16596 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.

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 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

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 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 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,

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
16598 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 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 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

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
16600 Federal Register / Vol. 62, No. 66 / Monday, April 7, 1997 / Notices

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 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
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

AGENCY: Substance Abuse and Mental

Health Services Administration

(SAMHSA), HHS.

ACTION: Clarification of Notice of

Funding Availability (NOFA).

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.

FOR FURTHER INFORMATION CONTACT: Rose

C. Kittrell, MSW, SAMHSA, Rockwall

II, Room 1075, 5600 Fishers Lane,

Rockville, MD 20857; (301) 443–0354 or

443–0365.

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

AGENCY: 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.

SUMMARY: 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