[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
NAG9@cdc.gov.
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 JAL2@cdc.gov.
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
