NEW APPROACHES TO PREVENT HYPOGLYCEMIA IN PATIENTS WITH DIABETES
Release Date: July 27, 2001
RFA: RFA-DK-01-032
National Institute of Diabetes and Digestive and Kidney Diseases
(http://www.niddk.nih.gov)
National Institute Of Neurological Disorders and Stroke
(http://www.ninds.nih.gov)
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
National Institute of Nursing Research
(http://www.ninr.nih.gov)
Juvenile Diabetes Research Foundation International
(http://www.jdrf.org)
Letter of Intent Receipt Date: October 17, 2001
Application Receipt Date: November 21, 2001
THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING
LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS
ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT
http://grants.nih.gov/grants/funding/phs398/phs398.html.
PURPOSE
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the National Institute of Neurological Disorders and Stroke
(NINDS), the National Institute of Child Health and Human Development
(NICHD), the National Institute of Nursing Research (NINR) and the
Juvenile Diabetes Research Foundation International (JDRF) solicit
applications for clinical studies designed to enhance understanding and
prevention of hypoglycemia in patients with diabetes. Large clinical
trials have demonstrated the efficacy of intensified glucose control in
the prevention of the long-term complications of diabetes. However,
episodes of severe hypoglycemia may complicate intensified treatment
and are often a major obstacle to the achievement of euglycemia in many
patients. This RFA solicits clinical studies to 1) define and
characterize hypoglycemia in diabetic individuals and 2) develop new
approaches to prevent the development of hypoglycemia or to ameliorate
its effects in individuals with diabetes.
A separate RFA (DK 01-031) solicits basic and clinical research
specifically addressing the problem of hypoglycemia unawareness. An
additional related RFA (NS-02-008) solicits basic research on the
effects of hypoglycemia on cerebral metabolism and neural cell function
and survival.
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 Request for
Applications (RFA), New Approaches to Prevent Hypoglycemia in Patients
with Diabetes, is related to the priority area of diabetes and chronic
disabling conditions. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople/.
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) and the Exploratory/Development Research Grant
(R21) award mechanisms. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.
The total project period for an R01 application submitted in response
to this RFA may not exceed 5 years.
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 $125,000 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.
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. The anticipated award date is July 2002.
FUNDS AVAILABLE
The NIDDK, the NINDS, the NICHD and the NINR intend to commit
approximately $3.25 million in FY 2002 to fund 4 to 8 grants in
response to this RFA. The JDRF intends to commit up to $500,000 in
additional funds to co-fund research project grants that are both
scientifically meritorious and fit within the mission and research
emphasis areas of the JDRF (see http://www.jdrf.org), for more
information). All awards will be issued by the NIDDK, the NINDS, the
NICHD and the NINR.
An R01 applicant may request a project period of up to 5 years. Because
the nature and scope of the research proposed may vary, it is
anticipated that the size of each award will also vary. Although the
financial plans of the NIDDK, the NINDS, the NICHD, the NINR and the
JDRF 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 applications of outstanding scientific and
technical merit.
RESEARCH OBJECTIVES
Background
The Diabetes Control and Complications Trial (DCCT), for type 1
diabetes, and the United Kingdom Prospective Diabetes Study (UKPDS),
for type 2 diabetes, established the importance of intensified diabetes
control in dramatically reducing the devastating complications that
result from poorly controlled diabetes. However, with current treatment
modalities, tight control remains an unattainable goal for many people
with diabetes. For example, in the DCCT, fewer than 5% of individuals
receiving intensified treatment maintained normal hemoglobin A1c
levels.
To achieve glycemic control, many patients must walk a tightrope,
balancing euglycemia against the danger of low blood glucose. Indeed,
for many individuals with diabetes, episodes of severe hypoglycemia are
the major obstacle to the achievement of euglycemia and the prevention
of long-term complications. Hypoglycemia is frightening to patients and
their families. In fact, for some individuals or their families, fear
of hypoglycemia may outweigh concern over long-term complications of
diabetes, leading to inadequate glycemic control. Fear of hypoglycemia
is well-founded, as low blood glucose levels impart significant
morbidity and mortality. Two to 4 per cent of deaths among individuals
with type 1 diabetes have been attributed to hypoglycemia. Acutely,
diminished brain function during a hypoglycemic episode poses potential
physical danger to the patient. In addition, recurrent hypoglycemia may
impose long-lasting damaging effects on the brain, resulting in
impairment of memory or other cognitive functions. This is especially a
concern in the early childhood years when the nervous system is still
developing.
Recurrent hypoglycemia may also impair the body’s defense mechanisms
against hypoglycemia, creating a vicious cycle for the patient. A major
problem in many individuals with diabetes is a progressive decay in the
counterregulatory response over time, resulting in hypoglycemia
unawareness. The individual fails to become aware of hypoglycemia and
does not initiate appropriate responses. This can result in prolonged
hypoglycemia, with consequent brain injury, seizure or loss of
consciousness. Children and the elderly may be particularly vulnerable
to the development of hypoglycemia and to its deleterious effects.
Young children cannot reliably report or interpret symptoms of
hypoglycemia. In older individuals, decline of beta adrenergic function
with age, coupled with other medical problems (e.g., mild renal
impairment which could alter drug metabolism), may predispose to the
risk of hypoglycemia and hypoglycemia unawareness. Unrecognized
hypoglycemia could contribute to subtle declines in mental function
that might simply be attributed to dementia.
Hypoglycemia occurs because of a mismatch between insulin dose, food
intake and energy expenditure. Despite vigilant blood sugar monitoring
and adherence to treatment regimens, euglycemia often cannot be
achieved safely (i.e., without the occurrence of hypoglycemia), because
current treatment modalities do not mimic normal, physiologically
regulated insulin secretion.
To address this critical problem in diabetes, the Juvenile Diabetes
Research Foundation International, the American Diabetes Association
(ADA), the NIDDK, the NINDS, the NICHD and NASA cosponsored a workshop
on Hypoglycemia and the Brain on Sept. 7-8, 2000. Participants in the
workshop identified a number of knowledge gaps requiring future
research (http://www.jdrf.org/research/workshop090800.pdf). Basic
research is needed to enhance understanding of the hypothalamic and
peripheral control mechanisms that counteract hypoglycemia, and the
pathogenic mechanisms involved in loss of counterregulatory control. In
addition, clinical studies are needed to better define the scope of the
problem and develop new prevention and treatment approaches. As a first
step toward addressing the problem of hypoglycemia in diabetes, the
NIDDK, the NINDS, the NICHD, the NINR and the JDRF have issued this
RFA.
Scope and Objectives
This RFA solicits clinical studies to 1) define the scope and nature of
hypoglycemia in individuals with diabetes, and 2) develop and test
strategies to prevent the development of hypoglycemia in patients with
diabetes, or to ameliorate its effects. Recent scientific advances,
including the availability of continuous glucose monitoring,
potentially open up new avenues of exploration. The NINR is
particularly interested in applications from qualified nurse
investigators that focus on reduction of hypoglycemia through the use
of advanced technologies, such as the use of insulin pumps in children
and adolescents.
While this RFA focuses on clinical studies of hypoglycemia, a separate
RFA (DK 01-031) solicits basic and clinical research specifically
addressing the problem of hypoglycemia unawareness. An additional
related RFA (NS-02-008) solicits basic research on the effects of
hypoglycemia on cerebral metabolism and neural cell function and
survival.
Appropriate topics for investigation under this RFA would include but
are not limited to:
o Studies to determine the prevalence of hypoglycemia in patients with
diabetes, with a focus on delineating differences among various age
groups (e.g., children, adults, the elderly),
o Studies to delineate the role of age, gender, race/ethnicity,
socioeconomic status and other factors in the risk of hypoglycemia,
o Studies to identify factors, including method of treatment, exercise,
nutrition, or duration of diabetes, which affect risk of hypoglycemia,
o Studies to establish normative data for blood glucose levels,
particularly in children, throughout a 24-hour period,
o Studies to determine whether there are changes in counterregulatory
mechanisms with age,
o Studies to determine whether intensive glucose control during
pregnancy has adverse effects on the developing fetus,
o Studies to determine whether alternative fuels (e.g., ketones) can
provide a buffer against hypoglycemia,
o Studies to assess the reliability and utility of continuous glucose
sensors in detecting falling blood glucose levels and in preventing
severe hypoglycemia,
o Studies to determine whether the occurrence of hypoglycemia can be
minimized by altering the timing of drug delivery or by drugs with
altered kinetics,
o Studies to determine whether different treatment regimens for
diabetes affect counterregulatory mechanisms,
o Studies to evaluate whether there are differences in
counterregulation between individuals with type 1 and type 2 diabetes,
o Studies to develop and test strategies for minimizing the risk of
hypoglycemia with intensive glucose management.
SPECIAL REQUIREMENTS
Letter of Authorization
Applicants should submit a brief letter to the NIDDK indicating whether
or not they wish their application to be considered for funding by the
JDRF. While applicants may request that their applications be
considered only by the NIH and not by the JDRF, it is necessary that
the record indicate the applicant"s consideration of this opportunity.
For those applicants who wish to have the JDRF consider their
application, all materials relating to the application will be promptly
forwarded to that organization and the summary statements for such
applications will be shared with the JDRF when available. This separate
letter of authorization may be submitted with the Letter of Intent (see
below).
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 sub-populations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are provided
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 research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a
complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable, and b) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
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.
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. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
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. This policy announcement is found
in the NIH Guide for Grants and Contracts Announcement dated June 5,
2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this RFA (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.
LETTER OF INTENT
Prospective applicants are asked to submit, by 10/17/01, 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 plan the review.
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8885
FAX: (301) 480-3505
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev.
5/2001) available at
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used
in applying for these grants. This version of the PHS 398 is available
in an interactive, searchable PDF format. Although applicants are
strongly encouraged to begin using the 5/2001 revision of the PHS 398
as soon as possible, the NIH will continue to accept applications
prepared using the 4/1998 revision until January 9, 2002. Beginning
January 10, 2002, however, the NIH will return applications that are
not submitted on the 5/2001 version. For further assistance contact
GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
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 NIH staff. The research grant
application form PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used
in applying for these grants, with modular budget instructions provided
in Section C of the application instructions. Applicants are
permitted, however, to use the 4/1998 revision of the PHS 398 for
scheduled application receipt dates until January 9, 2002. If you are
preparing an application using the 4/1998 version, please refer to the
step-by-step instructions for Modular Grants available at
http://grants.nih.gov/grants/funding/modular/modular.htm. Additional
information about Modular Grants is also available on this site.
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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
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)
Applications must be received by the application receipt date listed in
the heading of the RFA. 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
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIDDK. If the application is not responsive
to the RFA, NIDDK or CSR staff may contact the applicant to determine
whether to return the application to the applicant or submit it for
review in the competition with unsolicited applications at the next
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 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 NIDDK, the NINDS, the
NICHD and the NINR Advisory Councils.
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.
(1) Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge
be advanced? What will be the effect of these studies on the concepts
or methods that drive this field?
(2) Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
(4) Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
(5) Environment: Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional 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.
Schedule
Letter of Intent Receipt Date: October 17, 2001
Application Receipt Date: November 21, 2001
Peer Review Date: March 2002
Council Review: May 2002
Earliest Anticipated Start Date: July 1, 2002
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.
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:
Barbara Linder, M.D, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 699 MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-0021
FAX: (301) 480-3503
E-mail: bl99n@nih.gov
Toby Behar, Ph.D.
Neural Environment
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Rm. 2114A
Bethesda, MD 20892-9521
Telephone: (301) 496-1431
FAX: (301) 480-2424
E-mail: tb72z@nih.gov
Gilman D. Grave, M.D.
Chief, Endocrinology, Nutrition, and Growth Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B11A, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791
E-mail: gg37v@nih.gov
Nell Armstrong, Ph.D., R.N.
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD 20892 6300
Telephone, (301) 594-5973
FAX: (301) 480-8260
E-mail: na21f@nih.gov
Direct inquiries regarding fiscal matters to:
Charlette Kenley
Division of Extramural Activities
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 640 MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8847
FAX: (301) 480-3504
E-mail: ck128k@nih.gov
Mary Graham
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Rm. 3290
Bethesda, MD 20892
Telephone: (301) 496-9231
FAX: (301) 402-0219
E-mail: mg50p@nih.gov
Mary Daley
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17E, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1305
FAX: (301) 402-0915
E-mail: md74u@nih.gov
Robert L. Tarwater
Office of Grants and Contracts Management
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD 20892-6300
Telephone: (301) 594-2807
FAX: (310) 480-8260
E-mail: tarwater@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.847, 93.853, 93.865 and 93.361. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant 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 PHS mission to protect and
advance the physical and mental health of the American people.
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