MECHANISMS OF ALCOHOLIC PANCREATITIS
RELEASE DATE: October 08, 2003
PA NUMBER: PA-04-005
November 20, 2006 - The R01 portion of this funding opportunity has been replaced by
PA-07-067, which now uses the electronic SF424 (R&R) application for February 5, 2007
submission dates and beyond.
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission. Parent
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been
issued for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter. Applications relating to R33 and R34 activities
must be in response to NIH Institute/Center (IC)-specific announcements.
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R01 Applications: October 15, 2006 unless
re-issued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
(http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.273
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THE PA
The National Institute on Alcohol Abuse and Alcoholism (NIAAA),
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), and National Institute on Drug Abuse (NIDA) are seeking
research grant applications that will investigate the underlying
molecular, biochemical, and cellular mechanisms by which long-term
alcohol ingestion leads to the development of pancreatitis. Research is
also encouraged to understand the role of various predisposing factors,
including substance abuse, that make the pancreas susceptible to
alcoholic injury. Understanding the mechanisms as well as the role of
predisposing factors may help in developing strategies for the
prevention or treatment of the disease.
RESEARCH OBJECTIVES
Background:
Long-term heavy alcohol consumption is associated with both acute and
chronic pancreatitis. Acute pancreatitis is characterized by pain,
edema, hemorrhage, acinar cell vacuolation, necrosis and increased
serum levels of amylase and lipase. Chronic pancreatitis is
characterized by features of acute pancreatitis superimposed on a
background of chronic changes that include fibrosis, inflammation, some
level of calcification, and loss of exocrine tissue. Progression of
pancreatitis may lead to multiple co-morbidities including
maldigestion, diabetes, and pancreatic cancer. A recent advance in our
understanding of pancreatitis is the development of animal models of
alcoholic pancreatitis using co-factors such as cholecystokinin-8 (CCK-
8), unsaturated fat, and viral infection. However, further refinement
is required in the development of animal models of pancreatitis that
more closely mimic human conditions.
Premature activation of zymogens (inactive digestive enzymes) within
the pancreatic acinar cell results in the release of active enzymes
within pancreatic tissue, leading to autodigestion that may initiate
pancreatitis. Cerulin, an analogue of CCK has been shown to cause
zymogen activation in a time- and dose-dependent manner in pancreatic
acinar cells, an effect which is enhanced by alcohol. Moreover, ethanol
increased rat pancreatic amylase secretion and plasma CCK levels, which
were mediated through CCK-releasing factor. Further research is
required to understand the interactive effect of alcohol and CCK on
zymogen activation.
The pancreas can metabolize ethanol via oxidative as well as non-
oxidative pathways, generating acetaldehyde and fatty acid ethyl esters
(FAEE), respectively. The major oxidative enzyme system employs alcohol
dehydrogenase (ADH), and the non-oxidative pathway utilizes FAEE
synthases. Acetaldehyde causes tissue injury through genotoxicity,
adduct formation and associated immunotoxicity, but its role in causing
pancreatitis needs clarification. In the oxidative pathway, in addition
to ADH, alcohol may also be metabolized by cytochrome P4502E1 (CYP2E1),
which has been shown to be induced in rat pancreas by chronic ethanol
administration. Alcohol's metabolism by CYP2E1 results in the
generation of reactive oxygen species (ROS), which may initiate tissue
injury via activation of nuclear factor kappaB (NF-kB) and increased
transcription of proinflammatory cytokines. Fatty acid ethyl esters
have been shown to increase the fragility of pancreatic lysosomes which
may release hydrolases capable of activating trypsinogen within the
pancreas, thereby predisposing the pancreas to autodigestive injury.
Additional studies are required to understand the relative role of
oxidative and non-oxidative metabolism in ethanol-induced pancreatic
injury.
One of the major features of chronic alcoholic pancreatitis is fibrosis
resulting from increased production of extracellular matrix proteins,
including collagen, by activated pancreatic stellate cells (PSCs).
Although several factors such as acetaldehyde, oxidative stress, and
cytokines have been implicated in mediating alcohol's effect on PSCs
activation, the underlying molecular mechanisms need to be elucidated.
In addition to direct effects of alcohol, various factors such as
substance abuse, genetic makeup, bacterial and viral infection,
smoking, high fat diet, compromised immune function, gallstones, and
drinking patterns may render the pancreas more susceptible to alcohol-
induced tissue injury. Mechanisms underlying the interactive effects of
alcohol and these predisposing factors need to be elucidated.
Research Scope:
Appropriate topics for investigation under this PA would include, but
are not limited to:
o Elucidation of mechanisms by which alcohol induces or promotes
premature activation of pancreatic enzymes (zymogens) within the
pancreas directly or indirectly.
o Characterization of the interactive effects of alcohol and
cholecystokinin on the initiation and perpetuation of alcoholic
pancreatitis.
o Determination of the role of diet, including fat and protein, in the
modulation of gene expression and synthesis of various secretagogues.
o Investigation of the role of acetaldehyde and fatty acid ethyl esters
in the initiation and progression of alcoholic pancreatitis.
o Determination of the role of oxidative stress in the activation of
transcription factors that are involved in regulating proinflammatory
cytokines.
o Determination of the roles of cytokines, chemokines, adhesion
molecules, and inflammatory leukocytes in the initiation and
progression of inflammation of the pancreas.
o Investigation of the role of gut-derived endotoxin in triggering the
process of inflammation through activation of pancreatic acinar cells
and inflammatory leukocytes.
o Characterization of the molecular mechanisms of pancreatic stellate
cell activation leading to increased deposition of extracellular matrix
proteins and fibrosis.
o Investigation of the role of impaired immune function in rendering
the pancreas more susceptible to the injurious effect of alcohol.
o Determination of the influence of drinking patterns on the
pathogenesis of the disease.
o Investigation of the role of other factors such as substance abuse,
smoking, bacterial and viral infection, gallstones, and genetic
susceptibility in the initiation and progression of alcoholic
pancreatitis.
o Determination of the influence of gender and ethnicity on the course
of alcoholic pancreatitis.
o Characterization of the relationship between pancreatitis, diabetes,
obesity, and pancreatic cancer.
o Identification and characterization of biomarkers of early cell or
tissue perturbation that can be used for diagnosis of the disease.
o Study of pharmacology of drug-induced pancreatitis including that
caused by non-nucleotide and protease inhibitor anti-retroviral
therapeutic agents.
MECHANISM(S) OF SUPPORT
This PA will use the NIH R01 and Exploratory/Developmental Research
Grant (R21) award mechanisms
(http://grants1.nih.gov/grants/guide/pa-files/PA-03-107.html). As
an applicant, you will be solely responsible for planning, directing,
and executing the proposed project. Applications using the R21
mechanism may request a project period of up to two years with a
combined budget for direct costs of up $275,000 for the two year
period. For example, the applicant may request $100,000 in
the first year and $175,000 in the second year. The request should be
tailored to the needs of the project. Normally, no more than $200,000
may be requested in any single year.
This PA uses just-in-time concepts. It also uses the modular as well as
the non-modular budgeting formats (see
http://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. Otherwise
follow the instructions for non-modular research grant applications.
This program does not require cost sharing as defined in the current
NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Exploratory/developmental grant support is for new projects only;
competing continuation applications will not be accepted. Two revisions
of a previously reviewed exploratory/developmental grant application may
be submitted as defined in NIH Policy at
http://grants.nih.gov/grants/policy/amendedapps.htm.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) 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 institutions/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.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this PA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
two areas: scientific/research and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Vishnudutt Purohit, Ph.D.
Program Director
Biomedical Research Branch
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
6000 Executive Boulevard/ suite 402
Bethesda, M.D., 20892-7003
(for courier service use Rockville, MD 20852)
Phone: (301) 443-2689
Fax: (301) 594-0673
Email: vpurohit@niaaa.nih.gov
Jose Serrano M.D., Ph.D.
Director Liver & Biliary Programs
Liver Disease Research Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 657, MSC 5450
Bethesda, M.D., 20892-5450
(for courier service use 6707 Democracy Blvd, Room 657, Bethesda, M.D.,
20817)
Phone: (301) 594-8871
Fax: (301) 480-8300
Email: js362q@nih.gov
Jag H. Khalsa, Ph.D.
Pharmacologist/Health Scientist Administrator
Center on AIDS & Other Medical
Consequences of Drug Abuse (CAMCODA)
National Institute on Drug Abuse, NIH
6001 Executive Blvd., Room 5098, MSC 9593
Bethesda, M.D., 20892-5953
(for courier service use Rockville, MD 20852)
Phone: (301) 443-1801, (301) 443-2159 (direct)
Fax: (301) 480-4544, or (301) 594-6566
e-mail: jk98p@nih.gov
o Direct your questions about financial or grants management matters
to:
Judy Fox (formerly Simons)
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504
Bethesda, MD 20892-7003
(for courier service use Rockville, MD 20852)
Telephone: (301) 443-4704
Fax: (301) 443-3891
Email: jsimons@willco.niaaa.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 is available
at http://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.
The title and number of this PA must be typed on line 2 of the face
page of the application.
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard application
deadlines, which are available at
http://grants.nih.gov/grants/dates.htm. Application deadlines are also
indicated in the PHS 398 application kit.
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
http://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
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER
YEAR: Applications requesting $500,000 or more in direct costs for any
year must contact the proper program official identified above to
receive authorization to submit the proposal. The applicant must
include a cover letter identifying the NIAAA program official who has
agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following
steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff
member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended
or revised version of these grant application types. Additional
information on this policy is available in the NIH Guide for Grants and
Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the checklist, and five 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)
APPLICATION PROCESSING: Applications must be mailed on or before the
receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this PA 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 a substantial revision of an
application already reviewed, but such application must include an
Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. Appropriate scientific review
groups convened in accordance with the standard NIH peer review
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate
applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection 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.
o Receive a written critique
o Receive a second level review by the appropriate national advisory
council or board.
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. 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.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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?
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 genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals
of the research will be assessed. 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 REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of
the proposed research are expected to include a data sharing plan in
their application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or priority score.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program 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.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
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
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
http://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
http://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
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp and
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s)for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
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
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA 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 PA 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 http://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.
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