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 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 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 (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: zri4@cdc.gov

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: ADM6@CDC.GOV