and Human Services (HHS)
EXPIRED
Components of Participating Organizations
National Institute of Child Health and Human Development (http://www.nichd.nih.gov/)
Office of Research on Women’s Health (http://orwh.od.nih.gov/)
Title: Vulvodynia - Systematic Epidemiologic, Etiologic Or Therapeutic Studies (R01)
Announcement Type
This
is a reissue of PA-02-090 which was
previously released March 27, 2002.
Update: The following update relating to this announcement has been issued:
Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html. Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PA-06-302
Catalog of Federal Domestic Assistance
Number(s)
93.865
Key Dates
Release\Posted
Date: March 30, 2006
Application
Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details.
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details.
Council
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details.
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details.
Additional
Information to Be Available Date (Url Activation Date): Not
applicable
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2.Cost Sharing or Matching
3.Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
1. Research Objectives
Purpose
The Center for Population Research (CPR) of the National Institute of Child Health and Human Development (NICHD) and the NIH Office of Research on Women’s invite new and experienced basic scientists, epidemiologists, and clinical investigators to submit research grant applications to further our understanding of the epidemiology, etiology, prevalence, criteria for accurate diagnosis, underlying pathophysiology and pain mechanisms, and treatment strategies for vulvodynia. The purpose of this Program Announcement is to stimulate and strengthen a multidisciplinary approach to this complex, underresearched area of women's health. This solicitation seeks and encourages research grant applications that will use preclinical, clinical, translational, epidemiological, and/or behavioral research that concentrates on studies of relevance to vulvodynia.
Background
Vulvodynia remains one of the poorly understood complex chronic pain syndromes, representing a complex, multifactorial clinical syndrome of unexplained vulvar pain and sexual dysfunction. While the true prevalence remains unknown, several million women in the United States are estimated to have vulvodynia. Vulvodynia is a clinical condition with several different and poorly defined antecedents. Patients frequently experience dyspareunia, persistent vulvar irritation, burning, and pain. Symptoms also may be associated with the urinary and gastrointestinal tracts. Some women identify the pain and increased sensitivity as generalized or localized that may be provoked or occur spontaneously. Complicating our understanding is that the factors influencing a patient's decision to seek care and the criteria by which the clinician selects therapy are not uniform. Thus, in many instances, the treatment patients receive can be less than optimal. There is a need to increase knowledge and understanding about vulvodynia and the biological processes that lead to its development and long-term sequelae.
Frequently, diagnostic criteria that define the categories and subtypes of vulvodynia are neither well defined nor consistently utilized by many clinicians. Moreover, consistent nomenclature continues to be a problem. Two common diagnostic vulvodynia subtypes are based on whether the pain is generalized (dysesthetic) or localized (vestibulitis or vestibulodynia). While histologic studies suggest a chronic inflammatory reaction, the causes of the inflammation, as well as its significance to vulvodynia, remain unclear. The role of pelvic floor dysfunction as a catalyst for the development of vulvar pain syndromes, particularly dysesthetic vulvodynia, has been proposed in several published studies, but its true impact is uncertain. Published studies also comment on the influence of neurophysiologic parameters as a potential association that should be taken into account.
While surgery is rarely performed and appears to be reserved for women with vulvar vestibulitis who have severe and long-standing symptoms, optimum surgical management is still undetermined and very few studies have documented the outcome of surgical procedures. In addition, pharmacological and behavioral therapies would benefit from treatment standardization and prospective clinical studies. Despite the use of surgery, pharmaceutical regimens, psychological support, physical therapy, and pain management techniques such as biofeedback and behavior modification, there is no consensus on which procedure(s) offers the most improvement and patient satisfaction. A combination of therapies is frequently utilized and, although several treatment options are available, most of the literature supports the conclusion that cures for vulvodynia are uncommon and a specific inciting cause can be diagnosed in a relatively small percentage of patients. Consideration of these factors must be an integral part of the management of patients with vulvodynia and this underscores the need to examine this condition in a multidisciplinary context.
This PA will stimulate studies in this underresearched area that will form a foundation for assessing future research needs and complement our overall commitment to support research important to women's health. NIH-sponsored workshops and subsequent RFA and PA initiatives focusing on vulvodynia have introduced the research community to NICHD’s interest in this area. In 2003, NICHD in collaboration with the NIH Office of Rare Diseases and Office of Research on Women’s Health convened a second workshop, Vulvodynia-Toward Understanding a Pain Syndrome, to review the epidemiology, basic science, pain research, evolving therapies, and therapeutics associated with vulvar pain. In response to recommendations made at the conclusion of this workshop, emphasis was placed on continuing to encourage relevant research on promising preclinical, clinical, translational and/or behavioral studies that will expand our knowledge of vulvodynia. Notwithstanding this programmatic emphasis, additional efforts are needed to strengthen the science base and form a framework for assessing future research needs. This PA represents a continuation of ongoing research efforts aimed at reducing the burden of this disease and improving the quality of life for women affected with this disorder.
This elusive chronic pain syndrome has many unexplored questions. Thus, the overarching goal of this initiative is to build a substantive scientific knowledge base related to this debilitating condition. Improvements in pain management for what some investigators consider a neuropathic hypersensitivity syndrome, as well as approaches to the treatment and prevention of vulvodynia will require insight and increased knowledge of the underlying etiology and pathophysiologic mechanisms. Therefore, an overall strategy of augmenting and strengthening a multidisciplinary approach to this distressing condition, leading to improved diagnosis and therapy, is warranted.
Research Scope
This PA seeks applications that will use basic, translational, clinical, epidemiological, and/or behavioral, research approaches in order to define curative factors, characterize pathogenic mechanisms, and effective treatment modalities. Several research strategies are deemed important for the potential development of new leads or approaches.
Examples of research areas considered responsive to this announcement are listed below. Research relevant to this PA is not limited to these examples.
Studies that clarify pathogenic antecedents involved in stimulating the biological processes that lead to the development and long-term sequelae of vulvodynia. Describe the role of pathologic vaginal microbial and viral agents or altered vaginal flora in this process. Identify the genetic and immunologic variations that influence susceptibility to vulvodynia.
Identify and categorize chronicity and inclusion/exclusion criteria for refining the definition for and diagnosis of vulvodynia and its subtypes. Rigorous definitions will permit uniform study designs leading to comparability at the national and international levels.
Systematic investigations of novel experimental preclinical or clinical studies in animal models and/or humans to evaluate normal and dysfunctional neurophysiologic parameters and mechanisms. Determination of the role of neurogenic irritability and/or regional autonomic dysfunction and its influence on symptoms, muscle instability, tissue injury, and repair in vulvodynia.
Studies that examine and evaluate the utility of adjunctive therapy in clinical trials, including behavioral, surgical, and medical treatment, in women with vulvodynia. Investigation and translation of promising, innovative, preclinical findings into clinical research applications, including designing clinical trials of novel therapeutic interventions.
Assessment of the natural history of vulvodynia. Creation and validation of population-based epidemiological studies that assist in defining the prevalence and resolution of vulvodynia and its subtypes. Feasibility and effectiveness of risk factor modification for prevention of vulvodynia.
Initiation and implementation of epidemiological studies to determine if at-risk groups can be identified for prospective or interventional studies.
Research on the contextual factors associated with normal tissue structure, muscle integrity, cellular mechanisms, structural defects, and the factors involved in the transition between latent injury, symptoms, and tissue rehabilitation in vulvodynia. Detection of the role of nerve damage, muscular damage, and/or direct tissue disruption.
Initiation and implementation of well-controlled clinical trials of therapeutic protocols for treating vulvodynia in a well-defined population. Include long-term efficacy and outcome data
Research on the identification and influence of risk factors such as race, ethnicity, and co-morbid medical conditions or previous surgery associated with the occurrence of vulvodynia, treatment outcomes, and complications.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the Research Project Grant (R01) award mechanism.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/policy.htm#gps). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the Modular Budget Component described in the PHS 398 Application Package and Instructions Guide. Otherwise, follow the instructions for non-modular research grant applications.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.
Section III. Eligibility Information
Applications from foreign institutions must conform to the NIH's policy for foreign grants (see http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm).
1.B.
Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
programs.
2. Cost Sharing or Matching
Cost sharing or matching is not
required.
The
most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Not Applicable
Section
IV. Application and Submission Information
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed
research should provide a unique research opportunity not available in the U.S.
3. Submission Dates, Review Dates, and Times
Application
Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
3.A.1. Letter of Intent
A
letter of intent is not required for the funding opportunity.
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be
submitted on or before the application receipt/submission dates described above
(Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is
not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make the
award or to increase the amount of the approved budget if an award is made for
less than the amount anticipated and is inadequate to cover the pre-award costs
incurred. NIH expects the grantee to be fully aware that pre-award costs result
in borrowing against future support and that such borrowing must not impair the
grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statementhttp://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget format. The modular budget format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the research
grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year.
Applicants
requesting $500,000 or more in direct costs for any year must carry out the
following steps:
1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
2) Obtain agreement
from the IC staff that the IC will accept your application for consideration
for award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all
investigator-initiated new (type 1), competing continuation (type 2), competing
supplement, or any amended or revised version of these grant application types.
Additional information on this policy is available in the NIH Guide for Grants
and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing
Research Data
Data Sharing
Plan:
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing, the format of the final dataset, the
documentation to be provided, whether or not any analytic tools also will be
provided, whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use), and the mode of data sharing (e.g., under their own auspices by
mailing a disk or posting data on their institutional or personal website,
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to
data sharing may also be appropriate in other sections of the application.
The reasonableness
of the data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score. The
funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
Sharing Research
Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. Program staff may negotiate modifications of the data and
resource sharing plans with the awardee before recommending funding of an
application. The final version of the data and resource sharing plans
negotiated by both will become a condition of the award of the grant. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
The following will be considered in making funding decisions:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria 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 an 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.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
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? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant applications instructions will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. Is the percent effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
Period of Support: The appropriateness of the
requested period of support in relation to the proposed research.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each non-competing Grant Progress Report
(PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not
Applicable
Section VI. Award Administration Information
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions
of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
3. Financial or Grants Management Contacts:
Ms. Cecilia E. Bruce
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17L, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: (301) 496-1304
FAX: (301) 480-4782
Email: brucec@mail.nih.gov
Section VIII. Other Information
This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is
not subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants Policy
Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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