[Federal Register Volume 65, Number 49 (Monday, March 13, 2000)]
[Notices]
[Pages 13391-13394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00051]


Research on the Impact of Laws and Policies on Public Health 
Notice of Availability of Funds

A. Purpose

    In cooperation with the Office of Prevention Research (Prevention 
Research Initiative), the Public Health Practice Program Office at the 
Centers for Disease Control and Prevention (CDC) announces the 
availability of Fiscal Year (FY) 2000 funds for grant applications for 
research to evaluate the impact of laws and policies on public health. 
CDC is committed to achieving

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the health promotion and disease prevention objectives of ``Healthy 
People 2010,'' a national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to 
multiple Healthy People objectives and especially to objective 23-15. 
For the conference copy of ``Healthy People 2010'' visit the internet 
site: http://www.health.gov/healthypeople.
    The purpose of this program is to stimulate research evaluating the 
implementation and impact of federal, state, and local statutes, 
regulations, contract specifications, licensing requirements, and other 
legally enforceable public policies on the prevention of death, 
disease, injury, and disability, on the promotion of health, and on the 
conduct of public health services. Research is expected to produce 
scientific findings of interest to public health practitioners and 
policy makers at the state, local, and federal levels.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-profit organizations, small and minority women owned businesses, 
and by governments and their agencies; that is, universities, colleges, 
research institutions, other public and private nonprofit and for-
profit organizations, State and local governments or their bona fide 
agents, and federally recognized Indian tribal governments, Indian 
tribes, or Indian tribal organizations.

    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement, contract, loan 
or any other form.

C. Availability of Funds

    Approximately $500,000 is available in FY 2000 to fund 
approximately 2-3 research project grants. Awards are anticipated to 
range from $150,000 to $250,000 in total costs (direct and indirect) 
per year. It is expected that the awards will begin on or about 
September 30, 2000, and will be made for a 12-month budget period 
within a project period not to exceed 3 years. Funding estimates may 
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 in subsequent years.

Use of Funds

    Note: Grant funds will not be made available to support the 
provision of direct care services. Eligible applicants may enter 
into contracts, including consortia agreements (as set forth in the 
PHS Grants Policy Statement) as necessary to meet the requirements 
of the program and strengthen the overall application.

D. Programmatic Interest Areas

    Research applications are requested that address: (1) The specific 
areas of interest below (not listed in priority order), and (2) other 
areas that the applicant demonstrates are significant for the purpose 
identified in Section A of this announcement.

(1) Immunization

    The impact of laws on the achievement of recommended immunization 
rates or related public health services. For example, (a) the impact of 
laws relevant to state immunization registries (e.g., laws related to 
privacy/confidentiality of individual patient health care information, 
sharing of immunization information, and establishment of immunization 
registries) on immunization rates and/or on the development, quality, 
provider participation in, and coverage of state immunization 
registries; (b) comparison of the impact of alternative state laws for 
school enrollment and alternative approaches to their implementation 
(e.g., evaluating the impact of different requirements, implementation 
policies and programs, and attitudes of key stakeholders).

(2) HIV and Sexually Transmitted Diseases

    The impact of state or local laws and their enforcement on HIV/STD 
risk behaviors and incidence or on the use of preventive health 
services; for example: laws that proscribe certain sexual behaviors 
(e.g., sodomy laws), laws that regulate access to or possession of drug 
paraphernalia, laws mandating HIV testing of newborns, criminal 
penalties for drug use during pregnancy, laws that seek to affect youth 
behavior (e.g., curfews and/or drinking age), and laws that criminalize 
the knowing transmission of HIV or that require disclosure of HIV or 
other STD infection to sexual partners.

(3) Injury Related to Motor Vehicles

    The impact of state requirements for licensure of adolescents and 
older drivers on their mobility, health, and safety (crash, injury, or 
fatality risks).

(4) Occupational Safety and Health

    The impact of the following laws pertaining to the prevention of 
work injuries and diseases: (a) California and/or Washington state 
ergonomic standards to prevent work-related musculoskeletal disorders; 
(b) State ``needle-stick'' laws requiring safety-engineered devices and 
related measures to prevent ``needle stick'' injuries among health care 
workers; (c) State and local laws and requirements for ensuring 
healthful indoor air quality for office workers; and, (d) federal 
health standards of the Occupational Safety and Health Administration 
and Mine Safety and Health Administration for preventing occupational, 
noise-induced hearing loss among workers.

(5) Public Health Reporting Laws

    Impact of state public health laws and requirements for reporting 
by health care providers and medical testing laboratories (e.g., 
reporting of infectious disease cases and cases of elevated blood 
lead).

(6) Emergency Public Health Practice

    Impact of federal, state, and local laws on the preparedness of 
public health organizations for, and their response to: natural 
disasters, unintended releases of hazardous chemical or biological 
agents, threats and incidents of terrorism, and other types of 
disasters.

(7) Urban Planning

    Impact of local laws and requirements on infectious, chronic, and 
environmental diseases and their risk factors (e.g., air quality and 
respiratory diseases such as asthma, physical exercise, obesity, and 
cardiovascular disease), and on injury (e.g., pedestrian and cycling 
injuries).

(8) Infectious Disease Screening and Treatment for Immigrants

    Impact of infectious disease requirements of U.S. immigration laws 
on the appropriateness and quality of screening and treatment for 
infectious diseases provided to immigrants.

(9) Public Health System and Infrastructure

    Impact of laws on the public health system and its infrastructure: 
organizations; information, communications, laboratories, and other 
systems; and public health workforce; (e.g., laws pertaining to 
performance standards, practitioner competencies, and accountability 
for public health services).
    For all of these programmatic areas, it is the intent of this grant 
program to fund applications comprising

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innovative, multi-disciplinary research strategies. Model approaches 
are sought for evaluating the impact of public health laws, within or 
across different areas of public health (e.g., infectious diseases, 
chronic diseases and health promotion, environmental health, injury 
prevention, occupational safety and health, and public health systems).
    As appropriate and feasible, applications are encouraged to address 
the fullest complement of possible measures for assessing outcomes. 
These measures could include health and safety outcomes (e.g., 
frequency and severity of injury, illness, disability, or hazard 
exposure); economic outcomes (e.g., costs at the level of the 
individual, household, community, industry, or society; or distribution 
of costs among payers); social outcomes (e.g., impact on educational 
attainment, employment); as well as measures of change in behavior, 
knowledge, attitudes, use of technological interventions, organization 
of public health systems, quality and quantity of prevention services 
and public health practice and other proximate measures associated with 
health and other outcomes.
    Applications are encouraged which include plans to obtain and 
analyze information on the implementation of the referenced laws, as 
appropriate and necessary for evaluating their impact. Quantitative and 
qualitative information on application, enforcement, or compliance 
activities associated with a law under evaluation, and on compliance-
related knowledge, attitudes, and behaviors of the target audience(s), 
will often be important to the interpretation and inferential value of 
statistical findings on outcomes generated through regression analyses 
and other statistical methods. Information on implementation also may 
address factors that may either impede or promote the impact of laws 
and policies on public health.

E. Program Requirements

    The following are applicant requirements:
    1. A principal investigator who has conducted research, published 
the findings in peer-reviewed journals, and has specific authority and 
responsibility to carry out the proposed project.
    2. Demonstrated experience (on the applicant's project team) in 
conducting, evaluating, and publishing in peer-reviewed journals 
research evaluating public health law or other public policies, 
programs or interventions.
    3. Effective and well-defined working relationships within the 
performing organization and with outside entities that will ensure 
implementation of the proposed activities.
    4. The overall match between the applicant's proposed theme and 
research objectives described under the heading ``Programmatic Interest 
Areas.''

F. Application Content

Letter of Intent (LOI)

    Prospective applicants are asked to submit, by April 21, 2000, a 
letter of intent that includes the number and title of the 
Announcement, a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, and the 
identities of other key personnel and participating institutions. 
Although a letter of intent is not required, is not binding, and is not 
used in the review of an application, the information that it contains 
is used to estimate the potential review workload and avoid conflict of 
interest in the review. The letter of intent is to be submitted to the 
Grants Management Specialist listed under ``Where to Obtain Additional 
Information'' section of this announcement.

Application

    Use the information in the Programmatic Interest Areas, Evaluation 
Criteria and Other Requirements 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 research proposal.
    The grant applications for research on the impact of public health 
laws should include:
    1. Justification of the research needs and explanation of the 
scientific basis for the research, the expected outcome, and the 
relevance of the findings to preventing disease, injury, and 
disability.
    2. Specific, measurable, and explicitly scheduled objectives.
    3. A detailed plan describing the methods by which the objectives 
will be achieved, including their sequence.
    4. A description of the role and responsibilities of the principal 
investigator.
    5. A description of all the project staff and their role in the 
proposed research, regardless of their funding source. It should 
include their title, qualifications, experience, responsibilities in 
the proposed research, percentage of time each will devote to the 
research, as well as that portion of their salary to be paid by the 
grant.
    6. A description of those activities related to, but not supported 
by the grant.
    7. A description of the involvement of other entities that will 
relate to the proposed research, if applicable. It should include 
letters of support and a clear statement of their roles.
    8. A detailed first year's budget for the grant with future annual 
projections.
    An applicant organization has the option of having specific salary 
and fringe benefit amounts for individuals omitted from the copies of 
the application which are made available to outside reviewing groups. 
To exercise this option: on the original and five copies of the 
application, the applicant must use asterisks to indicate those 
individuals for whom salaries and fringe benefits are not shown; the 
subtotals must still be shown.

G. Submission and Deadline

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001). (Adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are in the application kit and are also available at 
the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    In addition to sending the original and five copies of the 
proposal, please also enclose a copy of the proposal on a 3.5 diskette 
in WordPerfect, Word, or ASCII format. If you have access to an 
electronic version of PHS-398 (OMB Number 0925-0001), please include 
the electronic forms on the diskette. If you do not have access or 
capability to use an electronic version, please ensure that the 
following items in narrative format are included on your diskette: 
Abstract, Biographical sketches, Research Plan (items A-I), and Other 
Support pages. Label the diskette with your name, operating system, 
software, and proposal title. (Example: John Doe, DOS, WordPerfect 6, 
Public Law Modeling in the 21st Century). If the title is too long, 
please truncate.
    Please submit on or before June 2, 2000, to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.
    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 
submission to the independent review group. (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

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(b) above are considered late applications, will not be considered, and 
will be returned to the applicant.

H. Evaluation Criteria

    Applications that are complete and responsive may be subjected to a 
preliminary evaluation by a peer review group to determine if the 
application is of sufficient technical and scientific merit to warrant 
further review (triage); the CDC will withdraw from further 
consideration applications judged to be noncompetitive and promptly 
notify the principal investigator/program director and the official 
signing for the applicant organization. Those applications judged to be 
competitive will be further evaluated by a dual review process.
    The evaluation process of the proposals will be conducted through a 
secure interactive Internet site. Each competitive application will be 
evaluated individually against the following criteria by a Special 
Emphasis Panel (SEP) appointed by CDC. The SEP will score each proposal 
based on scientific and technical merit. Factors to be considered by 
the SEP include:
    1. Significance--Does this study address an important problem 
related to the research goals outlined in the ``Programmatic Interest 
Areas'' section of this document? If the aims of the application are 
achieved, how would scientific knowledge be advanced? What would be the 
effect of this study on the concepts and methods that drive this field?
    2. Approach--Are the conceptual framework, design (including 
composition of study population), methods, and analyses adequately 
developed, well-integrated and appropriate to the aims of the project? 
Does the applicant acknowledge potential problem areas and consider 
alternative tactics?
    3. Innovation--Does the project employ novel concepts, approaches 
or methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies that can 
serve as models for future research?
    4. Investigator--Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers, 
if any?
    5. Environment--Does the scientific environment in which the work 
will be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
documentation of cooperation from necessary participants in the 
project, where applicable? Is there evidence of institutional support 
and availability of resources necessary to perform the project?
    6. Human Subjects--If Human Subjects are involved, does the 
applicant adequately address the requirements of 45 CFR Part 46 for the 
protection of human subjects?
    7. If Human Subjects are involved, has the applicant met the CDC 
Policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research. This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. 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.
    A second programmatic review will be conducted by a panel of Senior 
Federal Officials. The Senior Federal Officials will review the ranked 
proposals to assure maximal impact and balance of the proposed 
research. The factors to be considered will include:
    1. The results of the peer review.
    2. The imporantance of the proposed research for meeting the 
primary goals of this initiative, as described in ``Programmatic 
Interest Areas.''
    3. Budgetary considerations.

I. Other Requirements

    Technical Reporting Requirements
    Provide CDC with the original plus two copies of:
    1. Annual progress reports.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial status report and performance report, no more 
than 90 days after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    For descriptions of the following Other Requirements, see 
Attachment I in the application package:
AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-4  HIV/AIDS Confidentiality Provisions
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-13  Prohibition on Use of CDC Funds for Certain Gun Control 
Activities

J. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 1704 of the Public Health 
Service Act, 42 U.S.C. section 300u-3, as amended.
    The Catalog of Federal Domestic Assistance number is 93.283.

K. Where To Obtain Additional Information

    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.
    If you have questions after reviewing the contents of all the 
documents, business management assistance may be obtained from: Carrie 
Clark, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Announcement 00051, Centers for Disease 
Control and Prevention 2920 Brandywine Road, Room 3000, Atlanta, GA 
30341, Telephone (770) 488-2719, Email address: [email protected]
    For program technical assistance, contact: Anthony D. Moulton, 
Ph.D., Associate Director for Policy, Program Analysis and Academic 
Programs, Public Health Practice Program Office (PHPPO), Centers for 
Disease Control and Prevention, 4770 Buford Hwy. (K-36), Atlanta, GA 
30341-3724, Phone 770-488-2404/Fax 770-488-2420, E-mail: [email protected]

    Dated: March 7, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers of Disease Control and 
Prevention (CDC).
[FR Doc. 00-6030 Filed 3-10-00; 8:45 am]
BILLING CODE 4163-18-P