations and User I.D. File, HHS/NIH/

OD, published Federal Register, Vol. 58,

No. 248, December 29, 1993.

09–25–0007, Administration: NIH Safety

Glasses Issuance Program, HHS/NIH/ORS,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0010, Research Resources: Registry of

Individuals Potentially Exposed to

Microbial Agents, HHS/NIH/NCI,

published Federal Register, Vol. 56, No.

247, December 24, 1991.

09–25–0011, Clinical Research: Blood Donor

Records, HHS/NIH/CC, published Federal

Register, Vol. 56, Number 247, December

24, 1991.

09–25–0012, Clinical Research: Candidate

Normal Volunteer Records, HHS/NIH/CC,

published, Federal Register, Vol. 56, No.

247, December 24, 1991.

09–25–0014, Clinical Research: Student

Records, HHS/NIH/CC, published Federal

Register, Vol. 56, No. 8, January 11, 1991.

09–25–0015, Clinical Research: Collaborative

Clinical Epilepsy Research, HHS/NIH/

NINDS, published Federal Register, Vol.

56, No. 8, January 11, 1991.

09–25–0016, Clinical Research: Collaborative

Perinatal Project HHS/NIH/NINDS,

published Federal Register, Vol. 56, No.

247, December 24, 1991.

09–25–0026, Clinical Research: Nervous

System Studies, HHS/NIH/NINDS,

published Federal Register, Vol. 56, No.

247, December 24, 1991.

09–25–0028, Clinical Research: Patient

Medical Histories, HHS/NIH/NINDS and

HHS/NIH/NIDCD, published Federal

Register, Vol. 58, No. 8, January 13, 1993.

09–25–0031, Clinical Research: Serological

and Virus Data in Studies Related to the

Central Nervous System, HHS/NIH/NINDS,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0033, International Activities:

Fellowships Awarded by Foreign

Organizations, HHS/NIH/FIC, published

Federal Register, Vol. 56, No. 247,

December 24, 1991.

09–25–0034, International Activities:

Scholars-in-Residence Program, HHS/NIH/

FIC, published Federal Register, Vol. 56,

No. 8, January 11, 1991.

09–25–0035 International Activities: Health

Scientist Exchange Programs, HHS/NIH/

FIC, published Federal Register, Vol. 56,

No. 247, December 24, 1991.

09–25–0036, Extramural Awards and

Chartered Advisory Committees: IMPAC

(Grant/Contract/Cooperative Agreement/

Chartered Advisory Committee, HHS/NIH/

DRG and HHS/NIH/CMO, published

Federal Register, Vol. 58, No. 248,

December 29, 1993.

09–25–0037, Clinical Research: The

Baltimore Longitudinal Study of Aging,

HHS/NIH/NIA, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0038, Clinical Research: Patient Data,

HHS/NIH/NIDDK, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0039, Clinical Research: Diabetes

Mellitus Research Study of Southwestern

American Indians, HHS/NIH/NIDDK,

published Federal Register, Vol. 56, No.

247, December 24, 1991.

09–25–0040, Clinical Research: Southwestern

American Indian Patient Data, HHS/NIH/

NIDDK, published Federal Register, Vol.

56, No. 247, December 24, 1991.

09–25–0041, Research Resources: Scientists

Requesting Hormone Distribution, HHS/

NIH/NIDDK, published Federal Register,

Vol. 56, No. 8, January 11, 1991.

09–25–0042, Clinical Research: National

Institute of Dental Research Patient

Records, HHS/NIH/NIDR, published

Federal Register, Vol. 58, No. 248,

December 29, 1993.

09–25–0044, Clinical Research: Sensory

Testing Research Program, HHS/NIH/

NIDR, published Federal Register, Vol. 56,

No. 247, December 24, 1991.

09–25–0046, Clinical Research: Catalog of

Clinical Specimens from Patients,

Volunteers and Laboratory Personnel,

HHS/NIH/NIAID, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0053, Clinical Research: Vision

Studies, HHS/NIH/NEI, published Federal

Register, Vol. 56, No. 247, December 24,

1991.

09–25–0054, Administration: Property

Accounting, HHS/NIH/ORS, published

Federal Register, Vol. 56, No. 247,

December 24, 1991.

09–25–0057, Clinical Research: Burkitts’s

Lymphoma Registry, HHS/NIH/NCI,

published Federal Register, Vol. 56, No. 8,

January 11, 1991.

09–25–0060, Clinical Research: Division of

Cancer Treatment Clinical Investigations,

HHS/NIH/NCI, published Federal Register,

Vol. 58, No. 248, December 29, 1993.

09–25–0067, Clinical Research: National

Cancer Incidence Surveys, HHS/NIH/NCI,

published Federal Register, Vol. 56, No. 8,

January 11, 1991.

09–25–0069, NIH Clinical Center Admissions

of the National Cancer Institute, HHS/NIH/

NCI, published Federal Register, Vol. 58,

No. 248, December 29, 1993.

09–25–0074, Clinical Research: Division of

Cancer Biology and Diagnosis Patient

Trials, HHS/NIH/NCI, published Federal

Register, Vol. 56, No. 8, January 11, 1991.

09–25–0077, Biological Carcinogenesis

Branch Human Specimen Program, HHS/

NIH/NCI, published Federal Register, Vol.

56, No. 247, December 24, 1991.

09–25–0078, Administration: Consultant

File, HHS/NIH/NHLBI, published Federal

Register, Vol. 56, No. 8, January 11, 1991.

09–25–0087, Administration: Senior Staff,

HHS/NIH/NIAID, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0091, Administration: General Files

on Employees, Donors and

Correspondents, HHS/NIH/NEI, published

Federal Register, Vol. 56, No. 247,

December 24, 1991.

09–25–0093, Administration: Administration

Authors, Reviewers and Members of the

Journal of the National Cancer Institute,

HHS/NIH/NCI, published Federal Register,

Vol. 56, No. 8, January 11, 1991.

09–25–0099, Clinical Research: Patient

Medical Records, HHS/NIH/CC, published

Federal Register, Vol. 56, No. 247,

December 24, 1991.

09–25–0102, Administration: Grants

Associates Program Working Files, HHS/

NIH/OER, published Federal Register, Vol.

56, No. 8, January 11, 1991.

09–25–0105, Administration: Health Records

of Employees, Visiting Scientists, Fellows,

Contractors and Relatives of Inpatients,

HHS/NIH/ORS, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0106, Administration: Office of the

NIH Director and Institute/Center/Division

Correspondence Records, HHS/NIH/OD,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0108, Personnel: Guest Researchers,

Special Volunteers, and Scientists Emeriti,

HHS/NIH/OHRM, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4241

09–25–0112, Grants and Cooperative

Agreements: Research, Research Training,

Fellowship and Construction Applications

and Related Awards, HHS/NIH/OD,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0115, Administration: Curricula Vitae

of Consultants and Clinical Investigators,

HHS/NIH/NIAID, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0118, Contracts: Professional Services

Contractors, HHS/NIH/NCI, published

Federal Register, Vol. 58, No. 248,

December 29, 1993.

09–25–0121, International Activities: Senior

International Fellowships Program, HHS/

NIH/FIC, published Federal Register, Vol.

56, No. 247, December 24, 1991.

09–25–0124, Administration: Pharmacology

Research Associates, HHS/NIH/NIGMS,

published Federal Register, Vol. 58, No. 8,

January 13, 1993.

09–25–0126, Clinical Research: National

Heart, Lung, and Blood Institute

Epidemiological and Biometric Studies,

HHS/NIH/NHLBI, published Federal

Register, Vol. 58, No. 8, January 13, 1993.

09–25–0128, Clinical Research: Neural

Prosthesis and Biomedical Engineering

Studies, HHS/NIH/NINDS, published

Federal Register, Vol. 58, No. 248,

December 29, 1993.

09–25–0129, Clinical Research: Clinical

Research Studies Dealing with Hearing,

Speech, Language and Chemosensory

Disorders, HHS/NIH/NIDCD, published

Federal Register, Vol. 56, No. 247,

December 24, 1991.

09–25–0130, Clinical Research: Studies in

the Division of Cancer Cause and

Prevention, HHS/NIH/NCI, published

Federal Register, Vol. 56, No. 8, January

11, 1991.

09–25–0134, Clinical Research:

Epidemiology Studies, National Institute of

Environmental Health Sciences, HHS/NIH/

NIEHS, published Federal Register, Vol.

58, No. 248, December 29, 1993.

09–25–0140, International Activities:

International Scientific Researchers in

Intramural Laboratories at the National

Institutes of Health, HHS/NIH/FIC,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0142, Clinical Research: Records of

Subjects in Intramural Research,

Epidemiology, Demography and Biometry

Studies on Aging, HHS/NIH/NIA,

published Federal Register, Vol. 58, No. 8,

January 13, 1993.

09–25–0143, Biomedical Research: Records

of Subjects in Clinical, Epidemiologic and

Biometric Studies of the National Institute

of Allergy and Infectious Diseases, HHS/

NIH/NIAID, published Federal Register,

Vol. 58, ′No. 248, December 29, 1993.

09–25–0145, Clinical Trials and

Epidemiological Studies Dealing with

Visual Disease and Disorders in the

National Eye Institute, HHS/NIH/NEI,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0148, Contracted and ContractRelated Research: Records of Subjects in

Clinical, Epidemiological and Biomedical

Studies of the National Institute of

Neurological Disorders and Stroke and the

National Institute on Deafness and Other

Communication Disorders, HHS/NIH/

NINDS and HHS/NIH/NIDCD, published

Federal Register, Vol. 56, No. 247,

December 24, 1991.

09–25–0152, Biomedical Research: Records

of Subjects in National Institute of Dental

Research Contracted Epidemiological and

Biometric Studies, HHS/NIH/NIDR,

published Federal Register, Vol. 58, No. 8,

January 13, 1993.

09–25–0153, Biomedical Research: Records

of Subjects in Biomedical and Behavioral

Studies of Child Health and Human

Development, HHS/NIH/NICHD, published

Federal Register, Vol. 58, No. 8, January

13, 1993.

09–25–0154, Biomedical Research Records of

Subjects: (1) Cancer Studies of the Division

of Cancer Prevention and Control, HHS/

NIH/NCI; and (2) Women’s Health

Initiative (WHI) Studies, HHS/NIH/OD,

published Federal Register, Vol. 58,

Number 8, January 13, 1993.

09–25–0156, Records of Participants in

Programs and Respondents in Surveys

Used to Evaluate Programs of the Public

Health Service, HHS/PHS/NIH/OD,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0158, Administration: Records of

Applicants and Awardees of the NIH

Intramural Research Training Awards

Program, HHS/NIH/OD, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0160, United States Renal Data

System (USRDS), HHS/NIH/NIDDK

published Federal Register, Vol. 56, No. 8,

January 11, 1991.

09–25–0161, Administration: NIH Consultant

File, HHS/NIH/DRG, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0165, National Institutes of Health

Loan Repayment Program, HHS/NIH/OD,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0166, Administration: Radiation and

Occupational Safety and Health

Management Information System, HHS/

NIH/ORS, published Federal Register, Vol.

56, No. 247, December 24, 1991.

09–25–0167, National Institutes of Health

(NIH) Transhare Program, HHS/NIH/OD,

published Federal Register, Vol. 57, No.

171, September 2, 1992.

09–25–0168, Invention, Patent and Licensing

Documents Submitted to the Public Health

Service by its Employees, Grantees,

Fellowship Recipients and Contractors,

HHS/PHS/NIH/OTT, published Federal

Register, Vol. 58, No. 164, August 26, 1993.

09–25–0169, Medical Staff Credentials Files,

HHS/NIH/CC, published Federal Register,

Vol. 59, No. 207, October 27, 1994.

09–25–0170, Diabetes Control and

Complications Trial (DCCT) Data System,

HHS/NIH/NIDDK, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0201, Clinical Research: National

Institute of Mental Health Patient Records,

HHS/NIH/NIMH, published Federal

Register, Vol. 58, No. 8, January, 13, 1993.

09–25–0202, patient Records on PHS

Beneficiaries (1935–1974) and Civilly

Committed Drug Abusers (1967–1976)

Treated at the PHS Hospitals in Fort

Worth, Texas, or Lexington, Kentucky,

HHS/NIH/NIDA, published Federal

Register, Vol. 58, No. 8, January 13, 1993.

09–25–0203, National Institute on Drug

Abuse, Addiction Research Center, Federal

Prisoner and Non-Prisoner Research Files,

HHS/NIH/NIDA, published Federal

Register, Vol. 58, No. 8, January 13, 1993.

09–25–0205, Alcohol, Drug Abuse, and

Mental Health Epidemiologic and

Biometric Research Data, HHS/NIH/

NIAAA, HHS/NIH/NIDA and HHS/NIH/

NIMH, published Federal Register, Vol. 58,

No. 248, December 29, 1993.

09–25–0207, Subject-Participants in

Pharmacokinetic Studies on Drugs of

Abuse and on Treatment Medications,

HHS/NIH/NIDA, published Federal

Register, Vol. 58, No. 248, December 29,

1993.

09–25–0208, Drug Abuse Treatment Outcome

Study (DATOS), HHS/NIH/NIDA,

published Federal Register, Vol. 58, No.

248, December 29, 1993.

09–25–0209, Subject-Participants in Drug

Abuse Research Studies on Drug

Dependence and in Research Supporting

New Drug Applications, HHS/NIH/NIDA,

published Federal Register, Vol. 58, No. 8,

January 13, 1993.

09–25–0210, Shipment Records of Drugs of

Abuse to Authorized Researchers, HHS/

NIH/NIDA, published Federal Register,

Vol. 58, No. 248, December 29, 1993.

09–25–0211, Intramural Research Program

Records of In- and Out-Patients with

Various Types of Alcohol Abuse and

Dependence, Relatives of Patients With

Alcoholism, and Healthy Volunteers, HHS/

NIH/NIAAA, published Federal Register,

Vol. 58, No. 248, December 29, 1993.

09–25–0212, Clinical Research: Neuroscience

Research Center Patient Medical Records,

HHS/NIH/NIMH, published Federal

Register, Vol. 58, No. 8, January 13, 1993.

Dated: January 10, 1995.

Cdr. Cheryl A. Seaman,

Acting Director, Division of Management

Support, OMA, OA, OD, National Institutes

of Health.

09–25–0001

SYSTEM NAME:

Clinical Research: Patient Records,

HHS/NIH/NHLBI.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Building

10, 9000 Rockville Pike, Bethesda,

MD 20892

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Patients of the National Heart, Lung,

and Blood Institute (NHLBI) under

study at the National Institutes of Health

(NIH).

4242 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical histories, diagnostic studies,

laboratory data, treatment.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 USC 241(e), 287, 287a.

PURPOSE(S):

(1) For use by physicians in

evaluation and treatment of patients

under study at NIH. (2) To furnish

patient data to patients, their families,

and with patients’ consent, to their

private physicians.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Clinical research data are made

available to approved or collaborating

researchers, including HHS contractors

and grantees.

2. Certain diseases and conditions,

including infectious diseases, may be

reported to appropriate representatives

of State or Federal Government as

required by State or Federal law.

3. 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice or other appropriate Federal

agency to enable that agency to present

an effective defense, provided that such

disclosure is compatible with the

purpose for which the records were

collected.

4. (a). PHS 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 needlesharing partner(s); (3) The PHS

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).

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

File folders, card index, laboratory

books, computer memory.

RETRIEVABILITY:

Indexed by name or patient number.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location. Each site

implements personnel, physical, and

procedural safeguards such as the

following:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

authorized physicians and their

assistants.

2. Physical safeguards: Records are

kept in secure locked metal or wood file

cabinets and, in some instances, in

locked offices.

3. Procedural safeguards: Access to

files is strictly controlled by files staff.

Access to computerized records is

controlled by keyword codes available

only to authorized users.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific conditions on disposal.

SYSTEM MANAGER(S) AND ADDRESS:

Administrative Officer, Division of

Intramural Research, National Heart,

Lung, and Blood Institute, 10/7N220,

10 Center Drive, MSC 1670, Bethesda,

MD 20892–1670

NOTIFICATION PROCEDURE:

To determine if a record exists,

contact: National Institutes of Health,

Privacy Act Coordinator, NHLBI,

Building 31, Room 5A08, 9000

Rockville Pike, Bethesda, MD 20892.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing, a

responsible representative, who may be

a physician, who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

RECORDS ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and specify the

information to be contested, the

corrective action sought, and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Referring physicians, hospitals and

medical centers, patients and families,

results of procedures and tests of NIH

patients.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0005

SYSTEM NAME:

Administration: Library Operations

and User I.D. File, HHS/NIH/OD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

This system of records is an umbrella

system comprising separate sets of

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4243

records located in National Institutes of

Health (NIH) facilities in Bethesda,

Maryland, or facilities of contractors of

the NIH. Write to the appropriate system

manager listed below for list of current

contractor locations.

National Institutes of Health, Building

10, Room 1L07, 9000 Rockville Pike,

Bethesda, MD 20892

and

National Institutes of Health, Building

12A, Room 3018, 9000 Rockville Pike,

Bethesda, MD 20892

and

National Institutes of Health, Building

38, Room 1S33, 8600 Rockville Pike,

Bethesda, MD 20894

and

National Institutes of Health, Building

38, Room 1N21, 8600 Rockville Pike,

Bethesda, MD 20894

and

National Institutes of Health, Building

38, Room B1E21, 8600 Rockville Pike,

Bethesda, MD 20894

and

National Institutes of Health, Building

38A, Room 4N419, 8600 Rockville

Pike, Bethesda, MD 20894

and

National Technical Information Service,

Accounting Department, 8001 Forbes

Place, Room 208F, Springfield,

Virginia 22151

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Users of Library Services.

CATEGORIES OF RECORDS IN THE SYSTEM:

Name, organization, address, phone

number, user code and identification

number; and when applicable, credit

card number and billing information.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Section 301 of the Public Health

Service Act, describing the general

powers and duties of the Public Health

Service relating to research and

investigation (42 U.S.C. 241).

PURPOSES

(1) To monitor library material,

services, and circulation control; (2) to

provide user documentation; (3) to

provide copying services (duplication of

library materials); and (4) to manage

invoice and billing transactions for

library services.

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 an inquiry

from the congressional office made at

the request of that individual.

2. 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,

court or other tribunal is relevant and

necessary to the litigation and would

help in the effective representation of

the government party, provided,

however that in each case, HHS

determines that such disclosure is

compatible with the purpose for which

the records were collected.

3. Disclosure may be made to

contractors and staff to monitor library

material, services, circulation control; to

provide user documentation; and to

process or refine the records. Recipients

are required to maintain Privacy Act

safeguards with respect to those records.

4. Disclosure may be made for billing

purposes to: (a) Contractors providing

copying services: and (b) NTIS for

Medlars Services.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored on computer tape

and disc, microfiche, paper and file

cards.

RETRIEVABILITY:

Records are retrieved by name, user

code and/or identification number.

SAFEGUARDS:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

Library staff members who need to

verify that Library identification cards

have been issued to those Library users

requesting services such as MEDLINE

and other computer online bibliographic

searches, translations and interlibrary

loans. Other one-time and special access

by other employees is granted on a

need-to-know basis as specifically

authorized by the system manager. The

contractor maintains a list of personnel

having authority to access records to

perform their duties.

2. Physical safeguards: The offices

housing the cabinets and file drawers

for storage of records are locked during

all library off-duty hours. During all

duty hours offices are attended by

employees who maintain the files. The

contractor has secured records storage

areas which are not left unattended

during the working hours and file

cabinets which are locked after hours.

3. Procedural safeguards: Access to

the file is strictly controlled by

employees who maintain the files.

Records may be removed from files only

at the request of the system manager or

other authorized employees. Access to

computerized records is controlled by

the use of security codes known only to

authorized users. Contractor personnel

receive instruction concerning the

significance of safeguards under the

Privacy Act.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 8000–D–2,

which allows records to be kept until

superseded or for a maximum period of

6 years. Refer to the NIH Manual

Chapter for specific conditions on

disposal.

SYSTEM MANAGER(S) AND ADDRESS:

The Policy Coordinating Official for

this system is the Management Analyst,

Office of Administration, National

Library of Medicine; Building 38, Room

2N21; 8600 Rockville Pike; Bethesda,

MD 20894.

Chief, Reference and Bibliographic

Services Section, Library Branch,

National Center for Research

Resources, National Institutes of

Health, Building 10, Room 1L21, 9000

Rockville Pike, Bethesda, MD 20892

and

Chief, Division of Computer Research

and Technology Library, National

Institutes of Health, Building 12A,

Room 3018, 9000 Rockville Pike,

Bethesda, MD 20892

4244 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

and

Supervisory Librarian, Preservation and

Collection Management Section,

Public Services Division, Library

Operations, National Library of

Medicine, National Institutes of

Health, Building 38, Room B1E21,

8600 Rockville Pike, Bethesda, MD

20894

and

Chief, Public Services Division, Library

Operations, National Library of

Medicine, National Institutes of

Health, Building 38, Room 1S33, 8600

Rockville Pike, Bethesda, MD 20894

and

Head, Prints and Photographs

Collection, History of Medicine

Division, NLM, NIH, Building 38,

Room 1N21, 8600 Rockville Pike,

Bethesda, MD 20894

and

Chief, Medlars Management Section,

Bibliographic Services Division,

Library Operations, National

Institutes of Health, National Library

of Medicine, Building 38A, Room

4N419, 8600 Rockville Pike, Bethesda,

MD 20894

NOTIFICATION PROCEDURE:

Write to the System Manager to

determine if a record exists. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request an

accounting of disclosures that have been

made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to the official at the address

specified under notification procedures

above, and reasonably identify the

record and specify the information to be

contested, the corrective action sought,

and the reasons for the correction, along

with supporting information to show

how the record is inaccurate,

incomplete, untimely, or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Individual, NIH Library ID card data.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0011

SYSTEM NAME:

Clinical Research: Blood Donor

Records, HHS/NIH/CC.

SECURITY CLASSIFICATION:

None

SYSTEM LOCATION:

National Institutes of Health,

Transfusion Medicine Department, 10

Center Drive MSC 1184, Bethesda,

MD 20892–1184

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Donors of blood and blood

components to be used in the NIH

Clinical Center for patient infusions.

CATEGORIES OF RECORDS IN THE SYSTEM:

Past donations, blood types,

phenotypes. Laboratory results of

hepatitis testing, serologic reactions on

all blood samples, donations of blood or

blood components.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

‘‘Preparation of Biological Products’’

of the Public Health Service Act (42

U.S.C. 263).

PURPOSE(S):

(1) To provide a means for contacting

blood donors for patient care and

research. (2) To provide a medical

history of all donors for the transfusion

records of each blood unit.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors and their staff in order to

accomplish the purposes for which the

records are collected. The recipients are

required to comply with the

requirements of the Privacy Act with

respect to such records.

2. Certain diseases and conditions,

including infectious diseases, may be

reported to State or Federal government

as required by State or Federal law.

3. Disclosure may be made to a

congressional office from the record of

individual in response to an inquiry

from the congressional office made at

the request of that individual.

4. 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

here official capacity; (b) the United

States where the Department determines

that 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice or other appropriate Federal

agency to enable that agency to present

an effective defense, provided that such

disclosure is compatible with the

purpose for which the records were

collected.

5. (a). PHS 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 needlesharing partner(s); (3) The PHS

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).

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in a computer file,

on donor cards, and on microfilm.

RETRIEVABILITY:

Records are retrieved by a unique

control number assigned to each

individual donor.

SAFEGUARDS:

Access is granted only to authorized

employees in the Department of

Transfusion Medicine including

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4245

physicians, nurses, technologists,

computer operators, and the

department’s administrative officer.

1. Authorized users: Access is granted

only to authorized employees of the

Department of Transfusion Medicine

including physicians, nurses

technologists, computer operators and

the secretary to the Chief.

2. Physical safeguards: Record

facilities are locked when system

personnel are not present.

3. Procedural safeguards: Access to

manual files is limited to authorized

users. Access to computerized records is

controlled by the use of security codes

known only to the authorized users.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the HIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–E–50.

Refer to the NIH Manual Chapter for

specific conditions on disposal.

SYSTEM MANAGER AND ADDRESS:

Chief, Tranfusion Medicine Department,

National Institutes of Health, 10

Center Drive MSC 1184, Bethesda,

MD 20892–1184.

NOTIFICATION PROCEDURE:

Write to the System Manager to

determine if a record exists. The

requester must also verify his or her

identify by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing, a

responsible representative, who may be

a physician, who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

RECORD ACCESS PROCEDURE:

To obtain access to a record, contact

the system manager at the address

specified above. Requestors should

provide the same information as is

required under the notification

procedures above. Individuals may also

request listings of accountable

disclosures that have been made of their

records, if any.

CONTESTING RECORD PROCEDURE:

Write to the official specified under

notification procedures above, and

reasonably identify the record and

specify the information being contested,

the corrective action sought, and your

reasons for requesting the correction,

along with supporting information to

show how the record is inaccurate,

incomplete, untimely, or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Data are collected from the

individual.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0012

SYSTEM NAME:

Clinical Research: Candidate Normal

Volunteer Records, HHS/NIH/CC.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Social

Work Department, 10 Center Drive

MSC 1160, Bethesda, MD 20892–

1160.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Normally healthy individuals who

volunteer to participate in NIH studies.

CATEGORIES OF RECORDS IN THE SYSTEM:

Program application, health

questionnaire and record of

participation.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, 263.

PURPOSE(S) OF THE SYSTEM:

(1) To determine suitability for

participation in the normal volunteer

program, (2) to document remuneration

of normal volunteers, (3) to provide a

record of participation to be used (a) in

writing letters of recommendation/

reference for the volunteer, and (b)

preparing reports on the normal

volunteer program.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Clinical research data are made

available to approved or collaborating

researchers, including HHS contractors

and grantees.

2. Certain diseases and conditions,

including infectious diseases, may be

reported to appropriate representatives

of State or Federal Government as

required by State or Federal law.

3. Information may be used to

respond to congressional inquiries for

constituents concerning admission to

the NIH Clinical Center.

4. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Program applications and health

questionnaires are stored in file folders.

Records of participation are stored on

index cards.

RETRIEVABILITY:

Records are retrieved by name.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical, procedural safeguards such as

the following:

1. Authorized users: Access is granted

only to the Normal Volunteer Program

staff and to NIH physicians who have

requested the recruitment of volunteers

for their clinical research projects.

2. Physical safeguards: Access to the

files is strictly controlled by the files

staff. Records may be removed from the

file only at the request of the system

manager or other authorized employees.

Record facilities are locked when

system personnel are not present.

3. Procedural safeguards: Access to

the files is strictly controlled by the files

staff. Records may be removed from the

file only at the request of the system

manager or other authorized employees.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–E–61,

which allows records to be kept until

4246 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

superseded for a maximum period of 3

years. Refer to the NIH Manual Chapter

for specific conditions on disposal.

SYSTEM MANAGER AND ADDRESS:

Chief, Social Work Department,

National Institutes of Health, Social

Work Department, 10 Center Drive

MSC 1160, Bethesda, MD 20892–

1160.

NOTIFICATION PROCEDURES:

Write to the System Manager to

determine if a record exists. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing, a

responsible representative, who may be

a physician, who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURE:

To obtain access to a record, contact:

Chief, Social Work Department,

National Institutes of Health, Social

Work Department, 10 Center Drive MSC

1160, Bethesda, MD 20892–1160 and

provide the information described

under Notification Procedures above.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to the official at the address

specified under notification procedures

above, and reasonably identify the

record and specify the information to be

contested, the corrective action sought,

and the reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Volunteer, sponsoring contractor.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0014

SYSTEM NAME:

Clinical Research: Student Records,

HHS/NIH/CC.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Office of

Education, 10 Center Drive MSC 1158,

Bethesda, MD 20892–1158.

Write to the system manager at the

address below for the address of any

Federal Records Center where records

from this system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Potential and accepted Medical Staff

and Research Fellows, medical students,

and other students in NIH training

programs.

CATEGORIES OF RECORDS IN THE SYSTEM:

Application form, transcripts,

references, evaluations.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241.

PURPOSE(S):

(1) To identify candidates for Medical

Staff and Research Fellow, clinical

elective, and other training positions. (2)

To maintain a permanent record of

those individuals who have received

clinical research training at the NIH for

historical and reference uses.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Information may be used to

respond to congressional inquiries for

constituents concerning admission to

the program.

2. Information may be used to

respond to prospective future employers

of these individuals who wish to

confirm their presence at NIH.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders.

RETRIEVABILITY:

Records are retrieved by name and

year.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical, procedural safeguards such as

the following:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

health care personnel of the NIH who

are involved in the evaluation and

selection of training candidates.

2. Physical safeguards: Records are

maintained in locked cabinets with

access limited to authorized personnel,

including the systems manager and staff

of the Normal Volunteer Program.

3. Procedural safeguards: Access to

the files is strictly controlled by the files

staff. Records may be removed from the

file only at the request of the system

manager or other authorized employees.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), items 2300–320–1–

13, which allows records to be kept up

to a maximum period of 10 years. Refer

to the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Director, Office of Education, National

Institutes of Health, 10 Center Drive

MSC 1158, Bethesda, MD 20892–1158.

NOTIFICATION PROCEDURE:

Write to the System Manager to

determine if a record exists. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

To obtain access to a record, contact

the system manager at the above address

and provide the information described

under Notification Procedures above.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to the system manager at the

address specified above, and reasonably

identify the record and specify the

information to be contested, the

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4247

corrective action sought, and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Applicants, universities and teachers.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0026

SYSTEM NAME:

Clinical Research: Nervous System

Studies, HHS/NIH/NINDS.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Building 36, Room 5B20, NIH, 9000

Rockville Pike, Bethesda, MD 20892.

Write to the system manager at the

address below for the address of any

Federal Records Center where records

from this system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Research patients in NIH-related

studies having nervous system

disorders.

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical and demographic data.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, 289a, 289c.

PURPOSE(S):

Clinical research by HHS scientists on

patients with special diseases of the

nervous system, with particular

emphasis on those diseases known or

thought to be caused by slow or latent

viruses.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Clinical research data are made

available to approved or collaborating

researchers, including HHS contractors

and grantees.

2. Certain diseases and conditions,

including infectious diseases, may be

are reported to appropriate

representatives of State or Federal

Government as required by State or

Federal law.

3. Information may be used to

respond to congressional inquiries for

constituents concerning admission to

the NIH Clinical Center. 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 Untied 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 against a claim

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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice or other appropriate Federal

agency to enable that agency to present

an effective defense, provided that such

disclosure is compatible with the

purpose for which the records were

collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders, in

computer-accessible forms, bound

notebooks, graphs, and imaging films.

RETRIEVABILITY:

Records are retrieved by name,

disease and attending physician name.

SAFEGUARDS:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant access only to

scientists on the staff of the Central

Nervous System Studies Laboratory and

their assistants.

2. Physical safeguards: Records are

kept in a locked location.

3. Procedural safeguards: Personnel

having access to system are informed of

Privacy Act requirements.

This system of records will be

protected according to the standards of

Chapter 45–13 of the HHS General

Administration Manual, ‘‘Safeguarding

Records Contained in Systems of

Records,’’ supplementary Chapter PHS

hf: 45–13, and Part 6, ‘‘ADP Systems

Security,’’ of the HHS Information

Resources Management Manual and the

National Institute of Standards and

Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Assistant Director, CNP, DIR, NINDS,

NIH, Building 10, Room 5N226, 9000

Rockville Pike, Bethesda, MD 20892.

NOTIFICATION PROCEDURE:

To determine if a record exists,

contact: Chief, Administrative Services

Branch, NINDS, Building 31, Room

8A49, NIH, 9000 Rockville Pike,

Bethesda, MD 20892.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical/

dental record shall, at the time the

request is made, designate in writing, a

responsible representative who will be

willing to review the record and inform

the subject individual of its contents at

the representative’s discretion.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official at the address

specified under notification procedures

above, and reasonably identify the

record and specify the information to be

contested. The right to contest records is

limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Attending physicians.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0028

SYSTEM NAME:

Clinical Research: Patient Medical

Histories, HHS/NIH/NINDS and HHS/

NIH/NIDCD.

SECURITY CLASSIFICATION:

None.

4248 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

SYSTEM LOCATION:

Building 10, Building 31, and Building

36, NIH, 9000 Rockville Pike,

Bethesda, MD 20892.

Write to the system manager at the

address below for the address of any

Federal Records Center where records

from this system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Past and present patients of the

National Institute of Neurological

Disorders and Stroke (NINDS) and the

National Institute on Deafness and

Other Communication Disorders

(NIDCD), and individuals being referred

for admission to the NIH Clinical

Center.

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical histories and diagnoses.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, 289a, 289c.

PURPOSE(S):

Clinical research on various diseases

of the nervous system and hearing,

hearing loss, and communication

disorders by HHS scientists and their

authorized collaborators, with the

specific aim of improving patient care

and treatment by evaluating therapeutic

procedures.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Clinical research data are made

available to approved or collaborating

researchers, including HHS contractors

and grantees. Certain diseases and

conditions, including infectious

diseases, may be reported to appropriate

representatives of State or Federal

Government as required by State or

Federal law.

2. Information may be used to

respond to congressional inquiries for

constituents concerning admission to

the NIH Clinical Center.

3. 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice or other appropriate Federal

agency to enable that agency to present

an effective defense, provided that such

disclosure is compatible with the

purpose for which the records were

collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders and

in computer-accessible forms, bound

notebooks, charts, graphs, and imaging

films.

RETRIEVABILITY:

Records are retrieved by name.

SAFEGUARDS:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant access only to HHS

researchers and their authorized

collaborators.

2. Physical safeguards: Records are

kept locked in file cabinets when not in

use and in locations which are locked

during non-working hours. Data stored

in computer-accessible form is accessed

through the use of codes and key words

known only to principal investigators or

authorized personnel.

3. Procedural safeguards: Records are

returned to the files at the close of each

working day and are used only in the

system location or in a designated work

area.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Assistant Director, Clinical

Neurosciences Program, Building 10,

Room 5N226, NIH, 9000 Rockville

Pike, Bethesda, MD 20892

and

Acting Director of Intramural Research,

NIDCD, Building 31, Room 3C02,

NIH, 9000 Rockville Pike, Bethesda,

MD 20892

NOTIFICATION PROCEDURE:

To determine if a record exists,

contact:

Chief, Administrative Services Branch,

NINDS, Building 31, Room 8A49,

NIH, 9000 Rockville Pike, Bethesda,

MD 20892

or

Chief, Administrative Management

Branch, NIDCD, Building 31, Room

3C21, NIH, 9000 Rockville Pike,

Bethesda, MD 20892

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine. An

individual who requests notification of

or access to a medical/dental record

shall, at the time the request is made,

designate in writing, a responsible

representative who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURES:

Contact the official at the address

specified under notification procedures

above, and reasonably identify the

record and specify the information to be

contested, the corrective action sought,

and the reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Referring and attending physicians,

hospital records.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0036

SYSTEM NAME:

Extramural Awards and Chartered

Advisory Committees: IMPAC (Grant/

Contract/Cooperative Agreement

Information/Chartered Advisory

Committee Information), HHS/NIH/DRG

and HHS/NIH/CMO.

SECURITY CLASSIFICATION:

None.

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4249

SYSTEM LOCATION:

Westwood Building, 5333 Westbard

Avenue, Bethesda, MD 20892, and

Building 12, NIH Computer Center,

9000 Rockville Pike, Bethesda, MD

20892.

For information pertaining to the

chartered advisory committees of the

National Institutes of Health: Building

31, Room 3B–55, 9000 Rockville Pike,

Bethesda, MD 20892.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Applicant and Principal Investigators;

Program Directors; NRSA Trainees and

Fellows; Research Career Awardees; and

Chartered Advisory Committee

members.

CATEGORIES OF RECORDS IN THE SYSTEM:

Applications, awards, associated

records, trainee appointments, and

current and historical information

pertaining to chartered advisory

committees.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241c, 58 Stat. 691c & d

repealed.

PURPOSE(S):

(1) To support centralized grant

programs of the Public Health Service.

Services are provided in the areas of

grant application assignment and

referral, initial review, council review,

award processing and grant accounting.

The data base is used to provide

complete, accurate, and up-to-date

reports to all levels of management.

(2) To maintain communication with

former fellows and trainees who have

incurred a payback obligation through

the National Research Service Award

Program.

(3) To maintain current and historical

information pertaining to the

establishment of chartered advisory

committees of the National Institutes of

Health and the appointment or

designation of their members.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to the

National Technical Information Service

(NTIS), Department of Commerce, for

dissemination of scientific and fiscal

information on funded awards (abstract

of research projects and relevant

administrative and financial data).

2. Disclosure may be made to the

cognizant audit agency for auditing.

3. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

4. Disclosure may be made to

qualified experts not within the

definition of Department employees as

prescribed in Department Regulations

for opinions as a part of the application

review process.

5. Disclosure may be made to a

Federal agency, in response to its

request, in connection with the letting

of a contract, or the issuance of a

license, grant or other benefit by the

requesting agency, to the extent that the

record is relevant and necessary to the

requesting agency’s decision in the

matter.

6. 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, (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.

7. The Department contemplates that

it may contract with a private firm for

the purpose of collating, analyzing,

aggregating or otherwise refining

records in this system. Relevant records

will be disclosed to such a contractor.

The contractor will be required to

maintain Privacy Act safeguards with

respect to such records.

8. Disclosure may be made to the

grantee institution in connection with

performance or administration under

the conditions of the award.

9. 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 any interest in such litigation,

and HHS determines that the use of

such records by the Department of

Justice, 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored on discs and

magnetic tapes.

RETRIEVABILITY:

Records are retrieved by name,

application, grant or contract ID

number.

SAFEGUARDS:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

PHS extramural and committee

management staff. Other one-time and

special access by other employees is

granted on a need-to-know basis as

specifically authorized by the system

manager.

2. Physical safeguards: Physical

access to DRG work areas is restricted to

DRG employees.

3. Procedural safeguards: Access to

source data is strictly controlled by files

staff. Records may be removed from files

only at the request of the system

manager or other authorized employee.

Access to computer files is controlled by

the use of registered accounts, registered

initials, keywords, etc. The computer

system maintains an audit record of all

attempted and successful requests for

access.

These practices are in compliance

with the standards of Chapter 45–13 of

4250 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 4000–A–2,

which allows records to be destroyed

when no longer needed for

administrative purposes. Refer to the

NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER(S) AND ADDRESS:

Chief, Information Systems Branch,

Division of Research Grants,

Westwood Building, 5333 Westbard

Avenue, Bethesda, MD 20892

and

For chartered advisory committees of

the National Institutes of Health:

NIH Committee Management Officer,

Building 31, Room 3B–55, 9000

Rockville Pike, Bethesda, MD 20892.

NOTIFICATION PROCEDURE:

To determine if a record exists write

to:

Privacy Act Coordinator, Division of

Research Grants, Westwood Building,

Room 449, 5333 Westbard Avenue,

Bethesda, MD 20892

and

For information pertaining to the

chartered advisory committees of the

National Institutes of Health:

NIH Committee Management Officer,

Building 31, Room 3B–55, 9000

Rockville Pike, Bethesda, MD 20892.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Individual, individual’s educational

institution and references.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0042

SYSTEM NAME:

Clinical Research: National Institute

of Dental Research Patient Records,

HHS/NIH/NIDR.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Building

10, Room 1B01, 10 Center Drive MSC

1190, Bethesda, MD 20892–1190.

Write to system manager at the

address below for the address of the

Federal Records Center where records

from this system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Patients and other participants in

current and past research projects of the

National Institute of Dental Research

(NIDR).

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical and dental histories, dental

pathologies and therapies.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Sections 301, 401, 405 and 453 of the

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

241, 281, 284, 285h). These sections

establish the National Institute of Dental

Research and authorize the conduct and

support of dental oral research and

related activities.

PURPOSE(S):

(1) To record the diagnosis and

treatment of patients with diseases of

the mouth, tongue, teeth and

surrounding tissues; (2) To record the

normal condition of the mouth, tongue,

teeth and surrounding tissues of

individuals referred to the dental clinic;

(3) To provide clinical data for research

into the etiology, treatment and

prevention of oral diseases; (4) For

review and planning of the NIDR

clinical 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 HHS

contractors, grantees and collaborating

researchers and their staff in order to

accomplish the clinical and research

purposes for which the records are

collected. The recipients are required to

maintain Privacy Act safeguards with

respect to these records.

2. Certain diseases and conditions,

including infectious diseases, may be

reported to appropriate representatives

of State or Federal Government as

required by State or Federal law.

3. Information may be used to

respond to congressional inquiries for

constituents concerning admission to

the NIH Clinical Center.

4. 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,

when a claim is based upon an

individual’s mental or physical

condition and is alleged to have arisen

because of activities of the Public Health

Service in connection with such

individual, the Department may

disclose such records as it deems

desirable or necessary 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders.

RETRIEVABILITY:

Records are retrieved by name and

hospital ID number.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical, and procedural safeguards

such as the following:

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4251

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

dentists, physicians, dental hygienists,

dental assistants and other health care

personnel involved in the care and

treatment of patients in the NIDR dental

clinic, and to referring professionals.

Other one-time and special access by

other employees is granted on a needto-know basis as specifically authorized

by the system manager.

2. Physical safeguards: Records are

stored in a cabinet which is locked at all

times when not in use.

3. Procedural safeguards: Access is

controlled by clerical staff of the Dental

Clinic during clinic hours, and by the

Officer of the Day when the clinic is

closed.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER(S) AND ADDRESS:

National Institutes of Health, Deputy

Clinical Director, NIDR, Building 10,

Room 1N–113, 10 Center Drive MSC

1190, Bethesda, MD 20892–1190

NOTIFICATION PROCEDURE:

To determine if a record exists

contact:

NIDR Privacy Act Coordinator, Building

31, Room 2C–35, 10 Center Drive

MSC 1190, Bethesda, MD 20892–

1190.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine. An

individual who requests notification of

or access to a medical/dental record

shall, at the time the request is made,

designate in writing a responsible

representative who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Individual, parents or guardians.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0044

SYSTEM NAME:

Clinical Research: Sensory Testing

Research Program, HHS/NIH/NIDR.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Building

10, Room 1–N–114, 10 Center Drive,

MSC 1190, Bethesda, MD 20892–

1190.

Write to System Manager at the

address below for the address of the

Federal Records Center where records

from this system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Infants, children and adults

participating in the Sensory Testing

Research Program of the National

Institute of Dental Research (NIDR).

CATEGORIES OF RECORDS IN THE SYSTEM:

Test results, extracts from medical

records.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Sections 301, 401, 405 and 453 of the

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

241, 281, 284, 285h). These sections

establish the National Institute of Dental

Research and authorize the conduct and

support of dental and oral research and

related activities.

PURPOSE(S)

(1) To record the medical/dental

histories of individuals participating in

the Sensory Testing Research Program;

(2) To record the results of

chemosensory tests of individuals

participating in the Sensory Testing

Research Program; (3) For research on

sensitivity to oral nasal stimulation; (4)

For review and planning of the Clinical

Investigations and Patient Care Branch

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 HHS

contractors, grantees, referring health

professionals and collaborating

researchers and their staff in order to

accomplish the clinical and research

purposes for which the records are

collected. The recipients are required to

maintain Privacy Act safeguards with

respect to these records.

2. Certain diseases and conditions,

including infectious diseases, may be

reported to appropriate representatives

of State or Federal Government as

required by State or Federal law.

3. Information may be used to

respond to congressional inquiries for

constituents concerning admission to

the NIH Clinical Center.

4. 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,

when a claim is based upon an

individual’s mental or physical

condition and is alleged to have arisen

because of activities of the Public Health

Service in connection with such

individual, the Department may

disclose such records as it deems

desirable or necessary 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders, data

books and in a mini-computer

maintained by the NIDR Scientific

Systems Section.

4252 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

RETRIEVABILITY:

Records are retrieved by name, date of

observation and age of subject.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

Clinical Investigations Section staff, to

scientist colleagues by invitation of the

principal investigator and to referring

professionals. Other one time and

special access by other employees is

granted on a need to know basis as

specifically authorized by the System

Manager.

2. Physical safeguards: Records are

stored in rooms which are locked at all

times when not in use. Computer

terminals are in secured areas. Access to

computer file is controlled by software

protection codes associate with each

site.

3. Procedural safeguards: Access is

controlled by Clinical Investigation

Section staff.

These safeguards are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Research Psychologist, Clinical

Investigations, NIDR, Building 10, Room

1N114, 10 Center Drive, MSC 1190,

Bethesda, MD 20892–1190.

NOTIFICATION PROCEDURE:

To determine if a record exists

contact: NIDR Privacy Act Coordinator,

31 Center Drive, MSC 2290, Building 31,

Room 2C–35, Bethesda, MD 20892–

2290.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine. An

individual who requests notification of

or access to a medical/dental record

shall, at the time the request is made,

designate in writing a responsible

representative who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Subject individual, cooperating

clinician or health agency, family

members

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0054

SYSTEM NAME:

Administration: Property Accounting,

HHS/NIH/ORS.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Building

13, Room 2E43, 9000 Rockville Pike,

Bethesda, MD 20892

and

National Institutes of Health, Computer

Center, Building 12, 9000 Rockville

Pike, Bethesda, MD 20892

and

National Institutes of Health, Building

31, Room B3B16, 9000 Rockville Pike,

Bethesda, MD 20892

and

National Institute of Environmental

Health Sciences, Office of Facilities

Engineering, 102–01, P.O. Box 12233,

Research Triangle Park, N.C. 27709

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Employees of the National Institutes

of Health who are issued tools or card

keys.

CATEGORIES OF RECORDS IN THE SYSTEM:

Property management.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

5 U.S.C. 301; 5 U.S.C. 5901; 5 U.S.C.

7903; 40 U.S.C. 318a; 42 U.S.C. 241.

PURPOSE OF THE SYSTEM:

Used for tool and card keys issuance

and control.

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 an inquiry

from the congressional office made at

the 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, or foreign, 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. 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

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4253

(c) any Department employee in his or

her individual capacity where the

Justice Department has agreed to

represent such employee, the

Department may disclose such records

as it deems desirable or necessary 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders, and

on magnetic media.

RETRIEVABILITY:

Records are retrieved by name.

SAFEGUARDS:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

officials whose duties require use of the

information. Other one time and special

access by other employees is granted on

a need to know basis as specifically

authorized by the system manager.

2. Physical safeguards: Textual

records are stored in offices which are

locked when not in use.

3. Procedural safeguards: Computer

files are password protected.

This system of records will be

protected according to the standards of

Chapter 45–13 of the HHS General

Administration Manual, ‘‘Safeguarding

Records Contained in Systems of

Records,’’ supplementary Chapter PHS

hf: 45–13, and Part 6, ‘‘ADP Systems

Security,’’ of the HHS Information

Resources Management Manual and the

National Institute of Standards and

Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 1300–C–14,

which allows records to be destroyed

after all listed credentials are accounted

for or 3 months after the return of

credentials to the issuing office. Refer to

the NIH Manual Chapter for specific

instructions.

SYSTEM MANAGER AND ADDRESS:

For tools: National Institutes of

Health, Administrative Officer, DES,

Building 13, Room 13/2E43, 9000

Rockville Pike, Bethesda, MD 20892.

For card keys:

National Institutes of Health, Chief,

Crime Prevention Branch, Division of

Security Operations, ORS, Building

31, Room B3B16, 9000 Rockville Pike,

Bethesda, MD 20892.

National Institute of Environmental

Health Sciences, Chief, Office of

Facilities Engineering, 102–01, P.O.

Box 12233, Research Triangle Park,

NC 27709

NOTIFICATION PROCEDURE:

Write to the System Manager to

determine if a record exists. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to the official specified under

notification procedures above, and

reasonably identify the record and

specify the information being contested,

the corrective action sought, and your

reasons for requesting the correction,

along with supporting information to

show how the record is inaccurate,

incomplete, untimely or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Data is obtained from the individual.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0077

SYSTEM NAME:

Biological Carcinogenesis Branch

Human Specimen Program, HHS/NIH/

NCI.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Executive

Plaza North, Rm. 540, 6130 Executive

Blvd., Bethesda, MD 20892

and at private organizations under

contract. Write to the system manager

for a list of current locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Cancer and other patients, and normal

donors of biopsy and tumor specimens,

who are seen at clinically-oriented

organizations under contract to the

National Cancer Institute. Both adults

and children are covered.

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical history and diagnostic

information about the donor,

information on the type of specimen,

location of repository (if specimen is

stored before use), and distribution

record.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, 281, 282: ‘‘Research

and Investigation,’’ ‘‘National Cancer

Institute,’’ and ‘‘Cancer Research and

Other Activities.’’

PURPOSE(S):

(1) For cancer research, using byproducts of cancer treatment, such as

biopsy and tumor specimens that would

normally be discarded, to allow

interpretation of experimental results;

(2) To project future research needs; (3)

To monitor and evaluate the NCI

distribution system.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. The Department contemplates that

it may contract with a private firm for

storage and preservation of specimens.

Records necessary for identification,

retrieval and research use will be

disclosed to such a contractor. The

contractor will be required to comply

with the requirements of the Privacy Act

with respect to such records.

2. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

3. 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, the

Department may disclose such records

as it deems desirable or necessary to the

Department of Justice to enable that

4254 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

Department to present an effective

defense, provided that such disclosure

is compatible with the purpose for

which the records were collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Magnetic tape and discs.

RETRIEVABILITY:

Retrieved by name of donor and crossreferenced by identifying number,

procurement source, and various

epidemiological characteristics.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

physicians, scientists and support staff

of the National Cancer Institute, or its

contractors, whose duties require the

use of such information. Other one-time

and special access by other employees

is granted on a need-to-know basis as

specifically authorized by the system

manager.

2. Physical safeguards: Records,

computers and computer terminals are

kept in limited access areas. Offices are

locked during off-duty hours. Input data

for computer files is coded to avoid

individual identification.

3. Procedural safeguards: Access to

manual files is strictly controlled by

files staff. Files may be accessed only at

the request of the system manager or

other authorized employee. Access to

computer files is controlled through

security codes known only to

authorized users.

Contractor compliance is assured

through inclusion of Privacy Act

requirements in contract clauses, and

through monitoring by contract and

project officers. Contractors who

maintain records in this system are

instructed to make no disclosure of the

records except as authorized by the

system manager.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Program Director, Research Resources,

Biological Carcinogenesis Branch,

Division of Cancer Etiology, NCI,

National Institutes of Health,

Executive Plaza North, Room 540,

6130 Executive Blvd., Bethesda, MD

20892

NOTIFICATION PROCEDURE:

Write to System Manager to determine

if a record exists. The requester must

also verify his or her identity by

providing either a notarization of the

request or a written certification that the

requester is who he or she claims to be

and understands that the knowing and

willful request for acquisition of a

record pertaining to an individual under

false pretenses is a criminal offense

under the Act, subject to a five thousand

dollar fine.

An individual who requests

notification of or access to a medical/

dental record shall, at the time the

request is made, designate in writing a

responsible representative who will be

willing to review the record and inform

the subject individual of its contents at

the representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

your reasons for requesting the

correction, along with supporting

information to show how the record is

inaccurate, incomplete, untimely or

irrelevant. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Specimen Report Form filled out by

the organization providing specimens.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0078

SYSTEM NAME:

Administration: Consultant File,

HHS/NIH/NHLBI.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Westwood

Building, 5333 Westbard Avenue,

Bethesda, MD 20892

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

List of consultants available for use in

evaluation of National Heart, Lung, and

Blood Institute special grants and

contracts.

CATEGORIES OF RECORDS IN THE SYSTEM:

Names and re ́sume ́s.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241(d), 281.

PURPOSE(S):

(1) To identify and select experts and

consultants for program reviews and

evaluations. (2) For use in evaluation of

NHLBI special grants and contracts.

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 an inquiry

from the congressional office made at

the request of that individual.

2. 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

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4255

represent such employee, the

Department may disclose such records

as it deems desirable or necessary 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Computer disc and file folders.

RETRIEVABILITY:

Records are retrieved by name.

SAFEGUARDS:

1. Authorized users: Data on computer

files is accessed by keyword known

only to authorized users.

2. Physical safeguards: Rooms where

records are stored are locked when not

in use.

3. Procedural safeguards: During

regular business hours, rooms are

unlocked but are controlled by on-site

personnel.

This system of records will be

protected according to the standards of

Chapter 45–13 of the HHS General

Administration Manual, ‘‘Safeguarding

Records Contained in Systems of

Records,’’ supplementary Chapter PHS

hf: 45–13, and Part 6, ‘‘ADP Systems

Security,’’ of the HHS Information

Resources Management Manual and the

National Institute of Standards and

Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 1100–G. Refer to

the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Chief, Review Branch, National Heart,

Lung, and Blood Institute, Westwood

Building, Room 557A, 5333 Westbard

Avenue, Bethesda, MD 20892

NOTIFICATION PROCEDURE:

To determine if a record exists,

contact:

Privacy Act Coordinator, NHLBI,

National Institutes of Health, 31/

5A10, 31 Center Drive, MSC 2490,

Bethesda, MD 20892–2490

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Subject individual.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0093

SYSTEM NAME:

Administration: Authors, Reviewers,

Editorial Board, and Members of the

Journal of the National Cancer Institute,

HHS/NIH/NCI.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Building 82, Room 239, 9030 Old

Georgetown Road, Bethesda, MD

20814.

Write to System Manager at the

address below for the address of the

Federal Records Center where records

may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Authors and manuscript reviewers

and members of the Journal of the

National Cancer Institute (JNCI)

editorial board.

CATEGORIES OF RECORDS IN THE SYSTEM:

Accepted, rejected and pending

manuscripts and review comments.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, 281.

PURPOSE(S):

Manuscript review by NCI staff of

manuscripts submitted for possible

publication in the Journal of the

National Cancer Institute or JNCI

Monographs.

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 an inquiry

from the congressional office made at

the request of that individual.

2. Disclosure may be made to

qualified experts not within the

definition of Department employees for

opinions as a part of the review of

manuscripts.

3. 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, the

Department may disclose such records

as it deems desirable or necessary to the

Department of Justice to enable that

Department to present an effective

defense, provided such disclosure is

compatible with the purpose for which

the records were collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders.

RETRIEVABILITY:

Records are retrieved by name and

manuscript number.

SAFEGUARDS:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant access only to JNCI

staff personnel, the Editor in Chief, and

members of the Board of Editors whose

duties require the use of such

information.

2. Physical safeguards: Records are

kept in a limited access area where an

employee is present at all times during

working hours. The Building is locked

during off-duty hours.

3. Procedural safeguards: Access to

manual files is tightly controlled by

office staff. Only authorized users may

have access to the files.

Information that identifies reviewers

is not maintained in computer files.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

4256 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 8000–A–1(b),

which allows records to be kept for a

maximum period of one year after year

in which published or presented. Refer

to the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER AND ADDRESS:

System Specialist, Scientific

Publications Branch, Building 82,

Room 239, 9030 Old Georgetown

Road, Bethesda, MD 20814.

NOTIFICATION PROCEDURE:

Write to System Manager to determine

if a record exists. The requester must

also verify his or her identity by

providing either a notarization of the

request or a written certification that the

requester is who he or she claims to be

and understands that the knowing and

willful request for acquisition of a

record pertaining to an individual under

false pretenses is a criminal offense

under the Act, subject to a five thousand

dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Authors and reviewers.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0099

SYSTEM NAME:

Clinical Research: Patient Medical

Records, HHS/NIH/CC.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Medical

Record Department, 10 Center Drive

MSC 1192, Bethesda, MD 20892–

1192.

and at private organizations under

contract. Write to the system manager

for a list of current locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Registered Clinical Center patients.

Some individuals not registered as

patients but seen in Clinical Center for

diagnostic tests.

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical treatment records.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, 248: ‘‘Research and

Investigation,’’ and ‘‘Hospitals, Medical

Examination, and Medical Care.’’

PURPOSE(S):

(1) To provide a continuous history of

the treatment afforded individual

patients in the Clinical Center; (2) To

provide a data base for the clinical

research conducted within the hospital.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Information may be used to

respond to Congressional inquiries for

constituents concerning their admission

to NIH Clinical Center.

2. Social Work Department may give

pertinent information to community

agencies to assist patients or their

families.

3. Referring physicians receive

medical information for continuing

patient care after discharge.

4. Information regarding diagnostic

problems, or having unusual scientific

value may be disclosed to appropriate

medical or medical research

organizations or consultants in

connection with treatment of patients or

in order to accomplish the research

purposes of this system. For example,

tissue specimens may be sent to the

Armed Forces Institute of Pathology; Xrays may be sent for the opinion of a

radiologist with extensive experience in

a particular kind of diagnostic

radiology. The recipients are required to

maintain Privacy Act safeguards with

respect to these records.

5. Records may be disclosed to

representatives of the Joint Commission

on Accreditation of Hospitals

conducting inspections to ensure that

the quality of Clinical Center medical

record-keeping meets established

standards.

6. Certain diseases and conditions,

including infectious diseases, may be

reported to appropriate representatives

of State or Federal Government as

required by State or Federal law.

7. Medical information may be

disclosed to tumor registries for

maintenance of health statistics.

8. The Department contemplates that

it may contract with a private firm for

transcribing, updating, copying, or

otherwise refining records in this

system. Relevant records will be

disclosed to such a contractor. The

contractor will be required to comply

with the requirements of the Privacy Act

with respect to such records.

9. 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 of 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice to enable that agency to

present an effective defense, provided

that such disclosure is compatible with

the purpose for which the records were

collected.

10. (a). PHS 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 needlesharing partner(s); (3) The PHS

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).

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4257

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders and/

or on microfiche, and on computer

tapes.

RETRIEVABILITY:

Records are retrieved by unit number

and patient name.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical, and procedural safeguards

such as the following:

1. Authorized users: Employees

maintaining records in this system are

instructed to grant regular access only to

physicians and dentists and other health

care professionals officially

participating in patient care, to

contractors, or to NIH researchers

specifically authorized by the system

manager.

2. Physical safeguards: All record

facilities are locked when system

personnel are not present.

3. Procedural safeguards: Access to

files is strictly controlled by the system

manager. Records may be removed only

by system personnel following receipt of

a request signed by an authorized user.

Access to computerized records is

controlled by the use of security codes

known only to the authorized user.

Codes are user- and function-specific.

Contractor compliance is assured

through inclusion of Privacy Act

requirements in contract clauses, and

through monitoring by contract and

project officers. Contractors who

maintain records in this system are

instructed to make no disclosure of the

records except as authorized by the

system manager.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–E–22,

which allows records to be kept until no

longer needed for scientific reference.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Chief, Medical Record Department,

National Institutes of Health, 10

Center Drive MSC 1192, Bethesda,

MD 20892–1192.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the system manager at the above

address. The requester must provide

tangible proof of identify, such as a

driver’s license. If no identification

papers are available, the requester must

verify his or her identity by providing

either a notarization of the request or a

written certification that the requester is

who he or she claims to be and

understands that the knowing and

willful request for acquisition of a

record pertaining to an individual under

false pretenses is a criminal offense

under the Act, subject to a five thousand

dollar fine.

An individual who requests

notification of or access to a medical/

dental record shall, at the time the

request is made, designate in writing a

responsible representative who will be

willing to review the record and inform

the subject individual of its contents at

the representative’s discretion. The

representative may be a physician, or

other health professional, or other

responsible individual. The subject

individual will be granted direct access

unless it is determined that such access

is likely to have an adverse effect on

him or her. In that case, the medical/

dental record will be sent to the

designated representative.

The individual will be informed in

writing if the record is sent to the

representative.

A parent or guardian who requests

notification of or 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 personas well as his/her

own identity.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

identify the specific reports and related

dates pertaining to the information to be

released. There may be a fee for

reproducing more than 20 pages of

material. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the system manager and

reasonably identify the record and

specify the information to be contested,

and state the corrective action sought

and your reasons for requesting the

correction, along with supporting

information to show how the record is

inaccurate, incomplete, untimely or

irrelevant. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Referring physicians, other medical

facilities (with patient’s consent),

patients, relatives of patients.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0102

SYSTEM NAME:

Grants Associates Program Working

Files, HHS/NIH/OER.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Extramural Staff Training Office,

National Institutes of Health, Building

31, Room 5B35, 9000 Rockville Pike,

Bethesda, Maryland 20892.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Grants Associates Training Program

Participants.

CATEGORIES OF RECORDS IN THE SYSTEM:

Applications, curriculum vitae,

reports on assignments, critiques of

courses, supervisors endorsements,

summary of assignments, and

correspondence.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

5 U.S.C. Part III; 42 U.S.C. 241c.

PURPOSE(S): THE PURPOSE OF THE SYSTEM IS

FOR PROGRAM MANAGEMENT INCLUDING:

1. Assisting participants in obtaining

maximum benefits from the Program;

2. Providing information to current

Grants Associates about assignments

and opportunities;

3. Providing re ́sume ́s to other HHS

components for possible employment of

the Grants Associates trainee;

4. Reviewing and evaluating the

Programs.

4258 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

PURPOSES OF SUCH USES:

1. Disclosure may be made to the

Office of Personnel Management for

salary approval.

2. Disclosure may be made to a

congressional office from the record of

an individual in response to an 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

record by the Department of Justice, the

court or the 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 has

determined that such disclosure is

compatible with the purpose for which

the records were collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders.

RETRIEVABILITY:

Records are retrieved by name.

SAFEGUARDS:

1. Authorized users: Access limited to

system manager and staff. Other onetime and special access by other

employees is granted on a need to know

basis as specifically authorized by the

system manager.

2. Physical safeguards: Records are

stored in local cabinets in offices which

are locked during off-duty hours.

3. Procedural safeguards: Access to

the files is strictly controlled by

employees who maintain the files.

Records may be removed from files only

at the request of the system manager or

other authorized personnel.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 2300–320–1,

which allows records to be destroyed

after a maximum period of 2 years after

completion of grants associate

appointment.

SYSTEM MANAGER AND ADDRESS:

Director, HSA Development Programs,

NIH, Building 31, Room 5B35, 9000

Rockville Pike, Bethesda, MD 20892.

NOTIFICATION PROCEDURE:

Write to the System Manager to

determine if a record exists. The

requester must also verify his or her

own identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act subject

to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedure above.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to the official specified under

the notification procedures above, and

reasonably identify the record and

specify the information being contested,

the corrective action sought and your

reason for requesting the correction,

along with supporting information

showing how the record is inaccurate,

incomplete, untimely, irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

The subject individual, educational

institutions attended by the individual,

personal references; and the Office of

Personnel Management.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0105

SYSTEM NAME:

Administration: Health Records of

Employees, Visiting Scientists, Fellows,

Contractors and Others who Receive

Medical Care Through the Employee

Health Unit, HHS/NIH/ORS.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Building 10 and 13, NIH, 9000 Rockville

Pike, Bethesda, MD 20892;

Westwood Building, 5333 Westbard

Ave., Bethesda, MD 20892;

Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857;

Rocky Mountain Laboratories,

Hamilton, Montana 59840.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Employees, fellows, visiting

scientists, relatives of inpatients,

visitors, contractors, and others who

receive medical care through the

Employee Health Unit.

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical records.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

5 U.S.C. 7901.

PURPOSE(S):

1. For medical treatment;

2. Upon researcher request with

individual’s written permission, release

of record for research purposes to

medical personnel;

3. Upon request by HHS personnel

offices for determination of fitness for

duty, and for disability retirement and

other separation actions;

4. For monitoring personnel to assure

that safety standards are maintained.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to Federal,

State, and local government agencies for

adjudication of benefits under

workman’s compensation, and for

disability retirement and other

separation actions.

2. To district office of OPEC,

Department of Labor with copies to the

U.S. Office of Personnel Management

for processing of disability retirement

and other separation actions.

3. Upon non-HHS agency request, for

examination to determine fitness for

duty with copies to requesting agency

and to the U.S. Office of Personnel

Management.

4. Disclosure may be made to a

congressional office from the record of

an individual in response to any inquiry

from the congressional office made at

the request of the individual.

5. 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

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4259

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 any interest in such litigation,

and HHS determines that the use of

such records by the Department of

Justice, 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders.

RETRIEVABILITY:

Records are retrieved by name and

SSN.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project.

Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users: Access is limited

to authorized personnel (system

manager and staff; Occupational

Medicine Service staff; and personnel

and administrative officers with need

for information for fitness for duty,

disability, and other similar

determinations.)

2. Physical safeguards: Files are

maintained in locked cabinets.

3. Procedural safeguards: Access to

files is strictly controlled by authorized

staff.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule, Manual Chapter 1743

(HHS Records Management Manual,

Appendix B–361), item 2300–792–3.

SYSTEM MANAGER(S) AND ADDRESS:

Deputy Director, Division of Safety,

NIH, Building 31, Room 1C02, 9000

Rockville Pike, Bethesda, MD 20892

Chief, Rocky Mountain Operations

Branch, Rocky Mountain Laboratories

(RMS), National Institutes of Health,

Hamilton, MT 59840.

NOTIFICATION PROCEDURE:

Contact System Manager at

appropriate treatment location listed

above, to determine if a record exists.

The requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to 5,000 dollar fine.

RECORD ACCESS PROCEDURES:

Same as notification procedures.

Requester should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURES:

Write to the official specified under

notification procedures above, and

reasonably identify the record and

specify the information being contested,

the corrective action sought, and your

reasons for requesting the correction,

along with supporting information to

show how the record is inaccurate,

incomplete, untimely or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Records contain data resulting from

clinical and preventative services

provided at treatment location, and data

received from individual.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0106

SYSTEM NAME:

Administration: Office of the NIH

Director and Institute/Center/Division

Correspondence Records, HHS/NIH/OD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Executive Secretariat, Office of the

Director, Building 1, Room B1–55,

9000 Rockville Pike, Bethesda, MD

20892

Office of Legislative Policy and

Analysis, Office of the Director,

Building 1, Room 244, 9000 Rockville

Pike, Bethesda, MD 20892

and

Institute/Center/Division Staff Offices

that retain correspondence files. Write

to the appropriate system manager listed

in Appendix I for a list of current

locations and for the address of the

Federal Records Center where records

are stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Individuals who have contacted the

NIH Director or his/her subordinates, or

have been contacted in writing by one

of these officials.

CATEGORIES OF RECORDS IN THE SYSTEM:

Correspondence and other supporting

documents.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

5 USC 301 44 USC 3101.

PURPOSE(S):

1. To control and track all

correspondence documents addressed

or directed to the NIH Director or his/

her subordinates, as well as documents/

supporting documents initiated by

them, in order to assure timely and

appropriate attention.

2. Incoming correspondence and

supporting documentation is forwarded

to other HHS components when a

response from them is warranted.

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 an inquiry

from the congressional office made at

the request of that individual.

2. Disclosure may be made from this

system of records by the Department of

Health and Human Services (HHS) 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 any interest in such litigation,

and HHS determines that the use of

such records by the Department of

Justice, 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.

4260 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored by computer index,

optical image and in file folders.

RETRIEVABILITY:

Records are retrieved by name,

document number, date, and subject.

SAFEGUARDS:

1. Authorized users: Access to textual

records is limited to authorized

personnel (system managers and staff).

2. Physical safeguards. Physical

access to records is restricted to

authorized personnel.

3. Procedural safeguards: Access to

textual records is strictly controlled by

system managers and staff. Records may

be removed from files only at the

request of system managers or other

authorized employees. Computer files

are password protected.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 1700–C, which

allows records to be kept for a

maximum period of 6 years. Refer to the

NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER AND ADDRESS:

System Managers are listed in

Appendix I; each maintains full

responsibility for their specific

correspondence system.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the appropriate system manager as

listed in Appendix I. The requester must

also verify his or her identity by

providing either a notarization of the

request or a written certification that the

requester is who he or she claims to be

and understands that the knowing and

willful request for acquisition of a

record pertaining to an individual under

false pretenses is a criminal offense

under the Act, subject to a five thousand

dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought and the

reasons for the correction. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Records are derived from incoming

and outgoing correspondence.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

Appendix I: System Managers

Director, Executive Secretariat, Office of the

Director, Building 1, Room B1–55, 9000

Rockville Pike, Bethesda, MD 20892

Acting Associate Director, Office of

Legislative Policy and Analysis, Office of

the Director, Building 1, Room 244, 9000

Rockville Pike, Bethesda, MD 20892

National Cancer Institute (NCI), Secretary to

the Director, Building 31, Room 11A48,

Bethesda, MD 20892

National Heart, Lung and Blood Institute

(NHLBI), Secretary to the Director, OD,

Director’s Office, Building 31, Room 5A52,

31 Center Drive, MSC 2486, Bethesda, MD

20892–2486

National Institute of Diabetes and Digestive

and Kidney (NIDDK), Director, OHRR,

Building 31, Room 9A04, Bethesda, MD

20892

National Institute of Environmental Health

Sciences (NIEHS), Executive Secretariat,

PO Box 12233, South Campus, Building 2,

Room B201, Research Triangle Park, NC

27709

National Eye Institute (NEI), Administrative

Officer, Building 31, Room 6A19, 31 Center

Drive MSC 2510, Bethesda, MD 20892–

2510

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

(NIAMS), Director, Office of Scientific and

Health Communications, Building 31,

Room 4C05, Bethesda, MD 20892

National Institute on Deafness and Other

Communication Disorders (NIDCD), Chief,

Administrative Management Branch,

Building 31, Room 3C21, Bethesda, MD

20892

National Institute of General Medical Science

(NIGMS), Secretary to the Director,

Westwood Building, Room 926, Bethesda,

MD 20892

National Library of Medicine (NLM),

Executive Assistant, Office of the Director,

Building 38, Room 2E17, Bethesda, MD

20894

Fogarty International Center (FIC), Secretary

to the Director, Building 31, Room B2C06,

Bethesda, MD 20892

Office of Aides Research (OAR), Special

Assistant for Liaison Activities, Building

31, Room 5C12, Bethesda, MD 20892

National Institute on Drug Abuse (NIDA),

Executive Secretariat, Room 10–15,

Parklawn Building, Rockville, MD 20857

National Institute on Alcohol Abuse and

Alcoholism (NIAAA), Executive

Secretariat, Willco Building, Suite 400,

6000 Executive Blvd. MSC 7003, Bethesda,

MD 20892–7003

National Institute of Mental Health (NIMH),

Executive Secretariat, Room 17C–25,

Parklawn Building, Rockville, MD 20857

Washington National Records Center, 4205

Suitland Road, Washington, DC 20857

09–25–0112

SYSTEM NAME:

Grants and Cooperative Agreements:

Research, Research Training,

Fellowship and Construction

Applications and Related Awards, HHS/

NIH/OD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

See Appendix I.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Grant applicants and Principal

Investigators; Program Directors;

Institutional and Individual Fellows;

Research Career Awardees; and other

employees of Applicant and/or grantee

institutions.

CATEGORIES OF RECORDS IN THE SYSTEM:

Grant and cooperative agreement

applications and review history, awards,

financial records, progress reports,

payback records, and related

correspondence.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

‘‘Research and Investigation,’’

‘‘Appointment and Authority of the

Directors of the National Research

Institutes,’’ ‘‘National Institute of Mental

Health,’’ ‘‘National Institute on Drug

Abuse,’’ ‘‘National Institute on Alcohol

Abuse and Alcoholism,’’ ‘‘National

Cancer Institute,’’ ‘‘National Heart, Lung

and Blood Institute,’’ ‘‘National Institute

of Diabetes, and Digestive and Kidney

Diseases,’’ ‘‘National Institute of

Arthritis and Musculoskeletal and Skin

Diseases,’’ ‘‘National Institute on

Aging,’’ ‘‘National Institute on Allergy

and Infectious Diseases,’’ ‘‘National

Institute of Child Health and Human

Development,’’ ‘‘National Institute of

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4261

Dental Research,’’ ‘‘National Eye

Institute,’’ ‘‘National Institute of

Neurological Disorders and Stroke,’’

National Institute of General Medical

Sciences,’’ ‘‘National Institute of

Environmental Health Sciences,’’

‘‘National Institute on Deafness and

Other Communication Disorders,’’

‘‘National Institute of Nursing

Research,’’ and the ‘‘National Library of

Medicine,’’ of the Public Health Service

Act. (42 U.S.C. 241, 284, 285, 285(b), (c),

(d), (e), (f), (g), (h), (i), (j), (k), (l), (m),

286b–286b–7.

PURPOSE(S):

1. Information provided is used by

NIH staff for review, award, and

administration of grant programs.

2. Information is also used to

maintain communication with former

fellows who have incurred an obligation

through the National Research Service

Award Program.

3. Staff may also use curriculum vitae

to identify candidates who may serve as

ad hoc consultants or committee and

council members in the grant peer

review process.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made of

assignments of research investigators

and project monitors to specific research

projects to the National Technical

Information Service (NTIS), Department

of Commerce, to contribute to the

Smithsonian Science Information

Exchange, Inc.

2. Disclosure may be made to the

cognizant audit agency for auditing.

3. 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, the

Department may disclose such records

as it deems desirable or necessary to the

Department of Justice to enable that

Department to present an effective

defense, provided such disclosure is

compatible with the purpose for which

the records were collected.

4. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

5. Disclosure may be made to

qualified experts not within the

definition of Department employees as

prescribed in Department Regulations,

45 CFR 56.2, for opinions as a part of

the application review and award

administration processes.

6. Disclosure may be made to a

Federal agency, in response to its

request, in connection with the letting

of a contract, or the issuance of a

license, grant or other benefit by the

requesting agency, to the extent that the

record is relevant and necessary to the

requesting agency’s decision on the

matter.

7. 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, (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.

8. Disclosure may be made to a

private firm for the purpose of collating,

analyzing, aggregating or otherwise

refining records in a system. Relevant

records will be disclosed to such a

contractor. The contractor shall be

required to maintain Privacy Act

safeguards with respect to such records;

9. Disclosure may be made to the

grantee institution in connection with

the review of an application or

performance or administration under

the terms and conditions of the award,

or in connection with problems that

might arise in performance or

administration if an award is made on

a grant proposal.

10. Disclosure may be made to the

profit institution’s president or official

responsible for signing the grant

application in connection with the

review or award of a grant application

and in connection with the

administration and performance of a

grant under the terms and conditions of

the awards.

DISCLOSURE TO CONSUMER REPORTING

AGENCIES:

Disclosures pursuant to 5 U.S.C.

552a(b)(12): Disclosures may be made

from this system to ‘‘consumer reporting

agencies’’ as defined in the Fair Credit

Reporting Act (15 U.S.C. 1681a(f)) or the

Federal Claims Collection Act of 1966

(31 U.S.C. 3701(a)(3)).

The Department may disclose to

consumer reporting agencies

information on individuals who have

failed to meet payback obligations

incurred under awards made under

authority of the National Research

Service Awards Program (41 U.S.C.

289l–1). Information disclosed includes

data identifying the individual, the

amount, status and history of the

obligation, and that the obligation arose

from an award made under the National

Research Service Awards Program.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Stored in file folders, on computer

tapes and discs, cards and in notebooks.

RETRIEVABILITY:

Retrieved by name and grant number.

SAFEGUARDS:

A variety of physical and procedural

safeguards are implemented, as

appropriate, at the various locations of

this system:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

officials whose duties require use of the

information. These officials include

review groups, grants management staff,

other extramural program staff, health

scientist administrators, data processing

and analysis staff and management

officials with oversight responsibilities

for extramural programs. Other one-time

and special access is granted on an

individual basis as specifically

authorized by the system manager.

Authorization for access to

4262 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

computerized files is controlled by the

system manager or designated official

and is granted on a need-to-know basis.

Lists of authorized users are maintained.

2. Physical safeguards: Secured

facilities, locked rooms, locked cabinets,

personnel screening; records stored in

order of grant numbers which are

randomly assigned.

3. Procedural safeguards: Access to

file rooms and files is strictly controlled

by files staff or other designated

officials; charge-out cards identifying

users are required for each file used;

inactive records are transferred to

controlled storage in Federal Records

Center in a timely fashion; retrieval of

records from inactive storage is

controlled by the system manager or

designated official and by the NIH

Records Management Officer; computer

files are password protected and access

is actively monitored by the Computer

Center to prevent abuse. Employees are

given specialized training in the

requirements of the Privacy Act as

applied to the grants program.

These particular safeguards are

developed in accordance with Chapter

45–13, ‘‘Safeguarding Records

Contained in Systems of Records,’’ of

the HHS General Administration

Manual, supplementary Chapter PHS hf:

45–13, and Part 6, ‘‘ADP Systems

Security’’, of the HHS Information

Resources Management Manual and the

National Institute of Standards and

Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), items: 4000–B–1;

4000–B–4; 4000–C–1 and, 4600–D–1.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

See Appendix II.

NOTIFICATION PROCEDURE:

Write to Official at the address

specified in Appendix II to determine if

a record exists. The requester must also

verify his or her identity by providing

either a notarization of the request or a

written certification that the requester is

who he or she claims to be and

understands that the knowing and

willful request for acquisition of a

record pertaining to an individual under

false pretenses is a criminal offense

under the Act, subject to a five thousand

dollar fine.

RECORD ACCESS PROCEDURE:

Write to the official at the address

specified in Appendix IV to obtain

access to a record, and provide the same

information as is required under the

Notification Procedures above.

Requesters should also reasonably

specify the record contents being

sought.

Individuals may also request listings

of accountable disclosures that have

been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official at the address

specified in Appendix II, and

reasonably identify the record and

specify the information being contested,

the corrective action sought, and your

reasons for requesting the correction,

along with supporting information to

show how the record is inaccurate,

incomplete, untimely or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Information by applicant;

supplemented by outside reviewers and

internal staff.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

Appendix I: System Location

National Cancer Institute, Executive Plaza

South, Suite T–42, 6120 Executive

Boulevard, Bethesda, MD 20892

National Heart, Lung, and Blood Institute,

Westwood Building, Room 4A09, 5333

Westbard Avenue Bethesda, MD 20892

National Library of Medicine, Building 38A,

Room 5N509, 8600 Rockville Pike,

Bethesda, MD 20894

National Institute of Allergy and Infectious

Diseases, Chief, Grants Management

Branch, DEA, Solar Bldg., Room 4C–09,

6003 Executive Blvd., Rockville, MD 20892

National Institute of Allergy and Infectious

Diseases, Chief, Management Information

Systems Section, FMISB, OAM, Solar

Building, Room 4A–03, 6003 Executive

Blvd., Rockville, MD 20892

National Institute of Diabetes and Digestive

and Kidney Diseases, Westwood Building,

Room 610, 5333 Westbard Avenue,

Bethesda, MD 20892

National Institute of Arthritis and

Musculoskeletal and Skin Diseases,

Westwood Building, Room 5A03, 5333

Westbard Avenue, Bethesda, MD 20892

National Institute of Child Health and

Human Development, 6100 Executive

Blvd., Room 7A07, Bethesda, MD 20892

National Institute on Aging, Gateway

Building, Room 2N–212, 7201 Wisconsin

Avenue, Bethesda, MD 20892

National Institute of Dental Research, Grants

Management Officer, Natcher Building,

Room 4AS–55, 45 Center Drive, MSC 6402,

Bethesda, MD 20892–6402

National Institute of Environmental Health

Sciences, Grants Management Officer,

Building 2, Room 204, 104 Alexander

Drive, Research Triangle Park, NC 27709

National Institute of General Medical

Sciences, Grants Management Officer,

Natcher Building, Room 2AN52, 9000

Rockville Pike, Bethesda, MD 20892

National Institute of Neurological Disorders

and Stroke, Federal Building, Room 10A12,

7550 Wisconsin Avenue, Bethesda, MD

20892

National Institute on Deafness and Other

Communication Disorders, Executive Plaza

South, Room 400B, 6120 Executive

Boulevard, Rockville, MD 20852

National Eye Institute, Executive Plaza

South, Room 350, 6120 Executive

Boulevard, Bethesda, MD 20892

National Center for Research Resources,

Westwood Building, Room 853, 5333

Westbard Avenue, Bethesda, MD 20892

National Institute of Nursing Research,

Building 45, Room 3AN32 MSC 6301,

Bethesda, MD 20892–6301

Fogarty International Center, Building 31,

Room B2C32, 9000 Rockville Pike,

Bethesda, MD 20892

Washington National Records Center, 4205

Suitland Road, Suitland, MD 20409

National Institute on Drug Abuse, Grants

Management Branch, Room 8A–54,

Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857

National Institute on Alcohol Abuse and

Alcoholism, Grants Management Branch,

Willco Building, Suite 504, 6000 Executive

Blvd. MSC 7003, Bethesda, MD 20892–

7003

National Institute of Mental Health, Grants

Management Branch, ORM, Room 7C–15,

Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857

Appendix II: System Manager and Address

National Cancer Institute, Grants

Management Analyst, Executive Plaza

South, Suite 234, 6120 Executive

Boulevard, Bethesda, MD 20892

National Heart, Lung, and Blood Institute,

Chief, Grants Operations Branch, Division

of Extramural Affairs, Westwood Building,

Room 4A10, 5333 Westbard Avenue,

Bethesda, MD 20892

National Library of Medicine, Associate

Director for Extramural Programs, Building

38A, Room 5N505, 8600 Rockville Pike,

Bethesda, MD 20894

National Institute of Allergy and Infectious

Diseases, Chief, Grants Management

Branch, DEA, Solar Bldg., Room 4B–21,

6003 Executive Blvd., Bethesda, MD 20892

National Institute of Allergy and Infectious

Diseases, Chief, Management Information

Systems Section, FMISB, OAM, Solar

Building, Room 4A–03, 6003 Executive

Blvd., Bethesda, MD 20892

National Institute of Arthritis and

Musculoskeletal and Skin Diseases, Grants

Management Officer, Westwood Building,

Room 407, 5333 Westbard Avenue,

Bethesda, MD 20892

National Institute of Diabetes and Digestive

and Kidney Diseases, Grants Management

Officer, Room 637, Westwood Building,

5333 Westbard Avenue, Bethesda, MD

20892

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4263

National Institute of Child Health and

Human Development, Chief, Office of

Grants & Contracts, 6100 Executive Blvd.,

Room 8A01, Bethesda, MD 20892

National Institute on Aging, Grants

Management Officer, Gateway Building,

Room 2N–212, 7201 Wisconsin Avenue,

Bethesda, MD 20892

National Institute of Dental Research, Grants

Management Officer, NIDR, Natcher

Building, Room 4AS–55, 45 Center Drive

MSC 6402, Bethesda, MD 20892–6402

National Institute of Environmental Health

Sciences, Grants Management Officer,

Building 2, Room 204, 104 Alexander

Drive, Research Triangle Park, NC 27709

National Institute of General Medical

Sciences, Grants Management Officer,

NIGMS, Natcher Building, Room 2AN24,

9000 Rockville Pike, Bethesda, MD 20892

National Institute of Neurological Disorders

and Stroke, Grants Management Officer,

Federal Building, Room 1004A, Bethesda,

MD 20892

National Institute on Deafness and Other

Communication Disorders, Grants

Management Officer, Executive Plaza

South, Room 400B, 6120 Executive

Boulevard, Rockville, MD 20852

National Institute of Nursing Research,

Grants Management Officer, Building 45,

Room 3AN32 MSC 6301, Bethesda, MD

20892–6301

National Eye Institute, Grants Management

Officer, Executive Plaza South, Room 350,

6120 Executive Boulevard, Bethesda, MD

20892

National Center for Research Resources,

Director, Office of Grants and Contracts

Management, Westwood Building, Room

853, 5333 Westbard Avenue, Bethesda, MD

20892

Fogarty International Center, Scientific

Review Administrator, International

Studies Branch, Building 31, Room B2C32,

9000 Rockville Pike, Bethesda, MD 20892

National Institute on Drug Abuse, Chief,

Grants Management Branch, Room 8A–54,

Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857

National Institute on Alcohol Abuse and

Alcoholism, Chief, Grants Operation

Section, Willco Building, Suite 504, 6000

Executive Blvd. MSC 7003, Bethesda, MD

20892–7003

National Institute of Mental Health, Grants

Management Officer, ORM, Room 7C–15,

Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857

Appendix III: Notification Procedures

National Cancer Institute, See Appendix II

National Heart, Lung, and Blood Institute,

Privacy Act Coordinator, Building 31,

Room 5A10, 31 Center Drive, MSC 2490,

Bethesda, MD 20892–2490

National Library of Medicine, See Appendix

II

National Institute of Allergy and Infectious

Diseases, See Appendix II

National Institute of Diabetes and Digestive

and Kidney Diseases, Administrative

Officer, Building 31, Room 9A46, 9000

Rockville Pike, Bethesda, MD 20892

National Institute of Child Health and

Human Development, See Appendix II

National Institute of Aging, See Appendix II

National Institute of Dental Research, NIDR

Privacy Act Coordinator, Building 31,

Room 2C–35, 9000 Rockville Pike,

Bethesda, MD 20892

National Institute of Environmental Health

Services, See Appendix II

National Institute of General Medical

Sciences, See Appendix II

National Institute of Neurological Disorders

and Stroke, See Appendix II

National Institute on Deafness and Other

Communication Disorders, See Appendix

II

National Eye Institute, See Appendix II

National Center for Nursing Research, See

Appendix II

National Center for Research Resources, See

Appendix II

Fogarty International Center, See Appendix II

National Institute on Drug Abuse, See

Appendix II

National Institute on Alcohol Abuse and

Alcoholism, See Appendix II

National Institute of Mental Health, Privacy

Act Coordinator, Room 15–81, Parklawn

Building, 5600 Fishers Lane, Rockville, MD

20857

Appendix IV: Records Access Procedures

Naitonal Cancer Institute, Privacy Act

Coordinator, Building 31, Room 10A30,

9000 Rockville Pike, Bethesda, MD 20892

National Heart, Lung, and Blood Institute,

See Appendix III

National Library of Medicine, See Appendix

II

National Institute of Allergy and Infectious

Diseases, Privacy Act Coordinator, Solar

Bldg., Room 3C–23, Bethesda, MD 20892

National Institute of Diabetes and Digestive

and Kidney Diseases, See Appendix II

National Institute of Child Health and

Human Development, See Appendix II

National Institute on Aging, See Appendix II

National Institute of Dental Research, Grants

Management Officer, Westwood Building,

Room 518, 5333 Westbard Avenue,

Bethesda, MD 20892

National Institute of Environmental Health

Sciences, See Appendix II

National Institute of General Medical

Sciences, Privacy Act Coordinator, Natcher

Building, Room 3AS43, 9000 Rockville

Pike, Bethesda, MD 20892

National Institute of Neurological Disorders

and Stroke, Chief, Administrative Services

Branch, Building 31, Room 8A49, 9000

Rockville Pike, Bethesda, MD 20892

National Institute on Deafness and Other

Communication Disorders, Chief,

Administrative Management Branch,

Building 31, Room 3C02, 9000 Rockville

Pike, Bethesda, MD 20892

National Eye Institute, Administrative

Officer, Building 31, Room 6A17, 9000

Rockville Pike, Bethesda, MD 20892

National Center for Research Resources,

Privacy Act Coordinator, Westwood

Building, Room 10A15, 5333 Westbard

Avenue, Bethesda, MD 20892

Fogarty International Center, See Appendix II

National Institute on Drug Abuse, See

Appendix II

National Institute on Alcohol Abuse and

Alcoholism, See Appendix II

National Institute of Mental Health, See

Appendix II

National Institute of Nursing Research, See

Appendix II.

09–25–0118

SYSTEM NAME:

Contracts: Professional Services

Contractors, HHS/NIH/NCI.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Building 31, Room 3A44, DCT, 9000

Rockville Pike, Bethesda, MD 20892

Building 31, Room 11A33, OD, 9000

Rockville Pike, Bethesda, MD 20892

Executive Plaza North, Room 604, DEA,

9000 Rockville Pike, Bethesda, MD

20892

Building 31, Room 11A11, DCE, 9000

Rockville Pike, Bethesda, MD 20892

Building 31, Room 10A50, DCPC, 9000

Rockville Pike, Bethesda, MD 20892

Write to System Manager at the

address below for the address of the

Federal Records Center where records

may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Individuals under contract with the

National Cancer Institute.

CATEGORIES OF RECORDS IN THE SYSTEM:

Professional Services Contracts.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241(d), 281.

PURPOSE(S):

Used by staff for general

administrative purposes to assure

compliance with contract program

requirements.

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 an inquiry

from the congressional office made at

the request of that individual.

2. 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

individual capacity where the Justice

Department has agreed to represent such

employee, the Department may disclose

such records as it deems desirable or

necessary to the Department of Justice to

4264 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

enable that Department to present an

effective defense, provided such

disclosure is compatible with the

purpose for which the records were

collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Stored in file folders.

RETRIEVABILITY:

Retrieved by name.

SAFEGUARDS:

1. Authorized users: Access is limited

to authorized personnel (system

manager and staff).

2. Physical safeguards: Records are

maintained in offices which are locked

when not in use.

3. Procedural safeguards: Access to

files is strictly controlled by system

manager and staff.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 2600–A–4,

which allows records to be destroyed

after a maximum period of 6 years and

3 months after final payment. Refer to

the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Administrative Officer, DCT, Building

31, Room 3A44, 9000 Rockville Pike,

Bethesda, MD 20892

Administrative Officer, OD, National

Institutes of Health, Building 31,

Room 11A33, 9000 Rockville Pike,

Bethesda, MD 20892

Administrative Officer, DEA, Executive

Plaza North, Room 604, 9000

Rockville Pike, Bethesda, MD 20892

Administrative Officer, DCE, Building

31, Room 11A11, 9000 Rockville Pike,

Bethesda, MD 20892

Administrative Officer, DCPC, Building

31, Room 10A50, 9000 Rockville Pike,

Bethesda, MD 20892

NOTIFICATION PROCEDURE:

Write to the appropriate System

Manager listed above to determine if a

record exists. The requester must also

verify his or her identity by providing

either a notarization of the request or a

written certification that the requester is

who he or she claims to be and

understands that the knowing and

willful request for acquisition of a

record pertaining to an individual under

false pretenses is a criminal offense

under the Act, subject to a five thousand

dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Individuals in the system.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0126

SYSTEM NAME:

Clinical Research: National Heart,

Lung, and Blood Institute

Epidemiological and Biometric Studies,

HHS/NIH/NHLBI.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Records included in this system are

located in hospitals, universities,

research centers, research foundations,

and coordinating centers under contract

with the National Heart, Lung, and

Blood Institute, and in NHLBI facilities

in Bethesda, Maryland. Write to the

system manager at the address below for

a list of locations, including the address

of any Federal Records Center where

records from this system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Participants in these studies include

(1) individuals who have been or who

are presently being treated by the

National Heart, Lung, and Blood

Institute, for diseases or conditions of

the heart, lung, blood vessels and blood;

(2) individuals whose physical, genetic,

social, economic, environmental,

behavioral or nutritional conditions or

habits are being studied in relation to

the incidence of heart, lung, blood

vessel and blood diseases among human

beings; and (3) normal volunteers who

have agreed to provide control data

germane to these studies.

CATEGORIES OF RECORDS IN THE SYSTEM:

This system consists of a variety of

clinical, medical, and statistical

information resulting from or contained

in research findings, medical histories,

vital statistics, personal interviews,

questionnaires, or direct observation.

The system also includes records of

current addresses of study participants,

photographs, fingerprints, and

correspondence from or about

participants in these studies.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Sec. 412, 413 of the Public Health

Service Act (42 U.S.C. 287a, 287b).

PURPOSE(S):

(1) Summaries of data resulting from

these studies are used by the National

Heart, Lung, and Blood Institute to

monitor and evaluate the incidence of

the diseases or the conditions under

investigation and the relationship of

various factors to the occurrence of

these diseases.

(2) The summaries are also used for

program planning and evaluation

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 HHS

contractors, grantees and collaborating

researchers and their staff in order to

accomplish the research purpose for

which the records are collected. The

recipients are required to protect such

records from improper disclosure.

2. Referrals may be made of

assignments of research investigators

and project monitors to specific research

projects to the Smithsonian Institution

to contribute to the Smithsonian

Science Information Exchange, Inc.

3. In the event the Department deems

it desirable or necessary, in determining

whether particular records are required

to be disclosed under the Freedom of

Information Act, disclosures may be

made to the Department of Justice for

the purpose of obtaining its advice.

4. Where the appropriate official of

the Department, pursuant to the

Department’s Freedom of Information

Regulation determines that it is in the

public interest to disclose a record

which is otherwise exempt from

mandatory disclosure, disclosure may

be made from this system of records.

5. The Department contemplates that

it will contract with a private firm for

the purpose of collating, analyzing,

aggregating or otherwise refining

records in this system. Relevant records

will be disclosed to such a contractor.

The contractor shall be required to

maintain Privacy Act safeguards with

respect to such records.

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4265

6. 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice or other appropriate Federal

agency to enable that agency to present

an effective defense, provided that such

disclosure is compatible with the

purpose for which the records were

collected.

7. Disclosure may be made to

organizations deemed qualified by the

Secretary to carry out quality

assessments, medical audits or

utilization review.

8. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

9. 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, (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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders,

magnetic tapes or discs, punched cards,

bound note books.

RETRIEVABILITY:

Name and/or participant

identification number.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

authorized researchers, physicians and

their assistants whose duties require the

use of such information.

2. Physical safeguards: Records are

kept in locked file cabinets and in some

instances in locked offices or guarded

buildings. Locations are locked during

non-working hours, and are attended at

all times during working hours.

3. Procedural safeguards: Access to

the data is controlled by the System

Manager and the Project Officer. Data

stored in computers is accessed through

the use of key words known only to

principal investigators or authorized

personnel.

The particular safeguards

implemented at each site are developed

in accordance with Chapter 45–13,

‘‘Safeguarding Records Contained in

Systems of Records,’’ of the HHS

General Administration Manual,

supplementary Chapter PHS.hf: 45–13,

and Part 6, ‘‘ADP Systems Security’’, of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Senior Scientific Advisor, OD, Division

of Epidemiology and Clinical

Applications, National Heart, Lung,

and Blood Institute, Federal Building,

Room 220, 7550 Wisconsin Avenue,

Bethesda, MD 20892.

NOTIFICATION PROCEDURE:

To determine if a record exists,

contact: NHLBI Privacy Coordinator,

Building 31, Room 5A–08, National

Institutes of Health, 9000 Rockville

Pike, Bethesda, MD 20892.

Requesters must provide the

following information in writing:

1. Full name

2. Name and location of research

study

3. Approximate dates of enrollment.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical/

dental record shall, at the time the

request is made, designate in writing a

responsible representative who will be

willing to review the record and inform

the subject individual of its contents at

the representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to System Manager as indicated

above. The contestor must reasonably

4266 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

specify in writing the record contents at

issue and state the corrective action

sought and the reasons for the

correction. The right to contest with

supporting justification. The record is

limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Information contained in these

records is obtained directly from

individual participants and from

medical and clinical research

observations.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0128

SYSTEM NAME:

Clinical Research: Neural Prosthesis &

Biomedical Engineering Studies, HHS/

NIH/NINDS.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Federal Building, Room 9C02, 7550

Wisconsin Ave., Bethesda, MD 20892

and: (1) At hospitals and medical

centers under contract, and (2) Federal

Records Centers. A list of locations is

available upon request from the system

manager.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Patients and normal volunteers, males

and females, participating in clinical

studies to determine the feasibility of

neural prostheses, and in clinical

studies related to the development of

instrumentation for diagnosis and

treatment of neurological and sensory

disorders conducted under contract for

the National Institute of Neurological

Disorders and Stroke (NINDS).

CATEGORIES OF RECORDS IN THE SYSTEM:

Clinical research data as related to

studies which seek to determine the

feasibility of neural prostheses and to

develop instrumentation for diagnosis

and treatment of neurological and

sensory disorders.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 421, 289a, 289c.

PURPOSE(S):

(1) Clinical research on the

development of neural prosthesis

(artificial devices) to enhance function

of individuals with various disorders of

the central nervous system.

(2) Research on the development of

new instruments to improve diagnosis

and treatment of disorders of the

nervous system.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors, grantees and collaborating

researchers and their staff in order to

accomplish the research purpose for

which the records are collected. The

recipients are required to protect such

records from improper disclosure.

2. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

3. 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice or other appropriate Federal

agency to enable that agency to present

an effective defense, provided that such

disclosure is compatible with the

purpose for which the records were

collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders.

RETRIEVABILITY:

Records are retrieved by name.

SAFEGUARDS:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant access only to HHS

scientists and their authorized

collaborators.

2. Physical safeguards: Records are

kept in a locked room when not in use.

3. Procedural safeguards: Personnel

having access to this system are

informed of Privacy Act requirements.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Head, Neural Prosthesis Program,

NINDS, Federal Building, Room 916,

7550 Wisconsin Ave., Bethesda, MD

20892

NOTIFICATION PROCEDURE:

Write to:

Chief, Administrative Services Branch,

NINDS, Building 31, Room 8A49,

9000 Rockville Pike, Bethesda, MD

20892

and ask if a file with your name exists

in the Neural Prosthesis or Biomedical

Engineering Studies. The requester must

also verify his or her identity by

providing either a notarization of the

request or a written certification that the

requester is who he or she claims to be

and understands that the knowing and

willful request for acquisition of a

record pertaining to an individual under

false pretenses is a criminal offense

under the Act, subject to a five thousand

dollar fine.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing, a

responsible representative, who may be

a physician, who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

RECORD ACCESS PROCEDURES:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURES:

Write to system manager and

reasonably identify the record and

specify the information to be contested,

and state the corrective action sought

and the reasons for the correction.

RECORD SOURCE CATEGORIES:

Patients, patients’ families, hospital

records and clinical investigators.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4267

09–25–0129

SYSTEM NAME:

Clinical Research: Clinical Research

Studies Dealing with Hearing, Speech,

Language and Chemosensory Disorders,

HHS/NIH/NIDCD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institute on Deafness and

Other Communication Disorders

(NIDCD); 6120 Executive Boulevard,

Rockville, MD 20852

and at hospitals, medical centers,

universities and educational settings

under contract. Inactive records may be

stored at a Federal Records Center. A

list of locations is available upon

request from the System Manager at the

address below.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Patients and normal volunteers

participating in clinical research studies

dealing with hearing, speech, language

and chemosensory disorders.

CATEGORIES OF RECORDS IN THE SYSTEM:

Medical findings, clinical research

data, medical and educational histories

and research data on the hearing,

speech, language, cognition and

chemosensory systems of subjects being

tested.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, 289a, 289c.

PURPOSE(S)

Clinical research on the disorders of

speech, language, and hearing to

discover factors leading to these

disorders and to improve prevention,

diagnoses, and treatment.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors, grantees and collaborating

researchers and their staff in order to

accomplish the research purpose for

which the records are collected. The

recipients are required to protect such

records from improper disclosure.

2. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

3. 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 against a claim 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, the Department may

disclose such records as its deems

desirable or necessary to the Department

of Justice or other appropriate Federal

agency to enable that agency to present

an effective defense, provided that such

disclosure is compatible with the

purpose for which the records were

collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders.

RETRIEVABILITY:

Name or identifier code.

SAFEGUARDS:

1. Authorized users: Employees who

maintain the system are instructed to

grant access only to the principal

investigator and staff assigned to a

particular project, and to other

authorized personnel (project officer,

contracting officer).

2. Physical safeguards: Records are

locked in cabinets when not in actual

use and system location is locked

during non-working hours.

3. Procedural safeguards: Personnel

having access to system are trained in

Privacy Act requirements. Records are

returned to locked file cabinets at end

of working day.

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–3610, item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Director, Division of Human

Communication, NIDCD, Executive

Plaza South, Room 400B, 6120

Executive Boulevard, Rockville, MD

20852

NOTIFICATION PROCEDURE:

Write to:

Chief, Administrative Management

Branch, NIDCD, Building 31, Room

3C21, 9000 Rockville Pike, Bethesda,

MD 20892

and ask if a file exists with your name

in studies of the Division of

Communication Sciences and Disorders.

Please supply the following

information:

1. Approximate date and place of

examination and/or treatment.

2. Name of the study, if known.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing, a

responsible representative, who may be

a physician, who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to system manager and

reasonably identify the record, specify

the information to be contested, and

state the corrective action sought and

the reasons for the correction. The right

to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Information provided by patients,

patients’ families, hospital records,

school records, and clinical

investigators.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0140

SYSTEM NAME:

International Activities: International

Scientific Researchers in Intramural

Laboratories at the National Institutes of

Health, HHS/NIH/FIC.

4268 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Fogarty International Center, Building

16A, Room 101, 9000 Rockville Pike,

Bethesda, MD 20892

and

Division of Computer Research and

Technology, Building 12A, Room

3061, National Institutes of Health,

9000 Rockville Pike, Bethesda, MD

20892

Ancillary records are located in the

Office of the Associate Director for

Intramural Affairs, laboratories,

administrative and personnel offices

where participants are assigned. Write

to System Manager at the address below

for the address of the Federal Records

Center where records are stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Health scientists at all levels of their

postdoctoral or equivalent research

careers who are invited to the National

Institutes of Health for further training

or to conduct research in their

biomedical specialties under the

auspices of FIC’s administration of

International Activities. Most of these

scientists are foreign, however, some

may be resident aliens or U.S. citizens.

Individuals in these categories

include Visiting Associates, Visiting

Scientists, Foreign Special Experts who

are employees and Visiting Fellows,

Guest Researchers, Exchange Scientists,

International Research Fellows, Fogarty

Scholars, Special Volunteers, Adjunct

Scientists and Residents who are not

employees.

CATEGORIES OF RECORDS IN THE SYSTEM:

History of fellowship, employment

and/or stay at NIH; education,

immigration data and references. For

payroll purposes, social security

numbers are requested of all applicants

accepted into the program.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 USC 2421 and section 307 of the

Public Health Service Act.

PURPOSE(S)

To document the individual’s

presence at the NIH, to record

immigration history of the individual in

order to verify continued eligibility in

existing programs, and to meet

requirements in the Code of Federal

Regulations (8 CFR, ‘‘Aliens and

Nationality,’’ and 22 CFR, ‘‘Foreign

Relations’’).

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Information is made available to

authorized employees and agents of the

U.S. Government including, but not

limited to, the General Accounting

Office, the Internal Revenue Service,

and the FBI and Immigration and

Naturalization Service, Department of

Justice, for purposes of investigations,

inspections and audits.

2. Disclosures may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of the individual.

3. 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 any interest in such litigation,

and HHS determines that the use of

such records by the Department of

Justice, 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders,

computer tapes, and computer disks.

RETRIEVABILITY:

By name, country of citizenship,

country of birth, gender, fellowship case

number, visa and immigration status,

program category, NIH Institute and lab,

sponsor, degree attained, stipend or

salary level, dates of stay at NIH,

termination date, work address and

telephone number, and home address.

SAFEGUARDS:

A variety of safeguards is

implemented for the various sets of

records included under this system

according to the sensitivity of the data

they contain.

1. Authorized users: NIH

administrative and personnel staff

screened by FIC staff to access

information on a need-to-know basis.

Only FIC staff are authorized to add,

change, or delete data. Access by other

employees is granted on a need-to-know

basis as specifically authorized by the

system manager.

2. Physical safeguards: The records

are maintained in file cabinets in offices

that are located during off-duty hours.

3. Procedural safeguards. Access to

files is strictly controlled by files staff.

Records may be removed from files only

at the request of the system manager or

other authorized employees. For

computerized records, access is

controlled by the use of security codes

known only to authorized users; access

codes are changed periodically. The

computer system maintains an audit

record of all requests for access.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 2300–320,

which allows records to be destroyed

after a maximum period of 6 years after

the close of a case. Refer to the NIH

Manual Chapter for specific disposition

instructions.

SYSTEM MANAGER AND ADDRESS:

Chief, International Services and

Communications Branch, National

Institutes of Health, Fogarty

International Center, Building 16A,

Room 101, 16A Center Drive MSC

6710, Bethesda, MD 20892–6710

NOTIFICATION PROCEDURE:

Write to the System Manager to

determine if a record exists. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4269

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedure.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official listed under

notification procedure above, and

reasonably identify the record, and

specify the information to be contested,

and state the corrective action sought

and the reasons for the correction. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Subject individuals and other federal

agencies.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0142

SYSTEM NAME:

Clinical Research: Records of Subjects

in Intramural Research, Epidemiology,

Demography and Biometry Studies on

Aging, HHS/NIH/NIA.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Records included in this system will

be located in hospitals and clinics,

research centers and research

foundations, and in facilities of the

National Institute on Aging (NIA) in

Bethesda, MD. They may be stored at

Federal Records Centers. A list of

locations is available upon request from

the System Manager.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Participants in these studies will

include: (1) Individuals whose physical,

genetic, social, psychological, cultural,

economic, environmental, behavioral,

pharmacological, or nutritional

conditions or habits are studied in

relationship to the normal aging process

and/or diseases and other normal or

abnormal physical or psychological

conditions of the aged, and (2) normal

volunteers who are participants in such

studies.

CATEGORIES OF RECORDS IN THE SYSTEM:

This system will consist of a variety

of health, demographic, and statistical

information resulting from or contained

in research findings, medical histories,

vital statistics, personal interviews,

questionnaires, or direct observations.

The system will also include records of

current addresses of study participants,

and correspondence from or about

participants in the studies. When

supplied on a voluntary basis, Social

Security numbers will also be included.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Authority is provided by Section 301,

Research Contracting, and 463–4, Health

Research Extension Act of 1985, Pub. L.

99–158.

PURPOSE(S):

The National Institute on Aging will

use the data collected; (1) in research

projects on (a) the health status of

individuals and changes in health status

over time, (b) the incidence and

prevalence of certain diseases and

problems of the aged in certain

populations, and (c) the changes that

take place as individuals age; (2) and for

program planning and evaluation.

ROUTINE USE OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Records may be disclosed to HHS

contractors, collaborating researchers

and their staffs in order to accomplish

the basic research purpose of this

system. The recipients will be required

to maintain Privacy Act safeguards with

respect to such records.

2. Data may be disclosed to

organizations deemed qualified by the

Secretary to carry out quality

assessment, medical audits or

utilization review.

3. 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, (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.

4. In the event the Department deems

it desirable or necessary, in determining

whether particular records are required

to be disclosed under the Freedom of

Information Act, disclosure may be

made to the Department of Justice for

the purpose of obtaining its advice.

5. 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, the

Department may disclose such records

as it deems desirable or necessary 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.

6. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of the individual.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders,

boxes, network drives, magnetic tapes or

discs, punched cards, or bound

notebooks. Stored data may include

textual, photographic, X-ray, or other

material.

RETRIEVABILITY:

Information will be retrieved by

personal identifiers such as name, code

number and/or Social Security number,

when this is supplied on a voluntary

basis.

4270 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users: Access will be

limited to principal investigators,

collaborating researchers and necessary

support staff.

2. Physical safeguards: Hard copy

data will be maintained in locked file

cabinets. Information stored in

computer systems will be accessible

only through proper sequencing of

signal commands and access codes

specifically assigned to the Project

Officer or contractor.

3. Procedural safeguards: Access to

the information will be controlled

directly by the Project Officer or his or

her representative at remote locations,

and by the system manager at NIA

locations. Contractors and collaborating

researchers will be notified that they are

subject to the provisions of the Privacy

Act, and will be required to make formal

agreements to comply with these

provisions.

The particular safeguards

implemented in each project are

developed in accordance with Chapter

45–13 and supplementing Chapter PHS

hf: 45–13 of the HHS General

Administration Manual and Part 6, ADP

Systems Security, of the HHS

Information Resources Management

Manual, and the National Institute of

Standards and Technology Federal

Information Processing Standards (FIPS

Pub. 41 and FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Associate Director, Epidemiology,

Demography and Biometry Program,

National Institute on Aging, Gateway

Building, Suite 3C309, 7201

Wisconsin Avenue, Bethesda, MD

20892

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the System Manager at the above

address and provide the following

information in writing:

1. Full name at time of participation

in the study.

2. Date of birth.

3. Home address at the time of study.

4. The facility where the examination

was given or where information was

collected.

5. Approximate date or dates of

participation.

6. Name of study, if known.

7. Current name, address and

telephone number.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical or

dental record shall, at the time the

request is made, designate in writing a

responsible representative who will be

willing to review the record and inform

the subject individual of its contents at

the representative’s discretion.

RECORD ACCESS PROCEDURE:

Contact the system manager at the

above address and provide the same

information as outlined under the

notification procedures. Requesters

should also reasonably specify the

record contents being sought.

Individuals may also request listings of

accountable disclosures that have been

made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the System Manager at the

above address. The contestor must

reasonably identify the record, specify

in writing the information being

contested, and state the corrective

action sought and the reasons for the

correction. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Information will be obtained directly

from individual participants and from

medical and clinical research

observations, or indirectly from existing

source documents such as disease

registries.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0148

SYSTEM NAME:

Contracted and Contract-Related

Research: Records of Subjects in

Clinical, Epidemiological and

Biomedical Studies of the National

Institute of Neurological Disorders and

Stroke and the National Institute on

Deafness and Other Communication

Disorders, HHS/NIH/NINDS and HHS/

NIH/NIDCD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

At National Institutes of Health

facilities in Bethesda, Maryland, and at

hospitals, medical schools, universities,

research institutions, commercial

organizations, state agencies, and

collaborating Federal agencies. Inactive

records may be retired to Federal

Records Centers. A list of locations is

available upon request from the

respective System Managers of the

subsystems included in this notice.

CATAGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Patients with neurological diseases,

communicative disorders, stroke,

hearing loss, chemosensory deficits, and

related diseases; normal, healthy

volunteers who serve as controls for

comparison with patients, relatives of

patients; and other individuals whose

characteristics or conditions are suited

for possible connections with the

occurrence of the diseases and disorders

under investigations. Subject

individuals include both adults and

children.

CATEGORIES OF RECORDS IN THE SYSTEM:

This system consists of a variety of

clinical, biomedical, and

epidemiological information resulting

from or contained in direct

observations, medical records and other

histories, vital statistics reports, records

on biological specimens (e.g., blood,

urine, etc.), personal interviews,

questionnaires, progress reports,

correspondence, or research findings.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Sections 241, Research and

Investigation, and 289a, Establishment

of Institutes, of the Public Health

Service Act (42 U.S.C. 301, 431).

PURPOSE(S):

This system will be used to support

(1) contracted and contract-related

epidemiological, clinical and biometric

investigations into the causes, nature,

outcome, therapy, prevention and cost

of neurological and communicative

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4271

disorders, hearing loss, chemosensory

deficits, and stroke; (2) review and

evaluation of the progress of these

research projects, and identification and

planning for improvements or for

additional research.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors, grantees and collaborating

researchers and their staff in order to

accomplish the research purpose for

which the records are collected. The

recipients are required to protect such

records from improper disclosure.

2. Disclosure may be made to

organizations deemed qualified by the

Secretary to carry out quality

assessments, medical audits or

utilization review.

3. 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, (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.

4. The Department contemplates that

it may contract with a private firm for

the purpose of collating, analyzing,

aggregating or otherwise refining

records in this system. Relevant records

will be disclosed to such a contractor.

The contractor will be required to

maintain Privacy Act safeguards with

respect to such records.

5. 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary 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.

6. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders,

computer-accessible forms (e.g. tapes or

discs), punched cards, bound

notebooks, microfilm, charts, graphs

and X-rays.

RETRIEVABILITY:

Information is retrieved by name and/

or patient identification number.

SAFEGUARDS:

1 Authorized users: Access to or

disclosure of information is limited to

collaborating researchers, contractors

and employees, and other authorized

biomedical researchers who are

involved in the conduct, support or

review and evaluation of the research

activities supported by this system.

2. Physical safeguards: Data are kept

in secured areas (e.g. rooms which are

locked when not in regular use,

buildings with controlled access). Data

stored in computer-accessible form is

accessed through the use of key words

known only to principal investigators or

authorized personnel; all other

information is stored in locked files.

3. Procedural safeguards: Contractors

and collaborating or other researchers

are required to comply with the

provisions of the Privacy Act and with

HHS Privacy Act regulations.

These and other appropriate

safeguards are implemented in each

project in accordance with Chapter 45–

13, ‘‘Safeguarding Records Contained in

Systems of Records,’’ of the HHS

General Administration Manual,

supplementary Chapter PHS.hf: 45–13,

and Part 6, ‘‘ADP Systems Security’’, of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER(S) AND ADDRESS:

NINDS and NIDCD research activities

are divided, functionally and

administratively. In effect, there are six

subsystems within this single umbrella

system. NINDS has five programs and

NIDCD one. System Managers have been

designated for each subsystem as

follows:

Director, Division of Human

Communication, NIDCD, NIH,

Executive Plaza South, Room 400B,

620 Executive Boulevard, Rockville,

MD 20852

and

Director, Division of Fundamental

Neurosciences, NINDS, NIH, Federal

Building, Room 916, 7550 Wisconsin

Avenue, Bethesda, MD 20892

and

Deputy Director, Division of Convulsive,

Developmental and Neuromuscular,

Disorders, NINDS, NIH, Federal

Building, Room 816, 7550 Wisconsin

Avenue, Bethesda, MD 20892

and

Director, Division of Demyelinating

Atrophic, and Dementing Disorders,

NINDS, NIH, Federal Building, Room

810, 7550 Wisconsin Avenue,

Bethesda, MD 20892

and

4272 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

Director, Division of Stroke and Trauma,

NINDS, NIH, Federal Building, Room

8A08, 7550 Wisconsin Avenue,

Bethesda, MD 20892

and

Assistant Director, Clinical

Neurosciences Program, DIR, NIH,

Building 10, Room 5N226, 9000

Rockville Pike, Bethesda, MD 20892

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to:

NINDS Privacy Act Coordinator, Federal

Building, Room 816, 7550 Wisconsin

Avenue, Bethesda, MD 20892

or

NIDCD Privacy Act Coordinator,

Building 31, Room 3C02, 9000

Rockville Pike, Bethesda, MD 20892

and provide the following information:

1. System name,

2. Complete name and home address

at the time of the study,

3. Birth date,

4. Facility conducting the study,

5. Disease type (if known),

6. Approximate dates of enrollment in

the research study.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

Individuals seeking notification of or

access to medical records should

designate a representative (including

address) who may be a physician, other

health professional, or other responsible

individual, who would be willing to

review the record and inform the subject

individual of its contents, at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical record

shall designate a family physician or

other health professional (other than a

family member) of whom the record, if

any, will be sent. The parent or guardian

must verify relationship to the child or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURE:

Same as notifications procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Write to the system manager and

reasonably identify the record, specify

the information being contested and

state the corrective action sought and

the reasons for the correction. The right

to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Information in these records is

obtained directly from individual

participants, and from physicians,

research investigators and other

collaborating persons, and from medical

records and clinical research

observations at hospitals, HHS agencies,

universities, medical schools, research

institutions, commercial institutions,

state agencies, and collaborating Federal

agencies.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0152

SYSTEM NAME:

Biomedical Research: Records of

Subjects in National Institute of Dental

Research Contracted Epidemiological

and Biometric Studies, HHS/NIH/NIDR.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Records included in this system are

collected by contractors and are located

in hospitals and clinics; research

centers; educational institutions;

commercial; local, State and Federal

government agencies; and in National

Institute of Dental Research (NIDR)

facilities. Inactive records may be stored

at Federal Records Centers. A list of

locations and contracts is available

upon request from the System Manager.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Voluntary participants in

epidemiological and biometric studies

sponsored by NIDR, including adults

and minors, both males and females,

with known or suspected diseases or

disorders of the teeth and supporting

structures, as well as normal or

nonsuspect individuals in control or

study groups for purposes of

comparison.

CATEGORIES OF RECORDS IN THE SYSTEM:

This system consists of medical and

dental records and information resulting

from personal interviews,

questionnaires, or direct observation.

The system may also include current

addresses of study participants,

radiographs, records on biological

specimens (e.g., teeth, plaque, etc.),

study models, computerized

epidemiological data and

correspondence.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Sections 301, 401, 405 and 453 of the

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

241, 281, 284, 285h). These sections

establish the National Institute of Dental

Research and authorize the conduct and

support of dental and oral research and

related activities.

PURPOSE(S):

This system is used to: (1) Support

research on diseases and disorders of

the oral cavity (teeth and their

supporting structures); their causes and

treatment; the incidence and prevalence

of these diseases and disorders; and

familial, demographic and behavioral

factors related to their causes and

treatment; (2) provide data for program

review, evaluation, planning, and

administrative accountability.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USE:

1. Disclosure may be made to HHS

contractors, grantees and collaborating

researchers and their staff for the

purpose of analyzing data and preparing

scientific reports and articles in order to

accomplish the research purpose for

which the records are collected. The

recipients are required to maintain

Privacy Act safeguards with regards to

such records.

2. Disclosure may be made to

organizations deemed qualified by the

Secretary to carry out quality

assessment, medical audits or

utilization review.

3. 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, (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

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4273

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 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.

4. The Department contemplates that

it will contract with a private firm for

the purpose of collating, analyzing,

aggregating or otherwise refining

records in this system. Relevant records

will be disclosed to such a contractor.

The contractor will be required to

maintain Privacy Act safeguards with

respect to records.

5. Disclosure may be made to a

congressional office from the record to

an individual in response to an inquiry

from the congressional office made at

the request of the individual.

6. 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, for

example, in defending against a claim

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, the Department may

disclose such records as it deems

desirable or necessary 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders,

magnetic tapes or disks, punched cards,

or bound notebooks.

RETRIEVABILITY:

Information is retrieved by name and/

or a participant identification number.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

contractor personnel; consultants to the

contractor; the NIDR project officer; and

NIDR employees whose duties require

the use of such information. Access to

the data controlled by the Project

Director, the NIDR Project Officer, and/

or the System Manager.

2. Physical safeguards: Records are

stored in locked files or secured areas.

Computer terminals are in secured

areas.

3. Procedural safeguards: Names and

other identifying particulars are deleted

when data from original records is

encoded for analysis. Encoded data is

indexed by code numbers. Tables

linking these code numbers with actual

identifiers are maintained separately.

Code numbers and identifiers are linked

only if there is a specific need. Data

stored in computers is accessed through

the use of keywords known only to the

principal investigators or authorized

personnel. These keywords are changed

frequently.

The particular safeguards

implemented in each project will be

developed in accordance with Chapter

45–13, ‘‘Safeguarding Records

Contained in Systems of Records,’’ of

the HHS General Administration

Manual, supplementary Chapter PHS.hf:

45–13, and Part 6, ‘‘ADP Systems

Security’’, of the HHS Information

Resources Management Manual and the

National Institute of Standards and

Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Chief, Contract Management Section,

Extramural Program, National

Institute of Dental Research, Natcher

Building, Room 4AN–44B, 45 Center

Drive MSC 6402, Bethesda, MD

20892–6402

NOTIFICATION PROCEDURE:

Write to:

Privacy Act Coordinator, National

Institute of Dental Research, 31 Center

Drive MSC 2290, Building 31, Room

2C–35, Bethesda, MD 20892–2290

and provide the following information

in writing:

1. Full name at time of participation

in the study.

2. Name and description of the study.

3. Location and approximate dates of

participation.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of, or access to, a medical or

dental record shall, at the time the

request is made, designate in writing a

responsible representative who will be

willing to review the record and inform

the subject individual of its contents at

the representative’s discretion.

A parent or guardian who requests

notification of, or access to, the medical

record of a child or incompetent person

shall designate a family physician or

other health professional (other than a

family member) to whom the records, if

any, will be sent. The parent or guardian

must verify relationship to the child or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURES:

Same as notification. Requesters

should also reasonably specify the

record contents being sought.

Individuals may also request listings of

accountable disclosures that have been

made of their records, if any.

CONTESTING RECORD PROCEDURES:

Contact the System Manager at the

address above. The contestor must

reasonably identify the record, specify

in writing the information being

contested, and state the corrective

action sought, and the reason(s) for the

corrective action, with supporting

justification. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

4274 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

RECORD SOURCE CATEGORIES:

Information contained in these

records is obtained directly from

individual participants and from

medical/dental and clinical research

observations.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0153

SYSTEM NAME:

Biomedical Research: Records of

Subjects in Biomedical and Behavioral

Studies of Child Health and Human

Development, HSS/NIH/NICHD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Records included in this system in

this system are located in hospitals and

clinics, research centers, educational

institutions, commercial organizations,

local and State agencies, and other

Executive Branch agencies of the

Federal Government under contract to

the National Institute of Child Health

and Human Development (NICHD), and

in NICHD facilities in Bethesda,

Maryland. Inactive records may be

stored at Federal Records Centers. A list

of specific locations and contractors is

available upon request from the System

Manager, whose address is listed below.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Participants in these studies include

adults and children (a) who are

presently or have been treated by the

NICHD, (b) whose physical, genetic,

social, economic, environmental,

behavioral or nutritional conditions or

habits are being studied by the NICHD,

or (c) normal volunteers who have

agreed to provide control data for

purposes of comparison.

CATEGORIES OF RECORDS IN THE SYSTEM:

This system consists of a variety of

clinical, medical, and statistical

information collected in biomedical and

behavioral research studies, such as

medical histories, vital statistics,

personal interviews, questionnaires,

current addresses of study participants,

radiographs, records on biological

specimens, study models, and

correspondence from or about

participants in these studies.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Section 301, Research and

Investigation, and section 441, National

Institute of Child Health and Human

Development, of the Public Health

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

sections 241, 298d).

PURPOSE(S):

This system is used: (1) For program

review, evaluation, planning, and

administrative management for research

on child health and human

development; (2) to monitor the

incidence, prevalence or development

of the disease, condition, behavior, or

health status under investigation; (3) to

determine the relation of various factors

(e.g., social, economic, environmental,

physical, and medical) to the occurrence

of the disease, condition, development,

behavior, or health status under

investigation; (4) to identify abnormal

disease, condition, or health status and

inform the Centers for Disease Control

(CDC) or the Food and Drug

Administration (FDA) of the existence

of such conditions. CDC uses this

information in fulfilling its

congressionally mandated responsibility

for the monitoring of disease and

prevention of epidemics. FDA use this

information in carrying out its

congressional mandate for controlling

certain potentially harmful products.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors, grantees and collaborating

researchers and their staff for the

purposes of analyzing data and

preparing scientific reports and articles

in order to accomplish the research

purpose for which the records are

collected. The recipients are required to

comply with the requirements of the

Privacy Act with respect to such

records.

2. Disclosure may be made to

organizations deemed qualified by the

Secretary to carry out quality

assessment, medical audits or

utilization review.

3. The Department contemplates that

it may contract with a private firm for

the purpose of collating, analyzing,

aggregating or otherwise refining

records in this system. Relevant records

will be disclosed to such a contractor.

The contractor will be required to

comply with the requirements of the

Privacy Act with respect to such

records.

4. Certain diseases and conditions,

including infectious diseases, may be

reported to appropriate representatives

of State or Federal Government as

required by State or Federal law.

5. 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, (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.

6. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

7. 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 against a claim 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, the Department may

disclose such records as it deems

desirable or necessary to the Department

of Justice to enable that Department to

present an effective defense, provided

that such disclosure is compatible with

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4275

the purpose for which the records were

collected.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders,

microfilm, magnetic tapes or disks,

punched cards, or bound notebooks.

RETRIEVABILITY:

Information is retrieved by name and/

or a participant identification number.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users: Employees who

maintain records in this system are

instructed to grant regular access only to

contractor personnel; consultants to the

contractor; the NICHD project officer;

and NICHD employees whose duties

require the use of such information. One

time and special access to the data is

controlled by the System Manager, the

NICHD Project Officer, and the Contract

and/or Project Director.

2. Physical safeguards: Records are

stored in locked files or secured areas.

Computer terminals are in secured

areas.

3. Procedural safeguards: Names and

other identifying particulars are deleted

when data from original records is

encoded for analysis. Encoded data is

indexed by code numbers. Tables

linking these code numbers with actual

identifiers are maintained separately.

Code numbers and identifiers are linked

only if there is a specific need, such as

alerting the volunteer subjects to any

findings in the study that night affect

their health. Data stored in computers is

accessed through the use of passwords/

keywords known only to the principal

investigators or authorized personnel.

These passwords/keywords are changed

frequently.

The particular safeguards

implemented in each project will be

developed in accordance with Chapter

45–13, ‘‘Safeguarding Records

Contained in Systems of Records,’’ of

the HHS General Administration

Manual, supplementary Chapter PHS hf:

45–13; Part 6, ‘‘ADP Systems Security,’’

of the HHS ADP Systems Manual, and

the National Institute of Standards and

Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are trained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Chief, Contracts Management Branch,

NICHD, Executive Building, Room

7A07, 6100 Executive Blvd., North

Bethesda, MD 20892–7510

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to:

NICHD Privacy Act Coordinator,

Executive Building, Room 4A01B,

6100 Executive Blvd., North Bethesda,

MD 20892–7510

and provide the following information

in writing:

1. Full name and address at time of

participation in the study.

2. Name or description of the study.

3. Location and approximate dates of

participation.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of, or access to, a medical

record shall, at the time the request is

made, designate in writing a responsible

representative who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, the medical

record of a child or incompetent person

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 his or her relationship to the

child or incompetent person as well as

his or her own identity.

RECORD ACCESS PROCEDURES:

Same as notification procedure above.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURES:

Write to the official specified under

notification procedures above, and

reasonably identify the record and

specify the information being contested,

the corrective action sought, and your

reasons for requesting the correction,

along with supporting information to

show how the record is inaccurate,

incomplete, untimely or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Information contained in these

records is obtained directly from

individual participants, medical and

clinical research observations, and other

federal agencies.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0154

SYSTEM NAME:

Biomedical Research Records of

Subjects: (1) Cancer Studies of the

Division of Cancer Prevention and

Control, HHS/NIH/NCI; and (2)

Women’s Health Initiative (WHI)

Studies, HHS/NIH/OD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institutes of Health, Executive

Plaza North, Room 343K, 6130

Executive Blvd. MSC 7350, Bethesda,

MD 20892–7350

and

National Institutes of Health, Building

12, 9000 Rockville Pike, Bethesda,

MD 20892

and

National Institutes of Health, Building 1

Room 260, 9000 Rockville Pike,

Bethesda, MD 20892

and at hospitals, medical schools,

universities, research institutions,

commercial organizations, collaborating

State and Federal Government agencies,

and Federal Records Centers. Write to

system manager at the address below for

the address of current locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

NCI: Adults and children in the

following categories: Patients with

cancer; persons for whom cancer risk

can potentially be lowered; and persons

without signs or symptoms who may be

identified through screening and

detection methods as having cancer or

4276 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

being at increased risk of developing

cancer. For certain types of

epidemiologic studies, e.g., case-control

studies, NCI may also collect, for

purposes of comparison, records on

other persons. These comparison groups

could include normal individuals (e.g.,

family members or neighborhood

controls), or other patient groups (e.g.,

hospital controls) who do not have

cancer or are not at a particularly high

risk of developing cancer. Health care

and educators who provide services and

training for all such persons above.

WHI: Women for whom risk of cancer

and/or other chronic disease may

potentially be lowered. Women without

signs or symptoms of chronic disease

who may be identified through

screening and detection methods as

being at risk for serious chronic

ailments. WHI may also collect, for

purposes of comparison, longitudinal

records on other women for whom no

added disease risk has been identified.

CATEGORIES OF RECORDS IN THE SYSTEM:

Information identifying participants

(such as name, address, Social Security

Number), medical records, progress

reports, correspondence, epidemiologic

data, and records on biological

specimens (e.g., blood, tumors, urine,

etc).

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

NCI: Sections 301, Research and

Investigation, 405 Appointment and

Authority of the Directors of the

National Research Institutes, and Title

IV, Part C, Subpart 1—National Cancer

Institute, of the Public Health Service

(PHS) Act (42 U.S.C. 241, 284 and 285–

285a–5). WHI: 42 U.S.C. 241 and section

402, Appointment and Authority of

Director of NIH, of the PHS (42 U.S.C.

282).

PURPOSE(S):

Records in this system will be used,

(1) to evaluate cancer and other chronic

disease control programs, such as

prevention, screening, detection,

diagnosis, treatment, rehabilitation, and

continuing care; (2) to identify

characteristics of persons who may be

particularly susceptible to

environmental or occupational factors

for substances which cause or prevent

cancer and/or other chronic diseases; (3)

to determine risk factors or substances

which cause or prevent cancer and/or

other chronic diseases, and the ways in

which they do so; (4) to evaluate

statistical and epidemiological

methodologies for risk factor

assessment, clinical trials, cancer

control studies, and the study of the

natural history of cancers and/or other

chronic diseases; (5) to plan for,

administer, and review research

activities as described in the above

purposes; (6) information from this

system may be reported to the Food and

Drug Administration (FDA) as a

condition for approval of clinical

investigations of new drugs, or to report

adverse effects of drugs so that FDA can

make informed decisions on authorizing

use of such drugs.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors, grantees and collaborating

researchers and their staff in order to

accomplish the research purposes for

which the records are collected. The

recipients are required to comply with

the requirements of the Privacy Act with

respect to such records.

2. Disclosure may be made to

organizations deemed qualified by the

Secretary to carry out quality

assessments, medical audits or

utilization review.

3. The Department contemplates that

it may contract with a private firm for

the purposes of collating, analyzing,

aggregating or otherwise refining

records in this system. Relevant records

will be disclosed to such a contractor.

The contractor will be required to

comply with the requirements of the

Privacy Act with respect to such

records.

4. A record 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, (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.

5. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

6. 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, the Department may

disclose such records as it deems

desirable or necessary 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

File folders, microfilm, charts, graphs,

computer tapes, disks, and punch cards.

RETRIEVABILITY:

By name, Social Security Number

when supplied voluntarily or contained

in existing records used in projects

under this system, or other identifying

number.

SAFEGUARDS:

Measures to prevent unauthorized

disclosures are implemented as

appropriate for each location and for the

particular records maintained in each

project. Each site implements personnel,

physical and procedural safeguards

such as the following:

1. Authorized users. NCI and WHI

employees who maintain records in this

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4277

system are instructed to grant regular

access only to physicians, scientists,

and support staff of the National Cancer

Institute and Women’s Health Initiative,

respectively, or their contractors,

grantees or collaborators who need such

information in order to contribute to the

research or administrative purposes of

the system. The system managers

specifically authorize one-time and

special access by others on a need-toknow basis consistent with the purposes

and routine uses of the system.

2. Physical safeguards. Records are

kept in limited access areas. Offices and

records storage locations are locked

during off-duty hours. Input data for

computer files is coded to avoid

individual identification. Where

possible, information on individual

identities is kept separate from data

used for analysis.

3. Procedural safeguards. Access to

manual files is granted only to

authorized personnel, as described

above. Access to computer files is

controlled through security codes

known only to authorized users. Names

and other details necessary to identify

individuals are not included in data

files used for analysis. These files are

indexed by code numbers. Code

numbers and complete identifiers are

linked only if there is a specific need,

such as for data verification.

Contractors, grantees or collaborators

who maintain records in this system are

instructed to make no further disclosure

of the records except as authorized by

the system manager and permitted by

the Privacy Act. Privacy Act

requirements are specifically included

in contracts and in agreements with

grantees or collaborators participating in

research activities supported by this

system. HHS project director, contract

officers and project officers oversee

compliance with these requirements.

The particular safeguards

implemented at each site are developed

in accordance with Chapter 45–13,

‘‘Safeguarding Records Contained in

Systems of Records,’’ of the HHS

General Administration Manual,

supplementary Chapter PHS.hf: 45–13,

and Part 6, ‘‘ADP Systems Security’’, of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3,

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Associate Director, Surveillance

Program, DCPC, National Cancer

Institute, Executive Plaza North,

Room 343K, 6130 Executive Blvd,

MSC 7350, Bethesda, MD 20892–7350

and

Director, Women’s Health Initiative,

Office of the Director, National

Institutes of Health, Building 1, Room

260, 9000 Rockville Pike, Bethesda,

MD 20892

NOTIFICATION PROCEDURE:

To determine if a file exists, write to

the appropriate system manager and

provide the following information:

a. System name: ‘‘Biomedical

Research Records of Subjects: (1) Cancer

Studies of the Division of Cancer

Prevention and Control, HHS/NIH/NCI;

and (2) Women’s Health Initiative

Studies, HHS/NIH/OD.’’

b. Complete name at time of

participation;

c. Facility and home address at the

time of participation;

d. In some cases, where records are

retrieved by an identifying number,

such as the Social Security Number or

Hospital Identification Number, it may

be necessary to provide that number. In

some cases, to ensure proper

identification it may be necessary to

provide date(s) of participation (if

known), birth date, disease type (if

known), and study name and location (if

known).

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a maximum fine of five thousand

dollars.

Individuals seeking notification of or

access to medical records should

designate a representative (including

address) who may be a physician, other

health professional, or other responsible

individual, who would be willing to

review the record and inform the subject

individual of its contents, at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURES:

Write to the appropriate system

manager and provide the same

information as requested under the

notification procedure above.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURES:

Write to the appropriate system

manager, identify the record, and

specify the information contested. State

the corrective action sought and your

reasons for requesting the correction,

and provide supporting information to

show that the record is inaccurate,

incomplete, irrelevant, untimely, or

unnecessary. The right to contest

records is limited to information which

is incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

HHS agencies, institutions under

contract to the U.S. Government, such

as universities, medical schools,

hospitals, research institutions,

commercial institutions, state agencies,

other U.S. Government agencies,

patients and normal volunteers,

physicians, research investigators and

other collaborating personnel.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

02–25–0156

SYSTEM NAME:

Records of Participants in Programs

and Respondents in Surveys Used to

Evaluate Programs of the Public Health

Service, HHS/PHS/NIH/OD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

This system of records is an umbrella

system comprising separate sets of

records located either in the

organizations responsible for

conducting evaluations or at the sites of

programs or activities under evaluation.

Locations include Public Health (PHS)

facilities, or facilities of contractors of

the PHS. Write to the appropriate

System Manager below for a list of

current locations.

4278 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Individuals covered by this system are

those who provide information or

opinions that are useful in evaluating

programs or activities of the PHS, other

persons who have participated in or

benefitted from PHS programs or

activities; or other persons included in

evaluation studies for purposes of

comparison. Such individuals may

include (1) participants in research

studies; (2) applicants for and recipients

of grants, fellowships, traineeships or

other awards; (3) employees, experts

and consultants; (4) members of

advisory committees; (5) other

researchers, health care professionals, or

individuals who have or are at risk of

developing diseases or conditions

studied by PHS; (6) persons who

provide feedback about the value or

usefulness of information they receive

about PHS programs, activities or

research results; (7) persons who have

received Doctorate level degrees from

U.S. institutions; (8) persons who have

worked or studied at U.S. institutions

that receive(d) institutional support

from PHS.

CATEGORIES OF RECORDS IN THE SYSTEM:

This umbrella system of records

covers a varying number of separate sets

of records used in different evaluation

studies. The categories of records in

each set depend on the type of program

being evaluated and the specific

purpose of the evaluation. In general,

the records contain two types of

information: (1) Information identifying

subject individuals, and (2) information

which enables PHS to evaluate its

programs and services.

(1) Identifying information usually

consists of a name and address, but it

might also include a patient

identification number, grant number,

Social Security Number, or other

identifying number as appropriate to the

particular group included in an

evaluation study.

(2) Information used for evaluation

varies according to the program

evaluated. Categories of evaluative

information include personal data and

medical data on participants in clinical

and research programs; personal data,

publications, professional achievements

and career history of researchers; and

opinions and other information received

directly from individuals in evaluation

surveys and studies of PHS programs.

The system does not include any

master list, index or other central means

of identifying all individuals whose

records are included in the various sets

of records covered by the system.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Authority for this system comes from

the authorities regarding the

establishment of the National Institutes

of Health, its general authority to

conduct and fund research and to

provide training assistance, and its

general authority to maintain records in

connection with these and its other

functions (42 U.S.C. 203, 241, 2891–1

and 44 U.S.C. 3101), and section 301

and 493 of the Public Health Service

Act.

PURPOSE(S):

This system supports evaluation of

the policies, programs, organization,

methods, materials, activities or services

used by PHS in fulfilling its legislated

mandate for (1) conduct and support of

biomedical research into the causes,

prevention and cure of diseases; (2)

support for training of research

investigators; (3) communication of

biomedical information.

This system is not used to make any

determination affecting the rights,

benefits or privileges of any individual.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors and collaborating

researchers, organizations, and State

and local officials for the purpose of

conducting evaluation studies or

collecting, aggregating, processing or

analyzing records used in evaluation

studies. The recipients are required to

protect the confidentiality of such

records.

2. Disclosure may be made to

organizations deemed qualified by the

Secretary to carry out quality

assessments, medical audits or

utilization review.

3. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

4. The Department may disclose

information from this system of records

to the Department of Justice, to court or

other tribunal, or to another party before

such 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 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 tribunal, or

the other party 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders,

bound notebooks, or computeraccessible media (e.g., magnetic tapes or

discs).

RETRIEVABILITY:

Information is retrieved by name and/

or participant identification number

within each evaluation study. There is

no central collection of records in this

system, and no central means of

identifying individuals whose records

are included in the separate sets of

records that are maintained for

particular evaluation studies.

SAFEGUARDS:

A variety of safeguards are

implemented for the various sets of

records in this system according to the

sensitivity of the data each set contains.

Information already in the public

domain, such as titles and dates of

publications, is not restricted. However,

sensitive information, such as personal

or medical history or individually

identified opinions, is protected

according to its level of sensitivity.

Records derived from other systems of

records will be safeguarded at a level at

least as stringent as that required in the

original systems. Minimal safeguards for

the protection of information which is

not available to the general public

included the following:

1. Authorized users: Regular access to

information in a given set of records is

limited to PHS or to contractor

employees who are conducting,

reviewing or contributing to a specific

evaluation study. Other access is

granted only on a case-by-case basis,

consistent with the restrictions required

by the Privacy Act (e.g., when

disclosure is required by the Freedom of

Information Act), as authorized by the

system manager or designated

responsible official.

2. Physical safeguards: Records are

stored in closed or locked containers, in

areas which are not accessible to

unauthorized users, and in facilities

which are locked when not in use.

Records collected in each evaluation

project are maintained separately from

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4279

those of other projects. Sensitive records

are not left exposed to unauthorized

persons at any time. Sensitive data in

machine-readable form may be

encrypted.

3. Procedural safeguards: Access to

records is controlled by responsible

employees and is granted only to

authorized individuals whose identities

are properly verified. Data stored in

mainframe computers is accessed only

through the use of keywords known

only to authorized personnel. When

personal computers are used, magnetic

media (e.g. diskettes) are protected as

under Physical Safeguards. When data

is stored within a personal computer

(i.e., on a ‘‘hard disk’’), the machine

itself is treated as though it were a

record, or records, under Physical

Safeguards. Contracts for operation of

this system of records require protection

of the records in accordance with these

safeguards; PHS project and contracting

officers monitor contractor compliance.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 1100–C–2. Refer

to the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER(S) AND ADDRESS:

See Appendix 1.

Policy coordination for this system is

provided by:

Associate Director, Office of Strategic

Planning and Evaluation, Office of

Science Policy and Technology

Transfer, National Institutes of Health,

6006 Executive Boulevard, Suite 312,

Rockville, MD 20892

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the official of the organization

responsible for the evaluation, as listed

in Appendix 2. If you are not certain

which component of PHS was

responsible for the evaluation study, or

if you believe there are records about

you in several components of PHS,

write to:

NIH Privacy Act Officer, Building 31,

Room 1B25, 9000 Rockville Pike,

Bethesda, MD 20892.

Requesters must provide the

following information:

1. Full name, and name(s) used while

studying or employed;

2. Name and location of the

evaluation study or other PHS program

in which the requester participated or

the institution at which the requester

was a student or employee, if

applicable;

3. Approximate dates of participation,

matriculation or employment, if

applicable.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing, a

responsible representative, who may be

a physician, other health professional,

or other responsible individual, who

will be willing to review the record and

inform the subject individual of its

contents at the representative’s

discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURES:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURES:

Write to the official specified under

notification procedures above, and

reasonably identify the record and

specify the information being contested,

the corrective action sought, and your

reasons for requesting the correction,

along with supporting information to

show how the record is inaccurate,

incomplete, untimely or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Information contained in these

records is obtained directly from

individual participants; from systems of

records 09–25–0036, ‘‘Grants: IMPAC

(Grants/Contract Information), HHS/

NIH/DRG;’’ 09–25–0112, ‘‘Grants:

Research, Research Training,

Fellowship and Construction

Applications and Awards, HHS/NIH/

OD’’; NSF–6, ‘‘Doctorate Record File’’,

NSF–43, ‘‘Doctorate Work History File’’

(previously entitled NSF–43, ‘‘Roster

and Survey of Doctorate Holders in The

United States’’ and other records

maintained by the operating programs of

NIH; the National Academy of Sciences,

professional associations such as the

AAMC and ADA, and other contractors;

grantees or collaborating researchers; or

publicly available sources such as

bibliographies.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

Appendix 1: System Managers

Associate Director, Office of Strategic

Planning and Evaluation, Office of Science

Policy and Technology Transfer, National

Institutes of Health, 6006 Executive

Boulevard, Suite 312, Rockville, MD 20892

National Institutes of Health, Office of the

Director, Director, Division of Personnel

Management, Building 1, Room B1–60,

9000 Rockville Pike, Bethesda, MD 20892

National Heart, Lung, and Blood Institute

(NHLBI), NHLBI Minority Coordinate, OD,

OPPE, Building 31, Room 5A03/5A06, 31

Center Drive, MSC 2482, Bethesda, MD

20892–2482

National Library of Medicine (NLM),

Associate Director for Health Information

Programs Development, Building 38, Room

2S20, Bethesda, MD 20894

National Eye Institute (NEI), Associate

Director for Science Policy and Legislation,

Building 31, Room 6A25, Bethesda, MD

20892

National Cancer Institute (NCI), Public

Health Educator, OCC, NCI, National

Institutes of Health Building 31, Room

4B43, Bethesda, MD 20892

National Institute on Aging (NIA), Chief,

Office of Planning, Analysis, Technical

Information and Evaluation, Federal

Building, Room 6A09, 7550 Wisconsin

Avenue, Bethesda, MD 20892

National Institute of Allergy and Infectious

Diseases (NIAID), Chief, Evaluation and

Reporting Section, Policy Analysis and

Legislation Branch, Office of

Administration Management, Building 31,

Room 7A–16, Bethesda, MD 20892

National Institute of Child Health and

Human Development (NICHD), Chief,

Office of Science Policy and Analysis,

Building 31, Room 2A10, Bethesda, MD

20892

4280 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

National Institute on Deafness and Other

Communications Disorders, Chief, Program

Planning and Health Reports Branch,

Building 31, room 3C35, 9000 Rockville

Pike, Bethesda, MD 20892

National Institute of Dental Research (NIDR),

Director, Office of Planning Evaluation,

and Communications, Building 31, Room

2C34, 31 Center Drive MSC 2290,Bethesda,

MD 20892–2290

National Institute of Environmental Health

Sciences (NIEHS) Programs, Analyst,

Office of Program Planning and Evaluation,

P.O. Box 12233, Research Triangle Park,

NC 27709

National Institute of General Medical

Sciences (NIGMS), Chief, Office of Program

Analysis and Evaluation, Natcher Building,

Room 3AS49, 9000 Rockville Pike,

Bethesda, MD 20892

Fogarty International Center (FIC), National

Institutes of Health, Assistant Director for

Planning, Evaluation and Public Affairs,

Building 31, Room B2C32, Bethesda, MD

20892

Division of Research Grants (DRG), Assistant

Director for Special Projects, Westwood

Building, Room 457, 5333 Westbard

Avenue, Bethesda, MD 20892

National Center for Research Resources

(NCRR), Evaluation Officer, Office of

Science Policy, Westwood Building, Room

8A03, Bethesda, MD 20892

National Institute of Nursing Research

(NINR), Chief, Office of Planning, Analysis

and Evaluation, Building 31, Room 5B09,

Bethesda, MD 20892

Office of Research Integrity, Policy Analyst,

Division of Policy and Education, U.S.

Public Health Service, 5515 Security Lane,

Suite 700, Rockwell-II Building, Rockville,

MD 20852

Appendix 2: Notification and Access

Officials

NIH, Office of the Director, Associate

Director for Science, Policy and

Legislation, Building 1, Room 137, 9000

Rockville Pike, Bethesda, MD 20892

National Institutes Health, Office of the

Director, Director, Division of Personnel

Management, Building 1, Room B1–60,

9000 Rockville Pike, Bethesda, MD 20892

National Heart, Lung, and Blood Institute

(NHLBI), Privacy Act Coordinator,

Building 31, Room 5A29, Bethesda, MD

20892

National Library of Medicine (NLM),

Assistant Director for Planning and

Evaluation, Building 38, Room 2S18,

Bethesda, MD 20894

National Eye Institute (NEI), Executive

Officer, Building 31, Room 6A25,

Bethesda, MD 20892

Fogarty International Center (FIC), National

Institutes of Health, Assistant Director for

Planning, Evaluation and Public Affairs,

Building 31, Room B2C32, Bethesda, MD

20892

Division or Research Grants (DRG), Assistant

Director for Special Projects, Westwood

Building, Room 457, 5333 Westbard

Avenue, Bethesda, MD 20892

National Center of Research Resources

(NCRR), Evaluation Officer, Office of

Science Policy, NIH, Westwood Building,

Room 8A03, Bethesda, MD 20892

National Cancer Institute, Privacy Act

Coordinator, National Institutes of Health,

Building 31, Room 10A30, Bethesda, MD

20892

02–25–0156

SYSTEM NAME:

Records of Participants in Programs

and Respondents in Surveys Used to

Evaluate Programs of the National

Institutes of Health, HHS/NIH/OD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

This system of records is an umbrella

system comprising separate sets of

records located either in the

organizations responsible for

conducting evaluations or at the sites of

programs or activities under evaluation.

Locations include National Institutes of

Health (NIH) facilities in Bethesda,

Maryland, or facilities of contractors of

the NIH. Write to the appropriate

System Manager below for a list of

current locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Individuals covered by this system are

those who provide information or

opinions that are useful in evaluating

programs or activities of the NIH, other

persons who have participated in or

benefitted from NIH programs or

activities; or other persons included in

evaluation studies for purposes of

comparison. Such individuals may

include (1) participants in research

studies; (2) applicants for and recipients

of grants, fellowships, traineeships or

other awards; (3) employees, experts

and consultants; (4) members of

advisory committees; (5) other

researchers, health care professionals, or

individuals who have or are at risk of

developing diseases or conditions

studied by NIH; (6) persons who

provide feedback about the value or

usefulness of information they receive

about NIH programs, activities or

research results; (7) persons who have

received Doctorate level degrees from

U.S. institutions; (8) persons who have

worked or studied at U.S. institutions

that receive (d) institutional support

from NIH.

CATEGORIES OF RECORDS IN THE SYSTEM:

This umbrella system of records

covers a varying number of separate sets

of records used in different evaluation

studies. The categories of records in

each set depend on the type of program

being evaluated and the specific

purpose of the evaluation. In general,

the records contain two types of

information: (1) information identifying

subject individuals, and (2) information

which enables NIH to evaluate its

programs and services.

(1) Identifying information usually

consists of a name and address, but it

might also include a patient

identification number, grant number,

Social Security Number, or other

identifying number as appropriate to the

particular group included in an

evaluation study.

(2) Information used for evaluation

varies according to the program

evaluated. Categories of evaluative

information include personal data and

medical data on participants in clinical

and research programs; personal data,

publications, professional achievements

and career history of researchers; and

opinions and other information received

directly from individuals in evaluation

surveys and studies of NIH programs.

The system does not include any

master list, index or other central means

of identifying all individuals whose

records are included in the various sets

of records covered by the system.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Authority for this system comes from

the authorities regarding the

establishment of the National Institutes

of Health, its general authority to

conduct and fund research and to

provide training assistance, and its

general authority to maintain records in

connection with these and its other

functions (42 U.S.C. 203, 241, 289l–1

and 44 U.S.C. 3101).

PURPOSE(S):

This system supports evaluation of

the policies, programs, organization,

methods, materials, activities or services

used by NIH in fulfilling its legislated

mandate for (1) conduct and support of

biomedical research into the causes,

prevention and cure of diseases; (2)

support for training of research

investigators; (3) communication of

biomedical information.

This system is not used to make any

determination affecting the rights,

benefits or privileges of any individual.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to HHS

contractors and collaborating

researchers, organizations, and State

and local officials for the purpose of

conducting evaluation studies or

collecting, aggregating, processing or

analyzing records used in evaluation

studies. The recipients are required to

protect the confidentiality of such

records.

2. Disclosure may be made to

organizations deemed qualified by the

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4281

Secretary to carry out quality

assessments, medical audits or

utilization review.

3. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

4. The Department may disclose

information from this system or records

to the Department of Justice, to court or

other tribunal, or to another party before

such 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 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 tribunal, or

the other party 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders,

bound notebooks, or computeraccessible media (e.g., magnetic tapes or

discs).

RETRIEVABILITY:

Information is retrieved by name and/

or participant identification number

within each evaluation study. There is

no central collection of records in this

system, and no central means of

identifying individuals whose records

are included in the separate sets of

records that are maintained for

particular evaluation studies.

SAFEGUARDS:

A variety of safeguards are

implemented for the various sets of

records in this system according to the

sensitivity of the data each set contains.

information already in the public

domain, such as titles and dates of

publications, is not restricted. However,

sensitive information, such as personal

or medical history or individually

identified opinions, is protected

according to its level of sensitivity.

Records derived from other systems of

records will be safeguarded at a level at

least as stringent as that required in the

original systems. Minimal safeguards for

the protection of information which is

not available to the general public

include the following:

1. Authorized users: Regular access to

information in a given set of records is

limited to NIH or to contractor

employees who are conducting,

reviewing or contributing to a specific

evaluation study. Other access is

granted only on a case-by-case basis,

consistent with the restrictions required

by the Privacy Act (e.g., when

disclosure is required by the Freedom of

Information Act), as authorized by the

system manager or designated

responsible official.

2. Physical safeguards: Records are

stored in closed or locked containers, in

areas which are not accessible to

unauthorized users, and in facilities

which are locked when not in use.

Records collected in each evaluation

project are maintained separately from

those of other projects. Sensitive records

are not left exposed to unauthorized

persons at any time. Sensitive data in

machine-readable form may be

encrypted.

3. Procedural safeguards: Access to

records is controlled by responsible

employees and is granted only to

authorized individuals whose identities

are properly verified. Data stored in

mainframe computers is accessed only

through the use of keywords known

only to authorized personnel. When

personal computers are used, magnetic

media (e.g. diskettes) are protected as

under Physical Safeguards. When data

is stored within a personal computer

(i.e., on a ‘‘hard disk’’), the machine

itself is treated as though it were a

record, or records, under Physical

Safeguards. Contracts for operation of

this system of records require protection

of the records in accordance with these

safeguards; NIH project and contracting

officers monitor contractor compliance.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and Part 6, ‘‘ADP Systems Security,’’ of

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 1100–C–2. Refer

to the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER(S) AND ADDRESS:

See Appendix 1.

Policy coordination for this system is

provided by:

Associate Director, Office of Strategic

Planning and Evaluation, Office of

Science Policy and Technology

Transfer, National Institutes of Health,

6006 Executive Boulevard, Suite 312,

Rockville, MD 20892.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the official of the organization

responsible for the evaluation, as listed

in Appendix 2. If you are not certain

which component of NIH was

responsible for the evalaution study, or

if you believe there are records about

you in several components of NIH, write

to:

NIH Privacy Act Officer, Building 31,

Room 1B25, 9000 Rockville Pike,

Bethesda, MD 20892.

Requesters must provide the

following information:

1. Full name, and name(s) used while

studying or employed;

2. Name and location of the

evaluation study or other NIH program

in which the requester participated or

the institution at which the requester

was a student or employee, if

applicable;

3. Approximate dates of participation,

matriculation or employment, if

applicable.

The requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing, a

responsible representative, who may be

a physician, other health professional,

or other responsible individual, who

will be willing to review the record and

inform the subject individual of its

contents at the representative’s

discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical record

shall designate a family physician or

4282 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

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 or

incompetent person as well as his or her

own identity.

RECORD ACCESS PROCEDURES:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURES:

Write to the official specified under

notification procedures above, and

reasonably identify the record and

specify the information being contested,

the corrective action sought, and your

reasons for requesting the correction,

along with supporting information to

show how the record is inaccurate,

incomplete, untimely or irrelevant. The

right to contest records is limited to

information which is incomplete,

irrelevant, incorrect, or untimely

(obsolete).

RECORD SOURCE CATEGORIES:

Information contained in these

records is obtained directly form

individual participants; from systems of

records 09–25–0036, ‘‘Grants: IMPAC

(Grants/Contract Information), HHS/

NIH/DRG;’’ 09–25–0112, ‘‘Grants:

Research, Research Training,

Fellowship and Construction

Applications and Awards, HHS/NIH/

OD’’; NSF–6, ‘‘Doctorate Record File’’,

NSF–43, ‘‘Doctorate Work History File’’

(previously entitled NSF–43, ‘‘Roster

and Survey of Doctorate Holders in the

United States’’ and other records

maintained by the operating programs of

NIH: the National Academy of Sciences,

professional associations such as the

AAMC and ADA, and other contractors;

grantees or collaborating researchers; or

publicly available sources such as

bibliographies.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

Appendix 1: System Managers

Associate Director, Office of Strategic

Planning and Evaluation, Office of Science

Policy and Technology Transfer, National

Institutes of Health, 6006 Executive

Boulevard, Suite 312, Rockville, MD 20892

National Institutes of Health, Office of the

Director, Director, Division of Personnel

Management, Building 1, Room B1–60,

9000 Rockville Pike, Bethesda, MD 20892

National Heart, Lung, and Blood Institute

(NHLBI), NHLBI Minority Coordinator,

Building 31, Room 5A07, Bethesda, MD

20892

National Library of Medicine (NLM),

Associate Director for Health Information

Programs Development, Building 38, Room

2S28, Bethesda, MD 20894

National Eye Institute (NEI), Associate

Director for Science Policy and Legislation,

Building 31, Room 6A25, Bethesda, MD

20892

National Cancer Institute (NCI), Public

Health Educator, OCC, NCI, National

Institutes of Health Building 31, Room

4B43, Bethesda, MD 20892

National Institute on Aging (NIA), Chief,

Office of Planning, Analysis, Technical

Information and Evaluation, Federal

Building, Room 6A09, 7550 Wisconsin

Avenue, Bethesda, MD 20892

National Institute of Allergy and Infectious

Diseases (NIAID), Acting Director, Office of

Policy Analysis and Technology Transfer,

Building 31, Room 7A–52, Bethesda, MD

20892

National Institute of Child Health and

Human Development (NICHD), Chief,

Office of Science Policy and Analysis,

Building 31, Room 2A10, Bethesda, MD

20892

National Institute on Deafness and Other

Communication Disorders, Chief, Program

Planning and Health Reports Branch,

Building 31, Room 3C36, 9000 Rockville

Pike, Bethesda, MD 20892

National Institute of Dental Research (NIDR),

Chief, Office of Planning Evaluation, and

Communications, Building 31, Room 2C35,

Bethesda, MD 20892

National Institute of Environmental Health

Sciences (NIEHS) Program, Analyst, Office

of Program Planning and Evaluation, P.O.

Box 12233, Research Triangle Park, N.C.

27709

National Institute of General Medical

Sciences (NIGMS), Chief, Office of Program

Analysis, Westwood Building, Room 934,

5333 Westbard Avenue, Bethesda, MD

20892

Fogarty International Center (FIC), National

Institutes of Health, Assistant Director for

Planning, Evaluation and Public Affairs,

Building 31, Room B2C32, Bethesda, MD

20892

National Center for Research Resources

(NCRR), Evaluation Officer, Office of

Science Policy, Westwood Building, Room

8A03, Bethesda, MD 20892

National Institute of Nursing Research

(NINR), Chief, Office of Planning, Analysis

and Evaluation, Building 31, Room 5B09,

Bethesda, MD 20892

Appendix 2: Notification and Access

Officials

NIH, Office of the Director, Associate

Director for Science, Policy and

Legislation, Building 1, Room 137, 9000

Rockville Pike, Bethesda, MD 20892

National Institutes of Health, Office of the

Director, Director, Division of Personnel

Management, Building 1, Room B1–60,

9000 Rockville Pike, Bethesda, MD 20892

National Heart, Lung, and Blood Institute

(NHLBI), Privacy Act Coordinator,

Building 31 Room 5A29, Bethesda, MD

20892

National Library of Medicine (NLM),

Associate Director for Health Information

Programs Development, Building 38, Room

2S28, Bethesda, MD 20894

National Eye Institute (NEI), Executive

Officer, Building 31, Room 6A25,

Bethesda, MD 20892

Fogarty International Center (FIC), National

Institutes of Health, Assistant Director for

Planning, Evaluation and Public Affairs,

Building 31, Room B2C32, Bethesda, MD

20892

Division of Research Grants (DRG), Assistant

Director for Special Projects, Westwood

Building, Room 457, 5333 Westbard

Avenue, Bethesda, MD 20892

National Center for Research Resources

(NCRR), Evaluation Officer, Office of

Science Policy, NIH, Westwood Building,

Room 8A03, Bethesda, MD 20892

National Cancer Institute, Privacy Act

Coordinator, National Institutes of Health,

Building 31, Room 10A30, Bethesda, MD

20892

09–25–0161

SYSTEM NAME:

Administration: NIH Consultant File,

HHS/NIH/DRG.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

This system of records is an umbrella

system comprising separate sets of

records located in each of the NIH

organizational components or facilities

of contractors of the NIH.

Division of Computer Research and

Technology, Data Management

Branch, Building 12A, Room 4041B,

National Institutes of Health,

Bethesda, Maryland 20892

Write to the appropriate system manager

listed in Appendix I for a list of

current locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Consultants who provide the

evaluation of extramural grants and

cooperative agreement applications and

research contract proposals, including

the NIH Reviewers’ Reserve and/or

advise on policy. Consultants who

participate in NIH conferences,

workshops, evaluation projects and/or

provide technical assistance at site

locations arranged by contractors.

CATEGORIES OF RECORDS IN THE SYSTEM:

Names, addresses, Social Security

numbers, resumes, curriculum vitae

(C.V.s), areas of expertise, gender,

minority status, business status. AREAeligible status, publications, travel

records, and payment records for

consultants.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Section 301 of the Public Health

Service Act, describing the general

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4283

powers and duties of the Public Health

Service relating to research and

investigation, and section 402 of the

Public Health Service Act, describing

the appointment and authority of the

Director of the National Institutes of

Health, (42 U.S.C. 241, 282 and 290 aa).

PURPOSE(S):

This umbrella system comprises

separate sets of records located in each

of the NIH organizational components

or facilities of contractors of the NIH.

These records are used: (1) To identify

and select experts and consultants for

program reviews and evaluations; (2) To

identify and select experts and

consultants for the review of special

grant and cooperative agreement

applications and research contract

proposals and (3) To obtain and pay

consultants who participate in NIH

conferences, workshops, evaluation

projects and/or provide technical

assistance at site locations arranged by

contractors, and (4) To provide

necessary reports related to payment to

the Internal Revenue Service.

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 an inquiry

from the congressional office made at

the request of that individual.

2. 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; 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,

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. Disclosure may be made to

contractors to process or refine the

records. Contracted services may

include transcription, collection,

computer input, and other records

processing.

4. Information in this system of

records is used routinely to prepare W–

2 and 1099 Forms to submit to the

Internal Revenue Service and applicable

State and local governments those items

to be included as income to an

individual.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records may be stored in file folders,

computer tapes and disks, microfiche,

and microfilm.

RETRIEVABILITY:

Records are retrieved by name,

expertise, gender, minority status,

business status, AREA-eligible status

and experimental system used.

SAFEGUARDS:

1. Authorized users: Data on computer

files is accessed by keyword known

only to authorized users who are PHS or

contractor employees involved in

managing a review or program advisory

committee, conducting a review of

extramural grant applications,

cooperative agreement applications, or

research contract proposals, performing

an evaluation study or managing the

consultant file. Access to information is

thus limited to those with a need to

know.

2. Physical safeguards: Room where

records are stored are locked when not

in use. During regular business hours

rooms are unlocked but are controlled

by on-site personnel.

3. Procedural safeguards: Names and

other identifying particulars are deleted

when data from original records are

encoded for analysis. Data stored in

computers is accessed through the use

of keywords known only to authorized

users. Contractors who maintain records

in this system are instructed to make no

further disclosure of the records except

as authorized by the system manager

and permitted by the Privacy Act.

This system of records will be

protected according to the standards of

Chapter 45–13 of the HHS General

Administration Manual, ‘‘Safeguarding

Records Contained in Systems of

Records,’’ supplementary Chapter PHS

hf: 45–13, and Part 6, ‘‘ADP Systems

Security,’’ of the HHS Information

Resources Management Manual and the

National Institute of Standards and

Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 1100–G. Refer to

the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER(S) AND ADDRESS:

The policy coordinator for this system

is also the system manager listed for the

Division of Research Grants.

Chief, Biological and Physiological

Sciences Review Section, Referral and

Review Branch, Division of Research

Grants, Westwood Building, Room

417, 5333 Westbard Avenue,

Bethesda, Maryland 20892

and

See Appendix I

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the appropriate system manager as

listed in Appendix I.

The Requester must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requestor is whom

he or she claims to be. The request

should include: (a) Full name, and (b)

appropriate dates of participation.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requestors should also reasonably

specify the record contents being

sought. Individuals may also request

listing of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, reasonably identify

the record, specify the information to be

contested, and state the corrective

action sought with supporting

information. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Subject individual.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

Appendix I: System Managers

Office of the Director (OD), Extramural

Programs Management Officer, Building

31, Room 5B31, Bethesda, MD 20892

National Center for Research Resources

(NCRR), Director, Office of Review,

Westwood Building, Room 8A16,

Bethesda, MD 20892

National Cancer Institute (NCI), Chief,

Review Logistics Branch, Executive Plaza

North, Room 636, Bethesda, MD 20892

National Eye Institute (NEI), Review and

Special Projects Officer, Executive Plaza

South, Room 350, Bethesda, MD 20892

National Heart, Lung, and Blood Institute

(NHLBI), Chief, Review Branch, Westwood

4284 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

Building, Room 557A, 5333 Westbard

Avenue, Bethesda, MD 20892

National Institute on Aging (NIA), Chief,

Scientific Review Office, Gateway

Building, Suite 2C212, 7201 Wisconsin

Avenue, Bethesda, MD 20892

National Institute of Allergy and Infectious

Diseases (NIAID), Director, Scientific

Review Program, Division of Extramural

Activities, Solar Bldg., Room 3C–16, 6003

Executive Blvd., Bethesda, MD 20892

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

(NIAMS), Chief, Grants Review Branch,

Natcher Building, Room 5AS–25U,

Bethesda, MD 20892

National Institute of Child Health and

Human Development (NICHD), Director,

Division of Scientific Review, 6100

Executive Boulevard, Room 5E03H,

Bethesda, MD 20892

National Institute on Deafness and Other

Communication Disorders (NIDCD), Chief,

Scientific Review Branch, Executive Plaza

South, Room 400B, 620 Executive

Boulevard, Rockville, MD 20852

National Institute of Diabetes and Digestive

and Kidney Diseases (NIDDK), Chief,

Review Branch, Natcher Building, Room

6AS–37F, Bethesda, MD 20892

National Institute of Dental Research (NIDR),

Chief, Scientific Review Section, POB,

Natcher Building, Room 4AN–38D, 45

Center Drive MSC 6402, Bethesda, MD

20892–6402

National Institute of Environmental Health

Sciences (NIEHS), Chief, Scientific Review

Branch, Division of Extramural Research

and Training, P.O. Box 12233, Research

Triangle Park, NC 27709

National Institute of General Medical

Sciences (NIGMS), Chief, Office of

Scientific Review, Natcher Building, Room

1AS–13F, Bethesda, MD 20892

National Institute of Neurological Disorders

and Stroke (NINDS), Chief, Scientific

Review Branch, Federal Building, Room

9C10A, Bethesda, MD 20892

National Institute of Nursing Research

(NINR), Chief, Office of Review, Natcher

Building, Room 3AN24 MSC 6302,

Bethesda, MD 20892–6302

National Library of Medicine (NLM), Chief,

Biomedical Information Support Branch,

Building 38A, Room 5S522, Bethesda, MD

20894

National Center for Human Genome Research

(NCHGR), Chief, Office of Scientific

Review, Building 38A, Room 604,

Bethesda, MD 20892

National Institute of Mental Health, Associate

Director for Program Coordination,

Division of Extramural Activities,

Parklawn Building, Room 9C–15, 5600

Fishers Lane, Rockville, MD 20857

National Institute on Alcohol Abuse and

Alcoholism, Committee Management

Officer, Willco Building, Suite 504, 6000

Executive Blvd MSC 7003, Bethesda, MD

20892–7003

National Institute on Alcohol Abuse and

Alcoholism, Deputy Director, Office of

Scientific Affairs, Willco Building, Suite

409, 6000 Executive Blvd. MSC 7003,

Bethesda, MD 20892–7003

National Institute on Drug Abuse, Office of

Extramural Program Review, Parklawn

Building, Room 10–42, 5600 Rishers Lane,

Rockville, MD 20857

09–25–0165

SYSTEM NAME:

National Institutes of Health Loan

Repayment Program, HHS/NIH/OD.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Loan Repayment Program (LRP), Office

of the Director, National Institutes of

Health, Federal Building, Room 102,

7550 Wisconsin Avenue, Bethesda,

Maryland 20892–9015

Division of Computer Research and

Technology (DCRT), National

Institutes of Health, Building 12A,

Room 4037, 9000 Rockville Pike,

Bethesda, Maryland 20892

Operations Accounting Branch, Division

of Financial Management (DFM),

National Institutes of Health, Building

31, Room B1B55, 9000 Rockville Pike,

Bethesda, Maryland 20892

See Appendix I for a listing of other

NIH offices responsible for

administration of the Loan Repayment

Program. Write to the System Manager

at the address below for the address of

any Federal Records Center where

records from this system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Individuals who have applied for,

who have been approved to receive,

who are receiving, and who have

received funds under the NIH LRP; and

individuals who are interested in

participation in the NIH LRP.

CATEGORIES OF RECORDS IN THE SYSTEM:

Name, address, Social Security

number; service pay-back obligations,

standard school budgets, educational

loan data including deferment and

repayment/delinquent/default status

information; employment data;

professional and credentialing history of

licensed health professionals including

schools of attendance; personal,

professional, and demographic

background information; employment

status verification (which includes

certifications and verifications of

continuing participation in AIDS

research); Federal, State and local tax

information, including copies of tax

returns.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Section 487A (42 U.S.C. 288–1) of the

PHS Act, as amended, authorizes the

NIH to implement a program of

educational loan repayment for

qualified health professionals who agree

to conduct, as employees of NIH, AIDS

research (the NIH AIDS Research LRP).

The provisions of section 338B of the

PHS Act (42 U.S.C. 254l–1), as

amended, governing the NHSC loan

repayment program, are incorporated

except as inconsistent. Section 487E (42

U.S.C. 288–5) of the PHS Act authorizes

the NIH to establish and implement a

program of educational loan repayment

for qualified health professionals who

agree to conduct, as employees of the

NIH, clinical research (the NIH Clinical

Research LRP). Eligibility for the

Clinical Research LRP is restricted to

individuals who are from disadvantaged

backgrounds. The provisions of section

338C and 338E of the PHS Act (42

U.S.C. 254l–1), as amended, governing

the NHSC loan repayment program, are

incorporated except as inconsistent. The

Internal Revenue Code at 26 U.S.C. 6109

requires the provision of the SSN for the

receipt of loan repayment funds under

the NIH LRP.

PURPOSE(S):

(1) To identify and select applicants

for the NIH LRP; (2) To monitor loan

repayment activities, such as payment

tracking, deferment of service

obligation, and default; and (3) To assist

NIH officials in the collection of

overdue debts owed under the NIH LRP.

Records may be transferred to system

No. 09–15–0045, ‘‘Health Resources and

Services Administration Loan

Repayment/Debt Management Records

System, HHS/HRSA/OA,’’ for debt

collection purposes when NIH officials

are unable to collect overdue debts

owed under the NIH LRP.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USE:

1. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

2. 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 of 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,

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4285

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. 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 enforcing or

implementing the statute or rule,

regulation or order issued pursuant

thereto.

4. NIH may disclose records to

Department contractors and

subcontractors for the purpose of

collecting, compiling, aggregating,

analyzing, or refining records in the

system. Contractors maintain, and are

also required to ensure that

subcontractors maintain, Privacy Act

safeguards with respect to such records.

5. NIH may disclose information from

this system of records to private parties

such as present and former employers,

references listed on applications and

associated forms, other references and

educational institutions. The purpose of

such disclosures is to evaluate an

individual’s professional

accomplishments, performance, and

educational background, and to

determine if an applicant is suitable for

participation in the NIH LRP.

6. NIH may disclose information from

this system of records to a consumer

reporting agency (credit bureau) to

obtain a commercial credit report to

assess and verify the ability of an

individual to repay debts owed to the

Federal Government. Disclosures are

limited to the individual’s name,

address, Social Security number and

other information necessary to identify

him/her; the funding being sought or

amount and status of the debt; and the

program under which the applicant or

claim is being processed.

7. NIH may disclose from this system

of records a delinquent debtor’s or a

defaulting participant’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, as follows:

a. To another Federal agency so that

agency can effect a salary offset for debts

owed by Federal employees; if the claim

arose under the Social Security Act, the

employee must have agreed in writing

to the salary offset.

b. To another Federal agency so that

agency can effect an unauthorized

administrative offset; i.e., withhold

money, other than federal salaries,

payable to or held on behalf of the

individual.

c. To the Treasury Department,

Internal Revenue Service (IRS), to

request an individual’s current mailing

address to locate him/her for purposes

of either collecting or compromising a

debt, or to have a commercial credit

report prepared.

8. NIH may disclose information from

this system of records to another agency

that has asked the Department to effect

a salary or administrative offset to help

collect a debt owed to the United States.

Disclosure is limited to the individual’s

name, address, Social Security number,

and other information necessary to

identify the individual to information

about the money payable to or held for

the individual, and other information

concerning the offset.

9. NIH may disclose to the Treasury

Department, Internal Revenue Service

(IRS), information about an individual

applying for loan repayment under any

loan repayment program authorized by

the Public Health Service Act to find out

whether the applicant has a delinquent

tax account. This disclosure is for the

sole purpose of determining the

applicant’s creditworthiness and is

limited to the individual’s name,

address, Social Security number, other

information necessary to identify him/

her, and the program for which the

information is being obtained.

10. NIH may report to the Treasury

Department, Internal Revenue Service

(IRS), as taxable income, the written-off

amount of a debt owed by an individual

to the Federal Government when a debt

becomes partly or wholly uncollectible,

either because the time period for

collection under the statute of

limitations has expired, or because the

Government agrees with the individual

to forgive or compromise the debt.

11. NIH may disclose to debt

collection agents, other Federal

agencies, and other third parties who

are authorized to collect a Federal debt,

information necessary to identify a

delinquent debtor or a defaulting

participant. Disclosure will be limited to

the individual’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.

12. NIH may disclose information

from this system of records to any third

party that may have information about

a delinquent debtor’s or a defaulting

participant’s current address, such as a

U.S. post office, a State motor vehicle

administration, a professional

organization, an alumni association,

etc., for the purpose of obtaining the

individual’s current address. This

disclosure will be strictly limited to

information necessary to identify the

individual, without any reference to the

reason for the agency’s need for

obtaining the current address.

13. NIH may disclose information

from this system of records to other

Federal agencies that also provide loan

repayment at the request of these

Federal agencies in conjunction with a

matching program conducted by these

Federal agencies to detect or curtail

fraud and abuse in Federal loan

repayment programs, and to collect

delinquent loans or benefit payments

owed to the Federal Government.

14. NIH may disclose from this system

of records to the Department of

Treasury, Internal Revenue Service

(IRS): (1) A delinquent debtor’s or a

defaulting participant’s name, address,

Social Security number, and other

information necessary to identify the

individual; (2) the amount of the debt;

and (3) the program under which the

debt arose, so that IRS can offset against

the debt any income tax refunds which

may be due to the individual.

15. NIH may disclose information

provided by a lender to other Federal

agencies, debt collection agents, and

other third parties who are authorized to

collect a Federal debt. The purpose of

this disclosure is to identify an

individual who is delinquent in loan or

benefit payments owed to the Federal

Government.

DISCLOSURE TO CONSUMER REPORTING

AGENCIES:

Disclosures pursuant to 5 U.S.C.

552a(b)(12): Disclosures may be made

from this system to ‘‘consumer reporting

agencies’’ as defined in the Fair Credit

Reporting Act (15 U.S.C. 1681a(f)) or the

Federal Claims Collection Act of 1966

(31 U.S.C. 3701(a)(3)). The purposes of

these disclosures are: (1) To provide an

incentive for debtors to repay

delinquent Federal Government debts

by making these debts part of their

credit records, and (2) to enable NIH to

improve the quality of loan repayment

decisions by taking into account the

financial reliability of applicants,

including obtaining a commercial credit

report to assess and verify the ability of

an individual to repay debts owed to the

Federal Government. Disclosure of

records will be limited to the

individual’s name, Social Security

4286 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

number, and other information

necessary to establish the identity of the

individual, the amount, status, and

history of the claim, and the agency or

program under which the claim arose.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are maintained in file folders,

computer tape, discs, and file cards.

RETRIEVABILITY:

Records are retrieved by name, Social

Security number, or other identifying

numbers.

SAFEGUARDS:

1. Authorized users: Data on computer

files is accessed by keyword known

only to authorized users who are NIH

employees responsible for

implementing the NIH LRP. Access to

information is thus limited to those with

a need to know.

2. Physical safeguards: Rooms where

records are stored are locked when not

in use. During regular business hours

rooms are unlocked but are controlled

by on-site personnel. Security guards

perform random checks on the physical

security of the data.

3. Procedural and technical

safeguards: A password is required to

access the terminal and a data set name

controls the release of data to only

authorized users. All users of personal

information in connection with the

performance of their jobs (see

Authorized Users, above) protect

information from public view and from

unauthorized personnel entering an

unsupervised office.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

the Department’s Automated

Information System Security Handbook,

and the National Institute of Standards

and Technology Federal Information

Processing Standards (FIPS Pub. 41 and

FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 2300–537–1.

Participant case files are transferred to

a Federal Records Center one year after

closeout and destroyed five years later.

Closeout is the process by which it is

determined that all applicable

administrative actions and loan

repayments have been completed by the

LRP and service obligations have been

completed by the participant. Applicant

case files are destroyed three years after

disapproval or withdrawal of their

application. Official appeal and

litigation case files are destroyed six

years after the calendar year in which

the case is closed. Other copies of these

files are destroyed two years after the

calendar year in which the case is

closed.

SYSTEM MANAGER AND ADDRESS:

Director, NIH Loan Repayment

Program, Office of the Director, National

Institutes of Health, Federal Building,

Room 102, 7550 Wisconsin Avenue,

Bethesda, Maryland 20892–9015.

NOTIFICATION PROCEDURES:

To determine if a record exists, write

to the System Manager listed above. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be. The request should

include: (a) Full name, and (b)

appropriate dates of participation. The

requester must also understand that the

knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine.

Requesters appearing in person must

provide a valid driver’s license or

passport, including photo, and at least

one other form of identification.

RECORD ACCESS PROCEDURES:

Write to the System Manager

specified above to attain access to

records and provide the same

information as is required under the

Notification Procedures. Requesters

should also reasonably specify the

record contents being sought.

Individuals may also request an

accounting of disclosure of their

records, if any.

CONTESTING RECORD PROCEDURES:

Contact the System Manager specified

above and reasonably identify the

record, specify the information to be

contested, the corrective action sought,

and your reasons for requesting the

correction, along with supporting

information to show how the record is

inaccurate, incomplete, untimely or

irrelevant. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Subject individual; participating

lending institutions; educational

institutions attended; other Federal

agencies; consumer reporting agencies/

credit bureaus; and third parties that

provide references concerning the

subject individual.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

Appendix I: System Locations

Loan Repayment Program, National Institutes

of Health, Federal Building, Room 102,

7550 Wisconsin Avenue, Bethesda, MD

20892–9015

Division of Computer Research and

Technology, National Institutes of Health,

Building 12A, Room 4018, 9000 Rockville

Pike, Bethesda, MD 20892

Operations Accounting Branch, Division of

Financial Management, National Institutes

of Health, Building 31, Room B1B55, 9000

Rockville Pike, Bethesda, MD 20892

Division of Cancer Treatment, National

Cancer Institute, National Institutes of

Health, Building 31, Room 3A44, 9000

Rockville Pike, Bethesda, MD 20892

Division of Cancer Etiology, National Cancer

Institute, National Institutes of Health,

Building 31, Room 11A11, 9000 Rockville

Pike, Bethesda, MD 20892

Division of Cancer Biology, Diagnosis, and

Centers, National Cancer Institute, National

Institutes of Health, Building 31, Room

3A05, 9000 Rockville Pike, Bethesda, MD

20892

National Heart, Lung, and Blood Institute,

National Institutes of Health, Building 10,

Room 7N220, 9000 Rockville Pike,

Bethesda, MD 10892

National Institute of Dental Research,

National Institutes of Health, Building 31,

Room 2C23, 9000 Rockville Pike, Bethesda,

MD 20892

National Institute of Diabetes and Digestive

and Kidney Diseases, National Institutes of

Health, Building 10, Room 9N222, 9000

Rockville Pike, Bethesda, MD 20892

National Institute of Neurological Disorders

and Stroke, National Institutes of Health,

Building 10, Room 5N220, 9000 Rockville

Pike, Bethesda, MD 20892

National Institute of Allergy and Infectious

Diseases, National Instutes of Health,

Building 31, Room 7A05, 9000 Rockville

Pike, Bethesda, MD 20892

Pharmacological Sciences Program, National

Institute of General Medical Sciences,

National Institutes of Health, Building 45,

Room 2AS, 9000 Rockville Pike, Bethesda,

MD 20892

National Institute of Child Health and

Human Development, National Institutes of

Health, Building 31, Room 2A25, 9000

Rockville Pike, Bethesda, MD 20892

National Eye Institute, National Instutes of

Health, Building 10, Room 10N202, 9000

Rockville Pike, Bethesda, MD 20892

National Institute of Environmental Health

Sciences, National Institutes of Health,

South Campus, Building 101, Room B–248,

111 Alexander Drive, Research Triangle

Park, NC 27709

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4287

Gerontology Research Center, National

Institute on Aging, National Institutes of

Health, 4940 Eastern Avenue, Baltimore,

MD 21224

National Institute of Arthritis and

Musculoskeletal and Skin Diseases,

National Institutes of Health, Building 31,

Room 4C13, 9000 Rockville Pike, Bethesda,

MD 20892

National Institute of Deafness and

Communication Disorders, National

Institutes of Health, Building 31, Room

3C02, 9000 Rockville Pike, Bethesda, MD

20892

National Institute for Nursing Research,

National Institutes of Health, Building 31,

Room 5B06, 9000 Rockville Pike, Bethesda,

MD 20892

National Center for Research Resources,

National Institutes of Health, Building 31,

Room 3B36, 9000 Rockville Pike, Bethesda,

MD 20892

Clinical Center, National Institutes of Health,

Building 10, Room 1N312, 9000 Rockville

Pike, Bethesda, MD 20892

National Institute on Alcohol Abuse and

Alcoholism, National Institutes of Health,

Parklawn Building, Room 16C05, 5600

Fishers Lane, Rockville, MD 20857

National Institute on Drug Abuse, National

Institute of Health, Parklawn Building,

Room 10A38, 5600 Fishers Lane, Rockville,

MD 20857

National Institute of Mental Health, National

Institutes of Health, Parklawn Building,

Room 1599, 56 Fishers Lane, Rockville,

MD 20857

Clinical Center Nursing Recruiting Office,

National Institutes of Health, Building 10,

Room 2C206, 9000 Rockville Pike,

Bethesda, MD 20892

09–25–0166

SYSTEM NAME:

Administration: Radiation and

Occupational Safety and Health

Management Information Systems,

HHS/NIH/ORS.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Radiation Safety Branch (RSB), Division

of Safety, Office of Research Services,

NIH, Building 21, Room 134, 9000

Rockville Pike, Bethesda, MD 20892.

Occupational Safety and Health Branch

(OSHB), Division of Safety, National

Institutes of Health, Building 13,

Room 3K04, 9000 Rockville Pike,

Bethesda, Maryland 20892.

Write to appropriate System Manager

at the address below for the address of

contractor locations, including the

address of any Federal Records Center

where records from this system may be

stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Radiation Safety Branch (RSB): NIH

employees using radioactive materials

or radiation producing machinery,

contractor employees who provide

service to the Radiation Safety Branch

and any other individuals who could

potentially be exposed to radiation or

radioactivity as a result of NIH

operations and who, therefore, must be

monitored in accordance with

applicable regulations.

Occupational Safety and Health

Branch (OSHB): Individuals (including

NIH employees and NIH service

contract employees) who use or come

into contact with potentially hazardous

biological or chemical materials, and

participants of occupational safety and

health monitoring/surveillance

programs.

CATEGORIES OF RECORDS IN THE SYSTEM:

Employee name, title, organizational

affiliation, birth date, Social Security

number (optional), work address, work

telephone number, name of supervisor,

and other necessary employment

information; radiation/occupational

safety and health training information;

medical and technical information

pertaining to safety and health related

initiatives; research protocols and other

related documents used to monitor and

track radiation exposure and exposure

to potentially hazardous biological or

chemical materials; radiation materials

usage data; and incident data.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

42 U.S.C. 241, regarding the general

powers and duties of the Public Health

Service relating to research and

investigation; 5 U.S.C. 7902 regarding

agency safety programs; and 42 U.S.C.

2201, regarding general duties of the

Nuclear Regulatory Commission

including the setting of standards to

cover the possession and use of nuclear

materials in order to protect health.

PURPOSE(S):

1. To provide adequate administrative

controls to assure compliance with

internal NIH policies, and applicable

regulations of the Occupational Safety

and Health Administration (OSHA),

Department of Labor, and other Federal

and/or State agencies which may

establish health and safety requirements

or standards. Ensure legal compliance

with requirements of Nuclear

Regulatory Commission to maintain

internal and external radiation exposure

data.

2. To identify, evaluate and monitor

use or contact (including incident

follow-up) with:

a. Radiation (exposure maintained at

lowest levels reasonable)

b. Biological and/or chemical

(potentially hazardous materials).

3. To monitor, track, and assess the

use of personal protective equipment in

the work place to ensure availability,

effectiveness and proper maintenance.

4. To address emergent safety and

health issues or concerns.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USE:

1. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

2. 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 of 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,

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. Disclosure may be made to

contractors for the purpose of

processing or refining the records.

Contracted services may include

monitoring, testing, sampling,

surveying, evaluating, transcription,

collation, computer input, and other

records processing. The contractor shall

be required to maintain Privacy Act

safeguards with respect to such records.

4. Disclosure may be made to: (a)

Officials of the United States Nuclear

Regulatory Commission which, by

Federal regulation, licenses, inspects

and enforces the regulations governing

the use of radioactive materials; and (b)

OSHA, which provides oversight to

ensure that safe and healthful work

conditions are maintained for

employees. Disclosure will also be

permitted to other Federal and/or State

agencies which may establish health

and safety requirements or standards.

5. Radiation exposure and/or training

and experience history may be

transferred to new employer.

6. A record may be disclosed for a

research purpose, when the Department:

4288 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

(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, (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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are maintained in file

cabinets or in computer databases

maintained by the RSB and OSHB.

Records may be stored in file folders,

binders, magnetic tapes, magnetic disks,

optical disks and/or other types of data

storage devices.

RETRIEVABILITY:

Records are retrieved by name, Social

Security number, office address, or

unique RSB or OSHB assigned

identification number.

SAFEGUARDS:

1. Authorized users: Employees who

maintain this system are instructed to

grant regular access only to RSB/OSHB

staff, authorized contractor personnel,

U.S. Nuclear Regulatory Commission

Inspectors, Radiation Safety Committee

Members, Biosafety Committee

members, and other appropriate NIH

administrative and management

personnel with a need to know. Access

to information is thus limited to those

with a need to know.

2. Physical safeguards: Rooms where

records are stored are locked when not

in use. During regular business hours,

rooms are unlocked but are controlled

by on-site personnel. Individually

identifiable records are kept in locked

file cabinets or rooms under the direct

control of the Project Director.

3. Procedural safeguards: Names and

other identifying particulars are deleted

when data from original records are

encoded for analysis. Data stored in

computers is accessed through the use

of keywords known only to authorized

users. All users of personal information

in connection with the performance of

their jobs (see Authorized Users, above)

will protect information from public

view and from unauthorized personnel

entering an unsupervised office. The

computer terminals are in secured areas

and keywords needed to access data

files will be changed frequently.

4. Additional RSB technical

safeguards: Computerized records are

accessible only through a series of code

or keyword commands available from

and under direct control of the Project

Director or his/her delegated

representatives. The computer records

are secured by a multiple level security

system which is capable of controlling

access to the individual data field level.

Persons having access to the computer

database can be restricted to a confined

application which only permits a

narrow ‘‘view’’ of the data. Data on

computer files is accessed by keyword

known only to authorized users who are

NIH or contractor employees involved

in work for the program.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, supplementary Chapter PHS hf:

45–13, the Department’s Automated

Information Systems Security Program

Handbook, and the National Institute of

Standards and Technology Federal

Information Processing Standards (FIPS

Pub. 41 and FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361): Item 1300–B which

applies to Division of Safety records.

Refer to the NIH Manual Chapter for

specific disposition instructions.

Radiation exposure records are retained

under item 1300–B–10, which does not

allow disposal at this time.

SYSTEM MANAGER(S) AND ADDRESS:

Chief, Data and Analytical Services

Section, Radiation Safety Branch, DS,

ORS, Building 21, Room 104, 9000

Rockville Pike, Bethesda, Maryland

20892.

Chief, Occupational Safety and Health

Branch, Division of Safety, National

Institutes of Health, Building 13, Room

3K04, 9000 Rockville Pike, Bethesda,

Maryland 20892.

NOTIFICATION PROCEDURES:

To determine if a record exists, write

to the appropriate system manager as

listed above.

The requestor must also verify his or

her identity by providing either a

notarization of the request or a written

certification that the requestor is whom

he or she claims to be. The request

should include: (a) Full name, and (b)

appropriate dates of participation.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requestors should also reasonably

specify the record contents being

sought. Individuals may also request an

accounting of disclosure of their

records, if any.

CONTESTING RECORD PROCEDURE:

Contact the appropriate System

Manager specified above and reasonably

identify the record, specify the

information to be contested, and state

the corrective action sought with

supporting documentation. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Information is obtained from the

subject individual, previous employers

and educational institutions,

contractors, safety and health

monitoring/surveillance records,

employee interviews, site visits, or other

relevant NIH organizational

components.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0168

SYSTEM NAME:

Invention, patent and licensing

documents submitted to the Public

Health Service by its employees,

grantees, fellowship recipients and

contractors, HHS/PHS/NIH/OTT.

SECURITY CLASSIFICATION:

None.

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4289

SYSTEM LOCATION:

Office of Technology Transfer,

National Institutes of Health, 6011

Executive Boulevard, Third Floor,

Rockville, MD 20852.

Division of Financial Management

(DFM), Operations Accounting Branch,

National Institutes of Health, Building

31, Room B1B55, 9000 Rockville Pike,

Bethesda, Maryland 20892.

Division of Extramural Reports, Office

of Extramural Research, National

Institutes of Health, Building 31, Room

5B41, 31 Center Drive, Bethesda,

Maryland 20892–2184.

Public Health Service (PHS)

Technology Development Coordinators

and PHS Contract Attorneys retain files

supplemental to the records maintained

by the Office of Technology Transfer.

Write to the system manager at the

address below for office locations.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

PHS employees, grantees, fellowship

recipients and contractors who have

reported inventions, applied for patents,

have been granted patents, and/or are

receiving royalties from patents.

CATEGORIES OF RECORDS IN THE SYSTEM:

Inventor name, address, Social

Security number (required if inventor is

receiving royalties, otherwise optional),

title and description of the invention,

Employee Invention Report (EIR)

number, prior art related to the

invention, evaluation of the commercial

potential of the invention, prospective

licensees’ intended development of the

invention, associated patent prosecution

and licensing documents and royalty

payment information.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

45 CFR parts 6 (Inventions and

Patents (General)), 7 (Employee

Inventions) and 8 (Inventions Resulting

from Research Grants, Fellowship

Awards, and Contracts for Research),

describing Departmental standards for

assessing, reporting, and maintaining

rights, including patent rights, in

inventions of Departmental employees,

grantees, fellowship recipients, and

contractors, or inventions made through

other resources and activities of the

Department; Exec. Order No. 9865, as

amended, 35 U.S.C. 266 note, ‘‘Patent

protection abroad of inventions

resulting from research financed by the

Government,’’ describing the

Government-wide policy for obtaining

foreign patent protection for inventions

resulting from research conducted or

financed by the Government; and Exec.

Order No. 10096, as amended, 35 U.S.C.

266 note, ‘‘Uniform Government Patent

Policy for Inventions by Government

Employees,’’ describing Governmentwide policy pertaining to inventions

made by Government employees.

PURPOSE(S):

Records in this system are used to: (1)

Obtain patent protection of inventions

submitted by PHS employees; (2)

monitor the development of inventions

made by grantees, fellowship recipients

and contractors and protect the

government rights to patents made with

NIH support; (3) grant licenses to

patents obtained through the invention

reports; and (4) provide royalty

payments to PHS inventors.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USE:

1. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

2. 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,

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. Disclosure

may also be made to the Department of

Justice to obtain legal advice concerning

issues raised by the records in this

system.

3. 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 enforcing or

implementing the statute or rule,

regulation or order issued pursuant

thereto.

4. NIH may disclose records to

Department contractors and

subcontractors for the purpose of

collecting, compiling, aggregating,

analyzing, or refining records in the

system. Contractors maintain, and are

also required to ensure that

subcontractors maintain, Privacy Act

safeguards with respect to such records.

5. NIH may disclose information from

this system of records for the purpose of

obtaining patent protection for PHS

inventions and licenses for these patents

to: (a) Scientific personnel, both in this

agency and other Government agencies,

and in non-Governmental organizations

such as universities, who possess the

expertise to understand the invention

and evaluate its importance as a

scientific advance; (b) contract patent

counsel and their employees and foreign

contract personnel retained by the

Department for patent searching and

prosecution in both the United States

and foreign patent offices; (c) all other

Government agencies whom PHS

contacts regarding the possible use,

interest in, or ownership rights in PHS

inventions; (d) prospective licensees or

technology finders who may further

make the invention available to the

public through sale or use; (e) parties,

such as supervisors of inventors, whom

PHS contacts to determine ownership

rights, and those parties contacting PHS

to determine the Government’s

ownership; and (f) the United States and

foreign patent offices involved in the

filing of PHS patent applications.

6. NIH will report to the Treasury

Department, Internal Revenue Service

(IRS), as taxable income, the amount of

royalty payment paid to PHS inventors.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

The records will be stored in file

folders, computer tapes and computer

discs.

RETRIEVABILITY:

Records are retrieved by name of the

inventor, EIR number, or keywords

relating to the nature of the invention.

SAFEGUARDS:

1. Authorized users: Data on computer

files is accessed by keyword known

only to authorized users who are NIH or

contractor employees involved in

patenting and licensing of PHS

inventions. Access to information is

thus limited to those with a need to

know.

2. Physical safeguards: records are

stored in a locked room or in locking

4290 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

file cabinets in file folders. During

normal business hours, OTT Patent

Branch and Licensing Branch on-site

personnel regulate availability of the

files. During evening and weekend

hours the offices are locked and the

building is closed.

3. Procedural and technical

safeguards: Data stored in computers

will be accessed through the use of

keywords known only to the authorized

users. A password is required to access

the data base. All users of personal

information in connection with the

performance of their jobs (see

Authorized Users, above) protect

information, including confidential

business information submitted by

potential licensees, from public view

and from unauthorized personnel

entering an unsupervised office.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

the Department’s Automated

Information System Security Program

Handbook, and the National Institute of

Standards and Technology Federal

Information Processing Standards (FIPS

Pub. 41 and FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management manual,

Appendix B–361), item 1100–L, which

allows records to be kept for a

maximum of twenty (20) years. Refer to

the NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Chief, Technology Management

Branch, Office of Technology Transfer,

National Institutes of Health, 6011

Executive Boulevard, Third Floor,

Rockville, Maryland 20852.

Division of Extramural Reports, Office

of Extramural Research, National

Institutes of Health, Building 31, Room

5B41, 31 Center Drive, Bethesda, MD

20892–2184.

NOTIFICATION PROCEDURES:

To determine if a record exists, write

to the System Manager listed above. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine. The

request should include: (a) Full name,

and (b) appropriate identifying

information on the nature of the

invention.

RECORD ACCESS PROCEDURES:

Write to the System Manager

specified above to attain access to

records and provide the same

information as is required under the

Notification Procedures. Requesters

should also reasonably specify the

record contents being sought.

Individuals may also request an

accounting of disclosure of their

records, if any.

CONTESTING RECORD PROCEDURES:

Contact the System manager specified

above and reasonably identify the

record, specify the information to be

contested, the corrective action sought,

and your reasons for requesting the

correction, along with supporting

information to show how the record is

inaccurate, incomplete, untimely or

irrelevant. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Inventors and other collaborating

persons, grantees, fellowship recipients

and contractors; other Federal agencies;

scientific experts from non-Government

organizations; contract patent counsel

and their employees and foreign

contract personnel; Unites States and

foreign patent offices; prospective

licensees; and third parties whom PHS

contacts to determine individual

invention ownership or Government

ownership.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0170

SYSTEM NAME:

Diabetes Data System, HHS/NIH/

NIDDK.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

A list of all contractor/subcontractor

locations is available upon request for

the System Manager (see address

below).

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Individuals who participated in the

Diabetes Prevention Trial—Type 1

Diabetes (DPT–1); the Diabetes

Prevention Trial—Type 2 Diabetes

(DPT–2); the Epidemiology of Diabetes

Interventions and Complications Study

(EDIC); the International Pancreas and

Islet Transplant Registry (IPITR), and

family members of these participants.

CATEGORIES OF RECORDS IN THE SYSTEM:

Participant names, addresses, phone

numbers; Social Security numbers

(voluntary), phone numbers, driver’s

license numbers, employer information,

spouse names, study identification

numbers, educational background,

occupational history, names of medical

provider, medical record identification

numbers, health and medical record

data collected during these trials and

follow-up studies; the names, addresses

and phone numbers of acquaintances

and relatives to assist in follow-up; a

family tree (or pedigree) and

information pertaining to DCCT stored

biologic specimens (including blood,

urine and genetic materials).

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Section 301(a) of the Public Health

Service (PHS) Act (42 U.S.C. 241(a)),

describing the general powers and

duties of the Public Health Service

relating to research and investigation,

and section 426 of the PHS Act (42

U.S.C. 285c) describing the purpose of

the National Institute of Diabetes and

Digestive and Kidney Diseases to

conduct research with respect to, among

other areas, diabetes mellitus.

PURPOSE(S):

These records are used to: (1) Conduct

research on diabetes mellitus in order to

understand the disease and find better

treatments and/or an eventual cure; (2)

conduct follow-up studies (projected

follow-up of 7–10 years) on the

morbidity and mortality experiences of

study participants; and (3) provide

relevant demographic, health and

medical record data on participants to

biomedical researchers authorized to

use information and stored biologic

materials.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USE:

1. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

2. 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

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4291

affect directly the operations of the

Department or any of its components; or

(c) any Department employee in his or

her individual capacity where the

Department of Justice 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, the Department may

disclose such records as it deems

necessary 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.

3. NIH may disclose records to

Department contractors and

subcontractors for the purpose of

collecting, compiling, aggregating,

analyzing, or refining records in the

system. Contractors maintain, and are

also required to ensure that

subcontractors maintain, Privacy Act

safeguards with respect to such records.

4. 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, (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.

5. Information from this system may

be disclosed to Federal agencies, State

agencies (including the Motor Vehicle

Administration and State vital statistics

offices, private agencies, and other third

parties (such as current or prior

employers, acquaintances, relatives), in

order to obtain information on

morbidity and mortality experiences

and to locate individuals for the followup studies. Social Security numbers

may be disclosed: (1) To the National

Center for Health Statistics to ascertain

vital status through the National Death

Index; (2) to the Health Care Financing

Agency to ascertain morbidities; and (3)

to the Social Security Administration to

ascertain disabilities and/or location of

participants. Social Security numbers

may also be given to other Federal

agencies, and State and local agencies

for purposes of locating individuals for

participation in follow-up studies.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records may be stored in file folders

and computer types and diskettes,

microfiche, and file cards.

RETRIEVABILITY:

Records are retrieved by name, Social

Security number, or other identifying

numbers, keywords, and parameters of

individual patient health or medical

record data.

SAFEGUARDS:

1. Authorized users: Data on computer

files is accessed by keyword known

only to authorized users who are NIH or

contractor employees who have a need

for the data in performance of their

duties as determined by the system

manager. Researchers authorized to

conduct research on biologic specimens

will have access to the system through

the use of encrypted identifiers

sufficient to link individuals with

records in such a manner that does not

compromise confidentiality of the

individual. Access to information is

thus limited to those with a need to

know.

2. Physical safeguards: Records and

data tapes are stored in locked files in

secured areas with restricted access.

During regular business hours rooms are

unlocked but are controlled by on-site

personnel. Terminal access is controlled

by user ID and keywords; off-site data

backup is maintained in a separate

building; fire protection is maintained

by an on-site fire extinguisher system

and fire alarm system present in the

computer room.

3. Procedural and technical

safeguards: Names and other identifying

particulars are deleted when data from

original records are encoded for

analysis. Data stored in computers is

accessed through the use of keywords

known only to authorized users. A

password is required to access the

terminal and a data set name controls

the release of data to only authorized

users. All users of personal information

in connection with the performance of

their jobs (see Authorized Users, above)

protect information from public view

and from unauthorized personnel

entering an unsupervised office.

Contractors and subcontractors who

maintain records in this system are

instructed to make no further disclosure

of the records except as authorized by

the System manager and permitted by

the Privacy Act. Privacy Act

requirements are specifically included

in contracts and in agreements with

grantees or collaborators participating in

research activities supported by the

system. HHS project directors, contract

officers, and project officers oversee

compliance with these requirements.

These practices are in compliance

with the standards of Chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary Chapter PHS hf: 45–13,

and the Department’s Automated

Information System Security Program

Handbook, and the National Institute of

Standards and Technology Federal

Information Processing Standards (FIPS

Pub. 41 and FIPS Pub. 31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records’’

(HHS Records Management Manual,

Appendix B–361), item 3000–G–3(b),

which allows records to be kept as long

as they are useful in scientific research.

Refer to the NIH Manual Chapter for

specific disposition instructions.

SYSTEM MANAGER AND ADDRESS:

Chief, Diabetes Research Section,

DPB, DDEM, National Institutes of

Diabetes and Digestive and Kidney

Diseases, National Institutes of Health,

Westood Building, Room 622, 5333

Westbard Avenue, Bethesda, MD 20892.

NOTIFICATION PROCEDURES:

To determine if a record exists, write

to the System Manager listed above. The

4292 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

requester must also verify his or her

identity by providing either a

notorization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Act, subject

to a five thousand dollar fine. The

request should include: (a) Full name,

and (b) appropriate dates of

participation.

Individuals who request notification

of or access to a medical record shall,

at the time the request is made,

designate in writing a responsible

representative who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s/

incompetent person’s medical 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 their relationship to the

child/incompetent person as well as

his/her own identity.

RECORD ACCESS PROCEDURES:

Write to the System Manager

specified above to attain access to

records and provide the same

information as is required under the

Notification Procedures. Requesters

should also reasonably specify the

record contents being sought.

Individuals may also request an

accounting of disclosure of their

records, if any.

CONTESTING RECORD PROCEDURES:

Contact the System Manager specified

above and reasonably identify the

record, specify the information to be

contested, the corrective action sought,

and your reasons for requesting the

correction, along with supporting

information to show how the record is

inaccurate, incomplete, untimely or

irrelevant. The right to contest records

is limited to information which is

incomplete, irrelevant, incorrect, or

untimely (obsolete).

RECORD SOURCE CATEGORIES:

Subject individual; patient health and

medical record data; data generated

from the DCCT; Federal, State and local

agencies (including the Social Security

Administration), and if the person is

deceased, from the National Death

Index, and/or family members and other

knowledgeable third persons.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0202

SYSTEM NAME:

Patient Records on PHS Beneficiaries

(1935–1974) and Civilly Committed

Drug Abusers (1967–1976) Treated at

the PHS Hospitals in Fort Worth, Texas,

or Lexington, Kentucky, HHS/NIH/

NIDA.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institute on Drug Abuse,

Intramural Research Program, Johns

Hopkins Bayview Medical Center, P.O.

Box 5180, Baltimore, Maryland 21224.

Federal Records Center, 1557 St.

Joseph Avenue, East Point, Georgia

30344.

Washington National Records Center,

4205 Suitland Road, Washington, DC

20409.

National Business Activities, 8200

Preston Court, Suite One, Jessup,

Maryland 20794.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Civilly committed narcotic addicts

(1967–1976) and adult PHS

beneficiaries (1935–1974) treated at

either the PHS hospital in Fort Worth,

Texas, or Lexington, Kentucky.

CATEGORIES OF RECORDS IN THE SYSTEM:

Administrative records, such as

treatment admission and release dates,

name and address, and other

demographic data; medical records,

such as, but not limited to, medical

history information, drug abuse/use data

as well as treatment information, any

laboratory tests, etc.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Narcotic Addict Rehabilitation Act of

1966, and Narcotic Addict

Rehabilitation Amendments of 1971,

Titles I and III (42 U.S.C. 3411 et seq.

and 28 U.S.C. 2901 et seq.), and Public

Health Service Act, Sections 321–326,

341 (a) and (c) (42 U.S.C. 248–253, 257

(a) and (c).

PURPOSE(S):

The records were collected originally

to monitor the individual’s progress

while being treated at either of two PHS

hospitals and to ensure continuity of

that care. These systems are now

inactive. The records are used to

respond to requests from subject

individuals (or his/her designated

representative) to (1) establish eligibility

for certain Federal benefits for the

individual or his/her dependent(s), and

(2) provide information to subsequent

health care providers at the request of

the individual regarding medical

treatment received to ensure continuity

of care.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

None.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records at National Institute on Drug

Abuse (NIDA) are on microfilm and

contain only part of the admission and

discharge information. The microfilm is

stored in a file cabinet in a locked room.

Records sent to Federal Records Center

are stored in GSA-approved storage

containers.

RETRIEVABILITY:

The administrative records and

microfilm are filed by patient name. The

medical records are filed either by

patient name or by patient’s hospital

number with a cross-reference list at

NIDA matching number to name.

SAFEGUARDS:

1. Authorized users: Only the System

Manager and designated staff.

2. Physical safeguards: The microfilm

is in a room which has limited access,

or stored at a security coded warehouse.

The room is located in a building with

a 24-hour security patrol/television

surveillance system. Sign in and out

procedures are used at all times. The

warehouse has security access, records

can only be retrieved by the System

Manager or designated staff using a

confidential code number. The

warehouse is patrolled on a 24-hour

basis with television surveillance.

3. Procedural safeguards: Only the

System Manager and his/her staff have

access to the microfilm information and

have been trained in accordance with

the Privacy Act.

4. Implementation guidelines: DHHS

Chapter 45–13 and supplementary

Chapter PHS.hf: 45–13 of the General

Administration Manual.

RETENTION AND DISPOSAL:

All administrative and medical

records have been retired to a Federal

Records Center. The records collected

under the Narcotic Addict

Rehabilitation Act of 1966 will be

destroyed when they are 25 years old,

which will be in 2001 because the last

patient was released from treatment in

1976. The PHS beneficiaries’ records

will be destroyed at the same time. The

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4293

records will be shredded in 2003 upon

written request from the System

Manager.

SYSTEM MANAGER(S) AND ADDRESS:

Medical Records Officer, National

Institute on Drug Abuse, Intramural

Research Program, Johns Hopkins

Bayview Medical Center, Box 5180,

Baltimore, Maryland 21224.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the System Manager at the address

above. An individual may learn if a

record exists about himself or herself

upon written request with a notarized

signature. The request should include, if

known: Patient hospital record number,

full name or any alias used, patient’s

address during treatment, birth date,

veteran status (if applicable) and

approximate dates in treatment, and

Social Security Number.

An individual who requests

notification of a medical record shall, at

the time the request is made, designate

in writing a responsible representative

who will be willing to review the record

and inform the individual of its content

at the representative’s discretion.

RECORD ACCESS PROCEDURES:

Same as Notification Procedures.

Requesters should also reasonably

specify the record contents being

sought. An individual may also request

an accounting of disclosures of his/her

record, if any.

CONTESTING RECORD PROCEDURES:

Contact the official at the address

specified under Notification Procedures

above, and reasonably identify the

record, specify the information being

contested, and state the corrective

action sought, with supporting

information to show how the record is

inaccurate, incomplete, untimely, or

irrelevant.

RECORD SOURCE CATEGORIES:

Patients; patients’ drug treatment

program counselors; court records;

hospital personnel.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0203

SYSTEM NAME:

National Institute on Drug Abuse,

Intramural Research Program, Federal

Prisoner and Non-Prisoner Research

Files, HHS/NIH/NIDA.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

National Institute on Drug Abuse,

Intramural Research Program, P.O. Box

5180, Baltimore, Maryland 21224.

Maryland Medical Laboratories, Inc.,

Pathology Building, 1901 Silver Spring

Road, Baltimore, Maryland 21227.

Federal Records Center, 1557 St.

Joseph Avenue, East Point, Georgia

30344.

Washington National Records Center,

4205 Suitland Road, Washington, DC

20409.

NOVA, Johns Hopkins Bayview

Medical Center, Building C, 4940

Eastern Avenue, Baltimore, Maryland

21224.

National Business Activities, 8200

Preston Court, Suite One, Jessup,

Maryland 20794.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Volunteers, adult males (from 1968 to

present), adult females (beginning in

1985) and adolescents (ages 13–18,

beginning in 1983) and children

(neonate to 12 beginning in 1989).

Clinical research projects conducted at

the Addiction Research Center (ARC).

This system also includes records on

adult Federal prisoners involved in

research projects at ARC when located

at Lexington, Kentucky, from 1968–

1976, and some records from system 09–

30–0020 to be used for statistical

research only.

CATEGORIES OF RECORDS IN THE SYSTEM:

The categories of records involved are

administrative, medical and research

records.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Public Health Service Act, section

301(a) (42 U.S.C. 241(a)); sections 341(a)

and 344(d) (42 U.S.C. 257(a) and

260(d)); section 503 and 515 (42 U.S.C.

290aa-2 and 290cc). These sections

authorize the conduct of research in all

areas of drug abuse.

PURPOSE(S):

(1) To collect and maintain a data

base for research activities at ARC, and

(2) to enable Federal drug abuse

researchers to evaluate and monitor the

subjects’ health during participation in

a research project. The areas of research

include, but are not limited to,

biomedical, clinical, behavioral,

pharmacological, psychiatric,

psychosocial, epidemiological,

etiological, statistical, treatment and

prevention of narcotic addiction and

drug abuse.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. The National Institute on Drug

Abuse (NIDA) uses a contractor to

recruit volunteers and to screen these

individuals for their acceptability to

participate in specific research projects,

and limits the contractor’s access to the

records to these procedures. NIDA also

uses a contractor to perform routine

medical laboratory tests on blood and

urine samples. These routine tests verify

that the subject is in good health. Both

contractors disclose records from this

system only to NIDA and are required

to maintain Privacy Act safeguards with

respect to such records.

2. (a) PHS 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 needlesharing partner(s); (3) The PHS

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).

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Data may be stored in file folders or

on computer disks, magnetic tapes, or

microfilm.

RETRIEVABILITY:

Administrative and medical records

are indexed and retrieved by the

subject’s name and identification code

number. Research records are indexed

and retrieved by the subject’s name and

identification code number.

4294 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

SAFEGUARDS:

1. Authorized areas: Only authorized

ARC staff (Principal Investigator and

his/her research team) are allowed

access to these files. The contractor staff

has access to the files during the

recruitment/screening process.

2. Physical safeguards: Files and file

rooms are locked after business hours.

Building has electronic controlled entry

at all times with a 24-hour guard/

television surveillance system. The

computer terminals are in a further

secured area.

3. Procedural safeguards: All users of

personal information in connection with

the performance of their jobs protect

information from unauthorized

personnel. Access codes to the research

records are available only to the

Principal Investigator and his/her

research team. Access to the records is

strictly limited to those staff members

trained in accordance with the Privacy

Act. The contractor staff members are

required to secure the information in

accordance with the Privacy Act. ARC

Project Officer and contracting officials

will monitor contractor compliance.

4. Implementation guidelines: DHHS

Chapter 45–13 and supplementary

Chapter PHS.hf: 45–13 of the General

Administration Manual; and Chapter 6–

05, ‘‘Risk Management,’’ under Part 6 in

the Department’s ADP Systems Security

Manual.

In addition, because much of the data

collected in these research projects are

sensitive and confidential, special

safeguards have been established.

Certificates of confidentiality have been

issued under Protection of Identity—

Research Subjects Regulations (42 CFR

part 2a) to those projects initiated since

February 1980. This authorization

enables persons engaged in research on

mental health, including research on the

use and effect of psychoactive drugs, to

protect the privacy of research subjects

by withholding their names or other

identifying characteristics from all

persons not connected with the conduct

of the research. Persons so authorized

may not be compelled in any Federal,

State, or local civil, criminal,

administrative, legislative, or other

proceeding to identify such individuals.

In addition, these records are subject to

42 CFR part 2, the Confidentiality of

Alcohol and Drug Abuse Patient

Records Regulations (42 CFR 2.56),

which state: ‘‘Where the content of

patient records has been disclosed

pursuant to these regulations for the

purpose of conducting scientific

research * * * information contained

therein which would directly or

indirectly identify any patient may not

be disclosed by the recipient thereof

either voluntarily or in response to any

legal process whether Federal or State.’’

RETENTION AND DISPOSAL:

Records will be disposed of in

accordance with the NIH Records

Control Schedule, i.e., when the records

are 10 years old or no longer required

for administrative or research purposes.

The records on individuals who do not

qualify for a specific research project are

kept for one year by the contractor who

then destroys them by shredding.

SYSTEM MANAGER(S) AND ADDRESSES:

Medical Records Officer, NIDA,

Intramural Research Program, Johns

Hopkins Bayview Medical Center—

Building C, P.O. Box 5180, Baltimore,

Maryland 21224.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the System Manager at the address

above. Provide a notarized signature as

proof of identify. This can be waived if

the request is made through official

federal, state, or local channels. The

request should include the patient’s

register number and/or the number of

years of incarceration (for prisoner

subjects), full name at time of

participation in the research project,

date(s) of research participation, and

title of research project or name of drug

being studied. An individual who

requests notification of a medical record

shall, at the time the request is made,

designate in writing a responsible

representative who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

A parent or legal guardian who

requests notification of an adolescent’s

record shall designate a family

physician or other health professional

(other than a family member) of the

Addiction Research Center staff to

whom the record, if any, will be sent.

The parent or legal guardian must verify

in writing the relationship to the

adolescent as well as his/her own

identity.

RECORD ACCESS PROCEDURES:

Same as Notification Procedures.

Requesters should also reasonably

specify the record contents being

sought. An individual may also request

an accounting of disclosures that have

been made of his/her records, if any.

CONTESTING RECORD PROCEDURES:

Contact the official at the address

specified under Notification Procedures

above and reasonably identify the

record, specify the information being

contested, and state the corrective

action sought and reasons for requesting

the correction, along with supporting

information to show how the record is

inaccurate, incomplete, untimely, or

irrelevant.

RECORD SOURCE CATEGORIES:

The individual; observations and

medical recordings (such as blood

pressure, dosage of compound

administered, etc.) made by the

Principal Investigator and his/her

research team; system of records

number 09–30–0020; drug treatment

programs; Bureau of Prisons; case

workers; psychiatrists; research

laboratories; and pharmacies and

hospitals. Many of these records are

confidential and privileged

communication is guaranteed under

section 344(d) of the PHS Act.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0205

SYSTEM NAME:

Alcohol, Drug Abuse, and Mental

Health Epidemiologic and Biometric

Research Data, HHS/NIH/NIAAA, HHS/

NIH/NIDA and HHS/NIH/NIMH.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Records are located at the research

facilities which collect or provide

research data for this system under

contract to the agency. Contractors may

include, but are not limited to, research

centers, clinics, hospitals, universities,

research foundations, national

associations, and coordinating centers.

Records may also be located at the

research facilities of the National

Institute on Alcohol Abuse and

Alcoholism (NIAAA), the National

Institute on Drug Abuse (NIDA); and the

National Institute of Mental Health

(NIMH). A current list of sites is

available by writing to the appropriate

System Manager at the address below.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Individuals who are the subjects of

research in epidemiologic, clinical,

methodologic, and longitudinal research

studies and surveys of mental health

and alcohol and drug use/abuse and

mental, alcohol, and/or drug abuse

disorders. These individuals are

selected as representative of the general

adult and/or child population or of

special groups. Special groups include,

but are not limited to, normal

individuals serving as controls; clients

referred for or receiving medical, mental

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4295

health, and alcohol and/or drug abuse

related treatment and prevention

services; providers of services;

demographic sub-groups as applicable,

such as age, sex, ethnicity, race,

occupation, geographic location; and

groups exposed to hypothesized risks,

such as relatives of individuals who

have experienced mental health and/or

alcohol, and/or drug abuse disorders,

life stresses, or have previous history of

mental, alcohol, and/or drug abuse

related illness.

CATEGORIES OF RECORDS IN THE SYSTEM:

The system contains data about the

individual as relevant to a particular

research study. Examples include, but

are not limited to, items about the

health/mental health and/or alcohol or

drug consumption patterns of the

individual; demographic data; social

security numbers (voluntary); past and

present life experiences; personality

characteristics; social functioning;

utilization of health/mental health,

alcohol, and/or drug abuse services;

family history; physiological measures;

and characteristics and activities of

health/mental health; alcohol abuse,

and/or drug abuse care providers.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Public Health Service Act, sections

301 and 405 (42 U.S.C. 241, and 284,

General Research and Investigation

Authorities); Public Health Service Act,

sections 301, 302, 303 and Title V, Parts

A and B (42 US.C. 241, 242, 242(a).

PURPOSE(S):

The purpose of the system of records

is to collect and maintain databases for

research activities. Analyses of these

data involve groups of individuals with

given characteristics and do not refer to

special individuals. The generation of

information and statistical analyses will

ultimately lead to a better description

and understanding of mental, alcohol,

and/or drug abuse disorders, their

diagnosis, treatment and prevention,

and the promotion of good physical and

mental health.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. A record may be disclosed for a

research purpose, when the Department:

(a) As determined that the use or

disclosure does not violate legal or

policy limitations under which the

record was provided, collected, or

obtained; e.g., disclosure of alcohol or

drug abuse patient records will be made

only in accordance with the restrictions

of confidentiality statutes and

regulations 42 U.S.C. 290 (dd–3), 42

U.S.C. 241 and 405, 42 CFR part 2, and

where applicable, no disclosures will be

made inconsistent with an authorization

of confidentiality under 42 U.S.C. 242a

and 42 CFR part 2a; (b) as 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; and (d) has

secured a written statement attesting to

the recipient’s understanding of, and

willingness to abide by, these

provisions.

2. Disclosure may be made to a

congressional office from the record of

an individual in response to a verified

inquiry from a congressional office

made at the written request of that

individual.

3. In the event of litigation, where the

defendant is (a) the Department, any

component of the Department, or any

employee of the Department is 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; the

Department may disclose such records

as it deems desirable or necessary to the

Department of Justice to enable that

Department to present an effective

defense, provided such disclosure is

compatible with the purpose for which

the records were collected (e.g.,

disclosure may be made to the

Department of Justice or other

appropriate Federal agencies in

defending claims against the United

States when the claim is based upon an

individual’s mental or physical

condition and is alleged to have arisen

because of the individual’s participation

in activities of a Federal Government

supported research project).

4. The Department contemplates that

it will contract with a private firm for

the purpose of collecting, analyzing,

aggregating, or otherwise refining

records in this system. Relevant records

will be disclosed to such contractor. The

contractor shall be required to maintain

Privacy Act safeguards with respect to

such records.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records may be stored on index cards,

file folders, computer tapes and disks,

microfiche, microfilm, and audio and

video tapes. Normally, the factual data,

with study code numbers, are stored on

computer tape or disk, while the key to

personal identifiers is stored separately,

without factual data, in paper files.

RETRIEVABILITY:

During data collection stages and

followup, if any, retrieval by personal

identifier (e.g., name, social security

number) (in some studies), or medical

record number), is necessary. During the

data analysis stage, data are normally

retrieved by the variables of interest

(e.g., diagnosis, age, occupation).

SAFEGUARDS:

1. Authorized users: Access to

identifiers and to link files is strictly

limited to the authorized personnel

whose duties require such access.

Procedures for determining authorized

access to identified data are established

as appropriate for each location.

Personnel, including contractor

personnel, who may be so authorized

include those directly involved in data

collection and in the design of research

studies, e.g., interviewers and

interviewer supervisors; project

managers; statisticians involved in

designing sampling plans.

2. Physical safeguards: Records are

stored in locked rooms, locked file

cabinets, and/or secured computer

facilities. Personal identifiers and link

files are separated as much as possible

and stored in locked files. Computer

data access is limited through the use of

key words known only to authorized

personnel.

3. Procedural safeguards: Collection

and maintenance of data is consistent

4296 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

with legislation and regulations in the

protection of human subjects, informed

consent, confidentiality, and

confidentiality specific to drug and

alcohol abuse patients where these

apply. When an Institute Division or a

contractor provides anonymous data to

research scientists for analysis, study

numbers which can be matched to

personal identifiers will be eliminated,

scrambled, or replaced by the agency or

contractor with random numbers which

cannot be matched. Contractors who

maintain records in this system are

instructed to make no further disclosure

of the records. Privacy Act requirements

are specifically included in contracts for

survey and research activities related to

this system. The HHS project directors,

contract officers, and project officers

oversee compliance with these

requirements.

4. Implementation guidelines: DHHS

Chapter 45– and supplementary Chapter

PHS.hf: 45–13 of the General

Administration Manual and Part 6,

‘‘ADP System Security’’ of the HHS ADP

Systems Security Manual.

RETENTION AND DISPOSAL:

Personal identifiers are retained only

as long as they are needed for the

purposes of the current research project,

and for followup studies generated by

the present study. Removal or disposal

of identifiers is done according to the

storage medium (e.g., erase computer

tape, shred or burn index cards, etc.). A

staff person designated by the System

Manager will oversee and will describe

and confirm the disposal in writing.

SYSTEM MANAGER(S) AND ADDRESS:

Privacy Act Coordinator, National

Institute of Mental Health, Room 7C–22,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857.

Deputy Director, Division of Biometry

and Epidemiology, National Institute on

Alcohol Abuse and Alcoholism, Willco

Building, Suite 514, 6000 Executive

Blvd. MSC 7003, Bethesda, MD 20892–

7003.

Deputy Director, Division of Clinical

and Prevention Research, National

Institute on Alcohol Abuse and

Alcoholism, Willco Building, Suite 505,

6000 Executive Blvd. MSC 7003,

Bethesda, MD 20892–7003.

Privacy Act Coordinator, National

Institute on Drug Abuse, Room 10A–42,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the appropriate System Manager at

the address above. Provide individual’s

name; current address; date of birth;

date, place and nature of participation

in specific research study; name of

individual or organization

administering the research study (if

known); name or description of the

research study (if known); address at the

time of participation; and a notarized

statement by two witnesses attesting to

the individual’s identity.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. An individual may also request

an accounting of disclosures of his/her

record, if any.

An individual who requests

notification of, or access to, a medical

record shall, at the time the request is

made, designate in writing a responsible

representative who will be willing to

review the record and inform the subject

individual of its contents at the

representative’s discretion.

A parent or guardian who requests

notification of, or access to, a child’s or

incompetent person’s medical 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 or

incompetent person as well as his or her

own identity.

CONTESTING RECORD PROCEDURE:

Contact the appropriate official at the

address specified under System

Manager(s) above and reasonably

identify the record, specify the

information being contested, and state

corrective action sought, with

supporting information to show how the

record is inaccurate, incomplete,

untimely, or irrelevant.

RECORD SOURCE CATEGORIES:

The system contains information

obtained directly from the subject

individual by interview (face-to-face or

telephone), by written questionnaire, or

by other tests, recording devices or

observations, consistent with legislation

and regulation regarding informed

consent and protection of human

subjects. Information is also obtained

from other sources, such as health,

mental health, alcohol, and/or drug

abuse care providers; relatives;

guardians; and clinical medical research

records.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0207

SYSTEM NAME:

Subject-Participants in

Pharmacokinetic Studies on Drugs of

Abuse and on Treatment Medications,

HHS/NIH/NIDA.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

University of California, San

Francisco, Langley Porter Psychiatric

Institute, San Francisco, California

94143.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Normal, healthy adults who

voluntarily participate in studies on the

pharmacokinetics and

pharmacodynamics of psychoactive

drugs at Langley Porter Psychiatric

Institute, during the period September

1987 through June, 1997.

CATEGORIES OF RECORDS IN THE SYSTEM:

Research records on each subjectparticipant contain the following

information: Name; clinician’s records

including medical history, laboratory

test results, physical examinations,

psychological profile, and drug use

profile; drug study data including

records of drugs administered,

exposures to radioactivity, and drug

reactions; and date of study in which

the subject participated.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Public Health Service Act, sections

301(a), 503 and 405 (42 U.S.C. 241 and

284).

PURPOSE(S):

The primary purpose of this system is

to support research on the

pharmacokinetics and

pharmacodynamics of drugs of abuse as

well as treatment drugs. The term

‘‘pharmacokinetics’’ refers to the

manner in which the human body

processes a drug. ‘‘Pharmacodynamics’’

refers to the manner in which the drug

affects the human body.

The clinical investigator used data of

a medical nature that is contained in the

system to make determinations

regarding drug dosages and/or

radiochemical exposures appropriate to

the individual human subjectparticipants, in order to preserve and

protect the health of each. The system

also provides baseline data for studying

the drug effects.

The Food and Drug Administration

(FDA) also may use the records in

routine inspections FDA conducts in

accordance with its responsibilities to

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4297

develop standards on the composition,

quality, safety, and efficacy of drugs

administered to humans, and to monitor

experimental usage of drugs.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. We may disclose to a congressional

office the record of an individual in

response to a verified inquiry from the

congressional office made at the written

request of the individual.

2. NIH contractors, use the records in

this system to accomplish the research

purpose for which the records are

collected. The contractors are required

to maintain Privacy Act safeguards with

respect to such records.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

The contractor maintains the records

on paper in file folders.

RETRIEVABILITY:

The contractor indexes and retrieves

the records by the subject-participant’s

name.

SAFEGUARDS:

1. Authorized users: Only the contract

Project Director and his/her research

team and the Federal Project Officer and

his/her support staff have access to

these records.

2. Physical safeguards: The contractor

keeps all records in a locked metal file

cabinet in premises with limited

accessibility. Only the clinical

investigator (Project Director) has the

key to the locked files.

3. Procedural safeguards: Only the

contract staff have access to the files.

Persons other than subject participants

who request individually identifiable

data from a record, must provide written

consent from the subject participant

permitting the requested disclosure. The

only exception would be for disclosure

to persons or organizations permitted by

the Privacy Act, Section 3(B) to obtain

personally identifiable data.

4. Implementation guidelines: DHHS

Chapter 45–13 and supplementary

Chapter PHS.hf: 45–13 of the General

Administration Manual. In addition, the

contract staff complies with contractor’s

(University of California, San Francisco)

standard procedures for safeguarding

data.

RETENTION AND DISPOSAL:

The records will be kept no later than

June 2002 (5 years after the anticipated

completion of the studies). At that time,

the NIDA project officer will authorize

in writing the clinical investigators to

destroy the records by shredding or

burning.

SYSTEM MANAGER(S) AND ADDRESS:

Project Officer, Pharmacokinetic

Studies on Drugs of Abuse, Medications

Development Division, National

Institute on Drug Abuse, National

Institutes of Health, Room 11A55,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the system manager listed above.

Provide the following information:

Subject-participant’s full name and a

letter of request (or permission, if the

requester is not the subject-participant)

with notarized signature of the

individual who is the subject of the

record, approximate date(s) of

experiment(s) in which the individual

participated, and drug name (if known).

In addition, an individual who requests

notification of, or access to, a medical

record shall, at the time the request is

made, designate in writing a responsible

representative who will be willing to

review the record and inform the subject

individual of its content at the

representative’s discretion.

RECORD ACCESS PROCEDURES:

Same as Notification Procedures.

Requesters should also reasonably

specify the record contents being

sought. An individual may also request

an accounting of disclosures of his/her

record, if any.

CONTESTING RECORD PROCEDURES:

Contact the System Manager at the

address above and reasonably identify

the record, specify the information to be

contested, the corrective action sought,

with supporting information to show

how the record is inaccurate,

incomplete, untimely, or irrelevant.

RECORD SOURCE CATEGORIES:

The subject-participants and the

contractor personnel conducting the

research studies.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0208

SYSTEM NAME:

Drug Abuse Treatment Outcome

Study (DATOS), HHS/NIH/NIDA.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Research Triangle Institute, Center for

Social Research and Policy Analysis,

Research Triangle Park, North Carolina

27709.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Voluntary adult clients of federally

funded treatment programs, including

Treatment Alternative Street Crime

(TASC) Programs of the Department of

Justice, who requested to be included in

TOPS from 1979 through 1986. New

data collected from voluntary adults/

adolescent clients of public and private

funded-treatment programs beginning in

1991 and will continue through 1995.

CATEGORIES OF RECORDS IN THE SYSTEM:

The categories are: Demographic data,

treatment outcome data, treatment

process data, client locator information,

and personal identifiers (name and

assigned numerical identifier).

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Public Health Service Act, sections

301 and 405 (42 U.S.C. 241 and 284.

PURPOSE(S):

The purpose of the system is to

compile information on drug abusers in

drug abuse treatment programs in order

to derive information on the treatment

environments and abusers’ behaviors

and characteristics subsequent to

treatment. Researchers and drug abuse

service providers may use the aggregate

data to address issues and generate

hypotheses to understand better the

interactions among the client and

community.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Within the restrictions set forth in

HHS regulations concerning the

confidentiality of drug abuse patient

records (42 CFR 2.56), we may disclose

a record 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, (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

4298 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

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.

2. The Research Triangle Institute, an

NIH contractor, uses the records in this

system to accomplish the research

purpose for which the records are

collected. In the event of followup

studies or continuation studies because

the contract has been terminated for

convenience by the Government, we

may disclose records in this system to

a subsequent NIH contractor. We would

require the new contractor to maintain

Privacy Act safeguards with respect to

such records.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Interview forms, magnetic tapes, and

disks.

RETRIEVABILITY:

Records are indexed and retrieved by

unique alpha numerical identifier. In

order to relate the data collected to

specific individuals, one must use the

link file discussed under Safeguards.

SAFEGUARDS:

1. Authorized users: Contractor

personnel, the agency project officer,

and agency employees whose duties

require the use of the information in the

system.

2. Physical safeguards: The data

management task leader, the project

leader, or the project director provide

technical supervision of all data

collection and processing activities.

Individually identified forms are stored

in a secure, vault-like room provided for

this purpose. Authorized personnel

have access to the room by one locked

door with controlled entry, i.e., only on

the written authority of the professional

staff member in charge. Computerized

records are kept in a vault area with

limited accession.

3. Procedural safeguards: Because

some of the data collected in this study,

such as data on drug use, are sensitive

and confidential, special safeguards

have been established. A Certificate of

Confidentiality has been issued under

42 CFR part 2a. This authorization

enables persons engaged in research on

mental health, including research on the

use and effect of psychoactive drugs, to

protect the privacy of research subjects

by withholding the names or other

identifying characteristics from all

persons not connected with the conduct

of the research. Persons so authorized

may not be compelled in any Federal,

State, or local civil, criminal,

administrative, legislative, or other

proceedings, to identify such

individuals. In addition, these records

are subject to 42 CFR part 2, the

Confidentiality of Alcohol and Drug

Abuse Patient Records Regulations (42

CFR 2.56), which state: ‘‘Where the

content of patient records has been

disclosed pursuant to (these regulations)

for the purpose of conducting scientific

research * * * information contained

therein which would directly or

indirectly identify any patient may not

be disclosed by the recipient thereof

either voluntarily or in response to any

legal process whether Federal or State.’’

Another safeguard is that the forms

containing subject identification

information for client followup and data

matching purposes do not include any

reference to the purpose of the study.

Identification and location information

is kept separate from any information

that would suggest that the respondent

has been in a drug treatment program.

Information on completed forms is

entered immediately on the computer.

Completed forms and computerized

data are released only to authorized

persons. Only aggregate data are

provided and used in the preparation of

necessary and appropriate reports.

A link file system is used. This system

has three components: (1) Personal

information, (2) data base information,

and (3) the link file, which contains

identifying number pairs which can be

used to match data with individuals.

The advantage of this system is that the

data base can be used directly for report

generation, etc., without the use of

decrypting subroutines or access to the

personal information or matching link

files.

In addition, the computer center being

utilized has developed an extensive

security system to protect computer

account codes and data. This system is

described in a publication that is

available from the System Manager

upon request.

We do not anticipate any disclosure of

individually identifiable information to

other persons or organizations within

the Department of Health and Human

Services. Nor does the contractor

provide individually identification

information to the Department of

Justice, with which NIDA has a

cooperative agreement for this study.

4. Implementation guidelines: We

used the National Bureau of Standards

guidelines and Part 6, HHS ADP

Systems Security Manual, ‘‘ADP System

Security’’ in developing the computer

safeguard procedures. Safeguards for

nonautomated records are in accordance

with DHHS Chapter 45–13 and

supplementary Chapter PHS.hf: 45–13

of the General Administration Manual.

In addition, project staff complies with

the contractor’s (Research Triangle

Institute) standard procedures for

safeguarding data.

The contractor provides only

aggregate information to NIDA.

RETENTION AND DISPOSAL:

The contractor destroys interview

forms by shredding or burning

immediately after contractor staff have

completed and verified direct entry on

magnetic tape or disk storage. The

contractor will destroy individual

identification and location data by

shredding or burning, under the explicit

written authorization of the System

Manager, which is anticipated to be no

longer than 5 years after the termination

of the study unless the information is

needed for research purposes. We will

retain aggregate data tapes for research

purposes. These tapes will not have any

individually identifiable information. In

accordance with the NIH Records

Control Schedule, these tapes will be

retained for 5 years after completion of

the project (approximately 2000). At

that time, the tapes will be retired to the

Federal Records Center and destroyed

when they are 10 years old or when they

are no longer needed for research

purposes.

SYSTEM MANAGER(S) AND ADDRESS:

Drug Abuse Treatment Outcome

Study (DATOS), Project Officer,

Services Research Branch, Division of

Clinical and Services Research, National

Institute on Drug Abuse, National

Institutes of Health, Room 10A–30,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the System Manager at the address

above. An individual may learn if a

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4299

record exists about himself/herself upon

written request, with notarized

signature. The request should include, if

known, name of the researcher, location

of the research site, approximate date of

data collection, any alias used, and

subject identification number.

An individual who requests

notification of a medical record shall, at

the time the request is made, designate

in writing a responsible representative

who will be willing to review the record

and inform the subject individual of its

contents at the representative’s

discretion.

A parent or legal guardian who

requests notification of an adolescent’s

record shall designate a family

physician or other health professional

(other than a family member) of the

Division of Clinical Research staff to

whom the record, if any, will be sent.

The parent or legal guardian must verify

in writing the relationship to the

adolescent as well as his/her own

identity.

RECORD ACCESS PROCEDURES:

Same as Notification Procedures.

Requesters should also reasonably

specify the record contents being

sought. An individual may also request

an accounting of disclosures of his/her

record, if any.

Persons other than subject

individuals, who request individually

identifiable data from a record must

provide written consent from the subject

individual permitting the requested

disclosure. The only exception (if not in

conflict with confidentiality regulations)

would be for disclosure to persons or

organizations permitted by the Privacy

Act, section 3(b), to obtain personally

identifiable data.

CONTESTING RECORD PROCEDURES:

Contact the official at the address

specified under Notification Procedures

above and reasonably identify the

record, specify the information being

contested, the corrective action sought,

with supporting information to show

how the record is inaccurate,

incomplete, untimely, or irrelevant.

RECORD SOURCE CATEGORIES:

Research subjects, and staff in

participating drug abuse treatment

programs, written clinical evaluations,

counselors, psychiatrists,

psychotherapists, family members,

research assistants, hospitals.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0209

SYSTEM NAME:

Subject-Participants in Drug Abuse

Research Studies on Drug Dependence

and in Research Supporting New Drug

Applications, HHS/NIH/NIDA.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Veterans Administration Hospital,

Cooperative Studies Program,

Department of Veterans Medical Center,

Perry Point, MD 21902.

Dixon and Williams Pharmaceutical,

5775 Hyde Park Circle, Jacksonville,

Florida 32210.

Medications Development Division,

Room 11A–55, and Division of Clinical

Research, Room 10A–38, Parklawn

Building, National Institute on Drug

Abuse, 5600 Fishers Lane, Rockville,

MD 20857.

Veterans Affairs Medical Center, 50

Irving Street, NW., Washington, DC

20422.

Veterans Affairs Medical Center,

University and Woodland Avenues,

Philadelphia, PA 19104.

Veterans Affairs Medical Center,

Brentwood Division, Wilshire and

Sawtell Boulevards, Los Angeles, CA

90073.

National Institute on Drug Abuse,

Division of Intramural Research

Programs, 4940 Eastern Avenue,

Baltimore, MD 21224.

Write to the system manager at the

address below for the address of any

new locations where records from this

system may be stored.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Voluntary adult clients of federally

funded and other drug abuse treatment

programs who have requested to receive

investigational new or marketed drugs,

such as but not limited to, naltrexone,

levo-alpha acetylmethadol (LAAM), or

Buprenorphine as part of their

treatment. Data collection for the earlier

LAAM studies began in 1975 and

continued through September 1979;

additional LAAM studies began in 1992

and will continue through September

1997, naltrexone studies began in 1977

and continued through June 1984; and

studies for other investigational new

compounds (buprenorphine, gepirone,

etc.) began in 1992 and may continue

through September 1997.

CATEGORIES OF RECORDS IN THE SYSTEM:

Demographic data, treatment outcome

data, treatment process data, client

locator information, and personal

identifiers (name and assigned

numerical identifier).

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Public Health Service Act, sections

301, 464p, and 405 (42 U.S.C. 241, and

284).

PURPOSE(S):

1. To maintain information on the

safety and effectiveness of drugs for

treatment of drug dependence with or

without abuse potential in various

treatment environments and modalities

and changes in the behavior and

characteristics of drug abusers who

received these substances as part of

their treatment regimen.

2. To provide data required by the

Food and Drug Administration (FDA) to

support research on drug dependence

and potential new drug applications for

various drugs, and to treat drug

dependence with or without abuse

potential. A new drug application is a

notice to FDA that a pharmaceutical

company believes they have enough

data to demonstrate the safety and

efficacy of a substance to satisfy FDA for

marketing the substance. FDA may also

use the records in routine inspections

that FDA conducts in accordance with

its responsibilities to develop standards

on the composition, quality, safety and

efficacy of drugs administered to

humans, and to monitor experimental

usage of drugs.

3. To conduct research on the

pharmacology, toxicology, and

behavioral characteristics of drugs of

abuse alone or in combination with

proposed treatment drugs.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

NIH contractor(s) use the records in

the system in order to accomplish the

research and development purposes for

which the records were collected. In the

event of a followup study or

continuation study, the responsible

project officer may disclose records in

this system to a subsequent NIH

contractor(s). Any new contractor(s) is

and would be required to maintain

Privacy Act safeguards with respect to

such records and to comply with the

confidentiality restrictions of 42 CFR

part 2.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Interview and assessment forms,

video tapes, magnetic tapes, disks and

microfiche in boxes in closed cabinets

in a locked room with limited

accessibility.

4300 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

RETRIEVABILITY:

The records are indexed and retrieved

by subject-participant’s name code (i.e.,

initials—not name) and unique

numerical identifier. In order to relate

the data collected to specific

individuals, however, one must use the

link file discussed under safeguards.

SAFEGUARDS:

1. Authorized users: For the

naltrexone study, the System Manger or

Federal Project Officer and only

authorized contract staff have access to

the records (computerized and hard

copy files) in the system. The contractor

provides only aggregate data in reports

to NIDA, FDA, or the public. Only the

NIDA personnel mentioned previously

and selected authorized contract staff

have access to the stored LAAM records.

A certificate of confidentiality has

been issued to researchers conducting

the naltrexone study under 42 CFR, Part

2, Protection of Identity—Research

Subjects. This authorization enables

persons engaged in research on mental

health, including research on the use

and effect of psychoactive drugs, to

protect the privacy of research subjects

by withholding the names or other

identifying characteristics from all

persons not connected with the conduct

of the research. Persons so authorized

my not be compelled in any Federal,

State or local civil, criminal,

administrative, legislative, or other

proceedings to identify such

individuals. The earlier LAAM study

(from 1975 through 1979) was not

conducted under a certificate of

confidentiality. The 1992 LAAM studies

were conducted under the protection

afforded by a confidentiality certificate.

These regulations do not prohibit

voluntary disclosure by the researcher.

However, the records of these studies

also are subject to 42 CFR part 2, the

Confidentiality of Alcohol and Drug

Abuse Patient Records Regulations (42

CFR 2.56), which state: ‘‘Where the

content of patient records has been

disclosed. Pursuant to (these

regulations) for the purpose of

conducting scientific research * * *

information contained therein which

would directly or indirectly identify any

patient may not be disclosed by the

recipient thereof either voluntarily of in

response to any legal process whether

Federal or State.’’

The contractor’s institutional review

board reviewed and approved the

safeguards described above in

accordance with 45 CFR Part 46 on the

Protection of Human Subjects.

2. Physical safeguards: For the

naltrexone records, the contractor(s)

stored individually identified forms in a

locked room with controlled entry, i.e.,

only on written authority of the

professional staff member in charge of

data handling and processing). The

contractor staff entered the collected

information onto computer tape or disks

as soon after contact with the subjectparticipant as possible, and stores the

computerized records in a secured area

with access limited as above.

For the LAAM, buprenorphine and

other compound records, NIDA stores

the individually identified forms in a

lockable cabinet in a secure room. Only

authorized NIDA personnel, i.e.,

Division of Clinical Research and

Medications Development professional

staff and their support staff (program

assistant, clerk-typist, or secretary) have

access to the room with controlled

entry. The room is in a building which

has a 24-hour guard/television

surveillance system and has controlled

entry (picture identification sign in and

out procedures) before and after normal

working hours.

Another safeguard for these studies is

that the forms containing subject

identification information do not

include any reference to the purpose of

the study. The identification

information is separate from any

information that would suggest that the

respondent is or has been in a drug

abuse treatment program. In addition,

the computer center being utilized for

naltrexone has developed an extensive

security system to protect computer

account codes and data.

3. Procedural safeguards: Access to

the computerized records of the studies

(naltrexone and other research) is

protected by a computerized password

routine which is changed periodically.

In addition, the project staff complies

with the contractor’s standard

procedures for safeguarding data. The

link file system that identifies

individuals with personal data has three

components: (1) Identification

information, (2) data base information,

and (3) the link file, which contains

identifying number pairs which match

data with individuals. The advantage of

this system is that one may use the

baseline data directly for report

generation, etc., without using the

subroutines or accessing the personal

information or link files.

4. Implementation guidelines: DHHS

Chapter 45–13 and supplementary

Chapter PHS.hf: 45–13 of the General

Administration Manual and Part 6,

‘‘ADP System Security’’ in the HHS

ADP Systems Security Manual.

RETENTION AND DISPOSAL:

The naltrexone staff will destroy

identifiable information by shredding or

burning when it is no longer needed for

analysis or research purposes; then the

tapes will be erased. NIDA will destroy

individual identification and match-up

information from other studies by

shredding or burning 5 years after FDA

completes the review and approves the

new drug applications or when they are

no longer needed for research purposes.

NIDA will retain the aggregate data

tapes and/or paper records from studies

for research purposes. These tapes will

not have any individually identifiable

information. In accordance with the

FDA regulations governing new drug

applications, the aggregate tapes will be

retained for at least 2 years after FDA

approves the new drug applications. At

that time, the tapes will be retired to the

Federal Records Center and destroyed

when they are 5 years old or when they

are no longer needed for research

purposes.

SYSTEM MANAGER(S) AND ADDRESS:

Project Officer, Naltrexone Study,

Division of Clinical Research, Room

10A–30, Parklawn Building, National

Institute on Drug Abuse, 5600 Fishers

Lane, Rockville, MD 20857.

Project Officer, LAAM and Other

Research Records, Medications

Development Division, Room 11A–55,

Parklawn Building, National Institute on

Drug Abuse, 5600 Fishers Lane,

Rockville, MD 20857.

NOTIFICATION PROCEDURE:

An individual may determine if a

record exists about himself/herself upon

written request, with notarized

signature if request is made by mail, or

with suitable identification if request is

made in person, to the appropriate

system manager at the address above.

The following information should be

included, if known: Subjectparticipant’s full name and a letter of

request with notarized signature of the

subject-participant of the record, any

alias used, subject-participant’s

identification number, name of the

researcher, name of clinic or research

center, name of substance, and

approximate date of study participation.

An individual who requests

notification of a medical record must, at

the time the request is made, designate

in writing a responsible representative

who will be willing to review the record

and inform the subject individual of its

contents at the representative’s

discretion.

RECORD ACCESS PROCEDURES:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. An individual may also request

Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices 4301

an accounting of disclosures of his/her

record, if any.

CONTESTING RECORD PROCEDURES:

Contact the official at the address

specified under notification procedures

above and reasonably identify the

record, specify the information being

contested, the corrective action sought,

with supporting information to show

how the record is inaccurate,

incomplete, untimely, or irrelevant.

RECORD SOURCE CATEGORIES:

Research subject-participants, staff in

the participating drug abuse treatment

programs, written clinical evaluations,

private physicians, counselors,

psychiatrists, psychotherapists, family

members, research assistants, and

hospital records.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

09–25–0212

SYSTEM NAME:

Clinical Research: Neuroscience

Research Center Patient Medical

Records, HHS/NIH/NIMH.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Neuroscience Research Center at Saint

Elizabeths Hospital, William A. White

Building, Room 144, 2700 Martin Luther

King, Jr., Avenue, SE., Washington, DC

20032, and at private organizations

under contract. A list of specific sites is

available from the System Manager.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Registered clinical research patients

and some individuals not registered as

patients but seen for diagnostic tests.

CATEGORIES OF RECORDS IN THE SYSTEM:

Inpatient and outpatient medical

clinical records.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

The Public Health Service Act,

section 301 (42 U.S.C. 241), ‘‘Research

and Investigation,’’ and Section 321 (42

U.S.C. 248), ‘‘Hospital.’’

PURPOSE(S):

(1) To provide a continuous history of

the treatment afforded individual

patients in the National Institute of

Mental Health Neuroscience Research

Center.

(2) To provide a data base for the

clinical research conducted at the

Neuroscience Research Center.

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. Social work staff may give pertinent

information to community agencies to

assist patients for their families.

3. Referring physicians receive

medical information for continuing

patient care after discharge.

4. Information regarding diagnostic

problems, or having unusual scientific

value may be disclosed to appropriate

medical research organizations or

consultants in connection with

treatment of patient or in order to

accomplish the research purposes of

this system. For example, tissue

specimens may be sent to the Armed

Forces Institute of Pathology; x-rays may

be sent for the opinion of a radiologist

with extensive experience in a

particular kind of diagnostic radiology.

The recipients are required to maintain

Privacy Act safeguards with respect to

these records.

5. Records may be disclosed to

representative of the Joint Commission

on Accreditation of Hospitals

conducting inspections to ensure that

the quality of the Neuroscience

Research Center Program medical

recordkeeping meets established

standards.

6. Certain infectious diseases are

reported to government jurisdictions as

required by law.

7. Medical information may be

disclosed to tumor registries for

maintenance for health statistics.

8. The Department contemplates that

it may contract with a private firm for

transcribing, updating, copying or

otherwise refining records in this

system. Relevant records will be

disclosed to such a contractor. The

contractor will be required to comply

with the requirements of the Privacy Act

with respect to such records.

9. 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 operation 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 metal 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored in file folders and/

or on microfiche, and on computer

tapes. Files are stored in locked file

cabinets or locked rooms.

RETRIEVABILITY:

The records are retrieved by hospital

number and patient name.

SAFEGUARDS:

1. Authorized users: Employees

maintaining records in this system are

instructed to grant regular access only to

physicians and dentists and other health

care professionals officially

participating in patient care and to

contractors or to NIMH researchers

specifically authorized by the system

manager.

2. Physical safeguard: All record

facilities are locked when system

personnel are not present.

3. Procedural safeguards: Access to

files is strictly controlled by the system

manager. Records may be removed only

by system personnel following receipt of

a request signed by authorized user.

Access to computerized records is

controlled by the use of security codes

known only to the authorizer user.

Codes are user- and function-specific.

Contractor compliance is assured

through inclusion of Privacy Act

requirements in contract clauses, and

through monitoring by contract and

project officers. Contractors who

maintain records in this system are

instructed to make no disclosure of the

records except as authorized by the

system manager.

4. Implementation guidelines: DHHS

Chapter 45–13 and supplementary

Chapter PHS.hf: 45–13 of the General

Administration Manual, and Part 6,

‘‘ADP System Security’’ in the HHS

Information Resource Management

Manual.

RETENTION AND DISPOSAL:

Records are retained for 20 years after

last discharge or upon death of a patient

and then transferred to the Washington

National Records Center, where they are

retained until 30 years after discharge or

death.

4302 Federal Register / Vol. 60, No. 13 / Friday, January 20, 1995 / Notices

SYSTEM MANAGER(S) AND ADDRESS:

Clinical Director, Neuroscience

Research Center, Division of Intramural

Research Programs, National Institute of

Mental Health, Saint Elizabeths

Hospital, Room 133, William A. White

Building, 2700 Martin Luther King Jr.,

Avenue, SE., Washington, DC 20032.

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the System manager at the address

above. An individual or a legally

authorized representative may learn if a

record exists about that individual upon

written request with notarized

signature. The request should include:

(a) Full name or any alias used, (b)

social security number, and (c)

approximate time of participation in the

hospital/project.

An individual who requests

notification of or access to a medical

record shall, at the time the request is

made, designate in writing a family

physician or health professional (other

than a family member) to whom the

record will be released. The

representative must verify relationship

to the individual as well as his/her own

identity.

A parent or guardian who requests

notification of, or access to, a child’s/

incompetent person’s medical 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 PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request an

accounting of disclosures of their

records, if any.

CONTESTING RECORD PROCEDURES:

Contact the System Manager at the

address specified under Notification

Procedures above and reasonably

identify the record, specify the

information being contested, and state

the corrective action sought and the

reasons for correcting the information,

along with supporting justification to

show how the record is inaccurate,

incomplete, or irrelevant.

RECORD SOURCE CATEGORIES:

Referring physicians, other medical

facilities (with patient’s consent),

patients, relatives of patients.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

[FR Doc. 95–992 Filed 1–19–95; 8:45 am]

BILLING CODE 4101–01–M