[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Notices]
[Pages 15770-15772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8004]


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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]
BILLING CODE 4163-70-P