34656 Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices

Contact Person: Tracy Riley or Angie

Whitacre, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12534. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

new drug application (NDA) 20–961,

Vitravene (fomivirsen sodium

intravitreal injection, ISIS

Pharmaceuticals), for treatment of

cytomegalovirus (CMV) retinitis in

patients with acquired immune

deficiency syndrome (AIDS).

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 17, 1998. Oral

presentations from the public will be

scheduled between approximately 8

a.m. and 8:30 a.m., and between

approximately 1 p.m. and 1:30 p.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 17, 1998,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 12, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–16851 Filed 6–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Privacy Act of 1974; Altered System of

Records

AGENCY: National Institutes of Health,

HHS.

ACTION: Notification of an altered system

of records.

SUMMARY: In accordance with the

requirements of the Privacy Act, the

National Institutes of Health (NIH) is

publishing a notice of proposal to alter

an existing system of records 09–25–

0036, ‘‘Extramural Awards and

Chartered Advisory Committees: IMPAC

(Grant/Contract/Cooperative Agreement

Information/Chartered Advisory

Committee Information), HHS/NIH/OER

and HHS/NIH/CMO.’’ The system is

altered by including contractor past

performance information as a new

category of records; adding consultants

and contractors as individuals covered

by the system; and including a new

routine use which allows NIH to share

information it collects on contractor

past performance information with

other Federal agencies.

DATES: The NIH invites interested

parties to submit comments on the

proposed internal and routine uses on

or before July 27, 1998. The NIH sent a

Report of the Altered System to the

Congress and to the Office of

Management and Budget (OMB) on June

19, 1998. The alteration of this system

of records will be effective 40 days from

the date submitted to the OMB, unless

NIH receives comments which would

result in a contrary determination.

ADDRESSES: Please submit comments to:

NIH Privacy Act Officer, 6011 Executive

Boulevard, Room 601, MSC 7669,

Rockville, MD 20852, 301–496–2832.

(This is not a toll free number.)

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, 6011 Executive

Boulevard, Room 601, MSC 7669,

Rockville, MD 20852, 301–496–2832.

(This is not a toll free number.)

SUPPLEMENTARY INFORMATION: The

National Institutes of Health (NIH)

proposes to alter an existing system of

records 09–25–0036, ‘‘Extramural

Awards and Chartered Advisory

Committees: IMPAC (Grant/Contract/

Cooperative Agreement Information/

Chartered Advisory Committee

Information), HHS/NIH/DRG and HHS/

NIH/CMO.’’ The system is altered by

including contractor past performance

information as a new category of

records; adding consultants and

contractors as individuals covered by

the system; including a new routine use

which allows NIH to share information

it collects on contractor past

performance information with other

Federal agencies; and editorial changes

to accommodate normal updating

changes.

The purposes of this system of records

are to (1) support centralized grant

programs of the Public Health Service

by providing services in the areas of

grant application assignment and

referral, initial review, council review,

award processing and grant accounting;

maintain communication with former

fellows and trainees who have incurred

a payback obligation through the

National Research Service Award

Program; maintain current and

historical information pertaining to the

establishment of chartered advisory

committees of the National Institutes of

Health and the appointment or

designation of their members; and

maintain current and historical

information pertaining to contracts

awarded by the National Institutes of

Health, and performance evaluations on

NIH contracts and contracts awarded by

other Federal agencies that participate

in the NIH Contractor Performance

System.

This system will comprise records

that contain names, applications, grant

or contract ID number, contractor tax ID

number, awards, trainee appointments,

current and historical information

pertaining to chartered advisory

committees, and past performance

information pertaining to contractors.

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 Managers will

control access to the data. Authorized

users will be granted access only to

those records within their specific area

of responsibility. 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 NIH extramural

and committee management staff, NIH

contract management staff, and Federal

acquisition personnel. One-time and

special access by other employees is

granted on a need-to-know basis as

specifically authorized by the System

Manager. Records may be stored on hard

copy, discs and magnetic tapes, and in

other machine-readable format,

regardless of physical form or

characteristics. 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).

Access to source data files is strictly

controlled by files staff. Records may be

removed from files only at the request

of the System Manager or other
Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices 34657

authorized employee. Access to

computer files is controlled by the use

of registered accounts, registered

initials, keywords, and similar limited

access systems. Access to the contractor

performance files is restricted through

the use of secure socket layer encryption

and through an IBM password

protection system. Physical access to

work areas is restricted to employees or

authorized contractors with a valid

‘‘need-to-know.’’

The routine uses proposed for this

system are compatible with the stated

purposes of the system. The first routine

use allows disclosure to the National

Technical Information Service (NTIS),

Department of Commerce, for

dissemination of scientific and fiscal

information on funded awards. The

second routine use allows disclosure to

the cognizant audit agency for auditing.

The third routine use allows disclosure

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. The forth routine use

allows disclosure to qualified experts

not within the definition of Department

employees as prescribed in Department

regulations for opinions as a part of the

application review process. The fifth

routine use allows disclosure to a

Federal agency, in response to its

request, in connection with the issuance

of a license, grant or other benefit by the

requesting agency, to the extent that the

record is relevant and necessary to the

requesting agency’s decision in the

matter. The sixth routine use allows

disclosure of contractor past

performance information to a Federal

agency upon request and allows routine

access to contractor past performance

information to Federal agencies that

subscribe to the NIH Contractor

Performance System. The seventh

routine use allows disclosure for a

research purpose as authorized by the

Department or required by law. The

eighth routine use allows disclosure to

a private contractor or Federal agency

for the purpose of collating, analyzing,

aggregating or otherwise refining

records in this system. The ninth

routine use allows disclosure to a

grantee or contract institution in

connection with performance or

administration under the conditions of

the particular award or contract. The

tenth routine use allows disclosure to

the Department of Justice, or to a court

or other adjudicative body, from this

system of records when HHS determines

that the records are relevant and

necessary to the proceeding and would

help in the effective representation of

the governmental party.

We have also made editorial changes

throughout the System Notice to

enhance clarity and specificity and to

accommodate normal updating changes.

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: June 5, 1998.

Anthony L. Itteilag,

Deputy Director for Management.

SYSTEM NAME:

Extramural Awards and Chartered

Advisory Committees: IMPAC (Grant/

Contract/Cooperative Agreement

Information/Chartered Advisory

Committee Information), HHS/NIH/OER

and HHS/NIH/CMO.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Rockledge Centre II, 6701 Rockledge

Drive, Bethesda, MD 20817

Building 12, NIH Computer Center,

9000 Rockville Pike, Bethesda, MD

20892

Building 31, Room 3B–59, 9000

Rockville Pike, Bethesda, MD 20892.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Principal investigators; program

directors; program and projects staff and

others named in the application;

National Research Service Awards

(NRSA) trainees and fellows; research

career awardees; chartered advisory

committee members; contractor

personnel; subcontractor personnel; and

consultants.

CATEGORIES OF RECORDS IN THE SYSTEM:

Funding applications, awards,

associated records, trainee

appointments, current and historical

information pertaining to chartered

advisory committees, and past

performance information pertaining to

contractors.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

5 U.S.C. 301; 42 U.S.C. 217a, 241,

282(b)(6), 284a, and 288. 48 CFR

Subpart 15.3 and Subpart 42.15.

PURPOSE(S) OF THE SYSTEM:

(1) To support centralized grant

programs of the Public Health Service.

Services are provided in the areas of

grant application assignment and

referral, initial review, council review,

award processing and grant accounting.

The database is used to provide

complete, accurate, and up-to-date

reports to all levels of management.

(2) To maintain communication with

former fellows and trainees who have

incurred a payback obligation through

the National Research Service Award

Program.

(3) To maintain current and historical

information pertaining to the

establishment of chartered advisory

committees of the National Institutes of

Health and the appointment or

designation of their members.

(4) To maintain current and historical

information pertaining to contracts

awarded by the National Institutes of

Health, and performance evaluations on

NIH contracts and contracts awarded by

other Federal agencies that participate

in the NIH Contractor Performance

System.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

1. Disclosure may be made to the

National Technical Information Service

(NTIS), Department of Commerce, for

dissemination of scientific and fiscal

information on funded awards (abstract

of research projects and relevant

administrative and financial data).

2. Disclosure may be made to the

cognizant audit agency for auditing.

3. Disclosure may be made to a

congressional office from the record of

an individual in response to an inquiry

from the congressional office made at

the request of that individual.

4. Disclosure may be made to

qualified experts not within the

definition of Department employees as

prescribed in Department regulations for

opinions as a part of the application

review process.

5. Disclosure may be made to a

Federal agency, in response to its

request, in connection with the issuance

of a license, grant or other benefit by the

requesting agency, to the extent that the

record is relevant and necessary to the

requesting agency’s decision in the

matter.

6. Disclosure of past performance

information pertaining to contractors

may be made to a Federal agency upon

request. In addition, routine access to

past performance information on

contractors will be provided to Federal

agencies that subscribe to the NIH

Contractor Performance System.

7. A record may be disclosed for a

research purpose, when the Department:

(A) Has determined that the use or

disclosure does not violate legal or

policy limitations under which the

record was provided, collected, or

obtained; (B) has determined that the
34658 Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices

research purpose (1) cannot be

reasonably accomplished unless the

record is provided in individually

identifiable form, and (2) justifies 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 that information,

and (3) make no further use or

disclosure of the record except (a) in

emergency circumstances affecting the

health or safety of any individual, (b) for

use in another research project, under

these same conditions, and with written

authorization of the Department, (c) for

disclosure to a properly identified

person for the purpose of an audit

related to the research project, if

information that would enable research

subjects to be identified is removed or

destroyed at the earliest opportunity

consistent with the purpose of the audit,

or (d) when required by law; and (D) has

secured a written statement attesting to

the recipient’s understanding of, and

willingness to abide by these provisions.

8. Disclosure may be made to a

private contractor or Federal agency for

the purpose of collating, analyzing,

aggregating or otherwise refining

records in this system. The contractor or

Federal agency will be required to

maintain Privacy Act safeguards with

respect to these records.

9. Disclosure may be made to a

grantee or contract institution in

connection with performance or

administration under the conditions of

the particular award or contract.

10. Disclosure may be made to the

Department of Justice, or to a court or

other adjudicative body, from this

system of records when (a) HHS, or any

component thereof; of (b) any HHS

officer or employee in his or her official

capacity; or (c) any HHS officer or

employee in his or her individual

capacity when the Department of Justice

(or HHS, where it is authorized to do so)

his agreed to represent the officer or

employee; or (d) the United States or

any agency thereof where HHS

determines that the proceeding is likely

to affect HHS or any of its components,

is a party to proceeding or has any

interest in the proceeding, and HHS

determines that the records are relevant

and necessary to the proceeding and

would held in the effective

representation of the governmental

party.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are stored on hard copy, discs

and magnetic tapes, and in other

machine-readable format, regardless of

physical form or characteristics.

RETRIEVABILITY:

Records are retrieved by name,

application, grant or contract ID

number, and contractor tax ID number.

SAFEGUARDS:

1. Authorized Users: Employees who

maintain records in this system are

instructed to grant regular access only to

NIH extramural and committee

management staff, NIH contract

management staff, and Federal

acquisition personnel. Other one-time

and special access by other employees

is granted on a need-to-know basis as

specifically authorized by the System

Manager.

2. Physical Safeguards: Physical

access to Office of Extramural Research

(OER) work areas is restricted to OER

employees. Physical access to Office of

Contracts Management (OCM) work

areas is restricted to OCM employees.

Physical access to Committee

Management Office (CMO) work areas is

restricted to CMO employees. Access to

the contractor performance files is

restricted through the use of secure

socket layer encryption and through an

IBM password protection system. Only

authorized government contracting

personnel are permitted access. Access

is monitored and controlled by

permitted access. Access is monitored

and controlled by OCM.

3. Procedural Safeguards: Access to

source data files is strictly controlled by

files staff. Records may be removed from

files only at the request of the System

Manager or other authorized employee.

Access to computer files is controlled by

the use of registered accounts, registered

initials, keywords, and similar limited

access systems.

These practices are in compliance

with the standards of chapter 45–13 of

the HHS General Administration

Manual, ‘‘Safeguarding Records

Contained in Systems of Records,’’

supplementary chapter PHS hf: 45–13,

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

the HHS Information Resources

Management Manual and the National

Institute of Standards and Technology

Federal Information Processing

Standards (FIPS Pub. 41 and FIPS Pub.

31).

RETENTION AND DISPOSAL:

Records are retained and disposed of

under the authority of the NIH Records

Control Schedule contained in NIH

Manual Chapter 1743, Appendix 1—

‘‘Keeping and Destroying Records,’’ item

4000–A–2, which allows records to be

destroyed when no longer needed for

administrative purposes. Refer to the

NIH Manual Chapter for specific

disposition instructions.

SYSTEM MANAGERS AND ADDRESSES:

For extramural awards:

Director, Extramural Information

Systems, OD/OER/OPERA,

Rockledge II, Room 2172, Bethesda,

MD 20892

For chartered Federal advisory

committees of the National

Institutes of Health:

NIH Committee Management Officer,

Building 31, Room 3B–59, 31

Center Drive, Bethesda, MD 20892

For contracts:

Office of Contracts Management, 6100

Executive Boulevard, Room 6D01,

Rockville, MD 20892

NOTIFICATION PROCEDURE:

To determine if a record exists, write

to the System Manager listed above. The

requester must also verify his or her

identity by providing either a

notarization of the request or a written

certification that the requester is who he

or she claims to be and understands that

the knowing and willful request for

acquisition of a record pertaining to an

individual under false pretenses is a

criminal offense under the Privacy Act,

subject to a five thousand dollar fine.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requesters should also reasonably

specify the record contents being

sought. Individuals may also request

listings of accountable disclosures that

have been made of their records, if any.

CONTESTING RECORD PROCEDURE:

Contact the official under notification

procedures above, and reasonably

identify the record and specify the

information to be contested, and state

the corrective action sought and the

reasons for the correction, with

supporting justification. The right to

contest records is limited to information

which is incomplete, irrelevant,

incorrect, or untimely (obsolete).

RECORD SOURCE CATEGORIES:

Applicant institution, individual,

individual’s educational institution and

references, and participating Federal

acquisition personnel.
Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices 34659

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

[FR Doc. 98–16914 Filed 6–24–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Grant Award to the Department of

Community Medicine and Health Care,

University of Connecticut

AGENCY: Center for Substance Abuse

Treatment (CSAT), Substance Abuse

and Mental Health Services

Administration (SAMHSA), HHS.

ACTION: Availability of grant funds for

the Department of Community Medicine

and Health Care, University of

Connecticut.

SUMMARY: This notice is to inform the

public that CSAT is making available

approximately $200,000 for an award in

FY 1998 to the University of

Connecticut Department of Community

Medicine and Health Care to develop

knowledge concerning the effectiveness

of primary care referral and behavioral

health treatment for alcohol dependence

in managed care. Eligibility for this

program is limited to the Department of

Community Medicine and Health Care,

University of Connecticut. Using Robert

Wood Johnson funding, the University

of Connecticut has already implemented

an experimental design research

program on the cost effectiveness of

alcohol screening and brief intervention

in six managed care settings. This crosssite study in managed care settings is

unique in its design and scope.

However, none of the study settings are

testing the cost effectiveness of

Motivational Enhancement Therapy

(MET) vs. standard alcoholism

treatment. SAMHSA/CSAT, by means of

this relatively small investment in this

existing University of Connecticut

program, will be able to capitalize on

this unique opportunity to test the cost

effectiveness on different models of

alcoholism treatment for primary care

vs. non primary care referred patients in

managed care settings within the

context of the existing Robert Wood

Johnson funded study protocol. It is for

these reasons, and in order to obtain the

benefits of the additional information

for the affected provider communities,

that only the University of Connecticut

is invited to apply. The application will

be considered for funding on the basis

of its overall technical merit as

determined through the peer and CSAT

National Advisory Council review

processes.

Funding from CSAT will support

supplemental evaluation activities in

three Robert Wood Johnson supported

screening and brief intervention (SBI)

study sites. These sites will extend their

current evaluation studies, to include

the following: (l) implement data

information systems to track patients

who are referred by the primary care

practices into treatment; (2) evaluate the

cost effectiveness of primary care

physician vs. primary care intervention

specialist referrals for alcohol

dependence and (3) evaluate the cost

effectiveness of MET vs. standard

treatment for alcohol dependent

patients.

Authority: The award will be made under

the authority of Section 501(d)(5) of the

Public Health Service Act, as amended (42

U.S.C. 290aa). The Catalog of Federal

Domestic Assistance (CFDA) number for this

program is 93.230.

Contact: Dr. Mady Chalk, Director,

Office of Managed Care, Center for

Substance Abuse Treatment, SAMHSA,

Rockwall II, 7th floor, 5600 Fishers

Lane, Rockville, MD 20857, 301) 443–

8796.

Dated: June 19, 1998.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 98–16932 Filed 6–24–98; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meetings

Pursuant to Pub. L. 92–463, notice is

hereby given of the following meetings

of the SAMHSA Special Emphasis Panel

I in July 1998.

Summaries of the meetings and

rosters of the members may be obtained

from: Ms. Dee Herman, Committee

Management Liaison, SAMHSA, Office

of Policy and Program Coordination,

Division of Extramural Activities,

Policy, and Review, 5600 Fishers Lane,

Room 17–89, Rockville, Maryland

20857. Telephone: 301–443–7390.

Substantive program information may

be obtained from the individuals named

as Contact for the meetings listed below.

The meetings will include the review,

discussion and evaluation of individual

grant applications. These discussions

could reveal personal information

concerning individuals associated with

the applications. Accordingly, these

meetings are concerned with matters

exempt from mandatory disclosure in

Title 5 U.S.C. 552b(c)(6) and 5 U.S.C.

App.2, § 10(d).

Committee Name: SAMHSA Special

Emphasis Panel I (SEP I).

Meeting Date: July 22, 1998.

Place: Hyatt Regency at Crystal City,

2799 Jefferson Davis Highway,

Arlington, VA 22202.

Closed: July 22, 1998, 8:30 a.m.–10:00

a.m.

Panel: Center for Mental Health

Services Minority Fellowship Program

SM98–008.

Committee Name: SAMHSA Special

Emphasis Panel I (SEP I).

Meeting Date: July 22, 1998.

Place: Hyatt Regency at Crystal City,

2799 Jefferson Davis Highway ,

Arlington, VA 22202.

Closed: July 22, 1998, 10:30 a.m.–

12:00 p.m.

Panel: Center for Mental Health

Services Cooperative Agreement for a

Technical Assistance Center SM 98–

011.

Contact: Kenneth D. Howard, 17–89,

Parklawn Building, Telephone: 301–

443–9919 and FAX: 301–443–3437.

Committee Name: SAMHSA Special

Emphasis Panel I (SEP I).

Meeting Dates: July 27–30, 1998, 9:00

a.m.–5:00 p.m., July 31, 1998, 9:00

a.m.—adjournment

Place: Hyatt Regency at Crystal City,

2799 Jefferson Davis Highway,

Arlington, VA 22202.

Closed: July 27–30, 1998, 9:00 a.m.–

5:00 p.m., July 31, 1998, 9:00 a.m.—

adjournment.

Panel: Statewide Consumer and

Consumer Supporter Networking Grants

SM 98–013.

Contact: Clark K. Lum, Room 17–89,

Parklawn Building, Telephone 301–

443–9919, FAX: 301–443–3437.

Dated: June 22, 1998.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 98–16978 Filed 6–24–98; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Receipt of Applications for

Permit

The following applicants have

applied for a permit to conduct certain

activities with endangered species. This

notice is provided pursuant to Section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531, et

seq.):