SURROGATE ENDPOINTS FOR DIABETIC MICROVASCULAR COMPLICATIONS
Release Date: August 30, 2001
RFA: RFA-DK 02-016
National Institute of Diabetes and Digestive and Kidney Diseases
(http://www.niddk.nih.gov)
National Eye Institute
(http://www.nei.nih.gov)
National Institute of Neurological Disorders and Stroke
(http://www.ninds.nih.gov)
Letter of Intent Receipt Date: January 17, 2002
Application Receipt Date: February 14, 2002
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 Eye Institute (NEI) and the National Institute of Neurological
Disorders and Stroke (NINDS) seek applications to develop and validate
biomarkers for the microvascular complications of diabetes.
Prevention and treatment of long-term micro- and macrovascular complications
remain a critical problem in the management of type 1 and type 2 diabetes
mellitus. In the United States, diabetes is the leading cause of new
blindness in working-age adults, of new cases of end stage renal disease and
of non-traumatic lower leg amputations. Basic science advances in the coming
years are expected to lead to new therapies to prevent or treat the
development of nephropathy, retinopathy and neuropathy. Surrogate endpoints
for complications can be utilized in clinical trials to assess the efficacy
of these new therapies. In addition, such biomarkers may be useful for
predicting those patients who are at high risk for the development of
complications, and who may benefit from aggressive intervention.
This RFA invites basic and clinical research applications to develop
biochemical, cellular, physiologic or genetic surrogate endpoints that can be
used to predict risk, aid in early diagnosis and assess progression of the
microvascular complications of diabetes.
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, Surrogate
Markers for Diabetic Microvascular Complications, 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. Applications with requested budgets up to $250,000 direct
costs in any year must use the modular grants format. Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application instructions.
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.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the
NIH. Complete and detailed instructions and information on Modular Grant
applications have been incorporated into the PHS 398 (rev. 5/2001).
Additional information on Modular Grants can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm
FUNDS AVAILABLE
For fiscal year 2002, the NIDDK, the NEI and the NINDS intend to commit
approximately $2 million to fund 4 to 10 new and/or competing continuation
grants in response to this RFA. An applicant may request a project period of
up to 5 years for R01s and up to two years for R21s. 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
NEI and the NINDS 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. At this time, it is not known if this RFA will be reissued.
RESEARCH OBJECTIVES
Background
Prevention and treatment of long-term complications remain a critical problem
in the management of type 1 and type 2 diabetes mellitus. In the United
States, diabetes is the leading cause of new blindness in working-age adults,
of new cases of end stage renal disease and of non-traumatic lower leg
amputations. Diabetes has been estimated to cost the United States economy
over $98 billion annually, much of this cost is related to the treatment of
the long-term micro- and macrovascular complications of diabetes.
Identification of patients at risk for the development of complications, with
the hope of early intervention, is a public health priority. Early
intervention is essential, because, by the time symptoms of disease are
recognized, irreparable structural organ damage may have already occurred.
Diabetic nephropathy is the most common cause of end-stage renal disease
(ESRD) in the U.S., accounting for approximately 45% of new cases. Major risk
factors for the development of diabetic nephropathy include duration of
diabetes and poor metabolic control. However, there is considerable
ethnic/racial variability in the incidence of nephropathy, and not all
patients with prolonged hyperglycemia develop ESRD, suggesting a strong
genetic component to susceptibility. For renal disease, a valuable biomarker
exists microalbuminuria is the best available non-invasive predictor of
diabetic nephropathy risk. Screening for microalbuminuria is considered
standard of care and treatment of patients who have microalbuminuria with
angiotensin converting enzyme inhibitors is partially effective in slowing
progression to overt proteinuria and renal disease. However, the predictive
value of microalbuminuria for the progression to overt nephropathy is not
precise. More data are needed to delineate the extent to which increases in
microalbuminuria predict either pathological progression, or ultimate
progression to end stage disease. In addition, some patients in whom
microalbuminuria has not increased may nonetheless develop advanced renal
lesions. Finally, prevention strategies might be most effective in patients
with normal albumin excretion, if patients at high risk for the development
of nephropathy could be identified before the development of
microalbuminuria.
Neuropathy is a frequent complication of diabetes. Symptoms include weakness,
pain, and numbness, which may be serious enough to interfere with daily
activities. To evaluate symptoms of diabetic neuropathy, standardized
checklists have been developed and scoring systems devised that take into
account symptom frequency and intensity. This approach is not very reliable,
and is of little use for early intervention because symptoms may not occur
until after neurological damage has occurred. Nerve conduction studies have
been used to diagnose peripheral neuropathy for decades, however, results
vary by age and sex, and the reliability of the tests can be affected by
location of electrodes, distances measured, and temperature. Sural nerve
biopsies can provide a great deal of information, but the procedure is highly
invasive. Information on the status of nerves in the skin can also be
obtained from skin punch biopsies or from a recently described skin blister
method, but these diagnostic techniques are also relatively invasive. Reduced
sensation can be detected with a monofilament, however, symptoms may not
develop until after considerable nerve damage has occurred.
Diabetic peripheral neuropathy is often associated with peripheral vascular
disease and impaired wound healing, resulting in more than 200,000 cases of
foot ulcers and 80,000 amputations per year, with an annual medical cost of
over $2 billion. In fact, diabetes is the leading cause of non-traumatic
lower leg amputations in the United States. Thus, a top priority is the
development of simple and reliable surrogate markers of early damage, to
allow effective early intervention (i.e., before symptoms develop) to prevent
ulcerations and disability. In addition, there are currently no widely
accepted non-invasive surrogate markers that can be used to evaluate patient
status, to measure therapeutic effectiveness and define end points for
clinical trials. Surrogate markers for use in clinical trials are especially
needed for diabetic neuropathy, as effective therapies for the prevention and
treatment of diabetic neuropathy are not currently available.
Diabetes is the most common cause of new cases of blindness among working age
adults. As with other microvascular complications, risk is related to
duration of diabetes and glycemic control. After 15 years of diabetes, almost
all patients with type 1 diabetes and two thirds of patients with type 2
diabetes have background retinopathy. By the time visual acuity is affected,
significant retinal damage has already occurred. Fluorescein angiography and
fundus photography are effective methods for detecting retinopathy, however,
these techniques can only be used to detect disease in its late stages, when
some permanent visual loss has already occurred. Biomarkers are, therefore,
needed to determine those at risk for developing retinopathy and for
detecting disease at its earliest stages, so that more effective
interventions can be used to prevent visual loss. In addition, because these
techniques detect only late stages of retinopathy, trials of prevention or
treatment regimens require long follow-up to detect clinically significant
differences. Markers of early disease could potentially shorten the duration
of clinical trials by allowing more sensitive detection of retinopathy
progression.
Objectives and Scope
This RFA invites basic and clinical research applications to develop
biochemical, cellular, physiologic or genetic surrogate endpoints that can be
used to predict risk, aid in early diagnosis and assess progression of the
microvascular complications of diabetes. The overall goal of this RFA is to
develop biomarkers that could be used as diagnostic tools for the individual
patient, or as outcome measures to be used in clinical trials testing new
therapeutic agents. Ideally, such biomarkers will either predict
susceptibility to retinopathy, nephropathy or neuropathy, detect early
disease or correlate with pathological progression. Surrogate endpoints
should be reliable, standardized and easy to use. Investigators responding to
this RFA may wish to take advantage of existing epidemiological or long-term
clinical studies that may have been established for investigation of diabetes
or of other diseases. Studies in animal models will be considered responsive
to this RFA if these applications have a clear-cut long-term goal of
applicability to humans.
Recent studies of the pathogenesis of diabetic microvascular complications
may provide clues for potential surrogate markers of disease. For example,
several growth factors have been implicated in the development of
nephropathy, and some studies indicate that urinary excretion of TGF-beta may
be an early marker of nephropathy. Other urinary or circulating biomarkers
may predict risk for microvascular complications. In addition, recent
advances in molecular biology may open up new avenues of exploration for the
development of surrogate endpoints. Thus, the use of gene or protein
microarrays could provide powerful tools to screen for novel biochemical,
cellular or genetic markers associated with disease susceptibility or
progression.
New advances in imaging technologies also may provide opportunities to non-
invasively detect microvascular abnormalities and develop physiologic markers
that are associated with diabetic complications. A related RFA (DK 02-001)
solicits applications to develop imaging techniques to measure perfusion,
tissue oxygenation, angiogenesis or inflammation in the peripheral
microvasculature of skeletal muscle beds in individuals with diabetes.
Appropriate topics for investigation under this RFA would include but are not
limited to:
o Studies to identify and validate new biomarkers of early signs ( i.e.,
before the onset of symptoms) of retinopathy, nephropathy or neuropathy,
o Studies to identify and validate new biomarkers that identify patients at
risk for the development of retinopathy, nephropathy or neuropathy,
o Studies to identify and validate new diagnostic tools that can be used to
more sensitively monitor progression of retinopathy, nephropathy or
neuropathy, including studies to assess the correlation between non-invasive
markers of disease and pathological progression,
o Studies to identify biomarkers that could be useful in predicting
susceptibility to or development of multiple microvascular complications
(e.g., retinopathy and nephropathy),
o Studies to develop non-invasive measures of oxygenation or blood flow in
relevant tissues (e.g., retina),
o Studies, including ancillary studies to ongoing clinical trials, to clarify
the predictive value of existing biomarkers or surrogate endpoints.
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 January 17, 2002, 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)
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. For further assistance contact
GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.
All application instructions outlined in the PHS 398 application kit are to
be followed, with the following modifications for R21 applications:
The Research Plan for R21 applications cannot exceed 15 pages and appendix
material will not be accepted. Further details regarding the purpose and
format of R21 applications can be found by reading the NINDS guidelines
describing the R21 program (http://www.ninds.nih.gov/funding/r21guidelines.htm).
All R21 applications submitted in response to this Program Announcement should
follow the NINDS guidelines, regardless of Institute assignment. Applicants may
also contact one of the Program Officials listed under Inquiries for further
information. If there is other important information it should be included
in the PA.
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.
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 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
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
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 program staff representing the participating NIH
Institutes. Incomplete and/or non-responsive applications will be returned
to the applicant without further consideration.
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 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. 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
methods? 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.
Schedule
Letter of Intent Receipt Date: January 17, 2002
Application Receipt Date: February 14, 2002
Peer Review Date: July 2002
Council Review: September 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITERIA
Applications will compete for available funds with all other approved
applications. The following will be considered in making funding decisions:
o Quality of the proposed project as determined by peer review,
o Availability of funds,
o Program priority.
INQUIRIES
Inquiries 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@mih.gov
Paul Kimmel, M.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Rm. 639
Bethesda MD 20892-5458
Telephone: 301-594-7717
FAX: 301-480-3510
E-mail: pk77g@nih.gov
Peter Dudley, Ph.D.
Vision Research Program
National Eye Institute
Executive Plaza South, Rm. 350
Bethesda, MD 20892
Telephone: (301) 496-0484
FAX: (301) 402-0528
E-mail: pad@nei.nih.gov
Paul Nichols, Ph.D.
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Rm. 2118
6001 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-9964
FAX: (301) 401-2060
E-mail: pn13w@nih.gov
Direct inquiries regarding fiscal matters to:
Charlette Kenley
Division of Extramural Activities
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
Margie Baritz
Division of Extramural Activities
National Eye Institute
Executive Plaza South, Rm. 350
Bethesda, MD 20892-6600
Telephone: (301) 496-5884
FAX: (301) 496-9997
E-mail: mbaritz@nei.nih.gov
Denise Chatman
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3290
6001 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-9231
FAX: (301) 402-0219
E-mail: dc55g@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.847, 93.849, 93.867, and 93.853. Awards are made under authorization of
sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 285) and administered under NIH grants policies and Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, 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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