Federal_Notice_for_Privacy_Act[

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Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices

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.
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.

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 thirtyeight 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
FOR FURTHER INFORMATION CONTACT:

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

Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices
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 thirdparty 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,

16597

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

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Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices

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 needlesharing partner(s); (3) The PHS
employee or contractor determines that
the subject individual is unlikely to
provide the information to the sexual or
needle-sharing partner(s) or that the
provision of such information cannot
reasonably be verified; and (4) The
notification of the partner(s) is made,
whenever possible, by the subject
individual’s physician or by a
professional counselor and shall follow
standard counseling practices.
(b). PHS may disclose information to
State or local public health departments,
to assist in the notification of the subject
individual’s sexual and/or needlesharing partner(s), or in the verification
that the subject individual has notified
such sexual or needle-sharing partner(s).

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 thirdparty 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 onetime and special access by other
employees is granted on a need-to-know
basis as specifically authorized by the
system manager.

Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices
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 offduty 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

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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 ContractRelated Research: Records of Subjects in
Clinical, Epidemiological and
Biomedical Studies of the National
Institute of Neurological Disorders and
Stroke and the National Institute on
Deafness and Other Communication
Disorders, HHS/NIH/NINDS and HHS/
NIH/NIDCD
09–25–0152 Biomedical Research: Records
of Subjects in National Institute of Dental
Research Contracted Epidemiological
and Biometric Studies, HHS/NIH/NIDR
09–25–0153 Biomedical Research: Records
of Subjects in Biomedical and Behavioral
Studies of Child Health and Human
Development, HHS/NIH/NICHD
09–25–0154 Biomedical Research: Records
of Subjects: 1) Cancer Studies of the
Division of Cancer Prevention and
Control, HHS/NIH/NCI; and 2) Women’s
Health Initiative (WHI) Studies, HHS/
NIH/OD
09–25–0170 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

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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

Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices
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.

16601

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

16602

Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Fiscal Year (FY) 1997 Funding
Opportunities for Knowledge
Development and Application
Cooperative Agreements
Substance Abuse and Mental
Health Services Administration
(SAMHSA), HHS.
ACTION: Clarification of Notice of
Funding Availability (NOFA).
AGENCY:

This notice is to clarify questions/
issues that have been raised subsequent
to the publication of the NOFA for
SAMHSA’s ‘‘Cooperative Agreements

for Integrating Mental Health and
Substance Abuse Prevention and
Treatment Services with Primary Health
Care Service Settings or with Early
Childhood Service Settings, for Children
ages Birth to 7 and their Families/
Caregivers’’ (Short Title: Starting Early
Starting Smart—SESS). The NOFA was
published in the Federal Register (Vol.
62, No. 31), Friday February 14, 1997,
on pages 6974–6977. The receipt date
for applications is April 17, 1997.
Award Amounts: On page 6976 under
the Cooperative Agreements/Amounts
section, the notice states that
approximately $5.9 million will be
available to support approximately 10
SESS site awards and $500,000 to
support one data coordinating center
award. To clarify, it is anticipated that
funds available to support the data
coordinating center may increase
commensurate with the increased center
tasks and responsibilities in years 2–4.
In addition, proposed budgets must be
for total costs (direct + indirect).
Evaluation Costs: The percentage of
the total proposed budget for evaluation
costs is determined by the proposed
study design and the costs associated
with the steering committee and the
data coordinating center. The budget
must be consonant with the cost of
doing the evaluation required by the
study design. The proposed study
design, evaluation associated costs, and
overall budget will be evaluated by a
peer review group as part of their
overall assessment of the application.
Eligible Applicants: On page 6976
under the Eligible Applicants section,
the notice states that applications
‘‘* * * may be submitted by units of
State or local governments and by
domestic private nonprofit and forprofit organizations * * *,’’ and that
each SESS site proposal must include
documentation regarding the existence
of an infrastructure and two years of
experience providing behavioral health
and other relevant services to the target
population. SAMHSA has determined
that ‘‘home-based’’ early childhood
service settings are eligible applicants if
they meet other eligibility requirements
as specified in the announcement.
Rose
C. Kittrell, MSW, SAMHSA, Rockwall
II, Room 1075, 5600 Fishers Lane,
Rockville, MD 20857; (301) 443–0354 or
443–0365.
FOR FURTHER INFORMATION CONTACT:

Dated: April 1, 1997.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 97–8705 Filed 4–4–97; 8:45 am]
BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR
Central Utah Project Completion Act;
Notice of Availability of the Record of
Decision on the Wasatch County Water
Efficiency Project and Daniel
Replacement Project Final
Environmental Impact Statement
Documenting the Department of the
Interior’s Approval for the Central Utah
Water Conservancy District To
Proceed With the Construction of the
Proposed Action Alternative
Office of the Assistant
Secretary—Water and Science,
Department of the Interior.
ACTION: Notice of availability of the
Wasatch County Water Efficiency
Project and Daniel Replacement Project
Record of Decision.
AGENCY:

On March 21, 1997, Patricia J.
Beneke, Assistant Secretary—Water and
Science, Department of the Interior,
signed the Record of Decision (ROD)
which documents the selection of the
Proposed Action Alternative as
presented in the Wasatch County Water
Efficiency Project and Daniel
Replacement Project (WCWEP and DRP)
Final Environmental Impact Statement
(FEIS), INT FES 96–58, filed November
22, 1996, and as described in the
WCWEP Feasibility Study dated January
1997. The ROD also approves the
Central Utah Water Conservancy District
(CUWCD) proceeding with construction
of WCWEP and DRP, in accordance with
statutory and contractual obligations.
Construction of WCWEP will provide a
replacement water supply out of water
conserved in Wasatch County, for the
water presently being diverted from the
Strawberry River basin. The
replacement supply will be delivered by
means of the DRP.
The FEIS for WCWEP and DRP,
considered three alternatives to restore
flows in the upper Strawberry River and
to provide water and water conveyance
facilities from Jordanelle Reservoir to
the existing Daniel Irrigation Company
(DIC) water storage facilities as
mandated in section 303 of the Central
Utah Project Completion Act (CUPCA)
and a No Action Alternative. The
Department of the Interior (Interior), the
Utah Reclamation Mitigation and
Conservation Commission (Mitigation
Commission), and the CUWCD served as
the Joint Lead Agencies in the
preparation of the NEPA compliance
documents.
In addition to satisfying the
requirements and authorizations of
CUPCA, the construction of the WCWEP
and DRP will satisfy Interior’s
environmental commitment made in the
SUMMARY: