[Federal Register Volume 62, Number 66 (Monday, April 7, 1997)]
[Notices]
[Pages 16596-16602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8592]



[[Page 16596]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Privacy Act of 1974; New System of Records

agency: National Institutes of Health, HHS.

action: Notification of a new system of records.

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summary: In accordance with the requirements of the Privacy Act, the 
National Institutes of Health (NIH) is publishing a notice of a new 
system of records, 09-25-0200, ``Clinical, Epidemiologic and Biometric 
Studies of the National Institutes of Health (NIH), HHS/NIH/OD.'' This 
system notice serves as an umbrella system for most NIH clinical, 
epidemiologic and biometric research studies. Thirty-eight existing NIH 
system notices were subsumed under this notice (listed in the system 
notice under System Manager(s)), to reduce the number and avoid future 
proliferation of like system notices. We are also proposing routine 
uses for this new system; with two exceptions, these routine uses were 
already contained in the preceding system notices. The first new 
routine use will allow disclosure to authorized organizations which 
provide health services to subject individuals or provide third-party 
reimbursement or fiscal intermediary functions. The purpose of the 
disclosure is to plan for or provide such services, bill or collect 
third-party reimbursements. The second new routine use will allow 
disclosure for the purpose of reporting child, elder, or spousal abuse 
or neglect, or any other type of abuse or neglect as required by State 
or Federal law.

dates: NIH invites interested parties to submit comments on the 
proposed internal and routine uses on or before May 7, 1997. NIH has 
sent a report of a New System to the Congress and to the Office of 
Management and Budget (OMB) on November 6, 1996. This system of records 
will be effective 40 days from the date of publication unless NIH 
receives comments on the routine uses which would result in a contrary 
determination.

address: Please submit comments to: NIH Privacy Act Officer, Building 
31, Room 1B05, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075, 301-
496-2832.
    Comments received will be available for inspection at this same 
address from 9 a.m. to 3 p.m., Monday through Friday.

for further information contact: NIH Privacy Act Officer, Building 31, 
Room 1B05, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075, 301-496-
2832.
    The numbers listed above are not toll free.

supplementary information: The National Institutes of Health (NIH) 
proposes to establish a new system of records: 09-25-0200, ``Clinical, 
Epidemiologic and Biometric Studies of the National Institutes of 
Health (NIH), HHS/NIH/OD.'' This umbrella system of records will be 
used by NIH staff to document, track, monitor and evaluate NIH 
clinical, epidemiologic and biometric research activities. This 
inclusive system notice will achieve agency administrative 
efficiencies, avoiding confusion created by the current fragmented pool 
of Institute, Center and Division (ICD) system notices. Because of its 
unique organizational structure, NIH has, over the recent decades, 
experienced a proliferation of almost identical system notices that 
differ only by disease/disorder under study or ICD interest. This 
system notice subsumes thirty-eight existing system notices and will 
offer coverage for research not currently covered by an appropriate 
system notice. The consolidation of similar research systems of records 
into one generic-type notice will also serve the public interest. It 
will alleviate burden on the public associated with multiple attempts 
at notification, access and correction of record information when 
individuals are not sure which research system notice applied to their 
study participation.
    The system will comprise records about individuals as relevant to a 
particular research study. Examples include, but are not limited to: 
Name, study identification number, address, relevant telephone numbers, 
Social Security Number (voluntary), driver's license number, date of 
birth, weight, height, sex, race; medical, psychological and dental 
information, laboratory and diagnostic testing results; registries; 
social, economic and demographic data; health services utilization; 
insurance and hospital cost data, employers, conditions of the work 
environment, exposure to hazardous substances/compounds; information 
pertaining to stored biologic specimens (including blood, urine, tissue 
and genetic materials), characteristics and activities of health care 
providers and educators and trainers (including curriculum vitae); and 
associated correspondence. The amount of information recorded on each 
individual will be only that which is necessary to accomplish the 
purpose of the system.
    The records in this system will be maintained in a secure manner 
compatible with their content and use. NIH and contractor staff will be 
required to adhere to the provisions of the Privacy Act and the HHS 
Privacy Act Regulations. The System Manager will control access to the 
data. Only authorized users whose official duties require the use of 
such information will have regular access to the records in this 
system. Authorized users are HHS employees, and contractors responsible 
for implementing the research.
    Records may be stored on index cards, file folders, computer tapes 
and disks (including optical disks), photography media, microfiche, 
microfilm, and audio and video tapes. Manual and computerized records 
will be maintained in accordance with the standards of Chapter 45-13 of 
the HHS General Administration Manual, ``Safeguarding Records Contained 
in Systems of Records,'' supplementary Chapter PHS hf:45-13, the 
Department's Automated Information System Security Program Handbook, 
and the National Institute of Standards and Technology Federal 
Information Processing Standards (FIPS Pub. 41 and FIPS Pub. 31).
    Data on computer files is accessed by keyword known only to 
authorized users. Access to information is thus limited to those with a 
need to know. Rooms where records are stored are locked when not in 
use. During regular business hours rooms are unlocked but are 
controlled by on-site personnel. Researchers authorized to conduct 
research on biological specimens will typically access to the system 
through the use of encrypted identifiers sufficient to link individuals 
with records in such a manner that does not compromise confidentiality 
of the individual. All authorized users of personal information in 
connection with the performance of their jobs protect information from 
public view and from unauthorized personnel entering an unsupervised 
office. Depending upon the sensitivity of the information in the 
record, additional safeguard measures are employed.
    The routine uses proposed for this system are compatible with the 
stated purposes of the system. The first routine use permits disclosure 
of a record for an authorized research purpose under specified 
conditions. The second routine use permitting disclosure to a 
congressional office is proposed to allow subject individuals to obtain 
assistance from their representatives in Congress, should they so 
desire. Such

[[Page 16597]]

disclosure would be made only pursuant to a request of the individual. 
The third routine use allows disclosure to the Department of Justice 
for use in litigation. The fourth routine use allows disclosure of 
records to contractor, grantee, experts, consultants or volunteers who 
have been engaged by the agency to assist in the performance of a 
service related to this system of records and who need to have access 
to the records in order to perform the activity. The fifth routine use 
allows disclosure to certain relevant third parties (e.g., relatives, 
prior employees, Motor Vehicle Administration, State vita statistics 
offices) when necessary to obtain information on morbidity and 
mortality experiences and to locate individuals for follow-up studies. 
The sixth routine use allows disclosure to tumor registries for 
maintenance of health statistics. The seventh routine use allows the 
PHS to 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, or to disclose such information to State or 
local public health departments under specified circumstances. The 
eighth routine use allows disclosure of certain diseases and 
conditions, including infectious diseases, to appropriate 
representatives of State or Federal Government as required by State or 
Federal law. The ninth routine use allows records to be disclosed to 
authorized organizations which provide health services to subject 
individuals or provide third-party reimbursement or fiscal intermediary 
functions, for the purpose of planning for or providing such services, 
billing or collecting third-party reimbursements. The tenth routine use 
allows disclosure to organizations deemed qualified by the Secretary, 
DHHS, to carry out quality assessment, medical audits or utilization 
reviews. The eleventh routine use allows information to be disclosed 
for the purpose of reporting child, elder or spousal abuse or neglect, 
or any other type of abuse or neglect as required by State or Federal 
law.
    The following notice is written in the present, rather than future 
tense, in order to avoid the unnecessary expenditure of public funds to 
republish the notice after the system has become effective.

    Dated: October 30, 1996.
Anthony L. Itteilag,
Deputy Director for Management, National Institutes of Health.
09-25-0200

SYSTEM NAME:
    Clinical, Epidemiologic and Biometric Studies of the National 
Institutes of Health (NIH), HHS/NIH/OD.

SECURITY CLASSIFICATION:
    None.

SYSTEM LOCATION:
    Records are located at NIH and Contractor research facilities which 
collect or provide research data for this system. Contractors may 
include, but are not limited to: Research centers, clinics, hospitals, 
universities, medical schools, research institutions/foundations, 
national associations, commercial organizations, collaborating State 
and Federal Government agencies, and coordinating centers. A current 
list of sites, including the address of any Federal Records Center 
where records from this system may be stored, is available by writing 
to the appropriate Coordinator listed under Notification Procedure.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Adults and/or children who are the subjects of clinical, 
epidemiologic, and biometric research studies of the NIH. Individuals 
with disease. Individuals who are representative of the general 
population or of special groups including, but not limited to: Normal 
controls, normal volunteers, family members and relatives; providers of 
services (e.g., health care and social work); health care professionals 
and educators, and demographic sub-groups as applicable, such as age, 
sex, ethnicity, race, occupation, geographic location; and groups 
exposed to real and/or hypothesized risks (e.g., exposure to 
biohazardous microbial agents).

CATEGORIES OF RECORDS IN THE SYSTEM:
    The system contains data about individuals as relevant to a 
particular research study. Examples include, but are not limited to: 
Name, study identification number, address, relevant telephone numbers, 
Social Security Number (voluntary), driver's license number, date of 
birth, weight, height, sex, race; medical, psychological and dental 
information, laboratory and diagnostic testing results; registries; 
social, economic and demographic data; health services utilization; 
insurance and hospital cost data, employers, conditions of the work 
environment, exposure to hazardous substances/compounds; information 
pertaining to stored biologic specimens (including blood, urine, tissue 
and genetic materials), characteristics and activities of health care 
providers and educators and trainers (including curriculum vitae); and 
associated correspondence.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    ``Research and Investigation,'' ``Appointment and Authority of the 
Directors of the National Research Institutes,'' ``National Cancer 
Institute,'' ``National Eye Institute,'' ``National Heart, Lung and 
Blood Institute,'' ``National Institute on Aging,'' ``National 
Institute on Alcohol Abuse and Alcoholism,'' ``National Institute on 
Allergy and Infectious Diseases,'' ``National Institute of Arthritis 
and Musculoskeletal and Skin Diseases,'' ``National Institute of Child 
Health and Human Development,'' ``National Institute on Deafness and 
Other Communication Disorders,'' ``National Institute of Dental 
Research,'' ``National Institute of Diabetes, and Digestive and Kidney 
Diseases,'' ``National Institute of Drug Abuse,'' ``National Institute 
of Environmental Health Sciences,'' ``National Institute of Mental 
Health,'' ``National Institute of Neurological Disorders and Stroke,'' 
and the ``National Center for Human Genome Research,'' of the Public 
Health Service Act. (42 U.S.C. 241, 242, 248, 281, 282, 284, 285a, 
285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 
285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.)

PURPOSE(S)
    To document, track, monitor and evaluate NIH clinical, 
epidemiologic and biometric research activities.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OF USERS AND THE PURPOSES OF SUCH USES:
    1. A record may be disclosed for a research purpose, when the 
Department: (A) has determined that the use or disclosure does not 
violate legal or policy limitations under which the record was 
provided, collected, or obtained; e.g., disclosure of alcohol or drug 
abuse patient records will be made only in accordance with the 
restrictions of confidentiality statutes and regulations 42 U.S.C. 241, 
42 U.S.C. 290dd-2, 42 CFR part 2, and where applicable, no disclosures 
will be made inconsistent with an authorization of confidentiality 
under 42 U.S.C. 241 and 42 CFR part 2a; (B) has determined that the 
research purpose (1) cannot be reasonably accomplished unless the

[[Page 16598]]

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 property identified person for 
the purpose of an audit related to the research project, if information 
that would enable research subjects to be identified is removed or 
destroyed at the earliest opportunity consistent with the purpose of 
the audit, or (d) when required by law; and (D) has secured a written 
statement attesting to the recipient's understanding of, and 
willingness to abide by, these provisions.
    2. Disclosure may be made to a Member of Congress or to a 
Congressional staff member in response to an inquiry of the 
Congressional office made at the written request of the constituent 
about whom the record is maintained.
    3. The Department of Health and Human Services (HHS) may disclose 
information from this system of records to the Department of Justice 
when: (a) The agency or any component thereof; or (b) any employee of 
the agency in his or her official capacity where the Department of 
Justice has agreed to represent the employee; or (c) the United States 
Government, is a party to litigation or has an interest in such 
litigation, and by careful review, the agency determines that the 
records are both relevant and necessary to the litigation and the use 
of such records by the Department of Justice is therefore deemed by the 
agency to be for a purpose that is compatible with the purpose for 
which the agency collected the records.
    4. Disclosure may be made to agency contractors, grantees, experts, 
consultants, collaborating researchers, or volunteers who have been 
engaged by the agency to assist in the performance of a service related 
to this system of records and who need to have access to the records in 
order to perform the activity. Recipients shall be required to comply 
with the requirements of the Privacy Act of 1974, as amended, pursuant 
to 5 U.S.C. 552a(m).
    5. Information from this system may be disclosed to Federal 
agencies, State agencies (including the Motor Vehicle Administration 
and State vital statistics offices, private agencies, and other third 
parties (such as current or prior employers, acquaintances, relatives), 
when necessary to obtain information on morbidity and mortality 
experiences and to locate individuals for follow-up studies. Social 
Security numbers, date of birth and other identifiers may be disclosed: 
(1) To the National Center for Health Statistics to ascertain vital 
status through the National Death Index; (2) to the Health Care 
Financing Agency to ascertain morbidities; and (3) to the Social 
Security Administration to ascertain disabilities and/or location of 
participants. Social Security numbers may also be given to other 
Federal agencies, and State and local agencies when necessary to 
locating individuals for participation in follow-up studies.
    6. Medical information may be disclosed in identifiable form to 
tumor registries for maintenance of health statistics, e.g., for use in 
epidemiologic studies.
    7. (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).
    8. 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.
    9. Disclosure may be made to authorized organizations which provide 
health services to subject individuals or provide third-party 
reimbursement or fiscal intermediary functions, for the purpose of 
planning for or providing such services, billing or collecting third-
party reimbursements.
    10. The Secretary may disclose information to organizations deemed 
qualified to carry out quality assessment, medical audits or 
utilization reviews.
    11. Disclosure may be made for the purpose of reporting child, 
elder or spousal abuse or neglect or any other type of abuse or neglect 
as required by State or Federal law.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Records may be stored on index cards, file folders, computer tapes 
and disks (including optical disks), photography media, microfiche, 
microfilm, and audio and video tapes. For certain studies, factual data 
with study code numbers are stored on computer tape or disk, while the 
key to personal identifiers is stored separately, without factual data, 
in paper/computer files.

RETRIEVABILITY:
    During data collection stages and follow-up, retrieval is by 
personal identifier (e.g., name, Social Security Number, medical record 
or study identification number, etc.). During the data analysis stage, 
data are normally retrieved by the variables of interest (e.g., 
diagnosis, age, occupation).

SAFEGUARDS:
    1. Authorized Users: Access to identifiers and to link files is 
strictly limited to the authorized personnel whose duties require such 
access. Procedures for determining authorized access to identified data 
are established as appropriate for each location. Personnel, including 
contractor personnel, who may be so authorized include those directly 
involved in data collection and in the design of research studies, 
e.g., interviewers and interviewer supervisors; project managers; and 
statisticians involved in designing sampling plans. Other one-time and 
special access by other employees is granted on a need-to-know basis as 
specifically authorized by the system manager.

[[Page 16599]]

    Researchers authorized to conduct research on biologic specimens 
will typically access the system through the use of encrypted 
identifiers sufficient to link individuals with records in such a 
manner that does not compromise confidentiality of the individual.
    2. Physical Safeguards: Records are either stored in locked rooms 
during off-duty hours, locked file cabinets, and/or secured computer 
facilities. For certain studies, personal identifiers and link files 
are separated and stored in locked files. Computer data access is 
limited through the use of key words known only to authorized 
personnel.
    3. Procedural Safeguards: Collection and maintenance of data is 
consistent with legislation and regulations in the protection of human 
subjects, informed consent, confidentiality, and confidentiality 
specific to drug and alcohol abuse patients where these apply. When 
anonymous data is provided to research scientists for analysis, study 
numbers which can be matched to personal identifiers will be 
eliminated, scrambled, or replaced by the agency or contractor with 
random numbers which cannot be matched. Contractors who maintain 
records in this system are instructed to make no further disclosure of 
the records. Privacy Act requirements are specifically included in 
contracts for survey and research activities related to this system. 
The OHS project directors, contract officers, and project officers 
oversee compliance with these requirements. Personnel having access are 
trained in Privacy Act requirements. Depending upon the sensitivity of 
the information in the record, additional safeguard measures may be 
employed.
    4. Implementation Guidelines: DHHS Chapter 45-13 and supplementary 
Chapter PHS.hf: 45-13 of the HHS General Administration Manual and Part 
6, ``ADP System Security'' of the HHS ADP Systems Security Manual.

RETENTION AND DISPOSAL:
    Records are retained and disposed of under the authority of the NIH 
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix 
1--``Keeping and Destroying Records'' (HHS Records Management Manual, 
Appendix B-361), item 3000-G-3, which allows records to be kept as long 
as they are useful in scientific research. Collaborative Perinatal 
Project records are retained in accordance with item 3000-G-4, which 
does not allow records to be destroyed. William A. White Clinical 
Research Program medical records (Saint Elizabeths Hospital, NIMH) are 
retained for 5 years after last discharge or upon death of a patient 
and then transferred to the Washington National Records Center, where 
they are retained until 30 years after discharge or death. Refer to the 
NIH Manual Chapter for specific conditions on disposal or retention 
instructions.

SYSTEM MANAGER(S) AND ADDRESS:
    See Appendix I for a listing of current system managers. This 
system is for use by all NIH Institutes, Centers, and Divisions. The 
following system notices have been subsumed under this umbrella system 
notice.

09-25-0001  Clinical Research: Patient Records, HHS/NIH/NHLBI
09-25-0010  Research Resources: Registry of Individuals Potentially 
Exposed to Microbial Agents, HHS/NIH/NCI
09-25-0015  Clinical Research: Collaborative Clinical Epilepsy 
Research, HHS/NIH/NINDS
09-25-0016  Clinical Research: Collaborative Perinatal Project, HHS/
NIH/NINDS
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
09-25-0031  Clinical Research: Serological and Virus Data in Studies 
Related to the Central Nervous System, HHS/NIH/NINDS
09-25-0037  Clinical Research: The Baltimore Longitudinal Study of 
Aging, HHS/NIH/NIA
09-25-0038  Clinical Research: Patient Data, HHS/NIH/NIDDK
09-25-0039  Clinical Research: Diabetes Mellitus Research Study of 
Southwestern American Indians, HHS/NIH/NIDDK
09-25-0040  Clinical Research: Southwestern American Indian Patient 
Data, HHS/NIH/NIDDK
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
09-25-0046  Clinical Research: Catalog of Clinical Specimens from 
Patients, Volunteers and Laboratory Personnel, HHS/NIH/NIAID
09-25-0053  Clinical Research: Vision Studies, HHS/NIH/NEI
09-25-0057  Clinical Research: Burkitt's Lymphonma Registry, HHS/
NIH/NCI
09-25-0060  Clinical Research: Division of Cancer Treatment Clinical 
Investigations, HHS/NIH/NCI
09-25-0067  Clinical Research: National Cancer Incidence Surveys, 
HHS/NIH/NCI
09-25-0069  NIH Clinical Center Admissions of the National Cancer 
Institute, HHS/NIH/NCI
09-25-0074  Clinical Research: Division of Cancer Biology and 
Diagnosis Patient Trials, HHS/NIH/NCI
09-25-0077  Biological Carcinogenesis Branch Human Specimen Program, 
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
09-25-0130  Clinical Research: Studies in the Division of Cancer 
Cause and Prevention, HHS/NIH/NCI
09-25-0134  Clinical Research: Epidemiology Studies, National 
Institute of Environmental Health Sciences, HHS/NIH/NIEHS
09-25-0142  Clinical Research: Records of Subjects in Intramural 
Research, Epidemiology, Demography and Biometry Studies on Aging, 
HHS/NIH/NIA
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
09-25-0145  Clinical Trials and Epidemiological Studies Dealing with 
Visual Disease and Disorders in the National Eye Institute, HHS/NIH/
NEI
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
09-25-0170  Diabetes Control and Complications Trial (DCCT) Data 
System, HHS/NIH/NIDDK
09-25-0172  Clinical Research: National Center for Human Genome 
Research, HHS/NIH/NCHGR
09-25-0201  Clinical Research: National Institute of Mental Health 
Patient Records, HHS/NIH/NIMH
09-25-0205  Alcohol, Drug Abuse, and Mental Health Epidemiologic and 
Biometric Research Data, HHS/NIH/NIAAA, HHS/NIH/NIDA and HHS/NIH/
NIMH
09-25-0212  Clinical Research: Neuroscience Research Center Patient 
Medical Records, HHS/NIH/NIMH

[[Page 16600]]

NOTIFICATION PROCEDURE:
    To determine if a record exists, write to the appropriate ICD 
Privacy Act Coordinator listed below. In cases where the requestor 
knows specifically which System Manager to contact, he or she may 
contact the System Manager directly (See Appendix I). Notification 
requests should include: Individual's name; current address; date of 
birth; date, place and nature of participation in specific research 
study; name of individual or organization administering the research 
study (if known); name or description of the research study (if known); 
address at the time of participation; and in specific cases, a 
notarized statement (some highly sensitive systems require two 
witnesses attesting to the individual's identity). A requestor must 
verify his or her identity by providing either a notarization of the 
request or by submitting a written certification that the requestor is 
who he or she claims to be and understands that the knowing and willful 
request for acquisition of a record pertaining to an individual under 
false pretenses is a criminal offense under the Act, subject to a five 
thousand dollar fine.
    Individuals will be granted direct access to their medical records 
unless the System Manager determines that such access is likely to have 
an adverse effect (i.e., could cause harm) on the individual. In such 
cases when the System Manager has determined that the nature of the 
record information requires medical interpretation, the subject of the 
record shall be requested to 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, other health professional, or 
other responsible individual. In this case, the medical/dental record 
will be sent to the designated representative. Individuals will be 
informed in writing if the record is sent to the representative. This 
same procedure will apply in cases where a parent or guardian requests 
notification of, or access to, a child's or incompetent person's 
medical record. The parent or guardian must also verify (provide 
adequate documentation) their relationship to the child or incompetent 
person as well as his or her own identity to prove their relationship.
    If the requester does not know which Institute, Center or Division 
Privacy Act Coordinator to contact for notification purposes, he or she 
may contact directly the NIH Privacy Act Officer at the following 
address: NIH Privacy Act Officer, Office of Management Assessment, 
Building 31, Room 1B05, 31 Center Drive MSC 2075, Bethesda, MD 20892-
2075.

NIH Privacy Act Coordinators

Office of the Director, (OD), NIH
    Associate Director for Disease Prevention, OD, NIH
    Building 1, Room 260
    1 Center Drive
    Bethesda, MD 20892
National Cancer Institute (NCI)
    Privacy Act Coordinator, NCI, NIH
    Building 31, Room 10A34
    31 Center Drive
    Bethesda, MD 20892
National Eye Institute (NEI)
    Privacy Act Coordinator, NEI, NIH
    Building 31, Room 6A-19
    31 Center Drive
    Bethesda, MD 20892
National Heart, Lung and Blood Institute (NHLBI)
    Privacy Act Coordinator, NHLBI, NIH
    Building 31, Room 5A08
    31 Center Drive
    Bethesda, MD 20892
National Institute on Aging (NIA)
    Privacy Act Coordinator, NIA, NIH
    Building 31, Room 2C12
    31 Center Drive
    Bethesda, MD 20892
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Privacy Act Coordinator, NIAAA, NIH
    Wilco Building, Suite
    6000 Executive Blvd., MSC 7003
    Bethesda, MD 20892-7003
National Institute of Allergy and Infectious Diseases (NIAID)
    Privacy Act Coordinator, NIAID, NIH
    Solar Building, Room 3C-23
    6003 Executive Blvd.
    Bethesda, MD 20892
National Institute of Arthritis and Musculoskeletal and Skin 
Diseases (NIAMS)
    Privacy Act Coordinator, NIAMS, NIH
    Natcher Building, Room 5QS49
    45 Center Drive
    Bethesda, MD 20892
National Institute of Child Health and Human Development (NICHD)
    Privacy Act Coordinator, NICHD, NIH
    6100 Executive Blvd., Room 5D01
    North Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders 
(NIDCD)
    Privacy Act Coordinator, NIDCD, NIH
    Building 31, Room 3C02
    9000 Rockville Pike
    Bethesda, MD 20892
National Institute of Dental Research (NIDR)
    Privacy Act Coordinator, NIDR, NIH
    Building 31, Room 2C-35
    31 Center Drive, MSC 2290
    Bethesda, MD 20892-2290
National Institute of Diabetes and Digestive and Kidney Disease 
(NIDDK)
    Privacy Act Coordinator, NIDDK, NIH
    Building 31, Room 9A47
    31 Center Drive
    Bethesda, MD 20892
National Institute on Drug Abuse (NIDA)
    Privacy Act Coordinator, NIDA, NIH
    Parklawn Building, Room 10A-42
    5600 Fishers Lane
    Rockville, Maryland 20857
National Institute of Environmental Health Sciences (NIEHS)
    Chief, Epidemiology Branch, NIEHS, NIH
    P.O. Box 12233
    Research Triangle Park
    North Carolina 27709
National Institute of Mental Health (NIMH)
    Privacy Act Coordinator, NIMH, NIH
    Parklawn Building, Room 7C-22
    5600 Fishers Lane
    Rockville, Maryland 20857
National Institute of Neurological Disorders and Stroke (NINDS)
    Privacy Act Coordinator, NINDS, NIH
    Federal Building, Room 816
    7550 Wisconsin Avenue
    Bethesda, MD 20892
National Center for Human Genome Research (NCHGR)
    Chief, Office of Human Genome Communications, NGHGR, NIH
    Building 38A, Room 617
    9000 Rockville Pike
    Bethesda, Maryland 20892

RECORD ACCESS PROCEDURE:
    Same as notification procedures. Requesters should reasonably 
specify the record contents being sought. An individual may also 
request an accounting of disclosures of his/her record, if any.

CONTESTING RECORD PROCEDURE:
    Contact the appropriate official at the address specified under 
Notification Procedure, and reasonably identify the record, specify the 
information being contested, and state corrective action sought, with 
supporting information to show how the record is inaccurate, 
incomplete, untimely, or irrelevant.

RECORD SOURCE CATEGORIES:
    The system contains information obtained directly from the subject 
individual by interview (face-to-face or telephone), written 
questionnaire, or by other tests, recording devices or observations, 
consistent with legislation and regulation regarding informed consent 
and protection of human subjects. Information is also obtained from 
other sources, including but not limited to: Referring medical 
physicians, mental health/alcohol/drug abuse or other health care 
providers; hospitals; organizations providing biological specimens; 
relatives; guardians; schools; and clinical medical research records.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

Appendix I: System Managers and Addresses

Office of the Director, NIH

[[Page 16601]]

    Associate Director for Disease Prevention, OD, NIH
    Building 1, Room 260
    1 Center Drive
    Bethesda, MD 20892

National Cancer Institute
    Computer Systems Analyst, DCBD, NCI, NIH
    Executive Plaza North, Room 344
    Bethesda, MD 20892

    American Burkitt's Lymphoma Registry
    Division of Cancer Etiology, NCI, NIH
    Executive Plaza North, Suite 434
    6130 Executive Blvd.
    Bethesda, MD 20892

    Chief, Genetic Epidemiology Branch, EBP, DCE, NCI, NIH
    Executive Plaza North, Suite 439
    6130 Executive Blvd.
    Bethesda, MD 20892

    Chief, Clinical Genetics Section
    Clinical Epidemiology Branch, DCE, NCI, NIH
    Executive Plaza North, Suite 400
    6130 Executive Blvd.
    Bethesda, MD 20892

    Program Director, Research Resources
    Biological Carcinogenesis Branch, DCE, NCI, NIH
    Executive Plaza North, Room 540
    6130 Executive Blvd.
    Bethesda, MD 20892

    Chief, Environmental Epidemiology Branch, DCE, NCI, NIH
    Executive Plaza North, Room 443
    6130 Executive Blvd.
    Bethesda, MD 20892

    Associate Director, Surveillance Program, DCPC, NCI, NIH
    Executive Plaza North, Room 343K
    6130 Executive Blvd.
    Bethesda, MD 20892

    Head, Biostatistics and Data Management Section, DCT, NCI, NIH
    8601 Old Georgetown Road
    Bethesda, MD 20892

    Chief, Clinical Research Branch
    Biological Response Modifiers Program
    Frederick Cancer Research and Development Center, DCT, NCI, NIH
    501 W. 7th Street, Suite #3
    Frederick, MD 21701

    Deputy Branch Chief, Navy Hospital
    NCI--Naval Medical Oncology Branch, DCT, NCI, NIH
    Building 8, Room 5101
    Bethesda, MD 20814

    Chief, Pharmaceutical Management Branch
    Cancer Therapy Evaluation Program, DCT, NCI, NIH
    Executive Plaza North, Suite 804
    Bethesda, MD 20892

    Director, Extramural Clinical Studies, BRB, BRMP, DCT, NCI, NIH
    Frederick Cancer Research and Development Center
    Fort Detrick
    Frederick, MD 21701

National Eye Institute
    Clinical Director, NEI, NIH
    Building 10, Room 10N-202
    10 Center Drive
    Bethesda, MD 20892

    Director, Division of Biometry and Epidemiology, NEI, NIH
    Building 31, Room 6A-52
    31 Center Drive
    Bethesda, MD 20892
National Heart Lung and Blood Institute
    Administrative Officer, Division of Intramural Research, NHLBI, 
NIH
    Building 10 Room 7N220
    10 Center Drive, MSC 1670
    Bethesda, MD 20892-1670

    Senior Scientific Advisor, OD
    Division of Epidemiology and Clinical Applications, NHLBI, NIH
    Federal Building, 220
    7550 Wisconsin Avenue
    Bethesda, MD 20892

National Institute on Aging
    Computer Scientist, Longitudinal Studies Branch, IRP, NIH
    Gerontology Research Center, GRC
    4940 Eastern Avenue
    Baltimore, MD 21224

    Associate Director, Epidemiology,
    Demography and Biometry Program, NIA, NIH
    Gateway Building, Suite 3C309
    7201 Wisconsin Avenue
    Bethesda, MD 20892

National Institute on Alcohol Abuse and Alcoholism
    Deputy Director, Division of Biometry and Epidemiology, NIAAA, 
NIH
    Willco Building, Suite 514
    6000 Executive Blvd., MSC 7003
    Bethesda, MD 20892-7003

    Deputy Director, Div. of Clinical and Prevention Res., NIAAA, 
NIH
    Willco Building, Suite 505
    6000 Executive Blvd., MSC 7003
    Bethesda, MD 20892-7003

National Institute of Allergy and Infectious Diseases
    Chief, Respiratory Viruses Section, LID, NIAID, NIH
    Building 7, Room 106
    9000 Rockville Pike
    Bethesda, MD 20892

    Chief, Hepatitis Virus Section, LID, NIAID, NIH
    Building 7, Room 202
    9000 Rockville Pike
    Bethesda, MD 20892

    Chief, Epidemology and Biometry Branch, DMID, NIAID, NIH
    Solar Building, Room 3A24
    Bethesda, Maryland 20892

    Special Assistant, Clinical Research Program, DAIDS, NIAID, NIH
    Solar Building, Room 2C-20
    6003 Executive Blvd.
    Bethesda, MD 20892

National Institute of Arthritis and Musculoskeletal and Skin 
Diseases
    Clinical Director, NIAMS, NIH
    Building 10, Room 9S205
    10 Center Drive
    Bethesda, MD 20892

National Institute of Child Health and Human Development
    Chief, Contracts Management Branch, NICHD, NIH
    Executive Plaza North, Room 7A07
    6100 Executive Blvd.
    North Bethesda, MD 20892

National Institute on Deafness and Other Communication Disorders
    Acting Director of Intramural Research, NIDCD, NIH
    Building 31, Room 3C02
    31 Center Drive
    Bethesda, MD 20892

    Director, Division of Human Communication, NIDCD, NIH
    Executive Plaza South, Room 400B
    6120 Executive Boulevard
    Rockville, MD 20852

National Institute of Dental Research
    Deputy Clinical Director, NIDR, NIH
    Building 10, Room 1N-113
    10 Center Drive, MSC 1190
    Bethesda, MD 20892-1190

    Research Psychologist, Clinical Invsetigations, NIDR, NIH
    Building 10, Room 1N114
    10 Center Drive, MSC 1190
    Bethesda, MD 20892-1190

    Chief, Contract Management Section
    Extramural Program, NIDR, NIH
    Natcher Building, Room 4AN-44B
    45 Center Drive, MSC 6402
    Bethesda, MD 20892-6402

National Institute of Diabetes and Digestive and Kidney Diseases
    Chief, Clinical Investigations, NIDDK, NIH
    Building 10, Room 9N222
    10 Center Drive
    Bethesda, MD 20892

    Chief, Phoenix Clinical Research Section, NIDDK, NIH
    Phoenix Area Indian Hospital, Room 541
    4212 North 16th Street
    Phoenix, Arizona 85016

    Chief, Diabetes Research Section, DPB, DDEMD, NIDDK, NIH
    Natcher Building, Room 5AN-18G
    45 Center Drive, MSC 6600
    Bethesda, MD 20892

National Institute on Drug Abuse
    Privacy Act Coordinator, NIDA, NIH
    Parklawn Building, Room 10A-42
    5600 Fishers Lane
    Rockville, Maryland 20857

National Institute of Environmental Health Sciences
    Chief, Epidemiology Branch, NIEHS, NIH
    P.O. Box 12233
    Research Triangle Park
    North Carolina 27709

National Institute of Mental Health
    Director, Intramural Research Program, NIMH, NIH
    Building 10, Room 4N-224
    9000 Rockville Pike
    Bethesda, MD 20205

    Privacy Act Coordinator, NIMH, NIH
    Parklawn Building, Room 7C22
    5600 Fishers Lane
    Rockville, Maryland 20857

    Clinical Director, Neuroscience Research Center, DIRP, NIMH
    Saint Elizabeths Hospital,
    William A. White Building, Room 133
    2700 Martin Luther King Jr., Avenue, SE
    Washington, DC 20032

National Institute of Neurological Disorders and Stroke

[[Page 16602]]

    Chief, Epilepsy Branch, NINDS, NIH
    Federal Building, Room 114
    7750 Wisconsin Avenue
    Bethesda, MD 20892

    Chief, Development Neurology Branch, NINDS, NIH
    Federal Building, NIH
    7550 Wisconsin Avenue
    Bethesda, MD 20892

    Assistant Director, CNP, DIR, NINDS, NIH
    Building 10, Room 5N226
    10 Center Drive
    Bethesda, MD 20892

    Deputy Chief, Laboratory of Central Nervous Systems Studies
    Intramural Research Program, NINDS, NIH
    Building 36, Room 5B21,
    9000 Rockville Pike
    Bethesda, MD 20892

    Director, Division of Fundamental Neurosciences, NINDS, NIH
    Federal Building, Room 916
    7550 Wisconsin Ave
    Bethesda, MD 20892

    Director, Division of Convulsive, Developmental and 
Neuromuscular Disorders, NINDS, NIH
    Federal Building, Room 816
    7550 Wisconsin Avenue
    Bethesda, MD 20892

    Director, Division of Demyelinating Atrophic, and Dementing 
Disorders, NINDS, NIH
    Federal Building, Room 810
    7550 Wisconsin Avenue
    Bethesda, MD 20892

    Director, Division of Stroke and Trauma, NINDS, NIH
    Federal Building, Room 8A08
    7550 Wisconsin Avenue
    Bethesda, MD 20892

National Center for Human Genome Research
    Chief, Office of Human Genome Communications, NCHGR, NIH
    Building 38A, Room 617
    9000 Rockville Pike
    Bethesda, MD 20892

[FR Doc. 97-8592 Filed 4-4-97; 8:45 am]
BILLING CODE 4140-01-M