[Federal Register Volume 68, Number 74 (Thursday, April 17, 2003)]
[Notices]
[Pages 18984-18987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9424]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03049]


Research on the Impact of Law on Public Health; Notice of 
Availability of Funds

A. 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. 300u-3, as amended. The Catalog of Federal 
Domestic Assistance number is 93.283.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a grant program for 
research to evaluate the impact of law on public health. This program 
addresses all the ``Healthy People 2010'' focus areas.
    The purpose of the program is to stimulate research evaluating the 
implementation and impact of law on the prevention and control of 
death, disease, injury, and disability, on health promotion, on the 
conduct of public health services, and on the public health system and 
infrastructure. In this context, ``law'' means statutes, regulations 
and rules, contract specifications, licensing requirements, case law 
and other judicial rulings, and other legally enforceable policies of 
the federal government, state governments and their political 
subdivisions, tribes, and territories.
    Special emphasis will be given to research that will produce, on an 
accelerated basis, scientifically valid findings that can be used to 
improve law's contribution to public health preparedness for, and 
response to, terrorism, outbreaks of infectious disease, and other 
major public health threats and emergencies.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the CDC Public Health Practice Program 
Office (PHPPO): Prepare state and local health systems, departments and 
laboratories to respond to current and emerging public health threats.

C. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, technical schools, research institutions, 
public health and healthcare organizations, community-based 
organizations, faith-based organizations, and other public and private 
nonprofit organizations, State and local governments or their bona fide 
agents, including the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Commonwealth of the Northern Mariana 
Islands, American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau, federally 
recognized Indian tribal governments, Indian tribes, or Indian tribal 
organizations.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

    Applications that are incomplete or non-responsive to the below 
requirements will be returned to the applicant without further 
consideration. The following are applicant requirements:
    1. A principal investigator who has conducted scientific 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 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 research 
objectives and those described under the heading ``Program 
Requirements.''

D. Funding

Availability of Funds

    Approximately $500,000 is available in FY 2003 to fund 
approximately three awards. It is expected that the average award will 
be $165,000, ranging from $150,000 to $250,000. It is expected that the 
awards will begin on or about September 1, 2003, and will be made for a 
12-month budget period within a project period of up to three 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.

Recipient Financial Participation

    Matching funds are not required for this program.

E. Program Requirements

    Research applications are solicited that address the specific 
program areas of interest below (not listed in priority order), and 
other areas the applicant demonstrates are significant for improved 
public health.
    1. Terrorism: The impact of laws on public health preparedness for, 
and response to terrorism.
    2. Infectious Diseases: The impact of laws on the prevention and 
transmission of diseases not related to terrorism, on the prevention of 
drug-resistant disease, and on patient safety.
    3. Public Health Reporting: The effectiveness of state and local 
laws regarding the reporting of disease, injury, disability, and risk 
factors associated with those conditions.
    4. Child, Adolescent, and Adult Health:
    a. The impact of the absence of school-entry immunization laws on 
immunization levels.
    b. The impact of legislatively mandated immunization insurance 
benefits (e.g., first-dollar coverage laws) and of their enforcement on 
immunization levels.
    c. The impact of standing orders laws on adult immunization levels.
    d. The impact of state laws and case law on adolescent access to 
health care services and participation in research.
    e. The impact of alcohol taxes on adolescent alcohol use and 
alcohol-related conditions.
    5. HIV, STDs, and Tuberculosis: The impact of laws on the 
occurrence and transmission of HIV, sexually transmitted diseases, and 
tuberculosis, and the impact of laws on implementation of rapid HIV 
testing.
    6. Injury: The impact of legislative and regulatory interventions 
on injury, and the impact of differing levels of their enforcement on 
injury.
    7. The Built Environment and Public Health: The impact of State and 
local laws on the impact the Built Environment has on the health of the 
public.
    8. Chronic Diseases:
    a. The impact of State and local laws on chronic diseases and on 
risk factors for chronic diseases, with special

[[Page 18985]]

emphasis on diabetes, obesity, tobacco, physical activity, and 
nutrition.
    b. The impact of state and local laws on utilization of cancer 
screening services, on cancer incidence and mortality reporting, and on 
the variability of state coverage for Medicaid cancer services 
(including screening, diagnosis, treatment, and post-treatment 
services).
    c. The impact of State and local laws on the occurrence of 
environmental health hazards (e.g., mold and poor indoor air quality) 
in schools and on subsequent health and learning effects on students.
    d. The impact of laws on self-administration of prescribed 
medications for students and on subsequent health and learning effects 
on students.
    e. The impact of laws on the location of schools (e.g., in 
proximity to hazardous waste sites) and on subsequent health and 
learning effects on students.
    9. Occupational Health: The impact of Federal and State 
regulations, municipal ordinances, contract specifications, and health-
related litigation on the safety and health of workers.
    10. Public Health System: The impact of laws on the public health 
system and infrastructure and on the capacity of the public health 
workforce, health departments and laboratories, and private entities to 
perform essential public health services.
    11. Public Health Practice:
    a. The impact on public health practice of the ``Standards for 
Privacy of Individually Identifiable Health Information'' (the Privacy 
Rule) of the Health Insurance Portability and Accountability Act.
    b. The impact of privacy laws on establishment and use of 
electronic medical records, in general, and on immunization and other 
public health registries, in particular.
    For all these programmatic areas, it is the intent of this program 
to fund applications comprising innovative, multi-disciplinary research 
strategies. Model approaches also are sought for evaluating the impact 
of public health laws, within or across different areas of public 
health (e.g., infectious diseases, chronic diseases, environmental 
health, injury prevention, and public health systems and 
infrastructure).
    As appropriate and feasible, applicants 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; frequency of risk or of preventive behaviors; 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, the capacity of public 
health systems infrastructure, the quality and quantity of prevention 
services and public health practice, and other measures.
    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, including 
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). Information on implementation also may address factors 
that may either impede or promote the contribution laws make to public 
health.

F. Content

Letter of Intent (LOI)

    An LOI is required for this program. LOIs will be evaluated to 
determine which applicants will be invited to submit a full application 
based on the reviewer's evaluation of the LOI, as described in 
Evaluation Criteria. LOIs must be no more than four pages, double-
spaced, printed on one side, with one-inch margins, and unreduced 12-
point font.
Mandatory Identifying Information
    The following identifying information must appear only on the first 
page of the LOI:
    1. The Program Announcement and number.
    2. The name, address, telephone number, and fax number of the 
applicant and the e-mail address of a contact person.
    3. The names, degrees, and titles of the principal investigator and 
all key project personnel.

This identifying information must not appear on the second, third or 
the fourth page.
Mandatory Project Information
    The following information on the proposed research project must 
appear on the second, third and fourth pages:
    1. A narrative description of the proposed research plan.
    2. The number of months or years the project will take to 
completion.
    3. The total funding required for each year of the project.

LOIs that do not include the mandatory information will be deemed non-
responsive; the applicants will not be invited to submit full 
applications.

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Programmatic Interest Areas, 
Program Requirements, Other Requirements, and Evaluation Criteria 
sections to develop the application content. Your PHS 398 (OMB Number 
0925-0001) application will be evaluated on the criteria listed, so it 
is important to follow them in laying out your program plan. The 
narrative should be no more than 25 pages, single-spaced, printed on 
one side, with one-inch margins, and unreduced 12-point font.
    The narrative should consist of, at a minimum, a plan, objectives, 
methods, evaluation and budget. Applications for research on the impact 
of public health laws should include the following information:
    1. The project's focus that justifies the research needs and 
describes the scientific basis for the research, the expected outcome, 
and the relevance of the findings to improving law's contribution to 
public health.
    2. Specific, measurable, and time-framed objectives.
    3. A detailed plan describing the methods by which the objectives 
will be achieved, including their sequence. A comprehensive evaluation 
plan is an essential component of the application.
    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, including their 
title, qualifications, experience, percentage of time each will devote 
to the project, as well as the 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, including a letter of 
commitment from each and a clear statement of their role.
    8. A detailed first year's budget for the grant with future annual 
projections, if relevant, including direct and indirect costs.

[[Page 18986]]

G. Submission and Deadline

Letter of Intent (LOI) Submission

    The LOI must be received by 4 p.m. Eastern Time May 9, 2003. Submit 
the LOI to: Technical Information Management--PA03049, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.
    LOIs may not be submitted electronically.

Application Forms

    Submit the original and two copies of PHS 398 (OMB Number 0925-
0001) (Errata Instruction Sheet for PHS 398 is posted on the CDC Web 
site.) Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm. If you do not have access to the 
Internet, or if you have difficulty accessing the forms on-line, you 
may contact the CDC Procurement and Grants Office Technical Information 
Management Section (PGO-TIM) at: 770-488-2700. Application forms can be 
mailed to you.

Submission Date, Time, and Address

    The application must be received by 4 p.m. Eastern Time, July 9, 
2003.
    Submit the application to: Technical Information Management--
PA03049, Procurement and Grants Office, Centers for Disease 
Control and Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 
30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Letters of intent and applications shall be considered as meeting 
the deadline if they are received before 4 p.m. Eastern Time on the 
deadline date. Applicants sending applications by the United States 
Postal Service or commercial delivery services must ensure that the 
carrier will be able to guarantee delivery of the application by the 
closing date and time. If an application is received after closing due 
to 1) carrier error, when the carrier accepted the package with a 
guarantee for delivery by the closing date and time, or 2) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Applications that do not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Letter of Intent

    The Letter of Intent (LOI) will be reviewed by a panel to include 
reviewers other than CDC staff from the funding Centers/Institutes/
Offices, and who will be involved in the peer review panel for the 
applications. The panel will review the LOI to determine if it 
indicates research of sufficient relevance to CDC program priorities 
and potential scientific significance to warrant submission of a full 
application. Only principal investigators whose LOIs are determined to 
meet these criteria will be requested to submit full applications. 
Evaluation criteria to be applied include the following:
    1. Relevance to CDC program priorities; (60 percent)
    2. Potential Scientific Significance. (40 percent)

Application

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the grant. Measures of effectiveness must relate to the 
performance goal stated in the purpose section of this announcement. 
Measures must be objective and quantitative and must measure the 
intended outcome. These measures of effectiveness shall be submitted 
with the application and will be an element of evaluation.
    Applications will be reviewed for completeness and responsiveness 
as outlined under the ``Eligible Applicants'' Section (Items one 
through four.) Incomplete applications and applications that are not 
responsive will be returned to the applicant without further 
consideration. It is especially important that the applicant's abstract 
reflects the project's focus, because the abstract will be used to help 
determine the responsiveness of the application.
    Applications which are complete and responsive may be subjected to 
a preliminary evaluation procedure by a peer review group to determine 
if the application is of sufficient technical and scientific merit to 
warrant further review; 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 peer review group.
    Criteria to be considered in the review are listed below.
    All criteria are of equal importance, however, an application does 
not need to be strong in all categories to be judged likely to have a 
major scientific impact.
    1. Significance--Does this study address an important problem? If 
the aims of the application are achieved, how will scientific knowledge 
be advanced? What will be the effect of this study on the concepts or 
methods that drive this field?
    2. Approach--Are the conceptual framework, design, 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? Does the project include plans 
to measure progress toward achieving the stated objectives? Is there an 
appropriate work plan included?
    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?
    4. Investigator--Is the principal 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 significant investigator participants?
    5. Environment--Does the scientific environment in which the work 
will be done contribute to the probability of success? Does the 
proposed research take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? Is there an appropriate degree of 
commitment and cooperation of other interested parties as evidenced by 
letters detailing the nature and extent of the involvement?
    6. Human Subjects--Does the application adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects? An application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable.
    Does the application adequately address 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.

[[Page 18987]]

    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 communities and recognition of mutual benefits.
    7. Dissemination--What plans have been articulated for 
disseminating findings?
    A second programmatic review will be conducted by a panel of Senior 
Federal Officials. The 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 importance of the proposed research for meeting the primary 
goals of this initiative, as described in ``Program Requirements'' 
section.
    3. Budgetary considerations.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original plus two copies of:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activities and Objectives.
    b. Current Budget Period Financial Status.
    c. New Budget Period Proposed Activities and Objectives.
    d. Detailed Line-Item Budget and Justification for the new budget 
period.
    e. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, 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.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of this 
announcement as posted on the CDC Web site.

AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7 Executive Order 12372 Review
AR-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
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
AR-15 Proof of Non-Profit Status (if applicable)

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC home page Internet address--
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative 
Agreements''.
    Business management technical assistance may be obtained from: 
Merlin J. Williams, Grants Management Specialist, Procurement and 
Grants Office, Centers for Disease Control and Prevention, 2920 
Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: 
770-488-2765, E-mail address: [email protected].
    For program technical assistance, contact: Anthony D. Moulton, PhD, 
Public Health Law Program, Public Health Program Practice Office, 
Centers for Disease Control and Prevention, 4770 Buford Hwy. (K-36), 
Atlanta, Georgia 30341-3724, Phone: 770-488-2405/Fax 770-488-2474, E-
mail: [email protected].

    Dated: April 11, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-9424 Filed 4-16-03; 8:45 am]
BILLING CODE 4163-18-P