26836 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Notices

Late Application: Application which

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

above is considered a late application,

will not be considered, and will be

returned to the applicant.

G. Evaluation Criteria

The application will be evaluated

against the following criteria by an

independent review group appointed by

CDC.

1. Understanding of the problem (20

percent)

The applicant’s ability to demonstrate

an understanding of the nature of the

problem to be addressed. This

specifically includes description of the

public health importance of the planned

activities to be undertaken, and realistic

presentation of proposed objectives.

2. Technical approach (25 percent)

The extent to which the applicant’s

proposal addresses: (1) An overall

design strategy, including measurable

time lines; and (2) management analysis

of the data collected.

3. Ability to carry out the project (25

percent) Degree to which the applicant

provides evidence of ability to carry out

the proposed project and the extent to

which the applicant documents

demonstrated capability to achieve the

purpose of this project.

4. Personnel (20 percent)

The extent to which professional

personnel involved in this project are

qualified, including evidence of

experience similar to this project.

5. Plans for Administration (10

percent)

Adequacy of plans for administering

the project.

6. Budget (not scored)

Itemized budget for conducting the

project, along with justification, is

provided and is reasonable and

appropriate to the described project.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus

two copies of:

1. Semi-annual progress report;

2. Financial status report, no more

than 90 days after the end of the budget

period;

3. Final financial status report and

performance report, 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.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application package.

AR–7 Executive Order 12372 Review

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301 and 317 of the Public Health

Service Act, [42 U.S.C. section 241 and

247b] as amended. The Catalog of

Federal Domestic Assistance number is

93.283.

J. Where To Obtain Additional

Information

To obtain additional information,

contact: Sonia Rowell, Grants

Management Specialist Grants

Management Branch, Procurement and

Grants Office Centers for Disease

Control and Prevention (E–13) 2920

Brandywine Road, Room 3000 Atlanta,

GA 30341 Telephone (770) 488–2724

Email address svp1@cdc.gov

For program technical assistance,

contact: Patrick O. Bohan, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (F–48), 4770 Buford

Highway NE, Atlanta, Georgia 30341,

(770) 488–7303, E-mail address

pfb3@cdc.gov.

The CDC Homepage address on the

Internet is http://www.cdc.gov

Dated: May 3, 2000.

Henry S. Cassell III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–11514 Filed 5–8–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00076]

Cooperative Agreement for Early

Hearing Detection and Intervention

(EHDI) Tracking, Research, and

Integration With Other Newborn

Screening Programs; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year 2000 funds for

a cooperative agreement program to

promote the implementation and

integration of State-based surveillance

and tracking systems for Early Hearing

Detection and Intervention (EHDI) and

other disorders detected by newborn

screening.

The purpose of the EHDI program

includes screening newborns for hearing

loss, audiologic evaluation to identify

infants with hearing loss, and early

intervention for children identified.

This program addresses ‘‘Healthy

People 2010,’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related to the focus

area Vision and Hearing. For the

conference copy of ‘‘Healthy People

2010,’’ visit the internet site: <http://

www.health.gov/healthypeople>.

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. Only one application from each

State may be submitted.

Two levels of cooperative agreements

will be awarded:

Level I: Eligible applicants for Level I

funding are those that do not have an

established State or regional centralized

EHDI surveillance and tracking

program, or are in the beginning stages

of establishing their program and would

like to expand or improve their existing

surveillance and tracking program.

Level II: Eligible applicants for Level

II funding are those that have an

existing State or regional centralized

EHDI population-based (i.e., complete

geographic coverage) surveillance and

tracking program that includes data on

at least 75 per cent of infants from a

birth population of at least 30,000 live

births per year. States with fewer births

may form multi-State data collection

regions in order to meet the eligibility

requirements; these do not have to be

composed of contiguous States. Level I

applicants may belong only to one

multi-State regional data collection site.

Applicants from multi-State regions

must provide documentation from each

State of their willingness to collaborate

and pool data from each site in their

proposed region. One State must be

identified as the designated lead on a

multi-State application. The lead State

must submit the application and

administer the award.

Note: Effective January 1, 1996, Public Law

104–65 states that an organization described

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

Code of 1986 which engages in lobbying

Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Notices 26837

activities shall not be eligible to receive

Federal funds constituting an award, grant

(cooperative agreement), contract, loan, or

any other form.

C. Availability of Funds

Approximately $2,300,000 will be

available in FY 2000 to fund up to 13

awards. It is expected that up to nine

awards will be made to Level I

applicants, ranging from $100,000–

$150,000. It is expected that up to two

awards will be made to Level II option

1 applicants and up to two awards will

be made to Level II option 2 applicants.

Level II awards are expected to range

from $250,000–$350,000.

It is expected that awards will begin

on or about September 1, 2000, and will

be made for a 12-month budget period

within a project period of up to five

years, depending on availability of

funds. Funding estimates may vary and

are subject to change. Continuation

awards within the approved project

period will be made on the basis of

satisfactory progress as evidenced by

required reports and availability of

funds.

Use of Funds

Project funds may not be used to

supplant other available applicant or

collaborating agency funds or to

supplant State funds available for

screening, diagnosis, intervention or

tracking for hearing loss or other

disorders detected by newborn

screening. Project funds may not be

used for construction, for lease or

purchase of facilities or space, or for

patient care.

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’either

Level I or Level II). CDC will be

responsible for the activities listed

under 2 (CDC Activities).

1. Recipient Activities

Level I

a. Establish and implement a State or

regional surveillance and data tracking

system to assure minimal loss to followup by monitoring the status and

progress of infants through the three

components of the EHDI program

(screening, identification, and

intervention).

b. Develop standardized data

collection and tracking methods (i.e.,

linking with birth certificate files) and

forms, and data analysis plan in

collaboration with other recipients.

c. Collect standardized EHDI data

(including the type of hearing loss and

type of intervention services)from

appropriate sources, such as birthing

hospitals, diagnostic centers and/or

intervention programs.

d. Develop mechanisms to identify

and collect standardized data on

infants/children with late onset or

progressive hearing loss.

e. Use State or regional EHDI data in

order to obtain outcome data such as:

unexpected clusters of infants with

hearing loss in particular regions at

particular times; unexpected differences

in measure of EHDI screening

performance between participating

birthing hospitals; false positive rates;

loss to follow-up rates.

f. Document concerns from parents

and professionals about the EHDI

process.

g. Collaborate with State programs

such as Maternal and Child Health, Part

C of the Individuals with Disabilities

Education Act, private service programs,

and advocacy groups to build a

coordinated EHDI infrastructure.

h. Integrate with other screening

programs that identify children with

special health care needs such as

newborn blood spot screening and birth

defects surveillance.

i. Prepare and publish manuscript(s)

which describes the tracking system,

definitions, methodology, collaborative

relationships, data collection, findings,

and recommendations across sites.

Collaboration with other participating

sites is encouraged.

j. Develop an evaluation plan to

monitor progress on activities and to

assess the timeliness, completeness, and

success of the project.

Level II

Level II applicants will be responsible

for all required Level I activities, plus

implementing either Option 1 or Option

2 below, but not both options.

Option 1. Under this option, Level II

applicants will collaborate with other

recipients to develop and participate in

a common set of activities. Level II

applicants are encouraged to develop

collaborative relationships with

universities. They will:

a. Share information and collaborate

with other Level II recipients, and with

other federal and national agencies

(such as, but not limited to, Health

Resources and Services Administration,

National Institute on Deafness and other

Communication Disorders, Directors of

Speech and Hearing Programs in State

Health and Welfare Agencies, Joint

Committee on Infant Hearing, and

advocacy groups) to develop a set of

core research questions and analytic

guidelines for one or more of the

following areas:

i. costs of EHDI programs,

ii. causes and associated factors for

hearing loss,

iii. benefits of early identification and

intervention for children with hearing

loss,

iv. psychological and family issues.

b. Collaborate with other award

recipients to implement a common

research and analytic plan and analyze

data.

c. Collaborate with other Level II

award recipients in an anonymized

research data set. Data analysis will be

conducted at the State and federal levels

with the data being maintained at the

individual applicant sites.

d. Collect biological samples for

children identified with hearing loss.

Option 2. Under this option, Level II

applicants will be responsible for

activities that build on the integration of

EHDI with other newborn screening and

monitoring systems. They will:

a. Collaborate with programs that

perform State newborn blood spot

screening to identify an annual birth

cohort of infants for further monitoring.

Each program will select two conditions

to include in their cohort; either PKU or

glactosemia as one condition, and either

congenital hypothyroidism or

hemoglobinopathies as the other.

b. Develop a plan that is integrated

with the EHDI tracking system to

determine the effectiveness of the

program in identifying and tracking

infants with the selected conditions.

c. Develop a plan to annually

document the services received and the

condition (i.e., medical and

developmental complications) for each

affected child included in the cohorts.

d. Collaborate with other Level II/

Option 2 award recipients to develop a

data system for the cohorts that can be

integrated with other newborn screening

activities and can serve as a model for

other State programs.

2. CDC Activities

a. Provide technical assistance as

needed on the design, development, and

evaluation methods and approaches

used for State-based EHDI tracking and

surveillance.

b. Provide technical assistance as

needed on the development of research

questions and analytic guidance;

c. Provide technical assistance as

needed for the collection and analysis of

data across sites.

d. Facilitate collaborative efforts to

compile and disseminate program

results through presentations and

publications.

E. Application Content

Use the information in the Program

Requirements, Application Content,

26838 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Notices

Evaluation Criteria, and Other

Requirements sections to develop the

application content. Forms are in the

application kit. Applications will be

evaluated on the criteria listed, so it is

important to follow them in describing

the program plan. The applicant should

provide a detailed description of firstyear activities and briefly describe

future-year objectives and activities.

The application must contain the

following:

Cover Letter: A one-page cover letter

should state the Level and Option for

which the applicant is applying and

explain how the applicant fulfills

eligibility requirements.

Abstract and Table of Contents: A

one-page, single-spaced, typed abstract

must be submitted with the application.

The heading should include the title of

the grant program, project title,

organization, name and address, project

director and telephone number. The

abstract should clearly state which level

of activities the applicant is applying

for: Level I, Level II–Option 1, or Level

II–Option 2. The abstract should briefly

summarize the program for which funds

are requested, the activities to be

undertaken, and the applicant’s

organization structure. The abstract

should precede the Program Narrative.

A table of contents that provides page

numbers for each of the following

sections should follow the abstract (all

pages must be numbered).

Budget Justification: The budget

should be reasonable, clearly justified,

and consistent with the intended use of

the agreement funds. The applicant

must include a detailed first-year budget

justification with future annual

projections. Budgets should include

costs for travel for at least one project

staff person to attend two two-day

meetings. The applicant should provide

a budget justification for each budget

item. Proposed sub-contracts should

identify the name of the contractor, if

known; describe the services to be

performed; provide an itemized budget

and justification for the estimated costs

of the contract; specify the period of

performance; and describe the method

of selection.

Narrative: The narrative should be no

more than 25 double-spaced pages for

Level I applicants and no more than 35

double-spaced pages for Level II

applicants, printed on one side, with

one inch margins, and unreduced font

(12 pitch). The narrative must contain

the following sections:

a. Understanding the Problem and

Current Status

b. Goals and Objectives

c. Description of Program and

Methodology

d. Evaluation Plan

e. Collaborative Efforts

f. Staffing and Management System

(One-page CV or resume for each key

personnel must be included in an

attachment)

g. Organizational Structure and

Facilities (Must include an

organizational chart)

h. Human Subjects Review

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. The LOI

should specify the level (Level I or Level

II, and the option if applying for Level

II funding) for which the applicant is

applying. Include name, address, and

telephone number. The LOI is requested

on or before June 6, 2000. 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 two copies of

PHS 5161–1 (OMB Number 0937–0189)

on or before July 6, 2000 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%)

a. Extent to which the applicant has

a clear, concise understanding of the

requirements and purpose of the

cooperative agreement;

b. Extent to which the applicant

understands the challenges, barriers,

and problems associated with

developing and implementing an EHDI

tracking and surveillance program;

c. Extent to which the applicant

describes the need for an EHDI program

in their respective State(s) or the current

status of their respective State(s)

existing EHDI program: Number of

infants/children with hearing loss;

number of infants born, number of

birthing hospitals with and without

UNHS programs; number of infants

screened, identified and referred to

intervention; protocol for screening and

referral, including informed consent

information; description of EHDI

tracking and surveillance system (if any

exists); description of other relevant

tracking, surveillance systems, or

registries in the State and linkages with

these systems or plans to link;

description of diagnostic facilities and

intervention services available in the

State for infants/children with hearing

loss;

d. Extent to which applicant shows

willingness to integrate EHDI

surveillance and tracking system with

other newborn screening program

activities.

2. Goals and Objectives (10%)

a. Extent to which applicant clearly

describes the short- and long-term goals

and objectives of the project;

b. Extent to which applicant’s goals

and objectives are consistent with the

stated purpose of this announcement.

c. 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 the proposed

plan for the inclusion of both sexes and

racial and ethnic minority populations

for appropriate representation and

justification when representation is

limited or absent.

3. Description of Program and

Methodology (35%)

a. Extent to which applicant describes

target region and number of births/year

in that region;

b. Extent to which applicant

addresses all activities of Program

Requirements relevant to their chosen

Level/Option;

c. Extent to which applicant describes

the methods to be used to carry out the

activities and provides a time line

which includes personnel and other

resources to complete the project.

Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Notices 26839

4. Evaluation Plan (15%)

Extent to which applicant describes

an evaluation plan that will monitor

progress, and assess timeliness,

completeness, and success of the

project;

5. Collaborative Efforts (10%)

a. Extent to which applicant describes

their methods for collaboration with

(and includes written assurances) from

hospitals, diagnostic centers, and

intervention services;

b. Extent to which collaborative

efforts with other screening programs

are documented;

c. (Level II only) Extent to which

applicant is willing to work

collaboratively with other agencies and

recipients to develop multi-site research

questions and analytic guidelines. If

additional research questions are

proposed in order to address local

concerns, extent to which the applicant

provides a rationale and need for

choosing those questions, a clear

description of the methodology to be

used, the resources available or needed

to carry out the project;

d. (Level II only) Extent to which

applicant describes their plan for

integrating the EHDI program with other

screening programs such as blood spot

screening and birth defect registries,

(Letters of agreement and cooperation

from collaborating screening programs

should be included). Applicants must

state their willingness to work

collaboratively and to modify their

projects if necessary in order to

accommodate multi-site projects for the

purpose of integration and

standardization efforts.

6. Staffing and Management System

(10%)

a. Extent to which key personnel have

skills and experience to develop and

implement an EHDI tracking and

surveillance system;

b. Extent of the managerial ability to

coordinate the tracking, surveillance,

and research, and integration

components of the project;

c. Extent to which expertise in

abstracting screening, identification,

and intervention records are

demonstrated;

d. Extent to which expertise in

epidemiologic methods, public health

surveillance, data management and

computer programming is

demonstrated;

7. Organizational Structure and

Facilities (5%)

Extent to which organization structure

and facilities/space/equipment are

adequate to carry out the activities of

the program.

8. Human Subjects Requirements (Not

Scored)

The extent to which the applicant

complies with the Department of Health

and Human Services Regulations (45

CFR Part 46) regarding the protection of

human subjects.

9. Budget (Not Scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with stated

objectives and planned program

activities.

H. Other Requirements

Provide CDC with the original plus

two copies of:

1. Semi-annual progress reports, no

more than 30 days after the end of the

report period.

2. Financial status report, no more

than 90 days after the end of the budget

period;

3. Final financial report and

performance report, 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.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Addendum I in the application

kit.

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

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. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where To Obtain Additional

Information

This and other documents may be

downloaded through the CDC homepage

on the Internet at http://www.cdc.gov

(click on ‘‘Funding’’). Refer to Program

Announcement 00076 when you request

information.

For business management technical

assistance, contact: Mattie B. Jackson,

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:

770–488–2718, E-mail address:

mij3@cdc.gov.

For program technical assistance,

contact: June Holstrum, Ph.D., Early

Hearing Detection and Intervention

Program, National Center for

Environmental Health, Centers for

Disease Control and Prevention, 4770

Buford Highway, NE, Mailstop F–15,

Atlanta, GA 30341–3717, Telephone

number: 770–488–7361, E-mail address:

Jholstrum@cdc.gov.

Dated: May 3, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–11513 Filed 5–8–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00077]

Innovative Technology Development

Grant for the Assessment of

Micronutrient Status in Humans Notice

of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for an innovative technology

development grant program for the

development of appropriate and

sustainable technologies for the

assessment of micronutrient status in

humans. This program addresses

‘‘Healthy People 2010,’’ a national

activity to reduce morbidity and

mortality and improve quality of life.

This announcement is related to the

focus areas of Nutrition and Overweight;

Maternal, Infant, and Child Health;

Diabetes; Mental Health and Mental

Disorders; Immunization and Infectious

Diseases. For the conference copy of

‘‘Healthy People 2010,’’ visit the

internet site: <http://www.health.gov/

healthypeople>.

The purpose of the program is to

stimulate the development,

commercialization, and application of

innovative technologies which are

rugged, portable, easy to operate and