THE LIFE CYCLE OF THE ADIPOCYTE
RELEASE DATE: October 10, 2002
RFA: DK-03-002
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
LETTER OF INTENT RECEIPT DATE: February 14, 2003
APPLICATION RECEIPT DATE: March 14, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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 Diabetes and Digestive and Kidney Diseases (NIDDK)
and the National Institute of Aging (NIA) invite investigator-initiated
Research Projects (R01 and R21) to study the life cycle of adipocytes. This
initiative encourages investigators to develop the necessary biological
procedures and reagents for characterization of adipocyte progenitor cells at
multiple stages of determination and commitment into the adipocyte lineage,
for use in identifying fat cell commitment factors, and to use in the study
of adipose tissue turnover and remodeling. The goal of this initiative is to
increase our understanding of the life cycle of human adipocytes and to
catalyze the development of novel treatments for metabolic diseases including
type 2 diabetes, obesity, familial lipodystrophy, and acquired lipodystrophy
associated with HIV infection and treatment.
RESEARCH OBJECTIVES
Background
The adipocyte is a key cell in the development of many metabolic diseases
including diabetes, obesity, and both familial and acquired lipodystrophy.
Previous work supported by NIDDK and NIA have demonstrated important roles
for hormones, receptors and/or transcription factors, such as peroxisome
proliferator-activated receptor gamma?(PPAR-gamma) and CCAAT box enhancer
binding protein alpha?(C/EBP-alpha), in fat cell differentiation. Continued
dissection of the pathways involved in differentiation of preadipocytes into
adipocytes while important, is NOT the focus of this initiative. Rather, the
current initiative is designed to encourage studies of the factors and
pathways involved in the commitment of progenitor cells into the adipocyte
lineage; to increase our understanding of the cues signaling turnover and
remodeling of adult adipocytes from various fat depots; to determine how fat
tissues are maintained during adult life; to investigate how adipocytes are
affected by age and environmental factors; and to understand more about how
the life cycle of adipocytes is regulated in health and disease.
Recent advancements in our understanding of stem cell and progenitor cell
biology, and the development of methods for whole genome and proteome
analyses allow new approaches to be applied to the study of the adipocyte
life cycle. Moreover, the ready accessibility of both peripheral and
visceral adipose tissues to biopsy makes fat tissue a reasonable target for
animal and human studies.
The Human Genome Project and similar work in other species have made it
possible to address in new ways the important biological problems of how
different tissues and organs develop from small founder populations of stem
cells, how organs reach optimal size, are maintained throughout adult life,
and sometimes regenerate, and the effects of age and disease on this
capacity. There is emerging evidence that progenitor cells of different
tissues may share some common basic molecular mechanisms that allow them to
self-renew in the presence of appropriate environmental cues. The
elucidation of these mechanisms offers the promise of providing a complete
understanding of the factors that maintain normal tissues in health, and the
promise for novel approaches to the study of pathogenesis and treatment of
human diseases.
In addition, the Congressionally-established Diabetes Research Working Group
(DRWG) report "Conquering Diabetes, A Strategic Plan for the 21st Century"
http://www.niddk.nih.gov/federal/dwg/dwgsummary.htm and an international
workshop, entitled "Lipoatropic Diabetes and Other Syndromes of
Lipodystrophy", emphasized the importance of obtaining a greater
understanding of the life cycle of insulin responsive tissues (e.g. liver,
skeletal muscle, and fat) in healthy individuals, the cross-talk among these
tissues, and elucidating how the life cycle of these tissues is altered in
metabolic diseases such as diabetes and obesity.
Furthermore, with the widespread use of highly active antiretroviral therapy
(HAART) for the treatment of HIV disease, patients are now living longer.
Although the overall health of HIV-infected individuals is improving,
concerns are now arising that HAART therapies may be associated with adverse
metabolic effects, such as hyperlipidemia, insulin resistance, and changes in
body composition. Loss of subcutaneous fat in the buttocks, face and/or
extremities, either alone or in combination with abnormal fat accumulation in
other locations, has been widely reported in patients with HIV infection over
the past few years. The mechanisms underlying these various HIV associated
lipodystrophies, and their connection with antiretroviral therapies presently
remains unclear.
Scope of Research
The NIDDK and NIA intend to support multidisciplinary investigator-initiated
projects (R01s) that explore fundamental aspects of the life cycle of the
adipocyte, as well as Exploratory/Development Research projects (R21s).
Investigators applying to this RFA are encouraged to use genome-wide studies
(genomics and proteomics), advanced lineage tracing techniques, analytic
methods, and state-of-the-art cell biological approaches to study mouse and
human fat cell commitment/determination, adipocyte trans-differentiation and
remodeling, adult adipocyte turnover, and investigate how these processes are
altered by metabolic diseases such as diabetes, obesity and lipodystrophy.
Areas of research opportunities include, but are not restricted to the
following:
o Develop advanced tools and technologies to study the mechanism(s) used by
mice and humans to "signal" adult adipocytes to turnover or trans-
differentiate
o Develop advanced tools and technologies to study the mechanism(s) used by
mice and humans to "signal" progenitor cells to commit to the adipocyte
lineage
o Measure and compare the turnover rates of fat cells from various depots,
and investigate if and how these turnover rates are impacted by the
development of diabetes, obesity, and lipodystrophy or by treatment with
insulin sensitizing drugs or anti-retroviral therapies (e.g. specific HIV
protease inhibitors and nucleoside reverse transcriptase inhibitors)
o Define and/or develop specific biomarkers, such as high-specificity
antibodies or reporter gene constructs, for detection, classification, and
isolation of adipocyte progenitor cells at multiple stages of development or
in distinct fat depots. This might include the development of reliable and
convenient clonogenic assays for cell populations in developing and adult
tissues so that these cells can be purified and characterized
o Profile mRNA or protein expression in the relevant cell populations or
particular fat depots during aging or under different metabolic conditions or
drug treatments
o Use in silico methods to identify novel genes and transcript splice forms
specifically expressed in the targeted cell populations or specific fat
depots
o Produce and sequence full-length cDNA libraries and truncation libraries,
in which cDNAs are inserted downstream of a consensus translation initiation
sequence and an oligopeptide tag in an effort to generate dominant negative
protein fragments that can be expressed and studied in cells
o Develop custom clone sets for use in microarrays or other high-throughput
gene expression assays; use of arrays to characterize changes in gene
expression patterns in the target cell population during development, trans-
differentiation, tissue remodeling or disease progression
o Develop and apply single-cell gene expression methodologies to various
adipocyte populations
MECHANISMS OF SUPPORT
This RFA will use the NIH investigator-initiated Research Project Grant (R01)
and the Exploratory/Development Research Grant (R21) award mechanism(s). 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 September 30, 2003.
The R21 awards are to demonstrate feasibility and to obtain preliminary data
testing innovative ideas that represent clear departure from ongoing research
interests. These grants are intended to 1) provide initial support for new
investigators; 2) allow exploration of possible innovative new directions for
established investigators; and 3) stimulate investigators from other areas to
lend their expertise to research within the scope of this solicitation.
Applicants for the R21 must limit their requests to $150,000 direct costs per
year and are limited to two years. These R21 grants will not be renewable;
continuation of projects developed under this program will be through the
regular research grant (R01) program.
This RFA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (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. Otherwise follow the instructions for non-
modular research grant applications.
FUNDS AVAILABLE
The participating IC(s) intend to commit approximately $2 million dollars in
FY 2003 to fund 3 to 6 new grants in response to this RFA. An applicant may
request a project period of up to 5 years and a budget for direct costs of up
to $450,000 per year for more complex, multidisciplinary R01 applications,
and $150,000 per year in direct costs for up to 2 years for R21 applications.
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 IC(s) 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. At this time, it is not known if this RFA will be reissued.
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
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
Restricted availability of unique research resources, upon which further
studies are dependent, can impede the advancement of research and delivery of
medical care. Sharing biomaterials, data, and software in a timely manner
has been an essential element in the rapid progress that has been made in the
genetic analyses of mammalian genomes. NIH policy requires that
investigators make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication [NIH Grants Policy Statement
(https://grants.nih.gov/grants/policy/nihgps; Principles and Guidelines for
Recipients of NIH Research Grants and Contracts on Obtaining and
Disseminating Biomedical Research Resources: Final Notice, December
1999(http://www.ott.nih.gov/policy/rt_guide_final.html). Biomaterials
(constructs, cell lines, etc.) and other research resources that can be
patented (e.g., software tools, expression data) that are produced in
projects funded by this RFA are to be made available and distributed to the
broader scientific community.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
Carol Renfrew Haft, Ph.D.
Adipocyte Program Director
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 605
Bethesda, MD 20892-5460
Telephone: (301) 594-7689
FAX: (301) 480-3503
E-mail: cr84g@nih.gov
David B. Finkelstein, Ph.D.
Biology of Aging Program
National Institutes on Aging
7201 Wisconsin Avenue, Suite 2C231
Bethesda, MD 20892-9205
Telephone: (301) 496-6402
FAX: (301) 402-0010
E-mail: df18s@nih.gov
o Direct your questions about financial or grants management matters to:
Mary K. Rosenberg
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 722
Bethesda, MD 20892-5456
Telephone: (301) 594-8891
FAX: (301) 480-3504
E-mail: mr239s@nih.gov
Linda Whipp
Grants and Contracts Management Office
National Institutes on Aging
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
E-mail: lw17m@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 IC 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:
Carol Renfrew Haft, Ph.D.
Adipocyte Program Director
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 605
Bethesda, MD 20892-5460
Telephone: (301) 594-7689
FAX: (301) 480-3503
E-mail: cr84g@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.
SPECIFIC INSTRUCTIONS FOR R21 APPLICATIONS
All application instructions outlined in the PHS 398 application kit are to
be followed, with the following requirements for R21 applications:
1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME"
concepts, with direct costs requested in $25,000 modules, up to the total
direct costs limit of $150,000 per year.
2. Although preliminary data are not required for an R21 application, they
may be included.
3. Sections a-d of the Research Plan of the R21 application may not exceed
15 pages, including tables and figures.
4. R21 appendix materials should be limited, as is consistent with the
exploratory nature of the R21 mechanism, and should not be used to circumvent
the page limit for the research plan. Copies of appendix material will only
be provided to the primary reviewers of the application and will not be
reproduced for wider distribution. The following materials may be included
in the appendix:
o Up to five publications, including manuscripts (submitted or accepted
for publication), abstracts, patents, or other printed materials
directly relevant to the project. These may be stapled as sets.
o Surveys, questionnaires, data collection instruments, and clinical
protocols. These may be stapled as sets.
o Original glossy photographs or color images of gels, micrographs, etc.,
provided that a photocopy (may be reduced in size) is also included
within the 15 page limit of items a-d of the research plan
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 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 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 NIDDK and NIA.
Incomplete applications will be returned to the applicant without further
consideration. And, if the application is not responsive to the RFA, CSR
staff may contact the applicant to determine whether to return the
application to the applicant or submit it for review in competition with
unsolicited applications at the next appropriate NIH review cycle.
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 CSR 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 Diabetes and Digestive and
Kidney Diseases Advisory Council.
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 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: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field? Does your study provide an important resource and how will
the resource(s) impact the field?
(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? For R21 applications, is there evidence of feasibility?
(3) INNOVATION: 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: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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 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 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
included in the section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data. Do
investigators state their willingness to submit data to a public database in
a timely fashion or make the information available to the community at large
in another way? Do the investigators agree to share reagents such as knock-
out mice, cell populations, plasmids and antibodies? The plans proposed for
sharing and data release will be reviewed for adequacy by reviewers as well
as NIDDK staff prior to award and will be considered as a criterion for
award.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research. Funds to defray the costs
of submitting data and distribution of reagents may be included in the
application. Such requests must be adequately justified.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 14, 2003
Application Receipt Date: March 14, 2003
Peer Review Date: July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Award 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
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 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 are 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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://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 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
https://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
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 No. 93.847 and 93.866 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.