[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: 
[email protected].
    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