[Federal Register Volume 62, Number 112 (Wednesday, June 11, 1997)]
[Notices]
[Pages 31822-31825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15179]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement 757]
National Institute for Occupational Safety and Health;
Epidemiologic Studies To Evaluate Health Effects of Uranium Milling;
Notice of Availability of Funds for Fiscal Year for 1997
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1997 funds for a cooperative agreement
program to design and conduct epidemiologic studies evaluating the
health effects of uranium milling.
CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2000, a national activity to
reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of Occupational Safety and
Health. (For ordering a copy of Healthy People 2000, see the section
Where To Obtain Additional Information.)
Authority
This program is authorized under Section 501 of the Federal Mine
Safety and Health Act (30 U.S.C. 951).
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and promote the nonuse of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Applications may be submitted by public and private, non-profit and
for-profit organizations and governments, and their agencies. Thus,
universities, colleges, research institutions, hospitals, other public
and private organizations, State and local health departments or their
bona fide agents, federally recognized Indian tribal governments,
Indian tribes or Indian tribal organizations, and small, minority-and/
or women-owned businesses are eligible to apply.
Note: Public Law 104-65, dated December 19, 1995, prohibits an
organization described in section 501(c)(4) of the IRS Code of 1986,
that engages in lobbying activities to influence the Federal
Government, from receiving Federal funds.
Availability of Funds
Approximately $300,000 is available in FY 1997 to fund one award.
It is expected that the award will begin on or about September 1, 1997,
and will be made for a 12-month budget period with a one year project
period.
Preapplication Teleconference
Applicants are invited by CDC/NIOSH to attend a preapplication
technical assistance teleconference on Monday, June 16, 1997, at 2:00
p.m.(EDT) to discuss the programmatic issues and time constraints
regarding this program, and to ask question regarding its content. This
teleconference is expected to last approximately one hour. All
conference calls are scheduled on Eastern time. The conference name is
``Uranium Millers Technical Assistance''. The telephone bridge number
for Federal participants is 404/639-4100 and for Non-Federal
participants it is 800/713-1971. Participants will need the conference
code, 575934, to be connected.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352 (which has been in effect since
December 23, 1989), recipients (and their subtier contractors) are
prohibited from using appropriated Federal funds (other than profits
from a Federal contract) for lobbying Congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that,
in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition, the FY 1997 HHS Appropriations Act, which became
effective October 1, 1996, expressly prohibits the use of 1997
appropriated funds for indirect or ``grass roots'' lobbying efforts
that are designed to support or defeat legislation pending before State
legislatures. This new law, Section 503 of Pub. L. No. 104-208,
provides as follows:
Sec. 503(a) No part of any appropriation contained in this Act
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for
the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to
support or defeat legislation pending before the Congress, * * * except
in presentation to the Congress or any State legislative body itself.
(b) No part of any appropriation contained in this Act shall be
used to pay the salary or expenses of any grant or contract recipient,
or agent acting for such recipient, related to any activity designed to
influence legislation or appropriations pending before the Congress or
any State legislature.
Department of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus
Consolidated Appropriations Act, 1997, Division A, Title I, Section
101(e), Pub. L. No. 104-208 (September 30, 1996).
Background
The National Institute for Occupational Safety and Health (NIOSH)
is developing and conducting a study of the health effects associated
with uranium milling and will be awarding cooperative agreement funds
to support this effort.
NIOSH is conducting this research pursuant to an agreement with the
United States Army Environmental Hygiene Agency in follow-up to a 1994
Congressional mandate to the Department of Defense. Public Law 103-139
provides that the Department of Defense shall conduct ``* * * a study
of the health effects of uranium milling, including the effects of
exposure to radon chemicals and uranium, on the health of those
individuals employed in uranium mills in the southwestern United States
during the period beginning on January 1, 1947, and ending on December
31, 1971.''
NIOSH has been evaluating available personnel and exposure records
for uranium mills which operated in Colorado, New Mexico, Utah, and
Arizona between 1947 and 1971 to determine which types of epidemiologic
studies of the health effects of uranium milling would be feasible
given the
[[Page 31823]]
nature and extent of records available on uranium milling operations.
To date, NIOSH has determined that a cross sectional study of renal
and/or pulmonary disease among uranium millers would be feasible. In
addition, such a study is scientifically appropriate since prior
research has indicated that uranium millers may be at increased risk of
renal disease and non-malignant respiratory disease.
Purpose
The purpose of this cooperative agreement is to utilize the special
resources of the research community to conduct studies evaluating the
renal and/or pulmonary health effects of uranium milling, including the
effects of exposure to uranium dust, silica dust, inorganic acids,
organic solvents, and ionizing radiation. The project results should be
applicable to individuals employed in uranium mills in the southwestern
United States between January 1, 1947 and December 31, 1971. This
project could include: (a) A morbidity study of renal disease, (b) a
morbidity study of non-malignant respiratory disease, and/or (c) a
morbidity study of other health outcomes if substantial justification
is given for evaluating other endpoints. Personnel and/or exposure
records from U.S. uranium mills may be utilized to the extent
available. The recipient should develop an epidemiologic study design
which specifies the methods that will be used to select former uranium
millers and a non-uranium miller comparison group for the study.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under A.
(Recipient Activities), and CDC/NIOSH will be responsible for
activities under B. (CDC/NIOSH Activities).
A. Recipient Activities
1. Develop a study to evaluate the health effects of uranium
milling among individuals employed in uranium mills in the southwestern
United States during the period between January 1, 1947, and December
31, 1971.
2. Evaluate potential sources of recruitment of uranium millers
including company records, the registry kept by the Office of Navajo
Uranium Workers, and other sources in order to propose a recruitment
strategy.
3. Develop a final study protocol that reviews the pertinent
literature on potential health effects of uranium milling and
historical exposure data, describes the study methodology including the
selection of an unexposed (non-uranium miller) comparison group, the
data to be collected, and the proposed analysis of the data.
4. Present the protocol to a panel of scientific peer reviewers and
revise the protocol as required for final approval.
5. Perform data collection and management. Data collected may
include worker symptomatology, results of medical tests evaluating
renal and/or pulmonary function, and available exposure data.
6. Conduct statistical analyses of the data collected.
7. Report study results to the scientific community via
presentations at professional conferences and articles in peer-reviewed
journals. All reports should undergo appropriate scientific peer review
prior to public release.
8. Maintain the confidentiality of individually identifiable data.
Provide written assurance to the CDC that there are adequate technical
and administrative safeguards in place to protect the confidentiality
of such records and that the confidentiality of the records will be
maintained.
9. Notify study participants of their individual and overall study
results.
B. CDC/NIOSH Activities
1. Provide technical assistance with program development,
implementation, maintenance, priority setting, evaluation efforts, and
information and dissemination activities.
2. Provide scientific, epidemiologic, and medical collaboration for
the successful completion of this project.
3. Provide, obtain, and/or assist in obtaining available personnel
and/or exposure records from uranium mills located in the southwestern
United States that operated during the period between January 1, 1947
and December 31, 1971.
4. Assist in reporting study results to the scientific community
via presentations at professional conferences and articles in peer-
reviewed journals. Assist, if needed, in reporting individual and
overall study results to study participants.
Technical Reporting Requirements
An original and two copies of semi-annual progress reports are
required. Timelines for the semi-annual reports will be established at
the time of award. Final financial status and performance reports are
required no later than 90 days after the end of the project period. All
reports are submitted to the Grants Management Branch, Procurement and
Grants Office, CDC.
Semi-annual progress report should include:
A. A brief program description.
B. A listing of program goals and objectives accompanied by a
comparison of the actual accomplishments related to the goals and
objectives established for the period.
C. If established goals and objectives to be accomplished were
delayed, describe both the reason for the deviation and anticipated
corrective action or deletion of the activity from the project.
D. Other pertinent information, including the status of
completeness, timeliness and quality of data.
Final Report summarizing the methodology; results obtained,
conclusions reached, and recommendations regarding effectiveness and
costs of components of the Epidemiologic Studies to Evaluate Health
Effects of Uranium Milling program.
Application Content
The entire application, including appendices, should not exceed 40
pages and the Proposal Narrative section contained therein should not
exceed 25 pages. Pages should be clearly numbered and a complete index
to the application and any appendices included. The original and each
copy of the application must be submitted unstapled and unbound. All
materials must be typewritten, double-spaced, with unreduced type (font
size 12 point) on 8\1/2\'' by 11'' paper, with at least 1'' margins,
headers, and footers, and printed on one side only. Do not include any
spiral or bound materials or pamphlets.
The applicant should provide a detailed budget, with accompanying
justification of all operating expenses, that is consistent with the
stated objectives and planned activities of the project. CDC may not
approve or fund all proposed activities. Applicants should be precise
about the program purpose of each budget item. For contracts described
within the application budget, applicants should name the contractor,
if known; described the services to be performed and provide an
itemized breakdown and justification for the estimated cost of the
contract; the kinds of organizations or parties to be selected; the
period of performance; and the method of selection. Place budget
narrative pages showing, in detail, how funds in each object class will
be spent, directly behind form 424A. Do not put these pages in the body
of the application.
The applicant should provide a detailed description of all
activities.
[[Page 31824]]
A. Title Page
The heading should include the title of the program, project title,
organization, name and address, project director's name and telephone
number.
B. Abstract
A one page, singled-spaced, typed abstract must be submitted with
the application. The heading should include the title of grant program,
project title, organization, name and address, project director and
telephone number. This abstract should include a work plan identifying
activities to be developed, activities to be completed, and a timeline
for completion these activities.
C. Proposal Narrative
The narrative of each application must:
1. Briefly state the applicant's understanding of the need or
problem to be addressed and the purpose of this cooperative agreement.
This should be reflected in a draft protocol for the study.
2. Describe clearly the objectives, the steps to be taken in
planning and implementing this project, and the respective
responsibilities of the applicant for carrying out those steps. Provide
timelines for accomplishing each objective and a method of evaluating
the activities.
3. Inclusion of women, ethnic, and racial groups: Describe how the
CDC policy requirements will be met regarding the inclusion of women,
ethnic, and racial groups in the proposed research. (See Women, Racial
and Ethnic Minorities in the Evaluation Criteria and Other Requirements
sections.)
4. Provide documentation of access to potential study sites with
the sample characteristics specified in the Program Requirements
Section, and provide documentation of anticipated involvement of
management, labor, and community representatives in the study.
5. Document the applicant's expertise in the area of occupational
health, industrial hygiene, health physics, and project management.
6. Document the applicant's ability to provide staff, knowledge,
and other resources required to perform the responsibilities in this
project.
7. Provide the name, qualifications, and proposed time allocation
of the Project Director who will be responsible for administering the
project. Describe staff, experience, facilities, equipment available
for performance of this project, and other resources that define the
applicant's capacity or potential to accomplish the requirements stated
above. List the names (if known), qualifications, and time allocations
of the existing professional staff to be assigned to (or recruited for)
this project, the support staff available for performance of this
project, and the available facilities including space.
8. Human Subjects: State whether or not Humans are subjects in this
proposal. (See Human Subjects in the Evaluation Criteria and Other
Requirements sections.)
9. Provide a detailed budget which indicates: (a) Anticipated costs
for personnel, travel, communications, postage, equipment, supplies,
etc., and (b) all sources of funds to meet those needs.
10. Provide a detailed security plan to ensure that there are
reasonable administrative, technical, and physical safeguards to
prevent unauthorized use or disclosure of records.
Evaluation Criteria
The application will be reviewed and evaluated according to the
following criteria:
A. Understanding of the Problem (15%)
Responsiveness to the purpose of this announcement including:
1. Applicant's understanding of the general objectives, and
2. Evidence of the ability to understand the problem and to propose
effective methodologies for evaluating renal and/or pulmonary effects.
B. Program Personnel (30%)
1. Applicant's technical experience (e.g., in the areas of
occupational health, industrial hygiene, health physics, and project
management),
2. The qualifications (e.g., in the areas of industrial hygiene,
health physics, and occupational safety and health) and time allocation
of the professional staff to be assigned to this project, and
3. The applicant's ability to describe the approach to be used in
carrying out the responsibilities of the applicant in this project.
C. Study Design (30%)
1. Steps proposed in planning and implementing this project and the
respective responsibilities of the applicant for carrying out those
steps,
2. The adequacy of the applicant's evidence of access to study
populations, and
3. 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.
D. Project Planning and Evaluation (15%)
The extent to which the proposed goals and objectives are clearly
stated, time-phased, and measurable. The extent to which the methods
are sufficiently detailed to allow assessment of whether the objectives
can be achieved for the budget period. Clearly stated evaluation method
for evaluating the accomplishments and a detailed security plan to
safeguard and prevent disclosure of records. The extent to which a
qualified plan is proposed that will help achieve the goals stated in
the proposal.
E. Facilities and Resources (10%)
The adequacy of the applicant's facilities, equipment, and other
resources available for performance of this project.
F. Human Subjects (Not Scored)
Whether or not exempt from the Department of Health and Human
Services (DHHS) regulations, 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, (2) protections appear adequate, but there
are comments regarding the protocol, (3) protections appear inadequate
and the Objective Review Group 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. Budget Justification (Not Scored)
The budget will be evaluated to the extent that it is reasonable,
clearly justified, and consistent with the intended use of funds.
Executive Order 12372 Review
This program is not subject to Executive Order 12372 review.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number for this project
is 93.283.
[[Page 31825]]
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from ten or
more individuals and funded by this cooperative agreement will be
subject to review and approval by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act.
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the DHHS Regulations, 45 CFR part 46,
regarding the protection of human subjects. Assurance must be provided
to demonstrate the project will be subject to initial and continuing
review by an appropriate institutional review committee. The applicant
will be responsible for providing assurance in accordance with the
appropriate guidelines and form provided in the application kit.
In addition to other applicable committees, Indian Health Service
(IHS) institutional review committees also must review the project if
any component of IHS will be involved or will support the research. If
any American Indian community is involved, its tribal government must
also approve that portion of the project applicable to it.
Women, Racial and Ethnic Minorities
It is the policy of the Centers for Disease Control and Prevention
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)
to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian, Alaskan Native, Asian, Pacific Islander, Black and
Hispanic. Applicants shall ensure that women, racial and ethnic
minority populations are appropriately represented in applications for
research involving human subjects. Where clear and compelling rationale
exist that inclusion is inappropriate or not feasible, this situation
must be explained as part of the application. This policy does not
apply to research studies when the investigator cannot control the
race, ethnicity and/or sex of subjects. Further guidance to this policy
is contained in the Federal Register, Vol. 60, No. 179, pages 47947-
47951, and dated Friday, September 15, 1995.
Application Submission and Deadline
A. Preapplication Letter of Intent
Although not a prerequisite of application, a non-binding letter of
intent-to-apply is requested from potential applicants. The letter
should be submitted to Victoria F. Sepe, Grants Management Specialist,
Grants Management Branch, CDC at the address listed in this section. It
should be postmarked no later than July 11, 1997. The letter should
identify the Program Announcement number 757 and the name of principal
investigator. The letter of intent does not influence review or funding
decisions, but it will enable CDC to plan the review more efficiently
and will ensure that each applicant receives timely and relevant
information prior to application submission.
B. Application
The original and four copies of the application PHS Form 398
(Revised 5/95, OMB Number 0925-0001) must be submitted to Victoria
Sepe, Grants Management Specialist, Grants Management Branch,
Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), Mailstop E-13, 255 East Paces Ferry Road, NE., Room
321, Atlanta, GA 30305, on or before July 25, 1997.
1. Deadline: Applications will 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 group. (The applicants must request
a legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks will not be acceptable as proof of timely mailing.)
2. Late Applicants: Applications that do not meet the criteria in
1.(a) or 1.(b) above are considered late applications. Late
applications will not be considered in the current competition and will
be returned to the applicants.
Where To Obtain Additional Information
To receive additional written information call (404) 332-4561. You
will be asked to leave your name, address, and telephone number and
will need to refer to NIOSH Announcement 757. You will receive a
complete program description, information on application procedures,
and application forms. CDC will not send application kits by facsimile
or express mail.
Please refer to Announcement Number 757 when requesting information
and submitting an application.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Victoria Sepe, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), Mailstop E-13, Room 321, 255 East Paces Ferry Road,
NE., Atlanta, GA 30305, telephone (404) 842-6804, Internet:
vxw1@cdc.gov.
Programmatic technical assistance may be obtained from Lynne E.
Pinkerton, M.D., M.P.H., Medical Officer, Epidemiology 1 Section,
Industrywide Studies Branch, Division of Surveillance, Hazard
Evaluations, and Field Studies, National Institute for Occupational
Safety and Health, Centers for Disease Control and Prevention (CDC),
Mailstop R-15, 4676 Columbia Parkway, Cincinnati, OH 45226, telephone
(513) 841-4344, Internet: [email protected]
Potential applicants may obtain a copy of Healthy People 2000 (Full
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary
Report, Stock No. 017-001-00473-1) referenced in the Introduction
section through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325, telephone (202) 512-1800.
This and other CDC announcements are available through the CDC
homepage on the Internet. The address for the CDC homepage is: http://
www.cdc.gov.
Dated: June 4, 1997.
Diane D. Porter,
Acting Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention (CDC).
[FR Doc. 97-15179 Filed 6-10-97; 8:45 am]
BILLING CODE 4163-19-P
