27734 Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices

II. Procedure for Updating the List

The Modernization Act also requires

FDA to update the list annually. FDA

plans to update the list regularly and at

least annually. Individuals desiring to

comment on the procedure and criteria

used to develop the list may submit at

any time written comments identified

with the docket number found in

brackets in the heading of this

document. Persons seeking to add a

particular drug to the priority section of

the list or to have a drug removed from

the priority section of the list may

submit to the agency a citizen petition

that complies with the requirements of

21 CFR part 10. At its discretion, the

agency may consult with a sitting

advisory committee, which may include

pediatric research experts, before

determining whether to include a drug

on or remove a drug from the list.

III. Electronic Access

Persons with access to the Internet

may obtain the list and all updated

versions of the list by using the World

Wide Web (WWW). For WWW access,

connect to CDER at http://www.fda.gov/

cder/pediatric or to CBER at http://

www.fda.gov/CBER/publications.htm.

IV. Request for Comments

Interested persons may submit at any

time to the Dockets Management Branch

(address above) written comments

regarding the procedure and criteria

used to develop the list. Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The list and received

comments will be available for public

examination in the office above between

9 a.m. and 4 p.m., Monday through

Friday. Received comments will be

considered in determination whether

further revision of the list is warranted.

Dated: May 13, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–13554 Filed 5–19–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Privacy Act of 1974; Addition of

Routine Uses to an Existing System of

Records

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notification of an addition of

routine uses to an existing system of

records.

SUMMARY: In accordance with the

requirements of the Privacy Act, the

Health Resources and Services

Administration (HRSA) is publishing a

proposal to add three new routine uses

for the records in System of Records 09–

15–0056, National Vaccine Injury

Compensation Program (VICP), BHPr/

HRSA/HHS. HRSA proposes to specify

the categories of records in the system,

and to expand the list of routine use in

record disclosures to include

disclosures for research purposes,

disclosures to annuity brokers, and

disclosures to employees of life

insurance companies for the purposes of

providing benefits to recipients under

the VICP.

DATES: HRSA invites interested parties

to submit comments on the addition of

new routine uses on or before June 19,

1998. The HRSA/VICP will adopt the

new routine uses without further notice

30 days after the date of publication,

unless HRSA receives comments which

would result in a contrary

determination.

ADDRESSES: Please address comments

on the altered system of records to the

Health Resources and Services

Administration (HRSA) Privacy Act

Officer, Department of Health and

Human Services, 5600 Fishers Lane,

Room 14A–20, Rockville, Maryland

20857, telephone (301) 443–3780. This

is not a toll-free number.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Vaccine Injury

Compensation, BHPr/HRSA, Room 8A–

35, Parklawn Building, 5600 Fishers

Lane, Rockville, Maryland 20857;

telephone (301) 443–6593. This is not a

toll-free number.

SUPPLEMENTARY INFORMATION: The

routine use changes proposed are to

expand the ‘‘Routine Uses of Records’’

to specify conditions for approving

access to the system of records for

research purposes.

Access to the system is limited to

authorized users only. Stringent

physical and procedural safeguards are

in place to protect information.

The alteration of this system will have

a minimal effect on an individual’s

privacy and should not affect personal

rights. The information gathered for

research purposes or benefit payment

purposes will not be disclosed publicly

in identifiable form.

Disclosure of information from this

system of records may provide

important information about vaccine

safety, benefit-payment trends or the

VICP.

The following notice is written in the

present, rather than the future tense, to

avoid the unnecessary expenditure of

public funds to republish the notice

after the routine use has become

effective.

Dated: May 11, 1998.

Claude Earl Fox,

Acting Administrator.

Add to Routine Uses of Records

Maintained in the System:

7. A record may be disclosed to

annuity brokers and to employees of life

insurance companies for the purposes of

obtaining financial advice and for the

purchase of contracts to provide benefits

to recipients of benefits under the

Program. Organizations to which

information is disclosed for this use will

be required to maintain Privacy Act

safeguards with respect to such records.

8. A record may be disclosed to

contractors for the purpose of providing

medical review, analysis and

determination as to whether petitions

meet the medical requirements for

compensation. Contractors will be

required to maintain Privacy Act

safeguards with respect to such records.

9. A record may be disclosed for a

research purpose when the Department:

(A) Has determined that the

disclosure does not violate legal or

policy limitations under which the

record was provided, collected, or

obtained;

(B) Has determined that the research

purpose:

(1) Is consistent with the purpose for

which the program was formed, which

includes but is not limited to evaluating

the safety of vaccines covered under the

Program,

(2) Cannot be reasonably

accomplished with information in

statistical form, and must be provided in

an identifiable form to accomplish the

research purpose, and

(3) 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 of the record

except:
Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices 27735

1 In addition to persons who meet all

requirements of 45 CFR 400.43, ‘‘Requirements for

documentation of refugee status,’’ eligibility for

targeted assistance includes: (1) Cuban and Haitian

entrants, under section 501 of the Refugee

Education Assistance Act of 1980 (Pub. L. No. 96–

422); (2) certain Amerasians from Vietnam who are

admitted to the U.S. as immigrants under section

584 of the Foreign Operations, Export Financing,

and Related Programs Appropriations Act, 1988, as

included in the FY 1988 Continuing Resolution

(Pub. L. No. 100–202); and (3) certain Amerasians

from Vietnam, including U.S. citizens, under title

II of the Foreign Operations, Export Financing, and

Related Programs Appropriations Acts, 1989 (Pub.

L. No. 100–461), 1990 (Pub. L. No. 101–167), and

1991 (Pub. L. No. 101–513). For convenience, the

term ‘‘refugee’’ is used in this notice to encompass

all such eligible persons unless the specific context

indicates otherwise.

Refugees admitted to the U.S. under admissions

numbers set aside for private-sector-initiative

admissions are not eligible to be served under the

targeted assistance program (or under other

programs supported by Federal refugee funds)

during their period of coverage under their

sponsoring agency’s agreement with the Department

of State—usually two years from their date of

arrival or until they obtain permanent resident alien

status, whichever comes first.

(a) In emergency circumstances

affecting the health or safety of any

individual,

(b) 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

(c) 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.

[FR Doc. 98–13297 Filed 5–19–98; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Refugee Resettlement

Modification to the Standing

Announcement Published in the

Federal Register on December 9, 1997

(62 FR 236)

AGENCY: Office of Refugee Resettlement

(ORR) Administration for Children and

Families, DHHS.

ACTION: Notice of correction.

SUMMARY: Notice is hereby given that

the ORR Standing Announcement, 62

FR 236, with closing dates of January

31, 1998 and June 30, 1998 will have the

following changes.

The following programs will be

competed as scheduled in the December

9, 1997 notice: Category 1, Preferred

Communities, Category 2, Unanticipated

Arrivals, Category 5, Mental Health, and

Category 6, Ethnic Community

Organizations.

Category 3, Orientation, will be

canceled for the June 30, 1998 closing.

This program will be competed again

with closing date of January 31st

beginning in 1999 and each subsequent

year until the Standing Announcement

is revised or canceled.

Category 4, Technical Assistance to

Orientation Grantees, is hereby

canceled.

Dated: May 14, 1998.

Lavinia Limon,

Director, Office of Refugee Resettlement.

[FR Doc. 98–13433 Filed 5–19–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Notice of Availability of Funding To

Provide Community Service

Employment Opportunities for

Refugees Who Have Experienced

Long-term Difficulties in Assimilation

AGENCY: Office of Refugee Resettlement,

ACF, DHHS.

ACTION: Request for applications for

projects to provide community service

employment opportunities for refugees

who have experienced long-term

difficulties in assimilation.

SUMMARY: This program announcement

governs the availability of social

services funds and award procedures for

$16 million in FY 1998 discretionary

grants for community service

employment for refugees under the

Refugee Resettlement Program. These

grants, which will be awarded on a

competitive basis, are for localities with

large concentrations of refugees who

have experienced difficulty integrating

socially and economically into local

communities. Refugees are eligible to

participate in these projects regardless

of the length of time they have resided

in the U.S. Applications may include

requests for project periods of up to

three years, with an initial budget

period of one year. Where awards are

made for multiple year project periods,

continuation grant applications will be

entertained in subsequent years on a

non-competitive basis, subject to the

availability of funds, successful progress

of the project, and ACF/ORR’s

determination that this would be in the

best interest of the government.

The Catalog of Federal Domestic

Assistance (CFDA) number assigned to

this announcement is 93.576.

DATE: The closing date for receipt of

applications is July 20, 1998.

ADDRESS: Address applications to:

Office of Refugee Resettlement, Division

of Community Resettlement, 6th Floor

East, Aerospace Building, 370 L’Enfant

Promenade, SW, Washington, DC 20447

FOR FURTHER INFORMATION CONTACT:

Nguyen T. Kimchi at (202) 401–4556, email: Nkimchi@acf.dhhs.gov, or send

correspondence to the above listed

address.

SUPPLEMENTARY INFORMATION:

Part I. General Information

A. Background

There are communities across this

country with large concentrations of

refugees 1, many of whom entered the

United States over a decade ago. For

some refugees, language skills, cultural

barriers, the lack of financial resources,

and years of relying on public

assistance, have isolated them from the

mainstream, limited their employment

opportunities and hindered integration

into American communities. Their rate

of assimilation has been documented in

many localities on such key indicators

as poverty levels, welfare utilization, car

and home ownership, high school

completion, college attendance or

graduation, language fluency,

employment rates, household income,

per capita income, and naturalization

rates. Prior to their arrival in the U.S.,

some refugees have experienced torture,

starvation or prolonged malnutrition,

which have exacerbated their isolation

and difficulty in adapting to life in the

United States.

In some of these communities,

refugees represent a significant

percentage of the population and,

relative to non-refugee groups, have a

sizeable impact on local services,

medical clinics, and school systems.

The purpose of this announcement is

to improve refugee rates of assimilation

in heavily impacted communities by

providing funding for workforce

experience and training, earned income

for refugees and their families, and

access to needed services for refugee

communities.

Statutory and Regulatory Authority

The FY 1998 House Appropriations

Committee Report (H.R. Rept. No. 105–

205) stated that: ‘‘The Committee has

set-aside $16,000,000 for increased

support to communities with large