# Privacy Act of 1974; Annual Publication of Systems of Records

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A95-992

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** January 20, 1995
- **Citation:** 60 FR 4238

## Text

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 [[Page 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 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.
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. [[Page 4240]]
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. [[Page 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 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, 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
Clinical Research: Patient Records, HHS/NIH/NHLBI.
None.
National Institutes of Health, Building 10, 9000 Rockville Pike,
Bethesda, MD 20892
Patients of the National Heart, Lung, and Blood Institute (NHLBI)
under study at the National Institutes of Health (NIH). [[Page 4242]]
Medical histories, diagnostic studies, laboratory data, treatment.
42 USC 241(e), 287, 287a.
(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.
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 needle-sharing 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 needle-sharing partner(s), or in the verification that
the subject individual has notified such sexual or needle-sharing
partner(s).
File folders, card index, laboratory books, computer memory.
Indexed by name or patient number.
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).
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.
Administrative Officer, Division of Intramural Research, National
Heart, Lung, and Blood Institute, 10/7N220, 10 Center Drive, MSC 1670,
Bethesda, MD 20892-1670
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.
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.
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).
Referring physicians, hospitals and medical centers, patients and
families, results of procedures and tests of NIH patients.
None.
09-25-0005
Administration: Library Operations and User I.D. File, HHS/NIH/OD.
None.
This system of records is an umbrella system comprising separate
sets of [[Page 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
Users of Library Services.
Name, organization, address, phone number, user code and
identification number; and when applicable, credit card number and
billing information.
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).
(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.
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.
Records are stored on computer tape and disc, microfiche, paper and
file cards.
Records are retrieved by name, user code and/or identification
number.
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).
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.
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

[[Page 4244]] 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
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.
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.
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).
Individual, NIH Library ID card data.
None.
09-25-0011
Clinical Research: Blood Donor Records, HHS/NIH/CC.
None
National Institutes of Health, Transfusion Medicine Department, 10
Center Drive MSC 1184, Bethesda, MD 20892-1184
Donors of blood and blood components to be used in the NIH Clinical
Center for patient infusions.
Past donations, blood types, phenotypes. Laboratory results of
hepatitis testing, serologic reactions on all blood samples, donations
of blood or blood components.
``Preparation of Biological Products'' of the Public Health Service
Act (42 U.S.C. 263).
(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.
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 needle-sharing 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 needle-sharing partner(s), or in the verification that
the subject individual has notified such sexual or needle-sharing
partner(s).
Records are stored in a computer file, on donor cards, and on
microfilm.
Records are retrieved by a unique control number assigned to each
individual donor.
Access is granted only to authorized employees in the Department of
Transfusion Medicine including [[Page 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).
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.
Chief, Tranfusion Medicine Department, National Institutes of Health,
10 Center Drive MSC 1184, Bethesda, MD 20892-1184.
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.
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.
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).
Data are collected from the individual.
None.
09-25-0012
Clinical Research: Candidate Normal Volunteer Records, HHS/NIH/CC.
None.
National Institutes of Health, Social Work Department, 10 Center Drive
MSC 1160, Bethesda, MD 20892-1160.
Normally healthy individuals who volunteer to participate in NIH
studies.
Program application, health questionnaire and record of
participation.
42 U.S.C. 241, 263.
(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.
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.
Program applications and health questionnaires are stored in file
folders. Records of participation are stored on index cards.
Records are retrieved by name.
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.
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
[[Page 4246]] superseded for a maximum period of 3 years. Refer to the
NIH Manual Chapter for specific conditions on disposal.
Chief, Social Work Department, National Institutes of Health, Social
Work Department, 10 Center Drive MSC 1160, Bethesda, MD 20892-1160.
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.
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.
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).
Volunteer, sponsoring contractor.
None.
09-25-0014
Clinical Research: Student Records, HHS/NIH/CC.
None.
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.
Potential and accepted Medical Staff and Research Fellows, medical
students, and other students in NIH training programs.
Application form, transcripts, references, evaluations.
42 U.S.C. 241.
(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.
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.
Records are stored in file folders.
Records are retrieved by name and year.
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.
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.
Director, Office of Education, National Institutes of Health, 10
Center Drive MSC 1158, Bethesda, MD 20892-1158.
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.
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.
Write to the system manager at the address specified above, and
reasonably identify the record and specify the information to be
contested, the [[Page 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).
Applicants, universities and teachers.
None.
09-25-0026
Clinical Research: Nervous System Studies, HHS/NIH/NINDS.
None.
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.
Research patients in NIH-related studies having nervous system
disorders.
Medical and demographic data.
42 U.S.C. 241, 289a, 289c.
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.
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.
Records are stored in file folders, in computer-accessible forms,
bound notebooks, graphs, and imaging films.
Records are retrieved by name, disease and attending physician
name.
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).
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.
Assistant Director, CNP, DIR, NINDS, NIH, Building 10, Room 5N226, 9000
Rockville Pike, Bethesda, MD 20892.
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.
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.
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).
Attending physicians.
None.
09-25-0028
Clinical Research: Patient Medical Histories, HHS/NIH/NINDS and
HHS/NIH/NIDCD.
None. [[Page 4248]]
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.
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.
Medical histories and diagnoses.
42 U.S.C. 241, 289a, 289c.
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.
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.
Records are stored in file folders and in computer-accessible
forms, bound notebooks, charts, graphs, and imaging films.
Records are retrieved by name.
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.
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.
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
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.
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.
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).
Referring and attending physicians, hospital records.
None.
09-25-0036
Extramural Awards and Chartered Advisory Committees: IMPAC (Grant/
Contract/Cooperative Agreement Information/Chartered Advisory Committee
Information), HHS/NIH/DRG and HHS/NIH/CMO.
None. [[Page 4249]]
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.
Applicant and Principal Investigators; Program Directors; NRSA
Trainees and Fellows; Research Career Awardees; and Chartered Advisory
Committee members.
Applications, awards, associated records, trainee appointments, and
current and historical information pertaining to chartered advisory
committees.
42 U.S.C. 241c, 58 Stat. 691c & d repealed.
(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.
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.
Records are stored on discs and magnetic tapes.
Records are retrieved by name, application, grant or contract ID
number.
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 [[Page 4250]] 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).
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.
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.
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.
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.
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).
Individual, individual's educational institution and references.
None.
09-25-0042
Clinical Research: National Institute of Dental Research Patient
Records, HHS/NIH/NIDR.
None.
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.
Patients and other participants in current and past research
projects of the National Institute of Dental Research (NIDR).
Medical and dental histories, dental pathologies and therapies.
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.
(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.
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.
Records are stored in file folders.
Records are retrieved by name and hospital ID number.
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: [[Page 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 need-to-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.
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.
National Institutes of Health, Deputy Clinical Director, NIDR, Building
10, Room 1N-113, 10 Center Drive MSC 1190, Bethesda, MD 20892-1190
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.
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.
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).
Individual, parents or guardians.
None.
09-25-0044
Clinical Research: Sensory Testing Research Program, HHS/NIH/NIDR.
None.
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.
Infants, children and adults participating in the Sensory Testing
Research Program of the National Institute of Dental Research (NIDR).
Test results, extracts from medical records.
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.
(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.
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.
Records are stored in file folders, data books and in a mini-
computer maintained by the NIDR Scientific Systems
Section. [[Page 4252]]
Records are retrieved by name, date of observation and age of
subject.
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).
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.
Research Psychologist, Clinical Investigations, NIDR, Building 10,
Room 1N114, 10 Center Drive, MSC 1190, Bethesda, MD 20892-1190.
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.
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.
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).
Subject individual, cooperating clinician or health agency, family
members
None.
09-25-0054
Administration: Property Accounting, HHS/NIH/ORS.
None.
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
Employees of the National Institutes of Health who are issued tools
or card keys.
Property management.
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.
Used for tool and card keys issuance and control.
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 [[Page 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.
Records are stored in file folders, and on magnetic media.
Records are retrieved by name.
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).
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.
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
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.
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.
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).
Data is obtained from the individual.
None.
09-25-0077
Biological Carcinogenesis Branch Human Specimen Program, HHS/NIH/
NCI.
None.
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.
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.
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.
42 U.S.C. 241, 281, 282: ``Research and Investigation,'' ``National
Cancer Institute,'' and ``Cancer Research and Other Activities.''
(1) For cancer research, using by-products 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.
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
[[Page 4254]] Department to present an effective defense, provided that
such disclosure is compatible with the purpose for which the records
were collected.
Magnetic tape and discs.
Retrieved by name of donor and cross-referenced by identifying
number, procurement source, and various epidemiological
characteristics.
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).
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.
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
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.
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.
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).
Specimen Report Form filled out by the organization providing
specimens.
None.
09-25-0078
Administration: Consultant File, HHS/NIH/NHLBI.
None.
National Institutes of Health, Westwood Building, 5333 Westbard Avenue,
Bethesda, MD 20892
List of consultants available for use in evaluation of National
Heart, Lung, and Blood Institute special grants and contracts.
Names and resumes.
42 U.S.C. 241(d), 281.
(1) To identify and select experts and consultants for program
reviews and evaluations. (2) For use in evaluation of NHLBI special
grants and contracts.
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
[[Page 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.
Computer disc and file folders.
Records are retrieved by name.
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).
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.
Chief, Review Branch, National Heart, Lung, and Blood Institute,
Westwood Building, Room 557A, 5333 Westbard Avenue, Bethesda, MD 20892
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.
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.
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).
Subject individual.
None.
09-25-0093
Administration: Authors, Reviewers, Editorial Board, and Members of
the Journal of the National Cancer Institute, HHS/NIH/NCI.
None.
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.
Authors and manuscript reviewers and members of the Journal of the
National Cancer Institute (JNCI) editorial board.
Accepted, rejected and pending manuscripts and review comments.
42 U.S.C. 241, 281.
Manuscript review by NCI staff of manuscripts submitted for
possible publication in the Journal of the National Cancer Institute or
JNCI Monographs.
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.
Records are stored in file folders.
Records are retrieved by name and manuscript number.
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.
Records are retained and disposed of under the authority of the NIH
Records [[Page 4256]] 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 Specialist, Scientific Publications Branch, Building 82, Room
239, 9030 Old Georgetown Road, Bethesda, MD 20814.
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.
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.
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).
Authors and reviewers.
None.
09-25-0099
Clinical Research: Patient Medical Records, HHS/NIH/CC.
None.
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.
Registered Clinical Center patients. Some individuals not
registered as patients but seen in Clinical Center for diagnostic
tests.
Medical treatment records.
42 U.S.C. 241, 248: ``Research and Investigation,'' and
``Hospitals, Medical Examination, and Medical Care.''
(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.
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; 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 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 needle-sharing 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 needle-sharing partner(s), or in the verification that
the subject individual has notified such sexual or needle-sharing
partner(s). [[Page 4257]]
Records are stored in file folders and/or on microfiche, and on
computer tapes.
Records are retrieved by unit number and patient name.
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).
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.
Chief, Medical Record Department, National Institutes of Health, 10
Center Drive MSC 1192, Bethesda, MD 20892-1192.
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 se

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-992. Public record. Not legal advice.