Release Date:  February 22, 2001

PA NUMBER:  PAR-01-056 (see replacement PAR-04-082)

National Institute of Diabetes and Digestive and Kidney Diseases


This Program Announcement replaces Program Announcement, PAR-98-071 (Small 
Grants In Digestive and Nutritional Disorders), which was published in the 
NIH Guide May 15, 1998.


The Division of Digestive Diseases and Nutrition (DDDN) of the National 
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) encourages 
applications using the small grant (R03) mechanism in an attempt to encourage 
innovative clinical and epidemiological research into new therapies or means 
of prevention of digestive diseases and nutritional disorders.  The DDDN 
began using the R03 mechanism in 1995 to support short-term clinical studies 
and help stimulate the translation of promising and potentially relevant new 
developments from the laboratory into the clinical setting.  The current 
program announcement (PA) supersedes and expands upon the PAR-98-071, which 
was published in the NIH Guide, May 15, 1998. This PAR specifically 
encourages the submission of applications for pilot studies leading to full-
scale clinical trials and epidemiological studies relating to digestive 
diseases and nutritional disorders.  These R03 projects should focus on 
research that is particularly innovative and/or potentially of high impact. 
High impact research involves feasibility studies in which the technological, 
methodological, or theoretical approach to a problem lacks an historical 
precedent or sufficient preliminary data, but whose successful outcome would 
have a major effect on a scientific area.

The small grants (R03) may be used as planning grants for full-scale multi-
center clinical trials or for pilot studies that could lead to full-scale 
multi-center clinical trials designed to provide evidence for or against 
changes in the current standard of care.  Such trials may use 
pharmacological, dietary, surgical, or behavioral interventions given for 
disease therapy or prevention.  Pilot epidemiological studies are encouraged 
that could lead to more extended research that would provide evidence for or 
against changes in health policy, especially as related to disease 
prevention.  It is expected that these R03 grants will serve as a basis for 
planning future multi-center research project grant applications (R01) or 
cooperative agreement (U01) awards.  New and experienced investigators in 
relevant fields and disciplines may apply for these small grants.  
Investigators are encouraged to take advantage of recent laboratory 
developments.  In addition, the small grant is a good mechanism for new and 
experienced investigators to become better equipped to perform clinical and 
epidemiological research.

Areas of special interest in this PAR include but are not limited to: 
inflammatory bowel disease in children and adults; motility disorders of 
children; celiac disease; functional bowel disease; non-ulcer dyspepsia; 
Barrett’s esophagus; peptic ulcer disease caused by nonsteroidal anti-
inflammatory agents; endoscopic management of biliary disorders; acute and 
chronic diverticulitis; acute and chronic pancreatitis including hereditary 
pancreatitis; autoimmune hepatitis; primary biliary cirrhosis; sclerosing 
cholangitis; Wilson’s disease; biliary atresia; neonatal hepatitis; chronic 
hepatitis B and C; hepatotoxicity; prevention and treatment of complications 
of liver transplantation; living donor liver transplantation; small bowel 
transplantation; nutritional support of patients with intestinal failure; 
surgical therapy of obesity; binge eating disorders; anorexia nervosa and 


The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," in a 
PHS-led national activity for setting priority areas.  This Program 
Announcement (PA), Small Clinical Research Grants in Digestive Diseases and 
Nutrition (R03), is related to the priority area of chronic disabling 
conditions.  Potential applicants may obtain a copy of  "Healthy People 2010" 


Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
and laboratories, units of State and local governments, and eligible agencies 
of the Federal government.  Applications from minority individuals and women 
are encouraged.  Applications may be from a single institution or several
institutions (collaborating institutions or consortia), if appropriate.  
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as principal investigators.

This NIDDK small grant support is for new projects only; competing 
continuation applications will not be accepted.  Submission of an application 
under this PAR precludes concurrent submission of any other Public Health 
Service application containing substantially the same research proposal.  In 
addition, these R03 awards may not be used to supplement research projects 
currently supported by Federal or non-Federal funds, or to provide interim 
support of projects under review by the Public Health Service.

To be eligible for this award, the proposed Principal Investigator must be an 
independent researcher.  New investigators are eligible, but they must be 
independent of a mentor and have strong institutional support.  Small grant 
support may not be requested for thesis or dissertation research.  
Investigators who have questions about eligibility should contact one of the 
officials listed under INQUIRIES.


This PA will use the NIH small grant (R03) award mechanism.  Responsibility 
for the planning, direction, and execution of the proposed project will be 
solely that of the applicant.  The total project period for an application 
submitted in response to this PAR may not exceed two years.  The budget may 
be submitted for direct costs up to four modules of $25,000 each ($100,000 
direct costs per year).  These grants may not be renewed. Facilities and 
Administrative (F & A) costs will be awarded based on the negotiated rate at 
the time of each award.

Replacement of the Principal Investigator on this award is not permitted.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at  

Applications submitted in response to this PAR will compete for funds with 
all other R03 and regular research project grant (R01) applications assigned 
to NIDDK. The award of grants in response to this PAR is also contingent upon 
the availability of funds.  

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research.  If so, 
a letter of agreement from either the GCRC program director or principal 
investigator should be included with the application.

Applicants are encouraged to collaborate with the Directors of the Silvio O. 
Conte Digestive Diseases Centers, Clinical Nutrition Research Centers, and 
Obesity/Nutrition Research Centers for consultation in experimental design, 
intervention, and methodology, as well as usage of core facilities 
appropriate for carrying out their projects.  Information describing the 
centers and their cores can be requested from the person listed in INQUIRIES.



This PAR supersedes PAR-98-071 published in 1998.  The major changes in this 
PAR are an increase in the maximum direct costs available from $50,000 to 
$100,000 and a refocus on different priority areas for clinical research in 
digestive diseases and nutrition.  

The goal of this small grants program is to provide flexibility for 
initiating preliminary, short-term studies, thus allowing new ideas to be 
investigated in a more expeditious manner without stringent requirements for 
preliminary data.  Such support is needed to encourage experienced 
investigators as well as new investigators to pursue new approaches, 
underdeveloped topics, or more risky avenues of research.  If successful, 
these awards should lead to significant scientific advances in digestive 
disease and nutrition research.

New areas of special interest in this PAR are motility disorders and liver 
diseases of children; chronic hepatitis B and C; surgical therapy of 
digestive and nutritional disorders; and endoscopic research.  

A major focus of this PAR is on diseases that ordinarily have little research 
support because they are rare, or difficult to manage, or are not the focus 
of pharmacological therapy.  There are several rare digestive diseases that 
may, nevertheless, have lasting and major consequences for the patients who 
have these conditions. These conditions are particularly challenging when 
they occur in children and have life-long consequences.  These diseases are 
often too rare to be adequately investigated by a single individual or at a 
single medical research institution.  For these reasons, applications for 
study of these conditions might be best performed by a consortium of 
investigators that come together with a common protocol to focus on natural 
history and clinical investigation rather than a specific therapeutic 
intervention.  Examples of these rare digestive and liver diseases that are 
of particular focus in this PAR include gastrointestinal motility disorders 
of children; biliary atresia and neonatal hepatitis; Wilson’s disease; 
sclerosing cholangitis in children; and familial pancreatitis.

Many digestive diseases and nutritional disorders are diagnosed, monitored or 
treated using endoscopic or surgical techniques.  These techniques are often 
the consequence of years of study and development by a talented and 
innovative investigator or group of investigators.  Once the final technique 
is developed and reported in the medical literature, however, there is often 
little independent analysis of its efficacy and risk-benefit ratio.  Thus, 
endoscopic management of gastrointestinal bleeding, Barrett’s esophagus, 
retained biliary stones, pancreatitis and colonic ectasia may be widely 
practiced but have not been subjected to careful, large-scale, prospective 
randomized controlled trials.  Among surgical procedures in digestive and 
nutritional disorders, there is also often little controlled evidence for 
efficacy and safety.  Thus, small bowel transplantation, the use of living 
donor liver transplantation, the surgical therapy of obesity are a few areas 
in which surgical techniques have been introduced and widely used without 
controlled observations on the efficacy and relative safety of these 
approaches.  This PAR is meant to provide a means for investigators to 
develop prospective randomized controlled trials of endoscopic and surgical 

Also included as areas of special focus of this PAR are chronic hepatitis B 
and C.  These two diseases are major causes of morbidity and mortality from 
liver disease in the United States.  Current estimates suggest that chronic 
hepatitis B affects 1 million and hepatitis C approximately 2.5 million 
Americans.  Hepatitis C accounts for at least 30% of liver transplants done 
in the United States, while hepatitis B and its complications account for 5-
10% of transplants.  While there are many industry sponsored studies of new 
and innovative therapies of these diseases, many important approaches to the 
management, prevention and treatment of chronic hepatitis B and C are outside 
of the usual interest of industry-sponsors of clinical trials.  Thus, use of 
cytokines, innovative combination therapies, iron depletion, and 
complementary and alternative medical (CAM) treatments of hepatitis B and C 
might be the focus of a small grant application.  In addition, approaches to 
management and therapy of hepatitis B and C in special populations might be 
the focus of a small grant application; such populations might include 
children, patients with hemophilia, patients with renal failure, solid-organ 
transplant patients, patients with human immunodeficiency virus co-infection, 
injection drug users, patients with continuing problems with alcohol or 
substance abuse, and patients with significant psychiatric disease, such as 
schizophrenia and bipolar disorders.   

Other areas of importance in digestive disease research that would be 
appropriate for R03 applications are the hepatic and gastrointestinal adverse 
effects of medication use.  As an increasing number of the U.S. population is 
exposed to a greater number of pharmacological agents, hepatotoxicity and 
gastrointestinal toxicity have become increasingly more common causes of 
digestive disease morbidity and mortality.  It is difficult to study 
mechanisms of hepatic and gastrointestinal toxicity, as these adverse events 
are uncommon, unexpected and sporadic.  Of particular interest in this area 
would be the establishment of prospective epidemiological databases on 
hepatotoxicity or gastrointestinal toxicity with careful collection of 
clinical information, outcome and laboratory tests, as well as, creation of 
serum and tissue banks to aide in studies of the mechanisms and genetics of 
adverse reactions to medications.  

The NIDDK is currently sponsoring several large, multi-center studies of 
specific digestive diseases and nutritional disorders.  These studies include 
prospective studies in chronic hepatitis B and C; liver transplantation; 
acute liver failure; primary biliary cirrhosis; non-alcoholic 
steatohepatitis; functional bowel disease; helicobacter pylori associated 
peptic ulcer disease; portal hypertension; ascites; bleeding esophageal 
varices; gastrointestinal endoscopy; and both behavioral and pharmacological 
therapy of obesity.  Small grant applications for clinical studies that 
overlap with ongoing studies sponsored by NIDDK may be denied funding because 
of overlap.  Persons interested in applying for an R03 grant under this PAR 
are encouraged to contact NIDDK (as outlined below under INQUIRES) and 
discuss the planned application.


It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects unless a clear and 
compelling rationale and justification are provided 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
A complete copy of the updated Guidelines is available at:
The revisions relate to NIH defined Phase III clinical trials and require: a) 
all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 


It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.


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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.


The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

The PHS 398 grant application form (rev. 4/98) is to be used to submit the 
R03 grant at the standard application deadlines indicated in the application 
kit.  The form may be downloaded from the NIH web site at:
Application kits are also available at most institutional offices of 
sponsored research and may be obtained from the Division of Extramural 
Outreach and Information Resources, National Institutes of Health, 6701 
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, 


R03 Modular Grant applications will request Direct Costs in $25,000 modules, 
up to a Total Direct Cost request of $100,000 per year, with the 
modifications made to the standard PHS 398 application instructions described 

PHS 398

o FACE PAGE - The title,  “Small Clinical Research Grants in Digestive 
Diseases and Nutrition (R03)" and number of this PAR must be typed on line 
two of the face page and the YES box must be marked.  Items 7a and 7b should 
be completed, indicating Direct Costs (in $25,000 increments up to a maximum 
of $100,000) and Total Costs [Modular Total Direct plus Facilities and 
Administrative (F&A) Costs] for the initial budget period.  Items 8a and 8b 
should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

Page 4 of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
Page. (See for 
sample pages.)  At the top of the page, enter the Total Direct Costs 
requested for each year.  This is not a Form Page.

o Personnel - List all project personnel, including their names, percent of 
effort, and roles on the project.  No individual salary information should be 
provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs (Direct 
plus F&A Costs) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of all personnel, and their role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is 
included in the overall requested modular direct cost amount.  Include the 
Letter of Intent to establish a consortium.

o Provide an additional narrative budget justification for any variation in 
the number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o OTHER SUPPORT -- Do not complete this section.  It is not required and will 
not be accepted with the application.

o RESEARCH PLAN -- Items a - d of the Research Plan [Specific Aims, 
Background and Significance, Preliminary Studies (not required), and Research 
Design and Methods] may not exceed a total of ten pages.  Detailed 
descriptions of protocols for the proposed involvement of human subjects 
and/or vertebrate animals, literature cited, consortium/contractual 
arrangements and consultant letters are not included in the ten-page limit.

Describe the particularly innovative/high impact aspects of the proposed 
study in an introductory paragraph at the beginning of the research plan.  
Include a description of how the outcome of this project would provide a 
foundation for important new research in digestive diseases and nutritional 
disorders.  Label this paragraph, "Justification as Innovative/High Impact 

The significance of this section is to demonstrate the following as briefly 
as possible.

o  Professional credentials of the organizers indicating experience in such 
areas as:

o The problem under study

o  Clinical trial administration

o  Methodology

o  Adequate and similar participant recruitment

o  Methods for monitoring safety and efficacy of research

o  The proposed procedures.

o  Professional credentials of the participating center investigators in the 
clinical problem and in clinical trial participation.  Verification of the 
cooperating investigators and their institutions will be required later if 
considered for funding.

For revised applications, an Introduction (not to exceed one page) in 
addition to the Research Plan is required.  This Introduction should respond 
to the comments and concerns of the initial review group delineated in the 
summary statement.

o APPENDIX -- Appendix material will be limited to color/glossy figures, 
tables and manual of procedures or data collection forms.

o CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A Costs for the initial budget period and all 
future budget years.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

Submit a signed, typewritten original of the application, including the 
Checklist, and four signed photocopies in one package to:

BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, one additional copy of the application must be 
sent to:

Francisco Calvo, Ph.D.
Chief, Review Branch
6707 Democracy Blvd
Room 655, MSC 5452
Bethesda, MD 20892
(For FedEx and UPS: use 20817)
Telephone: 301-594-8897
Fax: 301-480-3505


Applications will be reviewed by the Center for Scientific Review (CSR) for 
completeness.  NIDDK staff will carry out an administrative review of all 
submissions.  Applications that lack the introductory justification, are 
incomplete, do not conform to the required format, or exceed the ten-page 
limit will not be reviewed and will be returned to the investigator.  

Applications will be evaluated for scientific and technical merit in 
accordance with the standard NIH procedures by an appropriate scientific 
review group convened by the NIDDK.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, 
generally the top half of applications under review, will be discussed and 
assigned a priority score.  All applications also receive a second level 
review by the National Diabetes, Digestive and Kidney Disease Advisory 

Review Criteria

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.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that 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.

(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 these studies on the concepts or methods that 
drive this field?  Will a successful outcome from this pilot study lead 
directly to more extensive studies that would likely advance the digestive 
disease research?

(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?

(3) Innovation:  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?  Will the 
project generate a new body of data that provides a foundation for important 
new research directions?

(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)?  Is the 
Principal Investigator an independent researcher?

(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 evidence of institutional 

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans or the environment, to 
the extent they may be adversely affected by the project proposed in the 

Additional considerations pertinent to the review of these NIDDK Small 
Research Grants (R03) applications:

o  Because the research plan is limited to ten pages, these R03 small grant 
applications may not have the same level of detail or extensive discussion 
normally found in a regular R01 research project grant application.  Review 
emphasis will be placed on the conceptual framework and general approach to 
the problem, with less emphasis on methodological details.

o  Since pilot/feasibility studies may not include preliminary data, the 
review will focus on whether the rationale for the study is well developed 
and whether the proposed research is likely to generate data that will lead 
to additional studies that could potentially be funded as a regular research 
project grant (R01).

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority. 


Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome. Direct inquiries regarding programmatic 
issues to:

Patricia Robuck, Ph.D., M.P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, 
6707 Democracy Blvd., Room 675
Bethesda, MD  20817
Telephone:  (301) 594-8879

Direct inquiries regarding specific epidemiological programmatic issues to:

James Everhart, M.D., M.P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza,  
6707 Democracy Blvd., Room 673
Bethesda, MD  20817
Telephone:  (301) 594-8878

Direct inquiries regarding fiscal matters to:

Ms. Sharon Bourque
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 612
6707 Democracy Blvd.
Bethesda, MD  20817
Telephone:  (301) 594-8860


This program is described in the Catalog of Federal Domestic Assistance No. 
93.867.  Awards are made under authorization of the Public Health Service 
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 
USC 241 and 285) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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, a 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.

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