Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 / Notices 35589

to section 906.5(b) of the Finance Board

regulations and exempt under section

552b(c)(8) of title 5 of the United States

Code.

CONTACT PERSON FOR MORE INFORMATION:

Elaine L. Baker, Secretary to the Board,

(202) 408–2837.

William W. Ginsberg,

Managing Director.

[FR Doc. 98–17540 Filed 6–26–98; 2:48 pm]

BILLING CODE 6725–01–P

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System.

TIME AND DATE: 11:00 a.m., Monday, July

6, 1998.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, N.W., Washington, D.C. 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Lynn S. Fox, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.bog.frb.fed.us for an electronic

announcement that not only lists

applications, but also indicates

procedural and other information about

the meeting.

Dated: June 26, 1998.

Jennifer J. Johnson,

Secretary of the Board.

[FR Doc. 98–17558 Filed 6–26–98; 3:36 pm]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 98035]

Epidemiologic Research Studies of

Acquired Immunodeficiency Syndrome

(AIDS) and Human Immunodeficiency

Virus (HIV) Infection Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds for new and competitive

continuation cooperative agreements for

epidemiologic and behavioral research

studies of AIDS and HIV infection. This

program addresses the ‘‘Healthy People

2000’’ priority area of HIV Infection.

These awards will help support

researchers in the conduct of HIVrelated epidemiologic research studies

that foster prevention of HIV infection

or HIV-related disease in children.

These include studies that address the

follow-up of HIV-infected children and

other HIV epidemiologic studies.

Research Issue: HIV Infection in

Children—Follow Up of PerinatallyInfected Children

Applications are solicited for

continued prospective follow-up of HIVinfected children enrolled in the

Perinatal AIDS Collaborative

Transmission Study (PACTS) between

1986 and 1998. This is a research issue

of programmatic interest to the health

care community and to CDC for FY

1998. This issue is considered

significant to gaining a greater

understanding of the epidemiology of

AIDS and HIV infection. Follow-up

should be done at least every 3 months,

and include: (1) collecting information

on HIV-related clinical conditions, HIVrelated medication use, hospitalizations,

and vital status; and (2) collecting blood

specimens for viral load testing,

lymphocyte immunophenotyping, and

storage for other HIV-related testing.

Applicants will use a common data

collection instrument, protocol, and

data management system designed and

implemented in collaboration with CDC.

Applications submitted by

organizations that examine additional

important HIV-related epidemiologic

research issues will also be accepted

and considered for funding.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, State and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes, or Indian

tribal organizations.

C. Availability of Funds

Approximately $4.5 million is

available in FY 1998 to fund

approximately 6 awards. It is expected

that awards will range from $250,000 to

$1.5 million. It is expected that 4

projects addressing HIV infection in

children and 2 other HIV epidemiologic

studies will be funded. Awards will

begin on or about September 29, 1998,

and will be made for a 12-month budget

period, within a project period of up to

3 years. Funding estimates may change.

Funding Preferences

Preference will be given to competing

continuation applications from

satisfactorily performing projects over

applications for projects not already

receiving support under the program.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

listed under ‘‘Recipient Activities,’’

below, and CDC will be responsible for

conducting activities listed under ‘‘CDC

Activities’’, below:

Recipient Activities

Applicants addressing the same

research issue should be willing to

participate in collaborative studies with

other CDC-sponsored researchers,

including using common data collection

instruments, specimen collection

protocols, and data management

procedures, as determined in postaward grantee planning conferences.

Applicants will be required to pool data

for analysis and publication. Applicants

are also required to:

A. Develop the research study

protocol and data collection forms.

B. Identify, recruit, obtain informed

consent from, and enroll an adequate

number of study participants as

determined by the study protocol and

the program requirements.

C. Continue to follow study

participants as determined by the study

protocol.

D. Establish procedures to maintain

the rights and confidentiality of all

study participants.

E. Perform laboratory tests (when

appropriate) and data analysis as

determined in the study protocol.
35590 Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 / Notices

F. Collaborate and share data and

specimens (when appropriate) with

other collaborators to answer specific

research questions.

G. Conduct data analysis with all

collaborators as well as present and

publish research findings.

CDC Activities

A. Provide technical assistance in the

design and conduct of the research.

B. Provide technical guidance in the

development of study protocols, consent

forms, and data collection forms.

C. Assist in designing a data

management system.

D. Assist in performance of selected

laboratory tests.

E. Coordinate research activities

among the different sites.

F. Assist in the analysis of research

information and the presentation and

publication of research findings.

E. Application Content

Competing Applications (New

Applications and Competing

Continuation Applications)

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan.

Applicants should identify their

proposed research issue on line one of

the face page of the application form.

Applicants must demonstrate adequate

capacity for continued follow-up of

children, routine virologic and

immunologic testing, data management,

and specimen storage. Applicants also

must demonstrate the capacity to

analyze data and specimens collected in

the PACTS project to address important

issues related to preventing HIV

infection and its manifestations in

children, and provide proposed

analyses to be completed during the

project period.

In future years, noncompeting

continuation applications submitted

within the approved project period

should include:

A. brief progress report describing the

accomplishments of the preceding

budget period;

B. new or significantly revised items

or information (objectives, scope of

activities, operational methods,

evaluation), that is, not in the initial

application; and

C. annual budget and justification

(budget items that are unchanged from

the preceding budget period do not need

rejustification, simply list the items in

the budget and note that they are

continuation items).

F. Submission and Deadline

On or before JULY 31, 1998, submit

the original and five copies of PHS–398

(OMB Number 0925–0001) (adhere to

the instructions on the Errata

Instruction Sheet for PHS 398) to: Kevin

Moore, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office,

Announcement 98035, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, N.E., Room

300, Mail Stop E–15, Atlanta, Georgia

30305–2209.

Applications must be postmarked by

the U.S. Postal Service or a commercial

carrier by the deadline date. If your

application does not arrive in time for

submission to the independent review

panel, it will not be considered in the

current competition unless you can

provide proof that you mailed it on or

before the deadline (i.e., receipt from

U.S. Postal Service or a commercial

carrier; private metered postmarks are

not acceptable).

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent reviewer

group appointed by CDC. Applicants

will be ranked on a scale of 100

maximum points according to the

research area identified. All applicants

must state which research category they

are addressing. Applicants should

demonstrate the applicant’s ability to

address the research problem in a

collaborative manner with other

collaborators. Applications will be

reviewed and evaluated based on the

evidence submitted.

HIV Infection in Children

A. Recruitment, Retention, and

Adherence to Study Protocol (20 Points)

(1) Extent of applicant’s experience in

perinatal and pediatric HIV infection

epidemiologic research.

(2) Evidence of ability to successfully

follow HIV-infected children in

longitudinal research studies.

(3) Evidence of ability to collect

complete data from HIV-infected

children.

B. Description and Justification of

Research Plans (30 Points)

(1) Extent of familiarity and quality of

experience pertinent to proposed

research activities.

(2) Understanding of the research

objectives as evidenced by high quality

of the proposed plan for research and a

study design that is appropriate to

answer research questions.

(3) Originality of research, extent to

which it does not replicate past or

present research efforts, and direct

relevance of research to guiding current

efforts to prevent perinatal HIV

transmission and HIV disease

progression in children.

(4) Feasibility of plans to follow study

participants, and adequacy of sample

size to address research questions. This

includes demonstration of the

experience of the investigator in

enrolling and following such persons,

and the comprehensiveness of the plan

to protect the rights and confidentiality

of all participants.

(5) Thoroughness of plans for data

management, data analysis, and

laboratory analysis; reasonableness of

data collected; and statistical rigor.

(6) Extent to which proposal

demonstrates feasible plans for

coordinating research activities of

multiple clinical sites, where

appropriate, and with CDC. Letters of

support from cooperating organizations

that demonstrate the nature and extent

of such cooperation should be included.

(7) The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes: (a)

The proposed plan for the inclusion of

both sexes and racial and ethnic

minority populations for appropriate

representation; (b) the proposed

justification when representation is

limited or absent; (c) a statement as to

whether the design of the study is

adequate to measure differences when

warranted; and (d) a statement as to

whether the plans for recruitment and

outreach for study participants include

the process of establishing partnerships

with community(ies) and recognition of

mutual benefits.

C. Research Capability (30 Points)

(1) Capacity to conduct study as

evidenced by quality of experience with

similar or related research as evidenced

by previous related research, including

demonstration of ability to collect,

manage, and analyze accurate data in a

timely manner.

(2) Demonstration of working

relationships with proposed

collaborators.

(3) Demonstration of epidemiologic,

behavioral, administrative, clinical,

laboratory, data management, and

statistical expertise needed to conduct

proposed research.
Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 / Notices 35591

D. Staffing, Facilities, and Time-line (20

Points)

(1) Availability of qualified personnel

with realistic and sufficient percentagetime commitments, and the clarity of

the descriptions of the duties and

responsibilities of project personnel.

(2) Adequacy of plans for project

oversight to assure quality of data.

(3) Adequacy of facilities, equipment,

data processing and analysis capacity,

and systems for management of data

security and participant confidentiality.

(4) Adequacy of time line for

completion of project activities.

E. Other (not Scored)

(1) Budget: Will be reviewed to

determine the extent to which it is

reasonable, clearly justified, consistent

with the intended use of funds, and

allowable. All budget categories should

be itemized.

(2) Human Subjects: Does the

application adequately address the

institutional review board requirements

for the protection of human subjects?

llll Yes llll No

Comments: lllllllllllllll

Other HIV/AIDS Epidemiologic

Research Studies

A. Familiarity With and Access to Study

Population (25 Points)

(3) Extent of applicant’s knowledge of

issues faced by study population and

experience in working with this

population.

(4) Existence of linkages to facilitate

recruitment from and referral to

programs providing services for the

study population and letters of support

from these programs.

(5) Feasibility of plans to involve the

study population, their advocates, or

service providers in the development of

research and intervention activities and

to inform them of research results.

(6) Evidence that plans for

recruitment of and outreach for study

participants will include establishing

partnerships with communities.

B. Description and Justification of a

Research Plan (40 Points)

(1) Quality of the review of the

scientific literature pertinent to the

proposed study, including theoretical

basis for research, and relevance of

research questions.

(2) The originality of research, the

extent to which it does not replicate

past or present research efforts

(including ongoing efforts not yet

described in publications), and

relevance to guiding current HIV

prevention efforts.

(3) Applicant’s understanding of the

research objectives as evidence by high

quality of the proposed research plan

with a study design that is appropriate

to answer research questions.

(4) Feasibility of plans to sample,

recruit, enroll, test, interview, and

follow study participants and adequacy

of sample size to address research

questions. This includes demonstration

of the availability of HIV-infected

potential study participants and persons

at risk for HIV infection and the

experience of the investigator in

enrolling and following such persons in

a culturally and linguistically

appropriate manner; the degree to

which the applicant has met the CDC

Policy requirements regarding the

inclusion of women, ethnic, and racial

groups in the proposed research,

including: (a) the proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation, (b) the

proposed justification when

representation is limited or absent, (c) a

statement as to whether the design of

the study is adequate to measure

differences when warranted, and (d) a

statement as to whether the plans for

recruitment and outreach for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits; comprehensiveness of

the plan to protect the rights and

confidentiality of all participants; and

proposed justification when

representation is limited or absent.

(5) Thoroughness of analysis plans,

reasonableness for data collected,

statistical rigor and complexity.

(6) Extent to which study proposal

demonstrates assurance of compliance

with multisite research requirements

(e.g., common protocol, data collection,

and computer and data management

systems), if appropriate.

C. Demonstrate Staff’s Capability to

Conduct Research (20 Points)

(1) Capacity to conduct study as

evidenced by experience with similar or

related research as evidenced by their

previous related research.

(2) Extent of the team’s productive

working relations with proposed

collaborators.

(3) Ability, willingness, and need to

collaborate with researchers from other

study sites in study design and analysis,

including use of common forms, and

sharing of specimens (when

appropriate) and data.

D. Staffing, Facilities, and Time-line (15

Points)

(1) Availability of qualified personnel

with realistic and sufficient percentagetime commitments; and the clarity of

the description of duties and

responsibilities of project personnel

with epidemiologic, behavioral,

administrative, clinical, laboratory, data

management, and statistical

responsibilities.

(2) Adequacy of the facilities,

equipment, data processing and analysis

capacity, and systems for management

of data security and participant

confidentiality.

(3) Adequacy of time line.

E. Other (not Scored)

(1) Budget: Will be reviewed to

determine the extent to which it is

reasonable, clearly justified, consistent

with the intended use of funds, and

allowable. All budget categories should

be itemized.

(2) Human Subjects: Does the

application adequately address the

institutional review board requirements

for the protection of human subjects?

llll Yes llll No

Comments: lllllllllllllll

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. Annual progress report;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial status report and

performance report, no more than 90

days after the end of the project period

send all reports to: Kevin Moore, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, N.E., Room 300, Mail

Stop E–15, Atlanta, GA 30305–2209.

For descriptions of the following

Other Requirements, see Attachment 1:

AR98–1 Human Subjects

AR98–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR98–4 HIV/AIDS Confidentiality

Provisions

AR98–5 HIV Program Review Panel

Requirements

AR98–6 Patient Care

AR98–7 Executive Order 12372

Review

AR98–8 Public Health System

Reporting Requirements

AR98–9 Paperwork Reduction Act

AR98–10 Smoke-Free Workplace

Requirements
35592 Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 / Notices

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under the

Public Health Service Act, Sections

301(a) and 317(k)(2) [42 U.S.C. 241(a)

and 247b(k) (2)], as amended. The

Catalog of Federal Domestic Assistance

number is 93.943.

J. Where To Obtain Additional

Information

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and to

identify the Announcement number,

98035. If you have questions after

reviewing the contents of all the

documents, business management

technical assistance may be obtained

from: Kevin Moore, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 98035, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, N.E., Room

300, Mail Stop E–15, Atlanta, GA

30305–2209, Telephone (404) 842–6550,

E-mail kgm1@cdc.gov.

See also the CDC Internet home page

at: www.cdc.gov

For program technical assistance,

contact: Jeff Efird, Acting Chief,

Epidemiology Branch, Division of HIV/

AIDS Prevention Surveillance &

Epidemiology, National Center for HIV,

STD, TB Prevention Centers for Disease

Control and Prevention (CDC) 1600

Clifton Road, NE., Mail Stop E–45,

Atlanta, Georgia 30333, Telephone (404)

639–6130, E-mail jle1@cdc.gov.

Eligible applicants are encouraged to

call before developing and submitting

their applications.

Dated: June 23, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–17305 Filed 6–29–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

National Institute for Occupational

Safety and Health

[Program Announcement 98096]

Economic Evaluation of Engineering

Control Interventions for Drywall

Sanding Construction Activities;

Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds for a cooperative agreement

program to conduct an economic

evaluation and variable analyses of

engineering control interventions during

drywall sanding construction activities.

This program addresses the ‘‘Healthy

People 2000’’ priority area of

Occupational Safety and Health.

The purpose of the program is to

identify the financial and behavior

factors which are affected by

implementing drywall sanding

engineering controls. These factors may

occur throughout the constructionmodel hierarchy from the individual

worker on up to the building owner. A

successful project will serve as an

example throughout the construction

industry that the cost and benefits of

providing a clean and safe working

environment should be evaluated from

the big-picture perspective as opposed

to the level of acquisition. Such an

example could lead to new

implementation strategies to increase

the use of engineering controls and

ultimately improve the construction

work environment.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit and forprofit organizations and by governments

and their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit and

for-profit organizations, State and local

governments or their bona fide agents.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $95,000 is available in

FY 1998 to fund one award. It is

expected that the award will be renewed

on an annual basis for an additional two

years at an approximate amount of

$95,000 per year. It is expected that the

awards will begin on or about

September 1, 1998, with 12-month

budget periods within project periods of

up to three years. The funding estimate

is subject to change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Use of Funds: The applicant should

allocate funds for at least one annual

CDC/NIOSH directed meeting.

Programmatic Interest: The applicant

should address the availability of

drywall sanding dust exposure

reduction interventions and the

economic impact and related variable

analyses of some or all of the identified

interventions upon the various

organizational layers (e.g. worker,

subcontractor, general contractor,

building owner) within the building

construction process.

D. Program Agreement Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for activities under

A. (Recipient Activities), and CDC/

NIOSH will be responsible for the

activities listed under B. (CDC/NIOSH

Activities).

A. Recipient Activities

1. Develop, implement, and evaluate

a study protocol.

2. Provide statistical analysis of the

data.

3. Disseminate study results to the

construction safety and health

community.

4. Collaborate with CDC/NIOSH on

these activities and the activities listed

below.

B. CDC/NIOSH Activities

1. Providing scientific and technical

collaboration including study design

and protocol development, and data

analysis.

2. Monitor and evaluate scientific and

operational accomplishments of the

project through site visits, telephone

calls, and review of technical reports

and interim data analysis.

3. Collaborate with awardee(s) on data

analysis, and interpretation of findings.

4. Review the results of the study and

collaborate, where appropriate, in the

preparation and publication of results in

peer-reviewed journals and construction

industry trade publications.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and