Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24373

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Mine Safety and Health Research

Advisory Committee (MSHRAC):

Notice of Recharter

This gives notice under the Federal

Advisory Committee Act (Public Law

92–463) of October 6, 1972, that the

Mine Safety and Health Research

Advisory Committee, National Institute

for Occupational Safety and Health, of

the Department of Health and Human

Services, has been rechartered for a 2-

year period, through November 30,

2002.

For further information, contact Larry

Grayson, Ph.D., Executive Secretary,

MSHRAC, CDC, 200 Independence

Avenue, SW., Room 715–H, Humphrey

Building, Washington, DC 20201.

Telephone 202/401–2192, fax 202/260–

4464, e-mail lhg9@cdc.gov.

The Director, Management Analysis

and Services office has been delegated

the authority to sign Federal Register

notices pertaining to announcements of

meetings and other committee

management activities, for both the

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: May 8, 2001.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 01–12000 Filed 5–11–01; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01086]

Centers of Excellence for Autism and

Other Developmental Disabilities

Epidemiology; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for Centers of Excellence for

Autism and Other Developmental

Disabilities Epidemiology. This program

addresses the ‘‘Healthy People 2010’’

focus area Maternal, Infant, and Child

Health.

The purpose of the program is to

collect and analyze epidemiologic data

on the prevalence, correlates, and

causes of autism and other

developmental disabilities. The Centers

will be part of a collaborative network

investigating autism spectrum disorder

(ASD) and other developmental

disabilities. The Centers will conduct

active population-based surveillance;

multi-Center analytic case-control

studies; and Center-initiated special

studies (see Attachment II for

Background).

B. Eligible Applicants

Assistance will be provided only to

the Health Departments of States or

their bona fide agents, including the

District of Columbia, the

Commonwealth of Puerto Rico, the

Virgin Islands, the Commonwealth of

the Northern Mariana Islands, American

Samoa, Guam, federally recognized

Indian tribal governments, the

Federated States of Micronesia, the

Republic of the Marshall Islands, and

the Republic of Palau.

Competition is limited to State Health

Departments because they maintain

public health responsibility for these

health conditions, and their record

systems and expertise are essential to

program success. State agencies, or their

bona fide agents, applying under this

announcement, that are other than the

official State Health Department must

provide written concurrence on the

application from the official State

Health Department.

Only one application from each State

or Territory may be submitted.

Applicants must document a study

population of at least 30,000 live births

per year within a State, a contiguous

area of a State (such as the catchment of

a local health agency), or a contiguous

area comprised of a combination of

States.

Applicants who are unable to

document the minimum study

population size based on live birth data

from their State Health Department or

proxy data from the US Census Bureau

(based on 1999 Postcensal estimates)

will be determined ineligible. The

applicant should include this

information as part of the abstract. If it

is not included, then the application

will be determined as non-responsive

and returned without review.

C. Availability of Funds

Approximately $2,000,000 will be

available in FY 2001 to fund

approximately four awards. It is

expected that the average award will be

$500,000, ranging from $400,000 to

$700,000. It is expected that the awards

will begin on or about September 30,

2001, and will be made for a 12-month

budget period within a project period of

up to five years. Funding estimates may

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.

Funding Preferences

Priority consideration may be given to

the establishment of Centers of

Excellence in different geographic areas

of the United States, its Territories, and

Indian tribal governments to assure a

broad geographic representation insofar

as possible. This is based on legislative

intent as provided in the Children’s

Health Act of 2000. Additional priority

consideration may be given to the

selection of Centers of Excellence

which, as a group, provide for a diverse

racial and ethnic population.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), CDC will

be responsible for the activities listed

under 2. (CDC Activities). A

Coordinating Committee will be

established to coordinate cross-Center

activities as listed under 3.

(Collaborative Responsibilities).

1. Recipient Activities

A. Surveillance System

1. Develop or enhance a populationbased epidemiologic surveillance

system for ASD and other

developmental disabilities to generate

timely population-based data. Activities

may include, but not be limited to,

development or enhancement of

surveillance case definitions, multiple

source case ascertainment methods (e.g.,

from educational and medical sources),

and data collection instruments.

2. Establish or enhance a multiplesource methodology for case

ascertainment by developing

collaborative relationships with

appropriate professionals and

organizations.

3. Develop or enhance a plan for

training community service providers to

improve case ascertainment.

4. Implement or enhance quality

assurance procedures to ensure that

study protocols are followed.

5. Develop or enhance an evaluation

plan for estimating the validity and

completeness of the surveillance

system.

6. Develop, implement, and evaluate

a plan to use surveillance data to

24374 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

improve community and service

provider awareness of ASD and other

developmental disabilities and/or access

of children with ASD and other

developmental disabilities to

comprehensive, community-based,

family-centered care.

B. Collaborative Case-Control Study

Collaborate with other Centers funded

by this announcement to design,

implement, analyze, and evaluate joint

case-control studies based on a pooled

study data base (see 3., Collaborative

Responsibilities, below). The pooled

data will be used by Centers funded

under this announcement to address a

variety of epidemiologic research issues

related to ASD and other developmental

disabilities. It is anticipated that the

collaborative protocol would be

developed and initiated in the first year

of the grant award. Each Center will be

responsible independently for on-site

activities, such as selection and

enrollment of study subjects,

implementation of the joint study

protocol, quality assurance procedures,

data management, and timely

submission of computerized data to a

central repository for inclusion in a

pooled data set (see 3., Collaborative

Responsibilities, below).

C. Center-Initiated Special Studies

Develop, implement, and evaluate a

Center-initiated special study drawing

on special strengths and expertise of

Center staff. It is anticipated that

development of the special study would

be initiated in Year 2 of the grant award

and utilize the Center’s surveillance and

case-control study infrastructure. The

study could include, but may not be

limited to, the following issues related

to ASD or other developmental

disabilities:

1. Evaluation of pre-, peri-, and/or

postnatal risk factors, including genetic

factors and environmental exposures.

2. Evaluation of natural history,

including associated developmental

disabilities and secondary conditions.

3. Identification of biomarkers.

4. Evaluation of economic costs.

5. Development, implementation, and

evaluation of intervention programs for

children with ASD and their families.

D. Disseminate Findings of the

Surveillance, Collaborative Case

Control, and Center-Initiated Special

Studies Activities for the Professional

Community and the Public to Increase

Public Health Awareness

E. Coordinating Committee (CC)—

Participate Fully in the Establishment

and Operation of the CC, Comprised of

Principle Investigators of the Centers of

Excellence (see 3., Collaborative

Responsibilities, below)

2. CDC Activities

A. Surveillance Activities

1. Assist recipient, as requested, in

the development and implementation of

surveillance activities including the

development of standardized

surveillance case definitions.

2. Provide current information on

surveillance methods, as requested,

including the identification of potential

sources for surveillance.

3. Assist recipient, as requested, in

the development of quality assurance

procedures.

4. Provide assistance, as requested, in

the development of an evaluation plan

for the completeness and validity of

data from the surveillance system.

5. Facilitate communication/

coordination among Centers, as

requested, to improve efficiency of

activities and quality of surveillance

data.

6. Provide technical consultation

regarding data analyses as requested.

B. Collaborative Case-Control Studies

1. Assist recipients as requested in

developing a plan for on-site activities,

such as selection and enrollment of

study subjects, implementation of the

joint study protocol, quality assurance

procedures, data management, and

timely submission of computerized data

to a central repository for inclusion in

a pooled data set.

2. Obtain Center for Disease Control

Institutional Review Board clearances

and OMB clearance as necessary.

C. Coordinating Committee

Provide assistance as requested to the

Centers in the establishment and

conduct of activities carried out by the

CC.

3. Collaborative Responsibilities

(Coordinating Committee)

The CC will provide leadership and

collaborative work to: (1) Enhance

surveillance efforts across all Centers,

including establishment of a multiCenter pooled data set, (2) develop a

plan for the multi-Center case-control

study, and (3) enhance communication

and collaboration among Centers. The

CC will combine the expertise and

resources of the Centers to achieve a

more integrated and effective program

in surveillance and epidemiologic

studies of ASD and other developmental

disabilities. It is anticipated that critical

issues for understanding the

epidemiology of ASD and other

developmental disabilities will be better

defined through the deliberations of the

CC. Periodic scientific meetings and

proceedings of these meetings will be

used to advance the state of knowledge

in the field of ASD and developmental

disabilities epidemiology. The CC may

designate working groups for specific

purposes, made up of staff members

from the Centers. The working groups

could include, but may not be limited

to:

1. Surveillance work groups to

establish common case definitions and

surveillance data elements for a multiCenter pooled surveillance data set;

2. For the collaborative case-control

study, working groups to establish (a)

suitable study hypotheses, (b) case and

control definitions, (c) study protocol

and methodology, such as collection of

biosamples, and/or (d) data collection

instruments.

A plan will be developed by the CC

for a Center-funded repository for the

pooled surveillance and case-control

study data for common use by all

Centers. The CC, or a designated work

group, will establish procedures for

management, access and use of the

repository and it’s pooled data.

E. Application Content

Applicants should use the

information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. The application

will be evaluated on the criteria listed,

so it is important for applicants to

follow them in laying out the program

plan. Forms are in the application kit.

F. Submission and Deadline

Letter of Intent

A letter of intent (LOI) is requested to

enable CDC to determine the level of

interest in the announcement. Include

name, address, and telephone number.

The LOI is requested on or before June

11, 2001. Submit the letter of intent to

the Grants Management Specialist

identified in the ‘‘Where to Obtain

Additional Information’’ section of this

announcement.

Application

Submit the original and five copies of

PHS 398 (OMB Number 0925–0001) on

Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24375

or before July 09, 2001, to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement. 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 Panel. (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.)

Late applications: Applications which

do not meet the criteria in (a) or (b)

above are considered late applications,

will not be considered, and will be

returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Understanding the Problem (15

Points)

a. Extent to which applicant has a

clear, concise understanding of the

requirements and purpose of the

cooperative agreement;

b. Extent to which applicant

understands the issues, challenges, and

barriers associated with developing and

implementing population-based

surveillance and epidemiologic studies

for ASD and other developmental

disabilities;

c. Extent to which applicant

understands the issues, challenges, and

barriers associated with case

ascertainment for ASD; and

d. Extent to which applicant describes

the need for funds to develop/enhance

ASD and other developmental disability

surveillance and epidemiologic studies

in their State.

2. Goals and Objectives (15 Points)

a. Extent to which applicant clearly

describes the short-term and long-term

goals and measurable objectives of the

project;

b. Extent to which applicant’s goals

and objectives are realistic and are

consistent with the stated goals and

purpose of this announcement;

c. The degree to which applicant has

met the CDC policy requirements

regarding the inclusion of women,

ethnic and racial groups in the proposed

research. This includes:

i. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

ii. The proposed justification when

representation is limited or absent.

iii. A statement as to whether the

design of the study is adequate to

measure differences when warranted.

iv. 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.

3. Description of Program and

Methodology (30 Points)

a. Extent to which applicant describes

the methods they will use to (1) identify

all relevant sources for surveillance case

ascertainment for ASD and other

developmental disabilities within the

study area; (2) obtain permission to

access records from relevant sources; (3)

develop standard case definitions for

ASD and other developmental

disabilities and implement a strategy to

conduct multiple-source case

ascertainment; (4) train community

service providers to improve case

ascertainment; (5) develop and

implement quality assurance procedures

and an evaluation plan for the

surveillance system; (6) develop and

implement a plan to use surveillance

data to improve public awareness of

ASD and other developmental

disabilities and/or access to care of

affected children; and (7) develop an

analytic and dissemination plan, and

prepare manuscripts.

b. Extent to which applicant describes

the plan for implementing the

collaborative case-control study,

including selection and enrollment of

cases and controls from the applicant’s

study population.

c. Extent to which the applicant

describes the objectives, based on

special strengths and expertise of the

applicant, for a Center-initiated special

study.

4. Collaborative Efforts (15 Points)

a. Extent to which applicant

demonstrates the ability to collaborate

with multiple sources such as school

systems, diagnostic centers, health/

mental health service providers and

other intervention service providers for

the purpose of case ascertainment

(include written assurances).

b. Extent to which applicant

demonstrates their willingness to

collaborate with other Centers to

develop joint project efforts and carry

out the joint project efforts in a manner

that allows for pooling of standardized

data.

c. Extent to which recipient identifies

possible collaborative relationships with

existing surveillance and research

programs that may enhance recipients’

future research activities (e.g., birth

defects surveillance, NIH CPEAs,

PROS).

d. Extent to which collaborative

efforts with other relevant programs are

documented (such as Part C, State

developmental disabilities programs,

genetics programs etc.)

5. Evaluation Plan (10 Points)

a. Extent to which applicant describes

an evaluation plan that will monitor

reliability, progress, timeliness, and

completeness of the objectives and

activities of the project.

b. Extent to which applicant describes

a study to evaluate the completeness of

ascertainment of children for the

surveillance portion of the study.

6. Staffing and Management System (15

Points)

a. Extent to which key personnel have

qualifications, skills and experience in

epidemiologic methods, public health

surveillance, data management and

analysis to develop and implement

surveillance and analytic studies in

ASD and other developmental

disabilities.

b. Extent to which applicant has the

ability to manage and coordinate

surveillance, research, and integration

components of the project.

c. Extent to which applicant

demonstrates expertise in abstracting

and reviewing records.

d. Extent to which there is

appropriate dedicated staff time to

develop and implement the project.

e. Extent to which applicant provides

an appropriate time line and includes

activities and personnel responsibilities.

f. Extent to which applicant

demonstrates an organizational

structure (include an organizational

chart) and facilities/space/equipment

that are adequate to carry out the

activities of the program.

7. Human Subjects Review (Not Scored)

Does the applicant adequately address

the requirements of 45 CFR Part 46 for

the protection of human subjects?

8. Budget (Not Scored)

The extent to which the budget is

reasonable, clearly justified, and

consistent with the intended use of

funds. Applicants should include in

their first year budget two trips to CDC,

Atlanta for up to two persons and two

days each trip.

24376 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Progress reports (semiannual);

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

For descriptions of the following

Other Requirements, see Attachment I.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7 Executive Order 12372 Review

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–22 Research Integrity

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

Health Service Act [42 U.S.C. sections

241 and 247b] as amended, and Section

102 of the Children’s Health Act of 2000

(Pub. L. 106–310). The Catalog of

Federal Domestic Assistance number is

93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

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.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Nancy

Pillar, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: 770–488–2721, Email:

nfp6@cdc.gov.

For program technical assistance,

contact: Diana Schendel, Ph.D., National

Center on Birth Defects and

Developmental Disabilities, 4770 Buford

Highway, Mail Stop F–15, Atlanta,

Georgia 30341, Telephone number: 770–

488–7359, Email: dcs6@cdc.gov.

Dated: May 8, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–11997 Filed 5–11–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01095]

Building Quality Parent Components

for School-Based Health Programs in

Elementary and Middle Schools;

Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for Building Quality Parent

Components for School-Based Health

Programs in Elementary and Middle

Schools. This program addresses the

‘‘Healthy People 2010’’ focus areas of

Family Planning, HIV, Nutrition and

Over weight, Physical Activity and

Fitness, Sexually Transmitted Disease,

and Tobacco Use. A goal of this program

is to eliminate health disparities among

different segments of the population.

The purpose of this cooperative

agreement is to develop and evaluate

parent-focused intervention components

to be used as a supplement for schoolbased sexual risk reduction and chronic

disease risk factor prevention programs

in elementary and middle schools.

These intervention components would

be designed to assist parents in reducing

the risk behaviors of their children. The

risk factors among young people being

targeted by this program are sexual risk

behaviors and chronic disease risk

factors which include tobacco use,

physical inactivity, poor nutrition, and

being overweight or at risk of becoming

overweight. Interventions will target

parents (i.e., primary caregivers) of

elementary or middle school students.

For the purposes of this

announcement, parents are defined as

primary caregivers who are biological

parents or legal guardians (e.g., adoptive

parent, stepparent, grandparent) of

elementary and middle school students.

Primary caregivers are individuals who

take primary responsibility for

providing care for their children.

Parents (i.e., primary care-givers) are

eligible for the study if their elementary

or middle school children currently

reside with them and if they have lived

in the same residence with their

elementary or middle school children

for at least one year prior to the study.

Sexual risk reduction interventions

are programs that show promise of

success or have demonstrated evidence

of efficacy in delaying initiation of

sexual activity among young people,

increasing condom or contraceptive use

among sexually active young people, or

decreasing frequency of intercourse or

number of sexual partners among

sexually active young people. Chronic

disease risk factor prevention

interventions are programs that show

promise of success or have

demonstrated evidence of efficacy in

preventing initiation or promoting a

decrease of tobacco use among young

people, increasing physical activity,

increasing healthy eating, or decreasing

the number of children who are

overweight or at risk of becoming

overweight. Youth tobacco use

prevention programs are included in

this announcement, however, youth

tobacco cessation programs are not

within the scope of this announcement.

Please reference to Appendix 1 for

background information relevant to this

program announcement.

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, territorial, and

local governments or their bona fide

agents, and federally recognized Indian

tribal governments, Indian tribes, or

Indian tribal organizations.

Successful applicants shall

demonstrate a history of conducting

evaluation research in partnership with

interdisciplinary groups of health

researchers and local racial and ethnic

minority communities on applied social

and behavioral science projects.

Note: Title 2 of the United States Code,

Chapter 26, Section 1611 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.