NEW STRATEGIES FOR THE TREATMENT OF TYPE 1 DIABETES
Release Date: September 30, 1999
RFA: DK-00-001
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
Letter of Intent Receipt Date: March 14, 2000
Application Receipt Date: April 14, 2000.
THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.
IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN
RESPONSE TO THIS RFA.
PURPOSE
The National Institute of Diabetes and Digestive and Kidney
Diseases, the National Institute of Allergy and Infectious
Diseases, and the National Institute of Child Health and Human
Development invite investigator-initiated research grant
applications for clinical studies of new approaches to therapy
for type 1 diabetes. The focus of this initiative includes
studies of cell-based therapies, glucose sensing devices, pumps,
biomechanical-artificial pancreas, gene therapy,
immunomodulation to arrest or reverse type 1 diabetes mellitus,
and methods to detect and prevent hypoglycemia. These
applications should propose clinical studies on individuals with
type 1 diabetes. For studies of immunomodulation to reverse
diabetes, individuals recently diagnosed with type 1 diabetes
might be the appropriate patient population. Support for
preclinical or clinical studies necessary to obtain approval for
an investigational new drug or for an investigational device
could be requested if the application also includes a clinical
component. Collaborative efforts linking expertise in molecular
biology, cell biology, bioengineering, gene therapy, and
immunology to expertise in type 1 diabetes are strongly
encouraged. While it is anticipated that improved glycemic
control will prevent or delay complications, studies of
therapies designed to address other aspects of prevention or
therapy of complications are not responsive to this RFA.
HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of "Healthy
People 2000," a PHS-led national activity for setting priority
areas. This Request for Applications (RFA), NEW STRATEGIES FOR
THE TREATMENT OF TYPE 1 DIABETES, is related to one or more of
the priority areas. Potential applicants may obtain a copy of
"Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign for-profit
and nonprofit organizations, public and private, such as
universities, colleges, hospitals, laboratories, units of State
and local governments, and eligible agencies of the Federal
government. Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal
Investigators.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH)
research project grant (R01) award mechanism, the Interactive
Research Project Grant (IRPG) award mechanisms and the
exploratory/developmental grant (R21) award mechanism. R21
awards are to demonstrate feasibility and obtain preliminary
data testing innovative ideas that represent clear departure
from ongoing research interests. Guidelines for preparing IRPG
applications are available from the program official or from the
internet at: http://grants.nih.gov/grants/guide/pa-files/PA-96-
001.html
Awards will be administered under NIH grants policy as stated in
the NIH Grants Policy Statement.
The R21 exploratory/developmental studies are intended to: (1)
provide initial support for new investigators; (2) allow
exploration of innovative new leads or new directions for
established investigators in diabetes; and (3) stimulate
investigators from other areas to lend their expertise to
research in this area. Pilot and feasibility grants are not
intended to support or supplement ongoing funded research of an
established investigator. This program enables investigators to
explore the feasibility of a novel concept related to
development of new therapies for type 1 diabetes and generate
sufficient data to pursue it through other funding mechanisms.
These grants will not be renewable; continuation of projects
developed under this program will be through the regular
research project mechanism (R01). R21 grants will be limited to
$100,000 direct costs per year and are limited to two years
duration.
Applicants from institutions which have a General Clinical
Research Center (GCRC) funded by the NIH National Center for
Research Resources may wish to identify the GCRC as a resource
for conducting the proposed research. In such a case, a letter
of agreement from either the GCRC program director or principal
investigator should be included with the application.
This RFA is a one-time solicitation. Future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to
the customary peer review procedures. Responsibility for the
planning, direction, and execution of the proposed project will
be solely that of the applicant. The total requested project
period for applications submitted in response to this RFA may
not exceed three (3) years.
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
http://grants.nih.gov/grants/funding/modular/modular.htm
FUNDS AVAILABLE
For FY 2000, $3 million will be committed to fund applications
submitted in response to this RFA. It is anticipated that 8 to
12 awards will be made. However, this funding level is
dependent upon the receipt of a sufficient number of
applications of high scientific merit. Although this program is
provided for in the financial plans of the NIDDK, the award of
grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.
RESEARCH OBJECTIVES
Background
Type 1 diabetes results from immune destruction of the beta
cells of the pancreas leading to loss of insulin secretion and
resultant hyperglycemia. Therapy with insulin prevents
ketoacidosis but not the devastating long-term outcomes of
diabetes. The Diabetes Control and Complications Trial (DCCT)
demonstrated that intensive treatment regimens to achieve tight
control of blood glucose can significantly reduce the onset and
progression of diabetic complications in individuals with type 1
diabetes. Intensive treatment of type 1 diabetes, although
effective in improving long-term outcome, is difficult to
implement for many patients and does not achieve euglycemia.
The level of glycemic control achieved using currently available
intensive treatment methods is at best 4-5 standard deviations
above the mean value for the nondiabetic population, as measured
by glycated hemoglobin (HbA1c). Intensive therapy is also
limited by the accompanying increased frequency of severe
hypoglycemia and weight gain, resulting in an increasing
prevalence of overweight patients with type 1 diabetes. This
RFA solicits applications for clinical studies of promising new
therapeutic approaches for the treatment of individuals with
type 1 diabetes. The objectives are to develop better methods
of optimizing glucose control in patients with type 1 diabetes,
to test promising strategies for immunomodulation to reverse
type 1 diabetes, and to develop approaches to prevent
hypoglycemia and prevent or reverse hypoglycemia unawareness.
The needs and opportunities to develop better methods to achieve
tight control of blood glucose were clearly stated in the
recently published Report of the Congressionally-Established
Diabetes Research Working Group entitled "Conquering Diabetes: A
Strategic Plan for the 21st Century." This report outlines a
number of recommendations to improve therapy for type 1
diabetes. It calls for increased research in a number of areas.
These include: evaluation of antigen-specific, cytokine or
antibody-based immunotherapy; application of cell based
therapies; prevention of transplant rejection or destruction by
autoimmune mechanisms; evaluation of alternate strategies for
insulin administration including mechanical approaches and
alternate routes for insulin administration; and improved
methods to prevent and detect hypoglycemia.
Scope and Objectives
The optimal treatment for individuals with type 1 diabetes would
be to reverse the disease. Towards this end, new clinical
interventions in the autoimmune disease process that lead to
type 1 diabetes are being developed. Currently being considered
for application to diabetes are strategies already being
utilized to block the progression of other autoimmune diseases.
T cell activation can be inhibited with an antibody that binds
to a cell membrane component (CD40L or CTLA4) of an activating T
cell and prevents further T cells from being activated (co-
stimulatory blockade). A second strategy would be to induce
tolerance to known islet cell antigens such as glutamic acid
decarboxylase (GAD) or IA-2. Another strategy involves
suppression or modulation of lymphocyte function using
appropriate cytokines such as IL-4 or IL-10. Individuals
recently diagnosed with type 1 diabetes might be a population in
which these strategies could be successful in arresting or
reversing the disease process. Evaluation of the success of
clinical protocols for immunomodulation/tolerance induction in
individuals with newly diagnosed type 1 diabetes may be
confounded by the occurrence of a spontaneous and transient
resolution of diabetes (the "honeymoon" period). Such proposals
must address how efficacy will be established.
The present therapies for optimizing glucose control have
inherent within them the risk of severe hypoglycemia which
represents the single greatest barrier to tight control of blood
glucose. The risk is magnified as a result of both impaired
recognition of an impending episode and compromised counter-
regulation to restore euglycemia. Thus, efforts to detect and
prevent hypoglycemia would be enhanced by the development of new
techniques for self-monitoring the circulating glucose
concentration. Methods also need to be developed to facilitate
recovery from hypoglycemia unawareness without the need for sub-
optimal glucose control. Applications proposing development of
methods to detect, prevent or limit hypoglycemia, to prevent
hypoglycemia unawareness, and/or to facilitate recovery from
hypoglycemia unawareness are encouraged.
Cell-based therapies are a promising approach to restore insulin
production in response to glucose in individuals with type 1
diabetes. Human islet transplantation trials are presently
ongoing. However, it is clear that with present methods for
harvesting and maintaining islets, there are insufficient human
islets to treat all the individuals with type 1 diabetes.
Therefore, several laboratories have been developing alternate
sources of insulin producing cells. These approaches have
included genetic manipulation of non-beta cells and transformed
beta cells to achieve regulated insulin secretion in response to
physiological levels of glucose or other physiological cues.
Other researchers have been investigating methods of expanding
human beta cells or their progenitors in culture. Studies of
genetic manipulations and of immunomodulation to protect
transplanted beta cells against rejection and autoimmunity are
also underway. Human studies of these cell-based therapies are
within the scope of this RFA.
Improved mechanical approaches to insulin replacement and to
assessment of blood glucose levels are a promising approach to
optimizing glucose control. Within the past ten years, external
insulin pumps have been shown to aid in the successful delivery
of insulin for individuals with type 1 diabetes. There have
also been several trials of implanted insulin pumps. These
pumps have been shown to have significant advantages over
multiple daily insulin injections. Development of non-invasive
or minimally invasive glucose sensors is a very high priority
area of research. While a number of approaches and devices
appear promising, additional research to optimize sensor
development and validate these devices in patients is necessary.
Linkage of the insulin pumps to these sensors and development
and testing of a ‘closed-loop’ system are within the scope of
this RFA.
R01 or R21 applications should focus on clinical studies to
develop new approaches to the cure or improved treatment of type
1 diabetes. In addition, support for preclinical studies
necessary to obtain approval for an investigational new drug or
for an investigational device could be requested if the project
also includes a clinical component.
Studies directed at complications of type 1 diabetes other than
hypoglycemia are not responsive to this RFA.
Relevant topics listed below are examples and should not be
construed as required or limiting.
o Evaluate immunomodulation regimens to reverse or arrest immune
destruction of beta cells in patients with new onset diabetes
o Utilize cell based therapies to enhance or restore euglycemia
o Evaluate methods to detect hypoglycemia
o Evaluate methods to prevent or lessen the severity of
hypoglycemia associated with intensive therapy
o Develop methods to identify people at increased risk for
hypoglycemia
o Develop interventions to prevent or facilitate recovery from
hypoglycemia unawareness
o Test promising glucose sensors
o Validate algorithms to relate blood glucose to glucose levels
in the interstitial space
o Evaluate linkage of a glucose sensor with an insulin pump to
form a closed-loop system
o Evaluate alternative methods of insulin administration,
including mechanical devices offering substantial advantages
over current pumps or alternate routes of insulin administration
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
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 is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the
research. This new 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 "NIH Guidelines For Inclusion of Women and
Minorities as Subjects in Clinical Research," which was
published in the Federal Register of March 28, 1994 (FR 59
14508-14513) and in the NIH Guide For Grants and Contracts, Vol.
23, No. 11, March 18, 1994, available on the web at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING
HUMAN SUBJECTS.
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 address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the
program staff listed under INQUIRIES. Program staff may also
provide additional relevant information concerning the policy.
LETTER OF INTENT
Prospective applicants are asked to submit, by March 14, 2000,
a letter of intent that includes a descriptive title of the proposed
research; the name, address, and telephone
number of the Principal Investigator; the identities of other
key personnel and participating institutions; and the number and
title of the RFA in response to which the application may be
submitted.
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 NIDDK staff to estimate the
potential review workload and avoid conflict of interest in the
review.
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
Natcher Building, Room 6AS-37F
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8885
FAX: (301) 480-3505
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be
used in applying for these grants. These forms are 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
301-435-0714, email: GrantsInfo@nih.gov.
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.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000
modules, up to a total direct cost request of $250,000 per year.
(Applications that request more than $250,000 direct costs in
any year must follow the traditional PHS398 application
instructions.)The total direct costs must be requested in
accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions
described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating
Direct Costs (in $25,000 increments up to a maximum of $250,000)
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.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not
complete Form Page 4 of the PHS 398. It is not required and will
not be accepted with the application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not
complete 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
http://grants.nih.gov/grants/funding/modular/modular.htm 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 Under Personnel, list key 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.
For Consortium/Contractual costs, provide an estimate of total
costs (direct plus facilities and administrative) 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 key
personnel, and the 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.
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 key
personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch
may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- 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 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.
The RFA label available in the PHS 398 (rev. 4/98)
application form must be affixed to the bottom of the
face page of the application. Failure to use this label
could result in delayed processing of your 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 on the RFA label and the YES box must be marked.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has
been modified to allow for this change. Please note this is in pdf format.
Submit a signed, typewritten original of the application,
including the Checklist, and three signed photocopies, in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At time of submission, two additional copies of the
application must be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
Natcher Building, Room 6AS-37F
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Applications must be received by April 14, 2000.
If an application is received after that date,
it will be returned to the applicant without review.
Supplemental documents containing significant revision or
additions will not be accepted, unless applicants are
notified by the Scientific Review Administrator. 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
previously reviewed, but such applications must include
an introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Applications that are complete and responsive to the RFA
will be evaluated for scientific and technical merit by
an appropriate peer review group convened by the NIDDK in
accordance with the review criteria stated below. 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 the
applications under review, will be discussed, assigned a
priority score, and receive a second level review by the
National Diabetes and Digestive and Kidney Diseases
Advisory Council or other appropriate National 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 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. 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.
o 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?
o 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?
o 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?
o 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)?
o 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?
In addition to the above criteria, in accordance with NIH
policy, all applications will also be reviewed with
respect to the following:
o 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
evaluated.
o The reasonableness of the proposed budget and duration
to the proposed research.
o The adequacy of the proposed protection of humans,
animals, or the environment, to the extent that they may
be adversely affected by the project proposed in the
application.
o Availability of special opportunities for furthering
research programs through the use of unusual talent
resources, populations, or environmental conditions in
other countries which are not readily available in the
United States or which provide augmentation of existing
U.S. resources.
AWARD CRITERIA
The anticipated date of award is September 30, 2000.
Award criteria that will be used to make award decisions
include:
o Scientific merit as determined by peer review;
o Level of interaction between researchers in appropriate
disciplines;
o Availability of funds;
o Programmatic priorities.
INQUIRIES
Inquiries concerning this RFA are encouraged. The
opportunity to clarify any issues or questions from
potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Joan T. Harmon, Ph.D.
Division of Diabetes, Endocrinology and Metabolic
Diseases
NIDDK
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8813
FAX: 301-480-3503
E-mail: joan_harmon@nih.gov
Elaine Collier, M.D.
Chief, Autoimmunity Section
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 5135
Bethesda, MD 20892-7640
Tel (301) 496-7104
Fax (301) 402-2571
E-mail: ec5x@nih.gov
Gilman D. Grave, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11 - MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791
Email: GRAVEG@HD01.NICHD.NIH.GOV
Direct inquiries regarding fiscal and administrative
matters to:
Florence Danshes
Division of Extramural Activities
NIDDK
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8861
FAX: (301)480-3504
E-mail: danshesf@extra.niddk.nih.gov
Maryellen Connell
Grants Management Specialist
NIAID, Division of Extramural Activities
Room 2123
6700-B Rockledge Drive, MSC 7614
Bethesda, MD 20892-7614 (Regular Mail)
Bethesda, MD 20817 (Express Mail)
Phone: (301) 402-5576
FAX: (301) 480-3780
Email: mc40u@nih.gov
E. Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17 - MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1303
FAX: (301) 402-0915
Email: SHAWVERD@HD01.NIH.GOV
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal
Domestic Assistance No. 93.847 (Diabetes, Endocrinology
and Metabolism Research), No. 93.855 (Immunology,
Allergy, and Transplantation Research) and No. 93.865
(Research for Mothers and Children). Awards are 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 NIH 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, 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 NIH mission to protect and
advance the physical and mental health of the American
people.
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