Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices 35231

Florida, and thereby indirectly acquire

Citizens Bank of Marianna, Marianna,

Florida, and Gladsen State Bank,

Chattahoochee, Florida.

B. Federal Reserve Bank of Chicago

(Philip Jackson, Applications Officer)

230 South LaSalle Street, Chicago,

Illinois 60690-1413:

1. Pilot Grove Savings Bank Employee

Stock Ownership Plan, Pilot Grove,

Iowa; to acquire 1.82 percent of the

voting shares of Pilot Bancorp, Inc.,

Pilot Grove, Iowa, and thereby

indirectly acquire Pilot Grove Savings

Bank, Pilot Grove, Iowa.

Board of Governors of the Federal Reserve

System, June 24, 1998.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 98–17252 Filed 6-26-98; 8:45 am]

BILLING CODE 6210-01-F

FEDERAL RESERVE SYSTEM

Formations of, Acquisitions by, and

Mergers of Bank Holding Companies;

Correction

This notice corrects a notice (FR Doc.

98-13790) published on pages 28385-

28386 of the issue for Friday, May 22,

1998.

Under the Federal Reserve Bank of

Richmond heading, the entry for

NationsBank Corporation and

NationsBank (DE) Corporation, both in

Charlotte, North Carolina (collectively

NationsBank), is revised to read as

follows:

A. Federal Reserve Bank of

Richmond (A. Linwood Gill III,

Assistant Vice President) 701 East Byrd

Street, Richmond, Virginia 23261-4528:

1. NationsBank Corporation and

NationsBank (DE) Corporation, both in

Charlotte, North Carolina (collectively,

NationsBank); to merge with

BankAmerica Corporation, San

Francisco, California (BankAmerica),

and thereby acquire the following bank

subsidiaries of BankAmerica: Bank of

America National Trust and Savings

Association, San Francisco, California;

Bank of America Texas, National

Association, Dallas, Texas; Bank of

America National Association, Phoenix,

Arizona; and Bank of America

Community Development Bank, Walnut

Creek, California. On consummation of

the proposed transaction, NationsBank

would be renamed BankAmerica

Corporation. NationsBank may form one

or more intermediate bank holding

companies.

In connection with the proposed

transaction, NationsBank has provided

notice to acquire all of the nonbank

subsidiaries of BankAmerica and to

engage, directly or indirectly through

such nonbank subsidiaries, in a variety

of nonbanking activities that previously

have been determined to be permissible

for bank holding companies.

NationsBank also would continue to

control all of its existing bank and

nonbank subsidiaries.

The comment period on this

application has been extended.

Comments on this application must be

received by July 9, 1998.

Board of Governors of the Federal Reserve

System, June 24, 1998.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 98–17253 Filed 6-26-98; 8:45 am]

BILLING CODE 6210-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 98086]

Translational Research Centers for

Diabetes Control Within Managed-Care

Settings; Availability of Funds for

Fiscal Year 1998

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds, and invites cooperative

agreement applications for a multicenter, collaborative, diabetes

translational research initiative within

managed-care settings to (1) evaluate the

extent to which healthcare providers

and healthcare delivery systems

implement accepted standards of

diabetes care (e.g., American Diabetes

Association), which can reduce the

burden of diabetes and its

complications; (2) explore the factors

that affect variations in implementing

quality diabetes care; and (3) develop

and test strategies aimed at closing the

gap between existing practice and

optimal standards of care.

The collaborative studies will consist

of two phases. Phase 1 (12 months)—

Planning, collaborative development of

the protocol(s), and development of the

manual of operations. Phase 2 (48

months)—Conduct of studies selected

by the Steering Committee, analysis,

and reporting of the results.

Under a Request for Contract, FY 1998

funds will be made available to fund

one Data Coordinating Center (DCC).

The organization funded for the DCC

will not be eligible to receive funds

under this Program Announcement. The

DCC will collaborate with the recipients

under this announcement in the design

and writing of the study protocol(s) and

consent forms, creation of the data

collection forms, and writing of the

manual(s) of operations. In addition, it

will assist with the development of the

operational plans, develop a system to

collect, manage, and store scientific

data, management and analysis, and

collaborate with the Translational

Research Centers in reporting of results.

CDC is committed to achieving the

health promotion and disease

prevention objectives of Healthy People

2000, a national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of Diabetes

and Chronic Disabling Conditions. (For

ordering a copy of Healthy People 2000,

see the section Where to Obtain

Additional Information.)

Authority

This program is authorized under

sections 301(a) and 317(k)(2) of the

Public Health Service Act, as amended

(42 U.S.C. 241(a) and 247b (k)(2)).

Applicable program regulations are

found in 42 CFR Part 51b—Project

Grants for Preventive Health Services.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Pub. L.

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, child care, health

care, and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants are public and

private nonprofit domestic

organizations operating within

managed-care settings and providing

services to a minimum of 5,000 people

with diabetes. Thus, managed-care

organizations, teaching hospitals,

universities, colleges, and research

institutions are eligible to apply.

Applicants claiming nonprofit status

must include evidence of nonprofit

status with their application.

Minority individuals and women are

encouraged to apply as Principal

Investigators. Institutions caring for

large numbers of racial and ethnic

minority groups with diabetes are

especially encouraged to apply.

Funding Preference: A funding

preference will be given to applications

under the following conditions: Women,

racial, and ethnic minority populations

to be accessed by the applicant—to

ensure that the selected Diabetes
35232 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices

Translational Research Centers will

together have a good balance of racial

and ethnic minority groups.

Applicants must have direct access to

a population of at least 5,000 people

with diabetes or access through a

partnership, operating within a

managed-care setting.

Institutions may apply as a single

entity or in a collaborative partnership.

In this regard, applicants are encouraged

to form collaborative arrangements with

investigators at minority institutions or

minority investigators at other

institutions. However, only one

institution will be named as the

recipient of grant funds in a partnership.

The expertise appropriate for the

Translational Research Center

applications includes a knowledge of

the clinical, epidemiological, and health

services research aspects of diabetes. All

eligible applicants must have diabetesrelated research capacity within a

managed-care setting, i.e., access to

large numbers of patients with diabetes

(minimum of 5,000); strong multi

disciplinary research groups, access to

good data systems, access to academic

skills in health services research,

epidemiology, survey design, behavioral

sciences, and health economics.

Eligibility characteristics must be

clearly specified with appropriate

documentation in the Application

Requirements section of your

application (see Application Content).

Note: Effective January 1, 1996, Pub. L.

104–65 states that an organization described

in section 501(c)(4) of the Internal Revenue

Code of 1986 which engages in Lobbying

activities shall not be eligible for the receipt

of Federal funds constituting an award, grant

(cooperative agreement), contract, loan, or

any other form.

Availability of Funds

Approximately $800,000 is available

in FY 1998 to fund up to four

Translational Research Centers. It is

expected that the average award during

the planning phase (Year 1) of this

project will be $200,000 (including

direct and indirect costs), ranging from

$150,000 to $250,000. However, it is

anticipated that additional funds may be

available in FY 1999 to increase the

average award for Year 01 to

approximately $500,000, ranging from

$300,000 to $700,000.

Please plan your project in

anticipation of these additional funds. It

is expected that awards will begin on or

before September 30, 1998, and will be

made for a 12-month budget period

within a project period of up to 5 years.

Funding estimates may vary and are

subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds. At this time, CDC

anticipates that there will not be a

renewed competition after five years.

Use of Funds

Allowable Uses: Funds are awarded

for a specifically defined purpose and

must be targeted for implementation

and management of the project. Funds

can support personnel, services directly

related to the project, and the purchase

of hardware and software for data

collection, analysis, and project

management and evaluation purposes.

Prohibited Uses: Cooperative

agreement funds under this program

announcement cannot be used for (1)

construction, (2) renovation, (3) the

purchase or lease of passenger vehicles

or vans, (4) to supplant non-federal

funds that would otherwise be made

available for this purpose, or (5) cost of

regular patient care.

Restrictions on Lobbying: Applicants

should be aware of restrictions on the

use of Health and Human Services

(HHS) funds for lobbying of Federal or

State legislative bodies. Under the

provisions of 31 U.S.C. Section 1352

(which has been in effect since

December 23, 1989), recipients (and

their subtier contractors) are prohibited

from using appropriated Federal funds

(other than profits from a Federal

contract) for lobbying Congress or any

Federal agency in connection with the

award of a particular contract, grant,

cooperative agreement, or loan. This

includes grants and cooperative

agreements that, in whole or in part,

involve conferences for which Federal

funds cannot be used directly or

indirectly to encourage participants to

lobby or to instruct participants on how

to lobby.

In addition, the FY 1998 Department

of Labor, Health and Human Services,

and Education, and Related Agencies

Appropriations Act, (Pub. L. 105–78)

states in section 503(a) and (b) that no

part of any appropriation contained in

this Act shall be used, other than for

normal and recognized executivelegislative relations, for publicity or

propaganda purposes, for the

preparation, distribution, or use of any

kit, pamphlet, booklet, publication,

radio, television, or video presentation

designed to support or defeat legislation

pending before the Congress or any

State legislature, except in presentation

to the Congress or any State legislature

itself. No part of any appropriation

contained in this Act shall be used to

pay the salary or expenses of any grant

or contract recipient, or agency acting

for such recipient, related to any activity

designed to influence legislation or

appropriations pending before Congress

or any State legislature.

Background

A considerable body of evidence

exists for the efficacy of interventions

(e.g., glycemic control, cardiovascular

disease (CVD) risks reduction, screening

for diabetes complications) to reduce

the avoidable burden of diabetes.

Nevertheless, the effectiveness,

generalizability, feasibility, and

sustainability of several of these

interventions in real-life settings are less

than clear. Furthermore, several reports

suggest that considerable gaps exist

between existing practice and

recommended standards of diabetes care

for people with diabetes. For example,

the American Diabetes Association has

recommended standards of care for

several aspects of diabetes management

(American Diabetes Association,

Clinical Practice Recommendations

1998, Diabetes Care 1998;21 (Suppl.1).

However, national estimates from the

Behavioral Risk Factor Surveillance

System indicate that the population of

Americans receiving appropriate

diabetes care practices such as foot and

eye examinations, glycosylated

hemoglobin, and other preventive care

evaluations fall short of the

recommended standards.

Managed care represents a revolution

in the way health care is funded,

organized, and delivered in the United

States, and has affected the way in

which diabetes treatment and control

are conducted in both the private and

public sectors. In the public sector,

many health departments are in some

stage of transition from directly

delivering clinical services to using

other delivery models that involve

managed care. Thus, managed-care

providers play a key role in the way

people with diabetes are diagnosed and

managed for increasing numbers of

Americans. With more diagnostic and

treatment services for diabetes being

conducted in managed care, new

partnerships are needed between

managed-care health plans and public

health agencies to design and

implement essential and innovative

diabetes-related services. Furthermore,

managed-care (by virtue of coordinating

all care for persons with diabetes) is

probably the closest approximation to

population medicine currently available

in the United States. Managed-care,

therefore, offers significant

opportunities to understand and test

intervention effectiveness and costeffectiveness within a real-life context,
Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices 35233

as well as the public health impact of

system wide interventions.

Purpose

The purpose of this diabetes

translational research initiative is to

initiate a multicenter, collaborative

program of applied population-based

research related to diabetes, and to

develop a knowledge base through

published research in scientific

literature and handbooks for

professional associations that will

improve the process, delivery, and

outcome of diabetes services within

managed-care settings. The knowledge

base to be developed will address

methods for and assessment of

effectiveness, cost-effectiveness,

generalizability, feasibility, and

sustainability of interventions. Such a

knowledge base may include a variety of

activities covering the range of diabetes

interventions, including diabetes

screening and diagnosis; treatment

approaches, glycemic control, CVD risk

reduction, and screening for diabetes

complications.

This program will improve the

availability, accessibility, quality of

process, effectiveness, costeffectiveness, and health outcomes of

diabetes-related services provided by

managed-care health plans. The benefit

of this program will be the

establishment of new partnerships and

relationships among managed-care

health plans and between managed-care

health plans and public health agencies.

Thus, the challenges of improving

diabetes control services may be

collaboratively assessed in a manner to

have a national public health impact.

The other goals of this program will

include provision of data for policy

development, assessment, and capacitybuilding at the State and local levels

with respect to managed care and the

CDC Diabetes Control Program’s ability

to develop appropriate diabetes control

policies and to conduct diabetes

surveillance in a changing health

environment.

Program Requirements

Work performed under this

cooperative agreement will be the result

of collaborative efforts among the

funded Translational Research Centers

and the Data Coordinating Center.

Recipients will be responsible for

implementing research methods and

study design, analysis, use of data, and

dissemination of results via peerreviewed scientific publications or other

related material.

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A., below, and CDC will be

responsible for carrying out the

activities described under B., below.

A. Recipient Activities

1. Participate in the protocol

development, data collection, quality

control, final data analysis and

interpretation, the preparation of

publications, and presentation of

findings.

2. Establish a Steering Committee that

will be the primary governing body of

the study and will be comprised of each

of the Principal Investigators from the

Translational Research Centers and the

Data Coordinating Center. The Steering

Committee will have primary

responsibility for developing common

study protocols, facilitating the conduct

and monitoring of the studies, and

reporting the study results.

3. Work cooperatively with the other

Translational Centers, the Data

Coordinating Center, and agree to follow

the common protocol(s) and manual(s)

of operations developed in Phase 1 of

the study by the Steering Committee.

4. Transmit all relevant study data to

a central Data Coordinating Center for

data editing, formatting, combination,

and primary analysis.

5. Collaborate with other health

organizations, community groups, etc.,

as necessary to accomplish program

activities.

6. Maintain an effective and adequate

management and staffing plan. The

success of the program will depend on

recruiting and hiring staff in a timely

manner. Staff should have the

education, background, and experience

to successfully conduct the activities

proposed in this application.

B. CDC Activities

1. Support and stimulate the

recipients’ activities by collaborating

and providing scientific and public

health consultation and assistance in

the development of activities related to

the cooperative agreement. Consistent

with this concept, the tasks and

activities in carrying out the studies will

be shared among the recipients and the

CDC.

2. Establish a Data Coordinating

Center that will serve as a resource for

standardized assessment, analysis,

reporting, and that will assist in the

design and writing of study protocol(s)

in collaboration with the Research

Centers.

3. Assist in the coordination of

activities between the Diabetes

Translational Research Centers and the

Data Coordinating Center.

4. Facilitate communication among

recipients and assist in quality control,

interim data monitoring, final data

analysis and interpretation, and

coordination and performance

monitoring.

5. Serve as a consultant to the

Steering Committee.

Technical Reporting Requirements

An original and two copies of the

following reports must be submitted to

the Grants Management Branch, CDC.

A. Semiannual progress reports are

required of all cooperative agreement

recipients. The first semiannual report

is required with each year’s

noncompeting continuation application

and should cover program activities

from date of the previous report (or date

of award for reporting in the first year

of the project). The second semiannual

report is due 30 days after the end of

each budget period and should cover

activities from the date of the previous

report. Progress reports should address

the status of all recipient activities

above, including:

1. A comparison of actual

accomplishments to the objectives

established for the period.

2. The reasons for slippage if

established goals were not met.

3. Other pertinent information

essential to evaluating progress.

4. Data pertaining to various project

activities.

B. A financial status report (FSR) is

required no later than 90 days after the

end of each budget period. The final

financial status report is required no

later than 90 days after the end of the

project period. Please submit the

original and two (2) copies of all reports

to the Grants Management Branch, CDC.

Notification of Intent To Apply

(Preapplication Letter)

To assist CDC in planning and

executing the evaluation of applications

submitted under this Program

Announcement (98086), a nonbinding

letter of intent-to-apply is requested

from potential applicants. Although not

a prerequisite of the application, the

letter should be submitted to Bernice A.

Moore, Epidemiology and Statistics

Branch, Division of Diabetes

Translation, National Center for Chronic

Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention (CDC), Mailstop K–10,

4770 Buford Highway NE., Atlanta, GA

30341–3717, telephone (770) 488–5855;

fax (770) 488–5966; or Internet or CDC

WONDER E-mail at bamo@cdc.gov. It

should be postmarked no later than one

month before the planned submission

deadline (due not later than July 15,

1998. The letter should identify the

Program Announcement number, the
35234 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices

name and address of the applicant’s

institution, and telephone number of a

contact person. The letter of intent does

not influence review or funding

decisions, but it will enable CDC to plan

the review more efficiently.

Application Content

It is anticipated that applications for

Diabetes Translational Research Centers

within this initiative will focus on

important aspects of the process and

outcome of care for people with

diabetes. Process of care may include

diabetes screening and diagnosis;

treatment approaches; glycemic control;

cardiovascular disease (CVD) risks

reduction; screening for diabetes

complications; and outcome of care may

include quality of life and avoidable

morbidity and death among people with

diabetes. In addition, the extent and

causes of variation in implementation of

accepted standards of diabetes care may

be explored at three levels—individuals,

healthcare providers, and health care

delivery systems. Emphasis should be

on identifying important and potentially

modifiable factors that contribute to the

failure to use recommended standards

of diabetes care, and on designing and

testing (using rigorous scientific

approaches) cost-effective strategies

aimed at achieving optimal care.

Furthermore, in keeping with the

philosophy of Translational Research,

designs should emphasize intervention

effectiveness which span diverse

populations and a variety of healthcare

approaches (e.g., type of managed care),

leading to findings with high

generalizability. Thus, good

translational research will require

multicenter participation and represent

populations of diverse age, ethnicity,

socioeconomic status, and severity of

diabetes. Furthermore, strategies aimed

at achieving optimal diabetes care

should aim for generalizability,

sustainability and cost-effectiveness.

Each applicant must propose the

research questions and study designs

that best address the objectives of this

initiative and are most appropriate for

their patient population. The outcome

of this initiative should result in the

following questions:

1. What are the current levels of care

provided to people with diabetes, and

how does it compare with the

recommended standards of diabetes care

(e.g., American Diabetes Association)?

2. What is the health-related quality of

life for people with diabetes and what

factors influence patient satisfaction and

quality of life?

3. What are the major factors that

influence the process, delivery,

effectiveness, costs, and sustainability of

interventions aimed at glycemic control,

and conventional CVD risk factor

(elevated blood pressure, dyslipidemia,

smoking, overweight, physical

inactivity) reduction among people with

diabetes?

4. What are the major factors that

influence the process, delivery,

effectiveness, costs, and sustainability of

interventions aimed at the early

detection of microvascular

complications of diabetes (e.g.,

retinopathy, nephropathy)?

Collaborative protocols to study the

above questions will be developed by a

Steering Committee composed of the

recipients and the Principal Investigator

of a Data Coordinating Center selected

under a separate Request for Contract.

The collaborative study protocol(s) will

move into the implementation stage

with the concurrence of the Steering

Committee.

It is not the intent of this Program

Announcement to solicit elaborately

detailed research plans for the above

proposed collaborative studies because

the final protocols will be

collaboratively developed by the

investigators during the planning phase

(Phase 1).

Specific Instructions

All applicants must develop their

applications in accordance with PHS

Form 5161–1 (Revised 5/96),

information contained in this Program

Announcement, and the format and

page limitations that follow. Provide a

clear and succinct description and

supportive references regarding how

each of the statements apply in your

application:

1. Experience in one or more of the

following areas: Health economics

research, health services research,

epidemiological research, or health

information systems research.

2. Employs or can engage

investigators in the fields of economics,

health services research, or information

systems research who have direct

experience at establishing, working

with, and researching diabetes-related

topics, and with a corresponding record

of substantial publication in the peerreviewed scientific literature.

3. Ability and willingness to designate

one experienced and published

investigator as the project’s principal

investigator.

4. The principal investigator for this

project has access to a population of at

least 5,000 people with diabetes who are

cared for within a managed-care setting,

and has access to research infrastructure

and to basic data necessary to carry out

this project.

5. Describe the composition of the

proposed study population (for

example, addressing the inclusion of

women and members of minority groups

and their subpopulations in the section

that will describe the research design).

A copy of the CDC policy on Women,

Racial and Ethnic Minorities is enclosed

with the application kit for guidance.

6. Nonprofit organizations must

document their status on application

PHS Form 5161–1 (Revised 5/96), Part

D of the Checklist.

Responses to the above may follow

the Table of Contents in your

application, but must appear as the first

page(s) of the text of your application

and be titled, Application

Requirements. Eligibility characteristics

must be clearly specified with

appropriate documentation in the

Application Requirements section of

your application.

The application narrative must

include the following sections in the

order presented below:

A. Rationale for the research

question(s) chosen to be addressed (not

to exceed 1 page):

Describe the research question(s)

chosen to be addressed and the rationale

for this selection. Include an

explanation of why this question is a

priority for the investigator(s) and what

types of interest, experience, or

expertise the investigator(s) brings to the

particular problem inherent in the

chosen research question(s).

The extent to which the rationale for

the chosen research question (1) is

based on public health importance, (2)

is based on the experience and expertise

of the investigator(s), and (3) clearly

communicates the anticipated value to

the purpose of the Diabetes

Translational Research Initiative.

B. Objectives of the research (not to

exceed 4 pages):

Itemize the objectives and timelines of

the research in relation to the chosen

research question(s), and describe: (1)

The extent to which the objectives of the

chosen research question(s) are

numerically measurable, specific,

realistic, time-phased, and suitable for

development into a collaborative,

multicenter study protocol; the extent to

which applicant presents a detailed

operational plan for initiating and

conducting the project that clearly and

appropriately addresses all Recipient

Activities; (2) the extent to which the

applicant clearly identifies specific

assigned responsibilities and time

commitment of all key professional

personnel; (3) the extent to which the

plan clearly describes applicant’s

technical approach and methods for

conducting the proposed studies and
Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices 35235

extent to which the approach and

methods are appropriate and adequate

to accomplish the objectives; (4) the

extent to which applicant describes

collaboration with CDC and others

during the various phases of the project

and shows commitment to a

multicenter, collaborative approach.

C. Design of the research (not to

exceed 3 pages):

The extent to which the proposed

methodology of the research is

scientifically sound, realistic, appears

likely to answer the chosen research

question(s), and will produce

generalizable findings; and, if

appropriate, the degree to which the

applicant has included women, racial

and ethnic minority populations in the

proposed research to include:

1. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representations.

2. The proposed justification when

representation is limited or absent.

3. A statement whether the design of

the study is adequate to measure

differences when warranted.

4. A statement whether the plans for

recruitment and outreach for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits.

D. Background and experience of the

principal investigator, coinvestigators,

and the applying institution,

organization, or agency (not to exceed 3

pages):

Describe the educational and

professional background of the principal

investigator, and document the relevant

experience of the principal investigator

and qualifications of the applying

institution, organization, or agency for

carrying out health economics, health

services, or information systems

research. Specifically, emphasize the

experience of the principal investigator

in participating in collaborative,

multicenter research projects, and

describe the data sources that are

available to the investigator. Describe

the population and number of people

with diabetes within the managed-care

health plan, and provide details of the

managed-care structure, organization,

financing, and percentage of the

Medicaid population under contract.

Provide a brief description of how the

project will be organized, and indicate

the proposed staffing plan.

E. Access to a large number of people

with diabetes (≤5000) cared for within

managed care (not to exceed 2 pages):

Describe the extent to which (1) the

population used in carrying out this

research project is sufficiently typical of

people with diabetes around the country

or accurately represents special groups

of people with the disease—so that a

solution to the collaborative research

question(s) will have the broadest

possible application; (2) the principal

investigators have sufficient access to

well developed data sources and ability

to use it for the purposes of carrying out

this research project; and (3) if

applicable, attach evidence of

collaboration specifying the

commitment of the parties involved and

provide details, including the terms of

access to data and to populations and

any specified limits to collaboration for

the purposes of this project.

F. Budget and budget justification (not

to exceed 5 pages):

Provide a detailed, line-item budget

with justification that demonstrates the

request is consistent with the purpose

and objectives of this program. The

budget for Phase I of the study should

be clearly delineated. Budgets should

allow for approximately three persons,

including the Principal Investigator, to

attend Steering Committee and

Subcommittee meetings. The detailed

budget for Phase I should be estimated

on the basis of monthly meetings during

Phase 1.

G. Human Subjects:

Whether or not exempt from DHHS

regulations, if the proposed project

involves human subjects, describe (in an

appendix) adequate procedures for the

protection of human subjects. Also,

ensure that women, and racial and

ethnic minority populations are

appropriately represented in

applications for research involving

human subjects.

Typing and Mailing

All pages must be clearly numbered

and a complete index to the application

and its appendixes must be included.

Do not bind, staple, or paper clip any

pages of any copy of the application,

including appendixes. Do not include

any bound documents (e.g., pamphlets

or other publications) in the

appendixes. Do not include cardboard,

plastic, or other page separators between

the sections. The entire application

must be typewritten, single-spaced, and

in unreduced type (12-point fonts) on

81⁄2′′ by 11′′ white paper, with at least

1′′ margins, including headers and

footers, and printed on one side only.

Evaluation Criteria (Total 100 Points)

Applications will be reviewed and

evaluated according to the following

criteria:

A. Rationale for the Research

Question(s) Chosen to be Addressed (15

points)

Describe the research question(s)

chosen to be addressed and the rationale

for this selection. Included in this

should be an explanation of why this

question is a priority for the

investigator(s) and what types of

interest, experience, or expertise the

investigator(s) brings to the particular

problem inherent in the chosen research

question(s).

The extent to which the rationale for

the chosen research question (1) is

based on public health importance, (2)

is based on the experience and expertise

of the investigator(s), and (3) clearly

communicates the anticipated value to

the purpose of the Diabetes

Translational Research Initiative.

B. Objectives of the Research (20

points).

(1) The extent to which the objectives

of the chosen research question(s) are

numerically measurable, specific,

realistic, and time-phased, and suitable

for development into a collaborative,

multicenter study protocol. The extent

to which the applicant presents a

detailed operational plan for initiating

and conducting the project that clearly

and appropriately addresses all

Recipient Activities; (2) the extent to

which the applicant clearly identifies

specific assigned responsibilities and

time commitment of all key professional

personnel; (3) the extent to which the

plan clearly describes applicant’s

technical approach and methods for

conducting the proposed studies and

the extent to which the approach and

methods are appropriate and adequate

to accomplish the objectives; and (4) the

extent to which applicant describes

collaboration with other translation

centers during the various phases of the

project, and shows commitment to a

multicenter, collaborative approach.

C. Design of the Research (20 points).

The extent to which the proposed

methodology of the research is

scientifically sound, realistic, appears

likely to answer the chosen research

question(s), and will produce

generalizable findings; and, if

appropriate, the degree to which the

applicant has included women, racial

and ethnic minority populations in the

proposed research to include:

1. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representations.

2. The proposed justification when

representation is limited or absent.

3. A statement whether the design of

the study is adequate to measure

differences when warranted.

4. A statement whether the plans for

recruitment and outreach for study

participants include the process of
35236 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices

establishing partnerships with

community(ies) and recognition of

mutual benefits.

D. Background and Experience of the

Principal Investigator and of the

Applying Institution, Organization, or

Agency (20 points).

Describe the educational and

professional background of the principal

investigator, and document the relevant

experience of the principal investigator

and qualifications of the applying

institution, organization, or agency for

carrying out health economics, health

services, or information systems

research. Specifically, emphasize the

experience of the principal investigator

in participating in collaborative,

multicenter research projects, and

describe the data sources that are

available to the investigator. Describe

the population and number of people

with diabetes within the managed-care

health plan, and provide details of the

managed-care structure, organization,

financing, and percentage of Medicaid

population under contract. Provide a

brief description of how the project will

be organized and indicate the proposed

staffing plan.

E. Access to a large Number of people

with diabetes (≤5000) cared for within

managed care (25 points).

Describe the extent to which (1) the

population used in carrying out this

research project is sufficiently typical of

people with diabetes around the country

or accurately represents special groups

of people with the disease—so that a

solution to the collaborative research

question(s) will have the broadest

possible application; (2) the principal

investigator has sufficient access to well

developed data sources and ability to

use it for the purposes of carrying out

this research project; and (3) if

applicable, attach evidence of

collaboration specifying the

commitment of the parties involved and

provide, including the terms of access to

data and to populations any specified

limits to collaboration for the purposes

of this project.

F. Budget and Budget Justification

(Not Weighted).

The extent to which the budget is

reasonable and consistent with the

purpose and objectives of this program.

G. Human Subjects (Not Weighted).

If the proposed project involves

human subjects, whether or not exempt

from the Department of Health and

Human Services (DHSS) regulations, the

extent to which adequate procedures are

described for the protection of human

subjects. Note: Objective Review Panel

recommendations on the adequacy of

protections include: (1) Protections

appear adequate and there are no

comments to make or concerns to raise;

(2) protections appear inadequate and

the Review Panel has concerns related

to human subjects; (3) disapproval of

the application is recommended

because the research risks are

sufficiently serious and protection

against the risks are inadequate as to

make the entire application

unacceptable, and (4) protections appear

adequate that women, racial and ethnic

minority populations are appropriately

represented in applications involving

human research.

Content of Noncompeting Continuation

Applications

Submitted within the project period

need only include:

A. A brief progress report that

describes the accomplishments of the

previous semi-annual period. This

report will be in lieu of the semi-annual

progress report.

B. Any new or significantly revised

items or information (objectives, scope

of activities, operational methods,

evaluation, key personnel, work plans,

etc.) not included in year 01 or

subsequent continuation applications.

C. An annual budget and justification.

Existing budget items that are

unchanged from the previous budget

period do not need rejustification.

Simply list the items in the budget and

indicate that they are continuation

items.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372, which sets up a

system for State and local government

review of proposed Federal assistance

applications. Applicants should contact

their State Single Point of Contact

(SPOC) as early as possible to alert them

to the prospective applications and

receive any necessary instructions on

the State process. For proposed projects

serving more than one State, the

applicant is advised to contact the SPOC

for each affected State. The application

kit includes a current list of SPOCs. If

the SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them to Sharron P. Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), Mailstop

E–18, Room 305, 255 East Paces Ferry

Road, NE., Atlanta, GA 30305, no later

than 30 days after the application due

date (a waiver has been requested).

Please include the Program

Announcement Number and Program

Title on the letter. The granting agency

does not guarantee to ‘‘accommodate or

explain’’ for State or tribal process

recommendations it receives after that

date.

Public Health System Reporting

Requirement

This program is subject to the Public

Health System Reporting Requirements.

Under these requirements, all

community-based nongovernmental

applicants must prepare and submit the

items identified below to the head of the

appropriate State or local health

agency(s) in the program area(s) that

may be impacted by the proposed

project no later than the receipt date of

the Federal application. The appropriate

State or local health agency is

determined by the applicant. The

following information must be

provided:

A. A copy of the face page of the

application (SF 424).

B. A summary of the project that

should be titled ‘‘Public Health System

Impact Statement’’ (PHSIS), not to

exceed one page, and should include

the following:

1. A description of the population to

be served.

2. A summary of the services to be

provided.

3. A description of the coordination

plans with the appropriate State or local

health agencies.

If the State and/or local health official

desires a copy of the entire application,

it may be obtained from the State Single

Point of Contact (SPOC) or directly from

the applicant.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.988.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by this cooperative

agreement will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR part 46,

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review
Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices 35237

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit. Should human subjects

reviews be required, the proposed word

play should incorporate timelines for

such development and review activities.

Women, Racial, and Ethnic Minorities

Policy

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDCsupported research projects involving

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian or

Alaskan Native, Asian, Black or African

American, Native Hawaiian or Other

Pacific Islander, and Hispanic or Latino.

Applicants shall ensure that women and

racial and ethnic minority populations

are appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is not feasible, this situation must be

explained as part of the application. In

conducting the review of applications

for scientific merit, review groups will

evaluate proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity and/

or sex of subjects. Further guidance to

this policy is contained in the Federal

Register, Vol. 60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Confidentiality

Any personal identifying information

obtained in connection with the

delivery of services provided to any

individual under any program that is

being carried out with a cooperative

agreement made under this Program

Announcement shall not be disclosed

unless required by a law of a State or

political subdivision or unless such an

individual provides written, voluntary

informed consent.

Application Submission and Deadline

The application must be carefully

completed, following the directions

provided in this Program

Announcement. An original and two

copies of the application PHS Form

5161–1 (Revised 5/96) must be

submitted to Sharron P. Orum, Grants

Management Officer, Procurement and

Grants Office, Centers for Disease

Control and Prevention, (CDC), 255 East

Paces Ferry Road, NE., Mailstop E–18,

Atlanta, GA 30305–2209, on or before

August 14, 1998.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.a. and

1.b. above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where To Obtain Additional

Information

A complete program description and

information on application procedures

are contained in the application

package. Business management

technical assistance may be obtained

from Locke Thompson, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–18, Atlanta, GA 30305–

2209, telephone (404) 842–6595; fax

(404) 842–6513; or Internet or CDC

WONDER E-mail at <lxt1@.cdc.gov>.

Programmatic technical assistance may

be obtained from Bernice A. Moore,

Epidemiology and Statistics Branch,

Division of Diabetes Translation,

National Center for Chronic Disease

Prevention and Health Promotion,

Centers for Disease Control and

Prevention (CDC), Mailstop K–10, 4770

Buford Highway NE., Atlanta, GA

30341–3701, telephone (770) 488–5855;

fax (770) 488–5966; or Internet or CDC

WONDER E-mail at <bamo@cdc.gov>.

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 will

be instructed to identify the

Announcement number of interest.

Please refer to Announcement

Number 98086 when requesting

information and submitting an

application.

You may obtain this and other CDC

Announcements from one of two

Internet sites on the actual publication

date: CDC’s homepage at http://

www.cdc.gov or at the Government

Printing Office homepage (including

free on-line access to the Federal

Register at http://www.access.gpo.gov.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325; telephone

202–512–1800.

Dated: June 22, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–17202 Filed 6–26–98; 8:45 am]

BILLING CODE 4163–18–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

The National Center for Infectious

Diseases (NCID), Hepatitis Branch of

the Centers for Disease Control and

Prevention (CDC) Announces the

Following Meeting

Name: Consultants Meeting on the

Prevention and Control of Hepatitis C Virus

(HCV) Infection.

Times and Dates: 6 p.m.–9:30 p.m., July

15, 1998. 8 a.m.-5 p.m., July 16, 1998. 8 a.m.–

12 p.m., July 17, 1998.

Place: Atlanta Marriott Marquis Hotel, 265

Peachtree Center Avenue, Atlanta, Georgia

30303.

Status: Open to the public, limited only by

the space available. Registration is required.

Purpose: The purpose of this working

meeting is to review and discuss draft

recommendations that will serve as a

resource to individuals and organizations

involved in evaluating persons for HCV

infection, and are based on currently

available knowledge.

Matters To Be Discussed: Participants will

discuss recommendations for identifying

persons at risk for HCV infection and the

appropriate counseling and testing of these

persons. Participants will also discuss

recommendations to guide appropriate

medical referral of HCV infected persons.

The agenda will include an overview of HCV

public health strategies; and sessions on (a)

screening; (b) counseling and referral; and (c)

implementation.

The participants will include

representatives from public, private,

voluntary and non-governmental

organizations.

Agenda items are subject to change as

priorities dictate.

Written comments are welcome and should

be received by the contact person listed

below prior to the opening of the meeting.