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

26840 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Notices

maintain, cost effective, and sustainable.

The program will assess micronutrient

status in people at risk for micronutrient

malnutrition living in developing

countries. The program will also

provide assessments of rural and innercity populations of the developing and

developed world, including domestic

programs in the United States, such as

the Special Supplemental Nutrition

Program for Women, Infants, and

Children (WIC). Such technologies may

also have applicability in clinical

laboratory and medical clinic settings.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit and forprofit organizations and by governments

and their agencies; that is, universities,

colleges, research institutions, hospitals,

businesses, small minority businesses,

other public and private nonprofit and

for-profit organizations, State and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes, or Indian

tribal organizations.

Public Law 104–65 states that an

organization described in section

501(c)(4) of the Internal Revenue Code

of 1986 that engages in lobbying

activities is not eligible to receive

Federal funds constituting an award,

grant, cooperative agreement, contract,

loan or any other form.

C. Availability of Funds

Approximately $500,000 is available

in FY 2000 to fund up to three awards.

It is expected that the average award

will be $175,000. It is expected that the

awards will begin on or about

September 30,2000, and will be made

for a 12-month budget period within a

project period of up to three 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, site

visits, and the availability of funds.

D. Programmatic Interest

Programmatic interest is focused on:

1. Research and development leading

to appropriate technology for assessing

individual and/or population status

with regard to the micronutrients of

iodine, iron, vitamin A, and folic acid.

The objective of the technology should

be aimed at detecting or monitoring

deficiencies (and/or excesses) of these

micronutrients by direct or indirect

measurements of the micronutrients or

their metabolites in blood or urine,

functional changes related to the

deficiency (or excess) of the

micronutrient, detection of deviations

from typical individual patient

characteristics (such as radiant or

absorbed electromagnetic energy,

expired volatile compounds, changes in

visual perception, changes in neurologic

function), or other approaches using

technologies that range from very

simple, such as dipstick or blood spot

type tests, to ‘‘smart’’ biosensor or

‘‘nano-lab’’ technologies.

2. Development of the technology

from research and development,

through product testing, clinical

evaluation, production, marketing, and

technical support. Research which

results ONLY in findings of academic

interest with no practical application to

the objectives of the grant will not be

considered.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The application must be submitted

unstapled and unbound.

Applications for research and

development grants should include

technology that:

1. Estimates the nutritional status of

individuals or populations with regard

to one or more of the micronutrients

targeted by this program. Is accurate and

traceable to an accepted accuracy base

or reference standard. Is sufficiently

precise and reproducible to be useful for

epidemiologic purposes and/or for the

management of individual cases.

2. Ability to operate under field

conditions of varied temperature and

humidity, is easy to operate and

maintain, is economical, generates

minimal disposables and/or biohazard

waste, consumes minimal reagents,

requires minimal training or operator

expertise, and can be sustained.

3. Demonstrates portability, compact,

energy efficient and, if external energy

is required, is capable of operating from

one or more power sources such as

batteries, fuel cells, solar cells, or

‘‘house current.’’

4. Is non-invasive or minimally

invasive, or requires very small amounts

of blood, urine, saliva, or other

accessible body fluids. If bodily fluids

are required for the proposed

technology, applicant must describe

sample collection techniques, biohazard

waste disposal, and specimen transport

and storage requirements.

5. Demonstrates adequate specificity

and sensitivity for the required

purposes.

6. Demonstrates the capability to

provide a hard copy or electronic output

to document patient ID together with

assayed values, if the technology used

has electronic processing capability.

7. Demonstrates an understanding of

the value of collaboration with other

researchers, partnerships, contracts,

venture capital relationships, etc., to

accomplish the objectives of this

project.

F. Submission and Deadline

Submit the original and five copies of

PHS 398 (OMB Number 0925–0001). On

or before July 10, 2000, submit the

application 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 a Special Emphasis Panel

appointed by CDC.

1. Technical Expertise and Research

Capacity (30 percent)

The applicant’s ability to plan,

implement, and conduct a successful

research and development program

aimed at clinical or nutritional

measurement systems including the

development and validation of

analytical methods and/or instruments,

and the ability to guide such

development efforts from concept,

through bench model or demonstrationof-concept prototype, to prototype for

field/clinical testing and approval, to

manufacture, production, marketing,

distribution and support. (If applicant

does not intend to carry the project from

initial development through final

production and marketing, a plan for

how these steps will be accomplished

through partnerships, or marketing/

licensing of the technology to others

should be described.)

Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Notices 26841

2. Technical Approach (30 percent)

a. The overall technical merit of the

research plan and the soundness and

scientific validity of the proposed

technologies. The research plan must be

thoroughly described and must include

a detailed explanation of the operating

principles of the technology to be

developed, and the rationale for

selecting the nutritional status marker to

be measured.

b. The adequacy of the research plan

includes the extent to which the

applicant has adequately addressed all

issues described and how well the

evaluation plan can be used to

effectively measure progress towards the

stated objectives.

c. The background of the application,

the critical evaluation of existing

knowledge, and the specific

identification of the knowledge gaps

which the application intends to

address.

3. Understanding the Problem (20

percent)

Applicant’s understanding of the

nature and difficulty of nutritional

assessments, and the special challenges

imposed in field settings for sample

collection, storage and transport,

maintenance, supply, and technical

support, and sustainability.

a. The clinical, nutritional,

biochemical, and practical basis for the

appropriate selection of measurement

parameters for the micronutrient(s)

addressed by the applicant.

b. The applicant’s demonstration of

an awareness and understanding of

strengths and weaknesses of previous

work related to the proposed

technology.

4. Program Personnel (10 percent)

The extent to which the application

has described:

a. The qualifications and commitment

of the applicant including training and

experience in chemistry, biochemistry,

biomedical engineering, medicine,

nutrition, or other relevant scientific

disciplines.

b. The qualifications of the proposed

key staff.

c. Detailed allocations of time and

effort of staff devoted to the project.

d. Information on how the applicant

will develop, implement, evaluate

progress, and administer the program.

e. 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:

(1) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation.

(2) The proposed justification when

representation is limited or absent.

(3) A statement as to whether the

design of the study is adequate to

measure differences when warranted.

(4) 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.

5. Collaboration (5 percent)

Collaboration is encouraged to

accomplish the research objectives in a

timely manner. The applicant should

demonstrate the ability to collaborate

and/or form partnerships with

appropriate research centers,

manufacturers, or commercial interests

to conduct the described research and

development plan.

6. Plans to Publicize the Research

Effort (5 percent)

The applicant should provide an

explanation of plans to encourage the

publication of the research findings or

otherwise make the information

available to the public as soon as is

feasible within the limits of protecting

proprietary interests of the developer.

7. Human Subjects Protection (Not

Scored) 

Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

8. Budget (Not Scored)

The budget will be evaluated for the

extent to which it is reasonable, clearly

justified, and consistent with the

intended use of grant funds.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. semiannual progress reports;

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial status 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.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment 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–3 Animal Subjects Requirements

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

section 301(a) and 317 of the Public

Health Service Act, [42 U.S.C. section

241(a) and 247(b), as amended.] The

Catalog of Federal Domestic Assistance

number is 93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

may be downloaded through the CDC

homepage on the Internet at http://

www.cdc.gov (click on funding). Please

refer to Program Announcement

Number 00077 when requesting

information. To receive an application

kit, call 1–888–GRANTS (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 any questions

after reviewing the contents of all the

documents, business management

technical assistance may be obtained

from:

Sonia V. Rowell, Grants Management

Specialist, Procurement and Grants Office,

Centers for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone: (770)

488–2724, Email address: svp1@cdc.gov

For program technical assistance, contact:

Dayton T. Miller, Ph.D., Centers for Disease

Control and Prevention, 4770 Buford

Highway (F–18), Atlanta, Georgia 30341,

Telephone: (770) 488–4452, Email address:

dtm1@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. 00–11515 Filed 5–8–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Mental Health and Community Safety

Initiative for American Indian/Alaska

Native Children, Youth and Families

AGENCY: Indian Health Service.