DYNAMIC HEALTH ASSESSMENTS FOR MEDICAL REHABILITATION OUTCOME
RELEASE DATE: August 21, 2002
RFA: HD-02-024
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
National Eye Institute (NEI)
(http://www.nei.nih.gov)
LETTER OF INTENT RECEIPT DATE: February 11, 2003
APPLICATION RECEIPT DATE: March 11, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Center for Medical Rehabilitation Research (NCMRR) at the
National Institute of Child Health and Human Development (NICHD) and the
National Eye Institute (NEI) seek to fund health assessment research focused
on disability concepts such as quality of life, health, functional and social
interaction status for persons with disabilities. The goal of this Request
for Applications (RFA) is to encourage multidisciplinary research on the
measurement of the health of persons with disabilities utilizing techniques
such as computer adaptive testing or simulations to improve the quality and
scientific power of data. The planning grants invited through this RFA will
provide a mechanism for early peer review of the rationale and design of the
potential health assessments and collaborations, and will provide successful
applicants with resources to assist in development of detailed health
assessments. This approach may be useful in developing an assessment tool
that could be used to diagnose or to document the impact of a rehabilitation
intervention. This approach may result in a tool for better evaluating
medical interventions at the impairment level and also lead to better
understanding of the relationship between health challenges and disability
concepts for individuals in widely differing circumstances.
The purpose of the planning grant is to obtain detailed information on
specific aspects of the proposed research. This may include organizing an
effective research group, developing a theoretical perspective, utilizing a
unique methodological approach and identifying or devising appropriate
instruments. Involvement of representatives from the targeted patient
populations in planning and conducting the research effort is highly
recommended. A phase II initiative is anticipated that will implement the
dynamic health assessment instrument in populations of interest.
RESEARCH OBJECTIVES
Background
Millions of people in the United States suffer disabling injuries or diseases
each year. Over 50 million individuals live with chronic physical
impairments and disabilities due to conditions such as cerebral palsy,
metabolic disorders, burns, arthritis, etc. For individuals with
disabilities, the process of rehabilitation may begin with acute illness and
continue through integration into the community. Thus, this population is a
valuable resource in understanding the relationship between the nature of a
health condition and the role of environmental and social interactions in
their health status. However, there is a dearth of measures that are
responsive and sensitive enough to track changes in disability from inpatient
rehabilitation to community participation or from pathophysiology to
community participation
Research Scope
With the increasing population of persons with disabilities, advances in
computer science, proliferation of new medical and treatment interventions,
and availability of a variety of outcome measures, there is a need as well as
a capacity for developing an efficient health assessment. One of the major
goals of the rehabilitation intervention is to improve the independence and
quality of life of the individual. An important challenge is to develop
instruments to measure these and other improvements in a valid and reliable
way. To accomplish this task, an instrument should incorporate advances in
areas such as: self-reports, research design, measurement techniques, data
collection processes and analytic methods.
Multidisciplinary approaches are strongly encouraged. Potential applicants
are urged to explore the ideas and methods developed in social science and
behavioral fields other than their own. Consulting relevant literature and
collaborating with colleagues from other disciplines may provide important
opportunities for cross-fertilization in developing improved methodology and
measurement.
Potential applicants specifically concerned with research regarding the
social and cultural dimensions of health should view two conference
proceedings:
In June 2000, the Office of Behavioral and Social Sciences Research held a
conference, "Toward Higher Levels of Analysis: Progress and Promise in
Research on Social and Cultural Dimensions of Health." In an agenda-setting
activity that followed the conference, a panel of scientists developed an
ambitious research agenda on the social and cultural dimensions of health. A
program announcement based on the panel's recommendations for substantive
research has been issued by the OBSSR and can be found at:
https://grants.nih.gov/grants/guide/pa-files/PA-02-043.html. However,
the research agenda also included detailed recommendations relating to needed
methodological research related to the social and cultural dimensions of
health. Potential applicants are encouraged to consult this report,
available at http://obssr.od.nih.gov/Conf_Wkshp/higherlevel/conference.html.
In September 2001, NIH sponsored an International Conference entitled "Stigma
and Global Health: Developing a Research Agenda." Among the recommendations
was to encourage research intended to develop methodological, evaluative, and
analytic tools for 1) studying stigma and its consequences with respect to
health and 2) development, evaluation, and optimization of interventions to
prevent or mitigate the negative effects of stigma and discrimination on
health. In both areas it was recommended that the social and cultural
dimensions of stigma and its manifestations be included. Applicants are
encouraged to refer to the stigma conference website
(http://www.stigmaconference.nih.gov) for further resources and
information.
Some examples of the topics that might be addressed in an application
responsive to this RFA are listed below:
o Processes Underlying Self-Report
o Processes Underlying Observation Measures
o Research Design
o Measurement Issues
o Data Collection Techniques
o Analytic Methods
o Data Display
(1) PROCESSES UNDERLYING SELF-REPORTS: Issues related to self-reports that
need to be taken into consideration are: comprehension of questions;
retrieval of information from memory; and use of heuristics and prior beliefs
in formulating responses. These may not only influence how one responds to
the question, but which individuals with disabilities may be able to respond.
(2) PROCESSES UNDERLYING OBSERVATION MEASURES: The rehabilitation health
professional is called upon to make subjective observations concerning the
progress of individuals receiving interventions. Continued improvement and
innovation in gathering clinical interview information and observational
methods is needed to understand how various methods work in diverse
rehabilitation populations and how they can be modified to address specific
needs of individuals. Techniques for validating and replicating findings
from qualitative research, including collection strategies, development of
coding protocols, and techniques that facilitate the integration and
validation of qualitative and quantitative measurement.
(3) RESEARCH DESIGN: Research design determines to a large extent how well a
research plan can accomplish stated purposes and test hypotheses. As a
result, the application should address the pilot sampling plan: selection of
appropriate study designs, methods, procedures, and measures, to assure
confidence in the study's internal and external validity. In addition,
methods for archiving and disseminating complex datasets, especially
longitudinal datasets on individuals with disabilities, in ways that protect
identifiers of study participants so that the datasets can be used by
investigators who were not part of the original research team.
(4) MEASUREMENT ISSUES: The dimensions covered and the depth of coverage
must be appropriate for specific rehabilitation patients in whom they are
applied. Ceiling and floor effects can occur when an instrument or certain
scales of an instrument are used for a group of individuals who have much
better or worse function than the scales are designed to measure. Balancing
the length of the instrument to solicit sufficient information in any
particular content area, but not increase the burden on the respondent is
another issue to consider. How to combine existing measures into a
comprehensive measure is also a challenge. Use of the instrument to provide
individual status versus group status is another area to consider.
(5) DATA COLLECTION TECHNIQUES: Innovative methodologies for data collection
can result in the collection of new or more complex types of data by
rehabilitation health professionals. Recent developments in computer-
assisted testing have permitted more complex question sequences as well as
web-based data collection. Utilizing virtual environments to simulate
consistent environments is another potential innovation. In addition, the
development of hand-held beepers programmed for data entry has permitted the
collection of time-specific data. How these or other advances will be used
with individuals with disabilities should be addressed.
(6) ANALYTIC METHODS: The goal of new and improved analytic methods is to
help make estimation, hypothesis testing, and causal modeling based upon
scientific data as sound as possible. Challenges include developing
techniques that distinguish underlying regularities from the 'noise' created
by variability and imprecise measurement, and developing appropriate analytic
techniques for use with new kinds of data and new approaches to
rehabilitation research.
(7) DATA DISPLAY: Making the results of the health assessment useful to
clinicians is another goal. One approach to this is to provide graphic or
other display of data that is interpretable to clinicians.
MECHANISM OF SUPPORT
This RFA will use NIH Exploratory/Development Grant (R21) award mechanism.
As an applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. The
anticipated award date is December 2003.
The R21 mechanism is to be used for support of creative, novel, and/or high
risk/high payoff approaches that could produce innovative advances in this
field. The R21 provides the means to acquire the necessary pilot
information, to attract talented new investigators, to carry out feasibility
studies and protocol planning, to incorporate new concepts from related
disciplines, and to foster the development of interdisciplinary, inter-
institutional collaborative efforts among investigators with diverse training
and expertise. These grants are non-renewable, and may not be used to
supplement an ongoing grant.
This RFA uses just-in-time concepts. It also uses the modular budgeting
format (see https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format.
FUNDS AVAILABLE
The participating institutes intend to commit approximately $1.5 million
(NICHD $1 million and NEI $500,000) in total costs [Direct plus Facilities
and Administrative (F&A) costs] in FY 2003 to fund up to 10 new grants in
response to this RFA. An applicant for an R21 may request a project period
of up to three years and a budget of $100,000 per year in direct costs.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the NICHD and NEI
provide support for this program, awards pursuant to this RFA are contingent
upon the availability of funds and the receipt of a sufficient number of
meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Domestic or foreign
o Faith-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Applicants will be expected to budget one meeting of funded Principal
Investigators in the Washington DC area each year.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Louis Quatrano, Ph.D.
Behavioral Sciences and Rehabilitation Engineering
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-402-4221
FAX: 301-496-0832
E-mail: quatranl@exchange.nih.gov
Maryann Redford, D.D.S., MPH
Director, Collaborative Clinical Research
National Eye Institute
Executive Plaza South,
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda MD 20892-7164
Telephone: 301-451-2020
FAX: 301-402-0528
Email: maryann.redford@nei.nih.gov
o Direct your questions about peer review issues to:
Robert H. Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-496-1485
FAX: 301-402-4104
Email: stretchr@nih.gov
o Direct your questions about financial or grants management matters to:
Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Telephone: 301-435-6996
FAX: 301-402-0915
Email: cm143g@nih.gov
William W. Darby
Grants Management Officer
National Eye Institute
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda MD 20892-7164
Telephone: 301-451-2020
FAX: 301-496-9997
Email: wwd@nei.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NICHD staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Louis Quatrano, Ph.D.
Behavioral Sciences and Rehabilitation Engineering
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-402-4221
FAX: 301-496-0832
Email: quatranl@exchange.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS: The Research Plan for the R21 application need
not include preliminary data and should be limited to 15 pages. Appendices
may not be submitted.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center for Scientific Review
National Institutes f Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Robert H. Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NICHD and NEI. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NICHD in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the NICHD National Advisory Council or
Board.
REVIEW CRITERIA
The NIH R21 "planning grant" is a mechanism for supporting exploratory
development projects that can realistically be expected to be completed in
three years and that require only a modest level of funding. Because this is
a planning grant, the application will not have the same level of detail or
extensive discussion found in an R01 application. Accordingly, reviewers
should evaluate the conceptual framework and general approach to the problem,
placing less emphasis on methodological details and certain indicators
traditionally used in evaluating the scientific merit of R01 applications
(e.g., hypothesis-driven design, supportive preliminary data).
In the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Scientific significance of the proposed assessment,
including analysis of the need and potential impact on health care,
comparison with competitive assessments, and relevance of the proposed
assessment to rehabilitation outcomes desired by the target patient
population.
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics? Is there an adequate basis for the project in relevant literature?
(3) INNOVATION: What is the potential of the proposed planning activity to
lead to a reliable and valid assessment that is briefer, more flexible, more
efficient, and a more precise assessment than conventional methods? Does
your project employ novel concepts, approaches or methods? Are the aims
original and innovative? Does your project challenge existing paradigms or
develop new methodologies or technologies?
(4) INVESTIGATOR: Qualifications and research experience of the principal
investigator in developing assessments, and for instrument development, a
group of multidisciplinary investigators, and a clear statement of the
leadership and proposed organization of the assessment team.
(5) ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the potential of the proposed planning activity to
establish necessary collaborative linkages, and the capacity of the group to
analyze data and prepare clinically relevant reports?
ADDITIONAL REVIEW CRITERIA
In addition to the above criteria, your application will also be reviewed
with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below.)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the requested budget and period of support
in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 11, 2003
Application Receipt Date: March 11, 2003
Peer Review Date: June/July 2003
Council Review: September/October 2003
Earliest Anticipated Start Date: December 1, 2003
AWARD CRITERIA
Criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete
copy of the updated Guidelines is available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants
may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance Nos. 93.929, and 93.867 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.