RESEARCH INTO MECHANISMS OF FETAL GROWTH RESTRICTION
RELEASE DATE: April 7, 2003
RFA: HD-03-018
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.865
LETTER OF INTENT RECEIPT DATE: June 23, 2003
APPLICATION RECEIPT DATE: July 23, 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 Institute of Child Health and Human Development (NICHD) invites
research grant applications to investigate the mechanisms of fetal growth
restriction. The aim of this initiative is to stimulate research into the
mechanisms of fetal growth restriction and to gain a better understanding of
the factors that regulate fetal growth during pregnancy.
RESEARCH OBJECTIVES
Background
Fetal growth restriction (FGR) results in significant perinatal
complications, including fetal death, prematurity, neonatal death, fetal
compromise in labor, neonatal morbidity, induction of labor, and cesarean
delivery. Studies have shown that nearly half of non-malformed stillborn
fetuses were growth restricted. Neonates with FGR who survive are at
increased risk for neonatal morbidity and mortality. The incidence of fetal
growth restriction is estimated to be approximately five percent in the
general obstetric population. However, the incidence varies depending on the
population under examination (including racial and geographic location). In
assessing perinatal outcome by weight, infants who weigh less than 2,500
grams (five pounds, eight ounces) at term have a perinatal mortality rate
that is five to 30 times greater than that of infants whose birth weights are
at the 50th percentile. The mortality rate is 70 to 100 times higher in
infants who weigh less than 1,500 grams (three pounds, five ounces).
Perinatal asphyxia involving multiple organ systems is one of the most
significant problems in growth-restricted infants. Despite expert neonatal
care, a significant proportion of these children suffer impairments (often
neurological) in childhood. In addition, there is evidence to suggest that
chronic diseases (such as hypertension, ischaemic heart disease, and
diabetes) of later adult life are more common in individuals born suffering
from fetal growth restriction. Inadequate fetal growth may occur in the
absence of recognized causal factors such as maternal hypertension, smoking
or inadequate nutrition. It may be associated with intrauterine fetal demise
or immediate neonatal and long-term consequences for the infant. In most
cases, the reasons for poor fetal growth are not known. Known associations
with fetal growth restriction include fetal chromosomal, Mendelian or
congenital structural abnormalities; placental factors such as placental
mosaicism and abnormal placentation; and maternal factors including
hypertension/preeclampsia, antiphospholipid antibody syndrome (APS), and
inherited thrombophilia. In addition, extrinsic factors such as altitude,
infectious agents, nutritional deficits, and toxins (cigarette smoking,
alcohol, illicit drugs) may result in fetal growth restriction. Currently,
the management of under-grown fetuses is empirical, aimed primarily at
selection of safest time for delivery. There are no effective treatments to
prevent or reverse fetal growth restriction. Further research into the
mechanisms that control normal fetal growth will lead to our understanding of
and prevention of situations of abnormal fetal growth. Providing the best
possible environment for the fetus would not only ensure adequate fetal
growth and health in the newborn period, but also protect against the
development of diseases in adult life.
Scientific Knowledge to be Achieved Through Research Supported by the RFA
The aim of this initiative is to stimulate research into the mechanisms of
fetal growth restriction and to gain a better understanding of the factors
that regulate fetal growth during pregnancy.
Objectives of this Research Program
The major objectives of this RFA are the identification and characterization
of the mechanisms of fetal growth; to clarify how these mechanisms are
altered in fetal growth restriction; and to develop noninvasive methods to
detect the abnormalities. The following are some examples of research topics
that are responsive to this RFA, but they are not to be viewed as exclusive
or restrictive:
o Identification of the cellular and molecular mechanisms that result in
fetal growth restriction such as studies dealing with apoptosis, oxidative
stress, abnormal cytokine milieu, etc.
o Elucidation of the mechanisms by which confined placental mosaicism (CPM)
and uniparental disomy (UPD) result in abnormal fetal growth. Examples
include studies on the role of imprinted genes, gene dosage, and cis and
trans regulatory factors responsible for mediating the effects of CPM and UDP
on fetal growth.
o Identification and characterization of novel genes and DNA polymorphisms
involved in fetal growth.
o Characterization of normal and abnormal placentation resulting in normal
and growth restricted fetuses.
o Characterization of the placenta, its blood flow, and its attachment to the
uterus during pregnancy that result in fetal growth restriction.
o Identification and characterization of marker molecule(s) such as growth
factors or cytokines that are associated with fetal growth restriction.
o Comparative study of animal and human tissues to determine applicability of
information obtained in the animal to human in terms of a mechanism, molecule
or process identified.
o Evaluation of the role of the fetus and its potential self-regulation of
fetal growth.
o Identification of the mechanisms underlying known maternal factors
including chronic diseases (e.g., hypertension, diabetes), environmental
factors such as toxins of abuse (smoking, alcohol), and environmental
exposures.
o Investigation of the differential effects of abnormal fetal growth on
specific organ maturation and development.
In addition to the above, potential applicants are encouraged to utilize
characterized mutant mice with phenotypes of abnormal fetal growth that are
being produced at NIH-funded mutagenesis facilities such as the mouse
mutagenesis and phenotyping facilities at Baylor College of Medicine, at
Jackson Laboratories or the Tennessee Mouse Genome Consortium. This RFA will
provide an excellent opportunity for researchers to exploit these rich
genomic and genetic resources.
MECHANISM OF SUPPORT
This RFA will use the NIH Program Project Grant (P01) and Research Project
Grant (R01) award mechanisms. The complex and multivariate nature of this
research goal necessitates the use of both individual-investigator research
studies (R01) and integrated, multidisciplinary, and multi-site approaches
involving expertise in a number of disciplines (PO1). NICHD Program Project
Guidelines may be obtained at:
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm. As an applicant you will
be solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. Future unsolicited, competing
continuation applications based on this project will compete with all
investigator-initiated applications and will be reviewed according to the
customary peer review procedures. The anticipated award date is April 01,
2004. Applications that are not funded in the competition described in this
RFA may be resubmitted as NEW investigator-initiated applications using the
standard receipt dates for NEW applications described in the instructions to
the PHS 398 application.
FUNDS AVAILABLE
The NICHD intends to commit approximately $2.5 million total costs [Direct
plus Facilities and Administrative (F and A) costs] in FY 2004 to support
three to five new and/or competing continuation grants in response to this
RFA. An applicant for an R01 may request a project period of up to five
years and a budget for DIRECT costs of up to $350,000 per year. An applicant
for a P01 may request a project period of up to five years and a budget for
TOTAL costs of up to $750,000 per year. 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 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 Eligible agencies of the Federal government
o Domestic or foreign
Foreign institutions are only eligible to apply for RO1 grants.
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
Principal Investigators from projects funded through this RFA will be
expected to attend an annual NICHD meeting to share findings, research
approaches, and core instrumentation. Application budget requests should
include funds to support travel to the Washington DC area for a two-day
meeting in each year of the grant. In addition, following the award of
grants resulting from this RFA, the funded investigators and NICHD will
develop an informal communication collaboration to provide ongoing
information and advice relevant to critical issues and trends in the field at
large to supplement the aforementioned formal annual meetings.
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:
John Ilekis, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5575
FAX: (301) 496-3790
Email: ilekisj@mail.nih.gov
o Direct your questions about peer review issues to:
Robert 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@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: kh246t@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:
John Ilekis, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5575
FAX: (301) 496-3790
Email: ilekisj@mail.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: Applications for the Program Project Grant (P01)
should be prepared in a manner consistent with the information presented in
the NICHD Program Project Guidelines, available from the contact listed under
WHERE TO SEND INQUIRIES, above, and at
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.
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 of 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 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 on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NICHD. 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 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 National Advisory Child Health and
Human Development Council.
REVIEW CRITERIA
REVIEW CRITERIA FOR P01 APPLICATIONS:
The scientific and technical merit peer review of Program Project (P01)
applications focuses on three areas: (1) review of the component research
subprojects; (2) review of the core units; and (3) review of the overall
program as an integrated effort. P01 applications submitted in response to
this RFA will be evaluated according to the review criteria described in the
NICHD P01 Guidelines, available at:
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.
REVIEW CRITERIA FOR R01 APPLICATIONS:
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of the 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 the application's overall score, weighting them as appropriate
for each application. The 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, an investigator may propose to
carry out important work that by its nature is not innovative but is
essential to move a field forward.
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 these studies on the concepts or methods that
drive this field?
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?
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 or technologies?
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)?
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 evidence of institutional support?
ADDITIONAL CRITERIA/CONSIDERATIONS APPLYING TO P01 AND R01 APPLICATIONS
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below.)
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both 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 in the sections on Federal Citations,
below.)
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 23, 2003
Application Receipt Date: July 23, 2003
Peer Review Date: October/November 2003
Council Review: January 2004
Earliest Anticipated Start Date: April 01, 2004
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
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 "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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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 at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
https://grants.nih.gov/grants/policy/policy.htm.
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.