[Federal Register Volume 65, Number 90 (Tuesday, May 9, 2000)]
[Notices]
[Pages 26839-26841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11515]


-----------------------------------------------------------------------

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

[[Page 26840]]

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 inner-city 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 
for-profit 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 
demonstration-of-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.)

[[Page 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: [email protected]

    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: [email protected]


    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