Human Health StudiesApplied Research and Development; Notice of Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 99076]

Human Health Studies--Applied Research and Development; Notice of

Availability of Funds

A. Purpose

The Agency for Toxic Substances and Disease Registry (ATSDR)

announces the availability of fiscal year (FY) 1999 funds for a grant

program entitled Human Health Studies--Applied Research and

Development. This program addresses the ``Healthy People 2000''

priority area of Environmental Health.

The purpose of this program is to fill gaps in knowledge regarding

human health effects of hazardous substances focusing on those health

conditions prioritized by ATSDR. The ATSDR Priority Health Conditions

are (in alphabetical order): (1) Birth defects and reproductive

disorders; (2) cancers (selected anatomic sites); (3) immune function

disorders; (4) kidney dysfunction; (5) liver dysfunction; (6) lung and

respiratory diseases; and (7) neurotoxic disorders. The program will

focus upon sensitive human populations (women, children and elderly),

the use of innovative methodologies to fill data gaps identified

through ATSDR's public health assessments and consultations at

hazardous waste sites, ecologic studies using data from multiple sites

to assess the health status of several communities, and analytical

studies, including meta-analysis of existing sets of human data.

Research activities may include, but not be limited to the

following: (1) Epidemiological studies, (2) health outcomes studies,

(3) further analysis of existing human data sets, (4) identification,

validation, and development of biomarkers of exposure, susceptibility,

and effect, and (5) further evaluating the link or lack of linkage

between specific hazardous substances and specific health effects.

B. Eligible Applicants

Assistance will be provided only to official public health agencies

of states or their bona fide agents or instrumentalities. This includes

the District of Columbia, American Samoa, the Commonwealth of Puerto

Rico, the Virgin Islands, the Federated States of Micronesia, Guam, the

Northern Mariana Islands, the Republic of the Marshall Islands, the

Republic of Palau, and federally recognized Indian tribal governments.

State organizations, including state universities, state colleges, and

state research institutions, must establish that they meet their

respective state's definition of a state entity or political

subdivision to be considered an eligible applicant.

C. Availability of Funds

Approximately $350,000 is available in FY 1999 to fund one or two

awards. The award(s) is expected to 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 are subject to 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.

Use of Funds

Funds may be expended for reasonable program purposes, such as

personnel, travel, supplies, and services. Funds for contractual

services may be requested; however, the grantee, as the direct and

primary recipient of grant funds, must perform a substantive role in

carrying out project activities and not merely serve as a conduit for

an award to another party or provide funds to an ineligible party.

Equipment may be purchased with grant funds, however, justification

must be provided which should include a cost comparison of purchase

versus lease, and title will be retained by ATSDR.

This program does not require in-kind support or matching funds,

however, the applicant should describe any in-kind support in the

application.

Funding Priorities

Priority will be given for studies which address one or more of the

following areas of investigation:

1. Evaluate the occurrence of adverse health effects in sensitive

populations. This will include the evaluation of the incidence or

prevalence of a disease, disease symptoms, self-reported health

concerns, or biological markers of disease, susceptibility, or

exposure. Sensitive populations are persons who are more susceptible to

developing adverse health effects resulting from exposures to hazardous

substances [e.g., extremes in age (children and the elderly), other

medical conditions, genetic factors, dietary or nutritional

deficiencies, poverty, or racial injustice].

2. Identify risk factors for adverse health effects in populations.

This will include hypothesis generating cohort or case-control studies

on potentially impacted populations to identify linkages between

exposure to hazardous substances and adverse health effects and those

risk factors which may be impacted by prevention actions.

D. Application Content

Use the information in the 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 should be presented in a manner that demonstrates

the applicant's ability to address environmental health problems.

The applicant's protocol should contain (when applicable) consent

forms and questionnaires, baseline morbidity and mortality information,

procedures for collecting biological and environmental specimens and

for conducting laboratory analysis and evaluation of the test results

of biological specimens, statistical and epidemiological analysis of

study information, and a description of the safeguards for protecting

the confidentiality of individuals on whom data are collected.

The application pages must be clearly numbered, and a complete

index to the application and its appendices must be included. A less

than 200 word abstract of the proposed project should be supplied with

the application. The original and two copies of the application must be

submitted unstapled and unbound. All material must be typed single-

spaced, with unreduced font on 8\1/2\'' by 11'' paper, printed on one

side, and with one inch margins.

E. Submission and Deadline

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-

0189). Forms are in the application kit. On or before June 18, 1999,

submit the application to:

Nelda Godfrey, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Announcement 99076, Centers

for Disease Control and Prevention (CDC), 2920 Brandywine Road,

Suite 3000, Atlanta, GA 30341-4146.

[[Page 15771]]

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.

F. Evaluation Criteria

Each application will be evaluated individually against the

following criteria by an independent review group appointed by ATSDR.

Review Criteria

1. Appropriateness and Knowledge of Study Design (25 percent)

Extent to which the applicant's proposal addresses: (a) The

scientific merit of the proposed project, including the novelty,

originality and feasibility of the approach and the adequacy of the

design; (b) the technical merit of the proposed project, including the

degree to which the project can be expected to yield or demonstrate

results that will be useful and desirable in furthering the program

objectives; and (c) the proposed project schedule, including clearly

established and obtainable project objectives for which progress toward

attainment can and will be measured.

2. Proposed Study (25 percent)

Adequacy of the proposal relevant to: (a) The study purpose,

objectives, and rationale; (b) the quality of program objectives in

terms of specificity, measurability, and feasibility; (c) the

specificity and feasibility of the applicant's timetable for

implementing program activities and timely completion of the study; (d)

the likelihood of the applicant agency completing proposed program

activities and attaining proposed objectives based on the thoroughness

and clarity of the overall program; and (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.

3. Relationship to Initiative (15 percent)

Extent to which the application addresses the areas of

investigation outlined.

4. Quality of Data Collection (15 percent)

Extent to which: (a) The study ascertains the information necessary

to meet the objectives, including (but not limited to) information on

pathways of exposure, confounding factors, and biomedical testing; (b)

the quality control and quality assurance of questionnaire data are

provided, including (but not limited to) interviewer training and

consistency checks of data; (c) the laboratory tests (if applicable)

are sensitive and specific for the analyte or disease outcome of

interest; and (d) the quality control, quality assurance, precision and

accuracy of information for the proposed tests are provided and

acceptable.

5. Capability and Coordination Efforts (10 percent)

Extent to which the proposal has described: (a) The capability of

the applicant's administrative structure to foster successful

scientific and administrative management of a study; (b) the capability

of the applicant to demonstrate an appropriate plan for interaction

with the community; and (c) the suitability of facilities and equipment

available or to be purchased for the project.

6. Program Personnel (10 percent)

Extent to which the proposed program staff is qualified and

appropriate, and the time allocated for them to accomplish program

activities is adequate.

7. Budget (Not scored)

Extent to which the budget is reasonable, clearly justified, and

consistent with intended use of funds.

8. Human Subjects (Not scored)

Does the application adequately address the requirements of 45 CFR

part 46 for the protection of human subjects? Are procedures adequate

for the protection of human subjects? Recommendations on the adequacy

of protections include: (1) Protections appear adequate and there are

no comments to make or concerns to raise, or (2) protections appear

adequate, but there are comments regarding the protocol, or (3)

protections appear inadequate and the Objective Review Group (ORG) has

concerns related to human subjects; or (4) disapproval of the

application is recommended because the research risks are sufficiently

serious and protection against the risks are inadequate as to make the

entire application unacceptable.

G. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Progress reports (annual);

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: Nelda Y. Godfrey, Grants Management Specialist

Grants Management Branch Procurement and Grants, Office, Grant Number:

__, Centers for Disease Control and Prevention (CDC), 2920 Brandywine

Road, Suite 3000, Atlanta, GA 30341-4146.

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-7--Executive Order 12372 Review

AR-9--Paperwork Reduction Act

AR-10--Smoke-Free Workplace Requirements

AR-11--Healthy People 2000

AR-12--Lobbying Restrictions

AR-17--Peer and Technical Reviews of Final Reports of Health Studies--

ATSDR

AR-18--Cost Recovery--ATSDR

AR-19--Third Party Agreements--ATSDR

H. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 104(i)(1)(E), (7), and

(15) of the Comprehensive Environmental Response, Compensation, and

Liability Act of 1980 (CERCLA) as amended by the Superfund Amendments

and Reauthorization Act of 1986 (SARA) (42 U.S.C. 9604 (i)(1)(E), (7),

and (15)). The

[[Page 15772]]

Catalog of Federal Domestic Assistance number is 93.161.

I. Where To Obtain Additional Information

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.

See also the CDC home page on the Internet for a complete copy of

the announcement: http://www.cdc.gov.

If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from: Nelda Y. Godfrey, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Announcement 99076, Centers for

Disease Control and Prevention (CDC), 2920 Brandywine Road, Suite 3000,

Atlanta, GA 30341-4146, telephone (770) 488-2722, E-mail address

NAG[email protected].

For program technical assistance, contact: Jeffrey A. Lybarger,

M.D., Director, Division of Health Studies, Agency for Toxic Substances

and Disease Registry, Executive Park, Building 4 Suite 2300, Atlanta,

GA 30305, telephone (404) 639-6200, E-mail address JAL[email protected].

Dated: March 26, 1999.

Georgi Jones,

Director, Office of Policy and External Affairs, Agency for Toxic

Substances and Disease Registry.

Background

Since 1993, ATSDR has applied this paradigm to the evaluation of

seven priority health conditions. This purpose of these evaluations

was to support the development of a body of knowledge about the

interrelationships of the model parameters and thus the relationship

between exposures to hazardous substances and adverse health

effects. Health studies were conducted and supported predominantly

evaluating a coss-section of the general public living near waste

sites. It is possible, however, that the occurrence of adverse

health effects and subclinical toxic effects are more common among a

small number of sensitive people. People may be more likely to

experience adverse health effects resulting from exposures to

hazardous substances if they have underlying illnesses, suffer

effects of poverty such as poor diet or education about health

seeking behaviors, have limited physiological reserve of organ

function due to being very young or very old, or are limited by

environmental injustices. The application of this paradigm to

selected groups of persons with hypothesized sensitivities would

assist in identifying affected people and evaluating risk modifying

factors.

[FR Doc. 99-8004 Filed 3-31-99; 8:45 am]

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