Part I Overview Information


Department of Health and Human Services

Participating Organizations
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

Components of Participating Organizations
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

Title: Obstetric Pharmacology Research Units (U10)

Announcement Type
This is a reissue of RFA-HD-03-017.

Update: The following updates relating to this announcement have been issued:

Request for Applications (RFA) Number: RFA-HD-09-002

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: December 16, 2008
Letters of Intent Receipt Date: February 28, 2009
Application Receipt Date: March 30, 2009
Peer Review Date(s): June/July 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 2009
Additional Information to Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 31, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose.  The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications to participate in the Obstetric Pharmacology Research Units (OPRU) Network to serve as a resource for performance of pharmacologic studies of drug disposition and effect during normal and abnormal pregnancies. Within the Network, the OPRUs will: (1) conduct multi-site cooperative clinical studies of therapeutic modalities used during pregnancy; (2) conduct studies of fetal, placental and maternal pharmacology; (3) conduct studies on the effect of pregnancy on drug metabolizing enzymes, transporters and effectors, including interactions with pharmacogenetics/pharmacogenomics; (4) facilitate the collection and utilization of clinical materials for basic research studies; and (5) perform studies of placental metabolism and transfer of drugs; (6) enhance the exchange of information between basic scientists and obstetricians and among various specialists involved in treating pregnant women; (7) promote collaborations in interdisciplinary translational research.  The Network will also serve as a resource for the training of health professionals, including pre- and post-doctoral fellows and PharmDs, in obstetric pharmacology, pharmacogenomics and clinical trials in pregnant women.

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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
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


Section I. Funding Opportunity Description


1. Research Objectives

Background

The study of drugs used during pregnancy is one of the most neglected areas in the fields of clinical pharmacology, drug development and drug research. Due to technical, ethical, legal, as well as social and psychological reasons, it may be difficult to conduct studies on drug disposition in pregnant women. Current data available on drug disposition and effect during pregnancy are scarce, fragmentary and frequently contradictory.  The lack of Food and Drug Administration obstetric labeling and the universal off-label use of drugs are the direct result of the lack of research and clinical trials of drugs in this special population.

Pharmacoepidemiological surveys have determined that nearly two thirds of all pregnant women take between four and five drugs during pregnancy and labor.  These data demonstrate that drug use during pregnancy is a public health concern because such drug use is based on an empiric understanding of dosing, safety and efficacy rather than evidence collected from well designed and carefully monitored clinical studies during pregnancy.  Current therapeutic practice does not take into account the profound changes characteristic of pregnancy.  These changes involve the mother, placenta and the fetus and typically lead to variations in the absorption, distribution and elimination of drugs, as well as response to treatment.

A number of factors influence the pharmacokinetics (PK) and pharmacodynamics (PD) of drugs in pregnancy.  For example, both the gastric emptying time and the intestinal transit time are altered during pregnancy and could affect the gastrointestinal absorption of drugs. There have been few bioavailability studies conducted during pregnancy, consequently the impact of pregnancy-related changes in transport proteins or alterations in gut function have not been characterized. 

The increase in cardiac output, plasma volume and extracellular water may profoundly affect the distribution of many drugs during pregnancy.  Pregnancy-associated changes in protein concentrations are thought to be associated with a decrease in drug-binding capacity, however few drugs have been studied in sufficient detail to determine if that observation is correct.  The total (bound and free) drug concentration for a number of drugs is decreased (e.g., phenytoin) in pregnancy compared to the non-pregnant state.

Drug elimination, by either metabolic inactivation or excretion may also be altered by the pregnant state. Pregnancy exerts a marked effect on the plasma concentrations of sex hormones that are known to alter drug metabolizing enzymes.  These effects of the pregnant state on the disposition of drugs are superimposed on the differences in pharmacokinetics and pharmacodynamics between women and men.

Renal function is significantly altered by pregnancy.  The glomerular filtration rate and renal plasma flow increase as early as the sixth week of pregnancy.  As a consequence, there is an increase in the renal elimination of some drugs such as beta-lactam antibiotics and lithium.  The increase in glomerular filtration observed during pregnancy is counterbalanced to a significant degree by modifications in tubular reabsorptive capacity.  The full effects of changes in renal function produced by pregnancy and their impact on drug elimination have not been sufficiently characterized.  The diversity of changes during normal gestation can be substantially modified by the pathophysiologic processes associated with various conditions and disease states.  Therefore, information accrued on the disposition and effects of drugs in normal pregnancy cannot be extrapolated to abnormal pregnancies.  There is a lack of information on the effects of the pathologic abnormalities associated with the disposition and action of drugs in abnormal pregnancies.

Genetic variations such as polymorphisms and copy number variations (CNVs) in genes encoding for drug metabolizing enzymes (DMEs) and drug transporters may influence drug metabolism and transport pathways altering drug efficacy and toxicity. In addition, epigenetic changes (DNA methylation and histone acetylation) can impact transcriptional regulation of genes encoding for DMEs and drug transporters affecting drug efficacy and toxicity. Furthermore, other factors and conditions such as patient’s age, ethnicity, nutritional status, smoking, alcohol consumption, concurrent disease state, and the presence of other drugs may also interact with genetic variations and impact drug efficacy and toxicity.

Pregnancy can have differential effects on DMEs. For example, the activities of CYP3A4, CYP2D6, CYP2C9, UGT1A4 and UGT2B7 increase, whereas the activities CYP1A2 and CYP2C19 decrease during pregnancy. The alterations in the activity of DMEs result in increased or decreased drug concentrations in pregnant women compared to non-pregnant women. Genetic polymorphisms of metabolic enzymes may alter the response to pregnancy-induced changes in drug metabolism.

Pregnancy may also influence the expression and functions of transporter proteins. For example, the expression of P-glycoprotein (P-gp) may vary depending on the stage of gestation. As pregnancy progresses the level of P-gp expression decreases. Genetic polymorphisms in drug transporters and their influences on drug absorption, distribution and excretion during pregnancy have been inadequately studied, and the results have often been inconsistent and controversial. Current advances in pharmacogenomics and the application of genome-wide approaches have opened a new frontier in developing and improving drug treatment for pregnant women. Understanding the genetic influences and alterations in drug metabolism and disposition pathways between pregnant and non-pregnant women is of great importance in developing safe, and effective therapies for pregnant women, filling a research gap and shifting the current paradigm from empirical treatment to personalized medicine.

Research Objectives and Scope

A major goal of this program is to identify, study and characterize drugs that are of therapeutic value during pregnancy and whose disposition and response are altered by the pregnant state in normal or abnormal pregnancies, for example, in association with gestational diabetes, hypertension and placental pathology. 

The development of studies of drugs in pregnancy is expected to follow sequential steps:

Step I:  Basic pharmacokinetic studies will be used as a screening tool to determine candidate drugs (typically those used frequently during pregnancy) which require pharmacokinetic and pharmacodynamic analysis to improve use during pregnancy. 

Step II:  Intensive pharmacokinetic, pharmacodynamic and systems biology analysis will be performed for drugs selected in Step I.  Drugs that are chronically administered during pregnancy will be studied serially during the first, second and third trimester and postpartum. 

Step III:  For those drugs that exhibit clinically significant changes in pharmacokinetics and/or pharmacodynamics during pregnancy, a determination will be made as to the need to make dose adjustments and to test modified dosing regimens in subsequent clinical studies.

Causes of the alterations in pharmacodynamics during pregnancy, demonstrated by pharmacokinetic-pharmacodynamic correlation studies, may be elucidated by mechanistic studies of transporters, receptors or signaling pathways performed within the basic studies components of the network sites.

In addition to the studies noted above, specific areas of interest include but are not limited to:

Collaboration of the Network with industry in the performance of pharmacologic studies, clinical trials and adjunct basic mechanistic studies is encouraged. Also strongly encouraged is collaboration of the Network with other NIH and non-NIH Networks (e.g., NICHD's Maternal Fetal Medicine, Neonatal, and Pediatric Pharmacology Research Unit networks; the Pharmacogenetics Research Network or other NIH disease-specific networks; and the DHHS Centers of Excellence in Women's Health units).  It is expected that the pharmacologic data gathered by the Network will form the basis for the design of drug efficacy trials to be performed in the Network, in cooperation with other Networks, or exclusively in other Networks.  To accelerate the acquisition of knowledge, interaction and collaboration with other investigators involved in ongoing basic and translational research, studies that complement or expand knowledge in specific areas of obstetric and fetal pharmacology are strongly encouraged. 

Organization of the OPRU Network

A. Components of an OPRU

Each OPRU site will include the following components:

(1) A pharmacology component to conduct pharmacokinetic, pharmacodynamic analysis to identify differences in drug disposition, effect and/or toxicity during pregnancy compared to the non-pregnant state; conduct pharmacogenetics or pharmacogenomics studies to determine the variations of gene(s) coding for drug metabolic enzymes, transporters, and receptors involved in pathways affecting drug efficacy and toxicity during pregnancy compared to the non-pregnant state.  The pharmacologic component will also be involved in Phase I and Phase II studies of existing or new molecular entities (NMEs) designed to treat pregnancy conditions or diseases.

(2) A clinical studies component to test the disposition and efficacy of drugs whose pharmacologic profiles were found to differ during pregnancy.  Efficacy of existing or new NMEs will also be studied.

(3) A multidisciplinary, interactive basic and/or non-clinical research component to elucidate basic mechanisms for differences in disposition of drugs as well as differences in response during normal and abnormal pregnancies.

The OPRU network will be a collaborative effort that will require all study sites to participate in a cooperative and interactive manner with one another and with the Data Coordinating and Analyses Center (DCAC) in all aspects of the OPRU network. In addition, PIs of each OPRU site are required to:

B. Data Coordinating and Analyses Center

The DCAC is awarded under a separate solicitation RFA-HD-07-019 using the U10 mechanism. The primary functions of the DCAC are to provide central data collection, data management, quality control and statistical analysis services to the OPRU Network. In addition, the DCAC will work closely with the OPRU NSC and its subcommittees, Data Safety and Quality Monitoring Board (DSMB) and the NICHD Program Scientists to provide coordination, organizational and logistic support for all research activities within the network.

Additional specific responsibilities of DCAC include:

C. Network Steering Committee 

The NSC will be the main governing body of the OPRU Network and the committee through which the NIH interacts and collaborates with.  The NSC voting members consist of the PIs of the OPRU Network and of the DCAC, and the NICHD Program Scientists. The NSC also includes a non-voting FDA representative and a non-voting independent chairperson appointed by the NICHD.  Subcommittees of the NSC will be established as necessary and will include a Publications and Presentations Subcommittee, and Quality Control Subcommittee. 

Meetings

The NSC will meet two or three times a year.  In addition, PIs will communicate weekly by formal conference calls.  Travel funds for these meetings should be included in the budget of the individual OPRU applications.

D. Data, Safety and Quality Monitoring Board

The NICHD will appoint an independent DSMB in accordance with established policies to ensure data quality and participant safety and to provide independent advice to the NICHD regarding progress and the appropriateness of continuing each study.

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 Cooperative Research Agreement (U10) award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

NICHD intends to commit approximately $5 million dollars in FY2010 to fund up to 5 new and/or competing continuation grant applications.

An applicant may request a project period of up to five years and a base/core budget for direct costs up to $650,000dollars per year.

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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

Special Requirements

Principal Investigators, Basic/Pre-clinical Research Investigator and other Investigators

The Principal Investigator (PI) of the OPRU is the person responsible for the overall management of the clinical pharmacology component. The PI is also responsible for coordination of the participating specialists whether within a single institution or a consortium of institutions, design and submission of proposed protocols for pharmacologic studies, implementation and monitoring of the clinical studies, and submission and analysis of study data. 

The application must identify a basic/pre-clinical research investigator as the person responsible for coordination of the OPRU basic pre-clinical research whether within a single institution or a consortium of institutions. The basic/pre-clinical research investigator is also responsible for development of adjunct basic/pre-clinical studies in cooperation with clinicians, conduct of the basic studies in conjunction with ongoing clinical trials/studies, and collaboration and sharing of basic resources and reagents within an OPRU and with other OPRUs. 

The application must list scientists who will be involved in the OPRU studies including medical subspecialists, geneticists, experimental pharmacologists, molecular and developmental biologists, developmental toxicologists, and maternal-fetal medicine specialists.  The application must detail the role of all co-investigators.

Collaboration with clinicians and/or basic scientists from different OPRUs is required, based on shared interests and complementary talents.

A clinical pharmacologist or pharmacist (e.g., PhD or PharmD), or other member of the Department of Pharmacology or Pharmacy, with capability and experience in performing PK/PD studies in a clinical setting, is strongly encouraged to apply.

Other investigators with obstetric privileges at the awardee institution will be eligible to utilize the OPRU resources for studies of drug efficacy, metabolism and/or effects in pregnant patients, supported by independent research funds, if the protocols have been approved and prioritized by the NSC.  These individual investigator protocols must not delay or interfere with the pursuit of the collaborative studies that are the OPRUs' primary responsibility.

The PI of the clinical component would ideally be an obstetrician with extensive training in clinical pharmacology and experience in clinical trials.  It is recognized that availability of individuals trained in both disciplines is limited.  To satisfy the requirements of this RFA, the NICHD also encourages applications from individuals with clinical experience in obstetrics in collaboration with individuals experienced in basic and clinical pharmacology with either a PhD or PharmD in pharmacology or other related basic scientific disciplines including but not limited to molecular biology, biochemistry, pathology and genetics. The applicants must provide the following evidence to meet the eligibility requirements: (1) collective experience in obstetrics, pharmacokinetics, pharmacodynamics, drug metabolism; (2) experience in multidisciplinary research collaboration; (3) experience in writing clinical study protocols; (4) experience in clinical study design and conducting clinical trials; and (5) accessibility to the appropriate population of subjects for such studies and ability or success in patient recruitment.

All OPRU study sites will be required to participate in a cooperative and interactive manner with one another and with the DCAC in all aspects of the OPRU network.

Budget Information

For the OPRU grant application, the applicant must submit budget information including the base/core costs as well as the protocol costs.  The base/core budget may not exceed $650,000 direct costs, and include personnel efforts, travels for PI, co-PIs and other individuals associated with the study to attend an average of 3 NSC meetings per year, supplies and equipment, and other items as appropriate.  The protocol budget costs required in the application is for the facilitation of peer review of the application, and includes expenses associated with the implementation and the conduct of a specific protocol. 

During the grant cycle covered by this FOA, all funds for protocol costs will be awarded to the DCAC. The DCAC will then be responsible for distributing the funds to the OPRU clinical study sites once the budget is approved by NICHD for each protocol and recruitment begins.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application. Applicants may not submit more than one application in response to this FOA.

Resubmissions. Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016  Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications from existing OPRU sites will be permitted for this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: February 28, 2009
Application Receipt Date: March 30, 2009
Peer Review Date(s): June/July 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Zhaoxia Ren, M.D., Ph.D.
Medical Officer
Obstetric and Pediatric Pharmacology Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
6100 Executive Boulevard, Room 4B15 MSC 7510
Bethesda, MD 20892-7510
Phone: 301-402-9340
Fax: 301-480-2897
Email: zren@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the 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 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 (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).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01D
Bethesda, MD 20892
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: stretchr@mail.nih.gov   

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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 Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Applications will be reviewed based on their ability to meet basic description (requirement) of the OPRU summarized in this RFA and to cooperatively participate in the network as follows: 

Qualifications and Commitment of Key Personnel:

Experience with Protocol and Procedures:

Additional Review Criteria.  As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations.  As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.2) Sharing Model Organisms Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.and 3) Genome Wide Association Studies (GWAS) NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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.

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

The NICHD will oversee the organization of the OPRU Network and thus will be substantially involved with the awardees in a partnership.

An NICHD Program Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NICHD Program Scientist will:

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NICHD Project Official will:

2.A.3. Collaborative Responsibilities (optional)

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Zhaoxia Ren, M.D., Ph.D.
Medical Officer
Obstetric and Pediatric Pharmacology Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
6100 Executive Boulevard, Room 4B15, MSC 7510
Bethesda, MD 20892-7510
Phone: 301-402-9340
Fax: 301-480-2897
Email: zren@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01D, MSC 7510
Bethesda, MD 20892
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: stretchr@mail.nih.gov   

3. Financial or Grants Management Contacts:

Bryan Clark, MBA
Grants Management
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01, MSC 7510
Rockville, MD 20892-7510
Telephone: (301) 435-6975
Fax: 301-451-5510
Email Brian.Clark@nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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 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 funding opportunity 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (http://grants.nih.gov/grants/funding/children/children.htm).

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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 FOA 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.

Authority and Regulations:
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. 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.


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