Notice of Availability of Funds; Innovative Technology Development Grant for the Detection and Monitoring of Diabetic Hypoglycemia by Non- or Minimally-Invasive Techniques

[Federal Register Volume 64, Number 103 (Friday, May 28, 1999)]
[Notices]
[Pages 29035-29036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99151]


Notice of Availability of Funds; Innovative Technology 
Development Grant for the Detection and Monitoring of Diabetic 
Hypoglycemia by Non- or Minimally-Invasive Techniques

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for an innovative 
technology development grant program for the development of technology 
for the non-invasive or minimally-invasive detection and monitoring of 
diabetic hypoglycemia (low blood sugar) in children, adults, and the 
elderly. This program addresses the ``Healthy People 2000'' priority 
areas of Diabetes and Chronic Disabling Conditions; Maternal and Infant 
Health; Unintentional Injuries; and Heart Disease and Stroke. The 
purpose of the program is to stimulate the development, 
commercialization, and application of innovative technology for 
monitoring diabetics, especially insulin dependent diabetics, who are 
at risk of developing hypoglycemia, a condition which can result in 
reduced alertness, temporary inability to communicate, loss of 
consciousness, seizures, coma, injury, or death.

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 $700,000 is available in FY 1999 to fund up to three 
(3) awards. It is expected that the average award will be $230,000, 
ranging from $100,000 to $700,000. It is expected that the awards will 
begin on or about September 30, 1999 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 
and the availability of funds.

D. Programmatic Interests

    Programmatic interest is focused on:
    1. Research and development leading to an appropriate technology 
for detecting and/or monitoring hypoglycemia, conditions related to 
hypoglycemia, or indicators of pre-hypoglycemia in diabetic patients 
during normal daily living. The objective of the technology should be 
aimed at detecting or monitoring the physiologic condition of 
hypoglycemia (e.g. Measurement of blood glucose concentration 
measurement, monitoring rates of change of blood glucose 
concentrations, measurement of metabolic products related to diabetes, 
monitoring changes in bodily radiant energy, or detection of deviations 
from typical individual patient characteristics using ``smart'' 
biosensor technology).
    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.
    Proposals for research and development should address technology 
that is:
    1. Non-intrusive to the patient's lifestyle.
    2. Non- or minimally-invasive(i.e., totally external to the body or 
very minimal intrusion through the skin barrier).
    3. Simple to operate, rugged, durable, and reliable.
    4. Sensitive enough to detect or alarm a hypoglycemic condition in 
time for the patient or caregiver to take effective action, but not 
prone to excessive false alarms.
    5. Capable of being attached to or placed near a sleeping infant, 
child, or elderly person in such a manner that normal movements during 
sleep will not dislodge or deactivate the device or cause a false 
alarm.
    6. Available at cost such that the typical diabetic patient or 
parent of a diabetic child can afford to purchase or lease the 
monitoring system.
    The research and development proposed should demonstrate an 
understanding of the value of collaboration with other researchers, 
partnerships, contracts, venture capital relationships, etc., to 
accomplish the objectives of this project.

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.

F. Submission and Deadline

Application

    Submit the original and five copies of PHS 398 (OMB Number 0925-
0001). On or before July 22, 1999, 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 
orderly processing. (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. Evidence of Technical Expertise and Research Capacity (30%)

    The applicant's ability to plan, implement, and conduct a 
successful research and development program aimed at clinical 
measurement systems including the development and validation of 
analytical methods and/or instruments.

[[Page 29036]]

2. Technical Approach (30%)

    a. The overall technical merit of the research plan and the 
soundness and scientific validity of the proposed hypoglycemia 
detection and monitoring system. The research plan must be thoroughly 
described and must include a detailed explanation of the operating 
principles of the technology to be developed.
    b. The adequacy of the research plan includes the extent to which 
the applicant has adequately addressed all issues described under the 
Programmatic Interests section of this announcement and how well the 
evaluation plan can be used to effectively measure progress towards the 
stated objectives.
    c. The background of the application, i.e., the basis for the 
present 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%)

    a. The applicant's understanding of the requirements, objectives, 
and interactions required for a successful research and development 
program.
    b. The applicant must also present evidence of understanding of the 
difficult analytical problem presented by the complexity of individual 
variability in diabetes, and the unique challenges presented for non- 
or minimally-invasive detection or monitoring of hypoglycemia in 
different patient age groups.
    c. The applicant must demonstrate an awareness and understanding of 
strengths and weaknesses of previous work related to the proposed 
technology.

4. Program Personnel (10%)

    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, diabetology, or other relevant scientific 
disciplines
    b. Detailed allocations of time and effort of staff devoted to the 
project
    c. Information on how the applicant will develop, implement and 
administer the program
    d. The qualifications of the support staff.

5. Collaboration (5%)

    Collaboration is encouraged to accomplish the research objectives 
in a timely manner. The applicant should demonstrate the ability to 
collaborate with other research centers, manufacturers, or commercial 
interests to conduct the described research and development plan.

6. Plans To Publicize the Research Effort (5%)

    The applicants 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)

    Applications which do not adequately address the requirements of 
Title 45 CFR Part 46 for the protection of human subjects will be 
rejected.

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 2000
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 99151 when requesting 
information. To receive 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 
any questions after reviewing the contents of all the documents, 
business management technical assistance may be obtained from: Mattie 
B. Jackson, Grants Management Specialist, Procurement and Grants 
Office, Centers for Disease Control and Prevention, 2920 Brandywine 
Road, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-2718, Email 
address: mij3@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, FAX: (770) 488-4541, EMAIL: dtm1@cdc.gov
    or
Gary L. Myers, Ph.D., Centers for Disease Control and Prevention, 4770 
Buford Highway (F-25), Atlanta, Georgia 30341, Telephone: (770) 488-
4606, FAX: (770) 488-4192, EMAIL: glm1@cdc.gov

    Dated: May 24, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-13602 Filed 5-27-99; 8:45 am]
BILLING CODE 4163-18-P