This Program Announcement expires on June 30, 2004, unless reissued.
CACHEXIA: RESEARCH INTO BIOBEHAVIORAL MANAGEMENT AND QUALITY OF LIFE
Release Date: June 11, 2001
PA NUMBER: PA-01-109
National Institute of Nursing Research (NINR)
National Cancer Institute (NCI)
National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Neurological Disorders and Stroke (NINDS)
THIS PA 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/PA.
PURPOSE
This Program Announcement (PA) solicits applications for investigator-
initiated research related to the prevention and management of cachexia to
improve the quality of life for these patients. Cachexia is a condition of
severe malnutrition characterized by anorexia, weight loss and muscle wasting
that occurs as a consequence of chronic conditions such as cystic fibrosis,
cerebral palsy, cancer, AIDS, congestive heart failure, failure to thrive in
older populations, end-stage organ failure, neurological degenerative
diseases, chronic obstructive lung disease, chronic liver disease, and chronic
renal disease. Cachexia has repeatedly been associated with adverse clinical
outcomes, and increased morbidity and mortality. Research findings are
reported in the literature which address individual symptoms and speculated
causes of cachexia but data are not available to provide a scientific base for
a multidisciplinary approach to prevent cachexia and manage the associated
symptoms to improve the quality of life for patients suffering from cachexia.
The goal of this PA is threefold: 1) to stimulate basic and clinical research
in cachexia, 2) to examine cachexia in relation to several related symptoms to
improve quality of life, and 3) to examine cachexia symptoms in two or more
chronic conditions.
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 Program Announcement (PA),
Cachexia: Research into Biobehavioral Management and Quality of Life, 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit 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 PA will use the National Institutes of Health (NIH) Research Project
Grant (R01) award mechanism. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant. The
total project period for an application submitted in response to this PA may
not exceed 5 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
RESEARCH OBJECTIVES
Background
Cachexia is a condition of severe malnutrition and negative nitrogen balance
characterized by anorexia, weight loss and muscle wasting. The physiological,
metabolic, and behavioral changes in cachexia are associated with patient
complaints of weakness, fatigue, gastrointestinal distress, sleep/wake
disturbances, pain, listlessness, shortness of breath, lethargy, depression,
malaise and the fear of being a burden on family and friends. Although
cachexia has been classically associated with chronic infections and malignant
conditions, it has also been identified in patients after extensive traumatic
injury and sepsis, and in aging persons with failure to thrive syndrome.
Muscle cachexia, mainly reflecting degradation of myofibrillar proteins, is an
important clinical feature in cachectic patients. A redistribution of the
body’s protein content occurs, with preferential depletion of skeletal muscle
and an increase in the synthesis of proteins involved in the response to
tissue injury. Muscle cachexia is associated with increased gene expression
and activity of the calcium/calpain and ubiquitin/proteasome-proteolytic
pathways. Calcium/calpain-regulated release of myofilaments from the
sarcomere is an early, and perhaps rate-limiting, component of the catabolic
response in muscle. Understanding the mechanisms regulating muscle protein
breakdown is important for the development of therapeutic strategies aimed at
preventing and managing muscle cachexia. The catabolic response in skeletal
muscle may result in muscle wasting and weakness that has important clinical
implications such as difficulty with ambulation, impaired rehabilitation and
increased risk for pulmonary complications.
The cachexia-anorexia syndrome involves metabolic pathology and is associated
with hypertriacylglycerolemia, lipolysis, and acceleration of protein
turnover. These changes result in the loss of fat mass and body protein.
Increased resting energy expenditure in weight-losing cachectic patients can
occur despite the reduced dietary intake, indicating systemic dysregulation of
host metabolism. Cachexia, regardless of the underlying diagnosis, can rarely
be explained by the actual energy and substrate demands or by the diagnosis
itself. Cachexia involves immune changes, and cytokines have been identified
in the development and/or progression of the cachexia-anorexia syndrome. For
example, interleukin-1, interleukin-6 (and its subfamily such as ciliary
neurotrophic factor and leukemia inhibitory factor), interferon-gamma, tumor
necrosis factor-alpha, and brain derived neurotrophic factor have been
associated in various cachectic conditions. Cytokines are proposed to
participate in the development and progression of cachexia. Data show that
cytokines may be involved in cachexia processes by being produced and by
acting locally in specific brain regions. Brain synthesis of cytokines has
been demonstrated in peripheral models of cancer, in peripheral inflammation,
and during peripheral cytokine administration. Since the data reveal a
multifactorial syndrome in cachexia, understanding the interactions between
peripheral and brain mechanisms may be pivotal to characterizing the
underlying integrative pathophysiology in this disorder and in designing
effective prevention and management strategies.
Immunological pathology has been linked to cachexia in different diseases such
as cancer and chronic heart failure. Data show that the development of
chronic heart failure includes phenotypic changes in numerous homeostasis
systems so that in late chronic heart failure, extra-cardiac manifestations
occur, in particular immunological abnormalities. Increased levels of the
proinflammatory cytokine tumor necrosis factor (TNF) are found in the
circulation and in the myocardium of patients with chronic heart failure in
higher numbers than in controls. Numerous therapies for chronic heart failure
directed against TNF are reported in the literature and represent an approach
to heart failure management. Basic and clinical research studies are needed
to measure the effectiveness of these therapies in ameriorating the multiple
symptoms affecting patients with cachexia.
Cachexia can be a hallmark condition of Acquired Immune Deficiency Syndrome
(AIDS). Limited success has been reported with the use of several anabolic
agents to retard or prevent progressive muscle wasting in persons with AIDS.
One recent published finding reported that insulin administration improved
metabolic profiles (lowering triglycerides, liver enzymes, and glycohemoglobin
concentrations and normalizing the 24 hour urine) to the point of patients
being in a positive energy balance. No adverse effects, including
hypoglycemic episodes, were reported and a marked rise in CD4 counts and an
improvement in the thyroid hormone profile were noted. The possibility that
insulin administration may improve cachexia in AIDS and in other chronic
conditions may warrant further evaluation.
Trials of conventional nutritional supplements in patients with cancer
cachexia have failed to show appreciable benefit in terms of weight gain or
quality of life. The difficulties in introducing sound and effective
nutritional support or metabolic manipulation to reverse cachexia are outlined
in the literature. A variety of pharmacological and dietary agents have been
studied in an attempt to normalize lipid and protein metabolic changes with
only limited success. For example, preliminary clinical studies have shown
that eicosapentanoic acid stabilizes body weight and protein and fat reserves
in cachectic patients with pancreatic carcinoma. Recent studies have
demonstrated the ability of anabolic and anticatabolic agents to mitigate the
loss of skeletal muscle and to improve clinical outcomes of cachectic patients
in selected circumstances. Preclinical initiatives target the cytokine
regulation of protein metabolism. Further, a recent study reported that an
energy-enriched formula was more effective in improving the nutritional status
of cachectic children with cancer during the intensive phases of treatment
than the standard formula. Combinations of nutritional, pharmacological, and
alternative/complementary medicine therapies to normalize the metabolic milieu
may have the potential to reverse cachexia and improve the associated symptoms
that affect quality of life. However, metabolic manipulations in cachexia
could have positive or negative clinical effects, which need to be
distinguished through basic and clinical research and appropriate clinical
trials.
In order to improve quality of life during cachexia, numerous educational
interventions are available for patients and families to treat and manage
physical and emotional symptoms associated with cachexia. However, they have
not been scientifically validated. There are published research results to
document interventions to ameliorate the inflammation and deterioration of
oral mucous membranes as a side effect of cancer therapy and interventions to
assist patients in modulating shortness of breath. However, data-based
research publications are lacking to describe how patients should manage
cachexia-anorexia syndrome to improve their quality of life. Clinical research
studies are needed to combine behavioral strategies with nutritional
interventions in order to impact the anorexia-cachexia syndrome. Clinical
research studies are warranted to test effective approaches to manage
unintentional weight loss as a side effect of cancer treatment and AIDS
progression. Research studies are needed to validate ways for cachectic
patients and their families to increase their ability to intervene
appropriately for pain, psychosocial needs, bereavement, depression, and
issues for end of life. Research is needed to document how interventions can
improve these diverse symptoms. Also, reversing cachexia may not always be
possible, for example in patients at the end stages of life. In these
conditions, research is needed to test ways to manage multiple associated
sequalae of cachexia.
Scope
This PA solicits applications that investigate ways to prevent and manage
cachexia in order to improve the quality of life of patients with this
condition. The purpose of the PA is: 1) to stimulate basic and clinical
research in cachexia, 2) to examine cachexia in relation to several related
symptoms or other sequalae to improve quality of life (e.g., decrease in pain
and weakness, fatigue and dyspnea, investigate ways to prevent muscle wasting
and evaluate the validity of its effectiveness on patients sleep/wake cycles
and complaints of shortness of breath), and 3) to examine cachexia symptoms in
two or more chronic conditions (e.g., test effective strategies to manage
anorexia in patients diagnosed with AIDS and cancer). Multidisciplinary
research teams composed of basic and clinical researchers are encouraged to
address the goals of this PA. For example, basic researchers could emphasize
the interactions among multiple underlying pathophysiological mechanisms of
cachexia while clinical researchers define the specific impact of loss of
independence or how patients can improve upon skeletal muscle function
recovery. In addition, both basic and clinical research could test multiple
combination therapy interventions that include nutritional, immunological,
pharmacological, and alternative/complementary medicine components. These
combination therapies could be evaluated for their effects on clusters of
symptoms occurring with cachexia such as subjective complaints by patients
that affect quality of life that include sleep/wake disturbances, malaise,
pain, listlessness, shortness of breath, fatigue and depression. Attention
could also be directed to differences in therapeutic interventions based on
age, gender, and underlying disease.
Listed below are examples of areas of basic and clinical research that would
be responsive to this program announcement. They are not listed in any
priority order and are not intended to be inclusive or restrictive. These
examples are only illustrative examples, and applicants are encouraged to
propose other topics consistent with the goals of this program.
o Determine which symptoms of cachexia are amenable to metabolic or
biochemical interventions and which symptoms require behavioral interventions
in order to improve quality of life,
o Identify and test nutritional, pharmacological, and
psychoneuroimmunological interventions to prevent or treat the anticipated
onset of anorexia with cachexia,
o Test biobehavioral interventions to promote quality of life in cachectic
patients who have different underlying conditions/diseases,
o Compare and contrast traditional treatments alone or in tandem with
alternative/complementary therapies to arrest cachexia in two or more
different underlying conditions/diseases,
o Identify biological, immunological, chemical, genetic or behavioral markers
to be used as an index of successful outcome measures in cachexia or the
treatment and management of cachexia,
o Explore regimens (e.g., physical activity and nutrient supplementation) to
improve dyspnea, impaired mobility, pain, anorexia and fatigue associated with
cachexia,
o Explore the role of the neuroendocrine system in the development of
cachexia, and
o Examine the contribution of cachexia to the progression of
neurodegenerative disease.
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 also may 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.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits 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 301/710-0267, email: GrantsInfo@nih.gov.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the
application must obtain agreement from the IC staff that the IC will accept
the application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute or Center who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
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.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
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 PHS
398 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 all 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 all 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 title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
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)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures. 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 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.
(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 method?
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 The 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 in relation to the
proposed research
o 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.
Additional scientific/technical merit criteria specific to the objectives of
the PA and the mechanism used must be included if they are to be used in the
review.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, availability of
funds, and 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:
Dr. Hilary Sigmon
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Room Number 3AN12, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-5970
FAX: (301) 480-8260
Email: Hilary_Sigmon@nih.gov
Dr. Claudette Varricchio
Program Director
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd. EPN 300
Bethesda, MD, 20892
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email: varriccc@mail.nih.gov
Dr. Louis A. Quatrano
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4221
FAX: (301) 402-0832
E-mail: lq2n@nih.gov
Dr. Frank A. Hamilton
Chief, Digestive Disease Program Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd. Room 669
Bethesda, Maryland 20892-5450
Telephone: (301) 594-8877
FAX: (301) 480-8300
Email: fh14e@nih.gov
Dr. Jill E. Heemskerk
Program Director
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Neuroscience Center, Room 2204
6001 Executive Boulevard
Bethesda, MD 20892-9525 (for courier service, use: Rockville, MD 20852)
Telephone: (301) 496-5680
FAX: (301) 480-1080
E-mail: jill_heemskerk@nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Tara Mowrey
Office of Grants and Contract Management
National Institute of Nursing Research
Building 45, Room Number 3AN12, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-5979
FAX: (301) 480-8260
Email: Tara_Mowrey@nih.gov
Ms. Eileen Natoli
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Rockville, MD 20892-7150
Telephone: (301) 496-8791
FAX: (301) 402-0275
Email: natolie@gab.nci.nih.gov
Ms. Carolyn Kofa
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Bethesda, MD 20892
Telephone: (301) 594-7687
FAX: (301) 480-3504
Email: KofaC@extra.niddk.nih.gov
Mr. Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17H, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6996
FAX: (301) 402-0915
E-mail: cm143g@nih.gov
Ms. Kimberly Pendleton
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., NSC Room 3260
Bethesda, Maryland 20892 (USPS)
Rockville, MD 20852 (Courier and FedEx)
Tel: 301-496-7480
Fax: 301-402-0219
Email: kp33e@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.361 (NINR), 93.393 (NCI),93.929, 93.848 (NIDDK), and 93.853 (NINDS). 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 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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