Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Avon Foundation (http://www.avoncompany.com/women/index.html)
Foundation for the National Institutes of Health (http://www.fnih.org)

Components of Participating Organizations
National Cancer Institute (NCI) (http://www.nci.nih.gov/)

Title: Avon-NCI “Progress for Patients” (PFP) Awards for Early Phase Clinical Interventions and Biomarkers in Breast Cancer (Limited Competitive Supplements [Revisions] for P30 Cancer Center Support Grants)
 
Announcement Type
New

Program Announcement (PA) Number: PAR-07-244

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395

Key Dates
Release Date: March 5, 2007
Letters of Intent Receipt Date(s): March 27, 2007; October 15, 2007
Application Receipt Date(s): April 27, 2007; November 15, 2007
Peer Review Date(s): June/July 2007; February/March, 2008
Council Review Date(s): August 2007; May 2008
Earliest Anticipated Start Date(s): September 24, 2007; July 24, 2008
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: November 16, 2007

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

This initiative is a partnership between the Avon Foundation, Foundation for the National Institutes of Health (FNIH), and the National Cancer Institute.  The Avon Foundation provides funds to FNIH, which is responsible for supplying funds to the NCI for the direct cost and the facilities and administrative (F&A) cost up to 10 percent of the direct cost of each award.  The NCI will be responsible for the application process (solicitation, receipt, and responsiveness), review, administration of the award, and for supplying funds for the remaining portion of the indirect (F&A) cost associated with each award.

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 and 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


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The purpose of this limited competition program announcement is to solicit competing supplement applications from the NCI Cancer Center Support Grant (CCSG)(P30) awardees for the 2007 "Avon-NCI ‘Progress for Patients’ (PFP) Awards Program:  A Special Public-Private Initiative in Early Phase Clinical Interventions and Biomarkers in Breast Cancer.”

The Avon-NCI competing supplements awards are designed to support activities that could not have been anticipated until recently, thus minimizing delays in conducting novel and promising Phase I and II clinical trials and studies focusing on risk assessment or validation of biomarkers in human subjects.  The inclusion of minorities or individuals from underserved populations as participants in the study and the involvement of a junior clinical investigator are encouraged.

This program announcement is the fifth solicitation for "Avon-NCI PFP Awards Program” and it is anticipated to be the last one (depending on availability of funds).  Applications will be subject to peer review managed by the NCI Division of Extramural Activities.

Guidelines and Specific Objectives

Guidelines include the following requirements:

1)       Each competing supplement application should be submitted by the PI of the parent grant;

2)       Avon-NCI PFP applications may only involve requests for 1- or 2-year funding periods that do not extend beyond the end dates of the corresponding parent (i.e., associated) P30 5-year grant award period;

3)       If investigators from other P30 Cancer Centers Support Grants (and/or P50 Breast and Ovarian SPORE awardees) are included in the application as subcontractors, the funding periods of these subcontractors should not exceed their respective parent P30/P50 grant award period(s); and

4)       Unfunded projects (i.e., applications) must be submitted as new rather than resubmitted as amended/revised applications.

5)       Each application should contain only one project; however, it may include investigators from other SPOREs (P50), Cancer Centers, and/or different entities outside of the SPOREs and Cancer Centers, as subcontractors.

These guidelines relate to the application for, and review of competitive supplements (i.e., revisions) to Cancer Center Support Grant programs for the conduct of innovative early phase clinical interventions and biomarker studies in breast cancer.  Resubmission (previously called amended or revised) applications are not allowed.  This program was developed to provide rapid means to support such interventions and studies aimed at the prevention, detection, diagnosis, and/or treatment of breast cancer.

To be considered responsive, applications must propose projects corresponding to at least one category from the following types of studies:

1.       Phase I, II, and/or I/II treatment trials with any novel or previously approved agents;

2.       Risk assessment or prevention studies involving humans;

3.       Validation testing of a biomarker (s) in human subjects (this type of study can involve the use of specimens from either a retrospective or prospective trial); and/or

4.       Imaging studies in early detection, treatment monitoring, and response to therapy.

Projects that are still within the discovery phase or the pre-clinical development stage (e.g., involving toxicity screens on animals), or that focus on technology development, are not considered responsive.  Additionally, funds from this program are not intended to create pilot or feasibility data for R01 or other applications. Questions regarding responsiveness of proposed projects to this initiative should be directed to the NCI Cancer Centers Branch:

Jaswant S. Bhorjee, Ph.D.
Cancer Centers Branch
Office of Centers, Training and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 700, MSC 8347
Bethesda, MD 20892-8341 (for U.S. Postal Service express and regular mail)
Rockville, MD 20852-8345 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8531
Fax: (301) 402-0181
Email: bhorjeej@mail.nih.gov

The inclusion of minorities or individuals from underserved populations as participants in the study and the involvement of a junior clinical investigator (Instructor, Assistant Professor, and Research Assistant Professor) in its design and execution are encouraged.  Junior investigators with appropriate qualifications are eligible to serve as project leaders of PFP awards.  However, only principal investigators (Directors) of NCI-designated Cancer Centers can serve as principal investigators of the Avon-NCI PFP awards.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the competing supplement award mechanism to NCI Cancer Center Support (P30) grants.

Unlike applications for Avon Foundation-supported supplements in the previous years, the revision (i.e., competing supplement) applications submitted in response to this PA will be subject to peer review (managed by the NCI).

This funding opportunity uses the just-in-time budget concepts.  It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).  A detailed categorical budget for 1 year of support is submitted with the application.

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 NCI and Avon Foundation 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.

Several applications can be submitted from the same institution as long as the total cost allowed ($350,000 per institution) is not exceeded.  If one application involving a study that is exclusive to its own Cancer Center is submitted, the request cannot exceed a maximum of $250,000 in total cost (direct plus Facilities and Administration costs) per participating Cancer Center per year.  If two or more applications are submitted from the same Cancer Center, the combined total cost for both applications cannot exceed $350,000 per participating institution.  The budget cap for an application, which includes costs for subcontracts, is $350,000.  An exception to the project budget cap may be considered in rare cases, but prior approval from the assigned NCI Cancer Center Program Director (designated in Section I.1) is required.  Any project involving more than one subcontractor also should be discussed in advance with the NCI Program Director designated in Section I.

Central coordination of submissions by the Cancer Center Director is essential, especially if the Cancer Center is submitting two applications or is listed as a subcontractor in other SPORE/Cancer Center Avon-NCI PFP applications.  Budget for each must be negotiated to ensure that total cost for all applications do not exceed $350,000.

Research and clinical activities performed outside of an NCI-designated Cancer Center can be included as subcontracts on a project but count toward the total cost cap for the parent institution ($350,000).

Funds may be used for any clinical or laboratory activity pertinent to the intervention with the exception of research involving animals.  Pre-clinical research on animals will not be supported.  In addition, it is not the intent of these awards to fund equipment or duplicate resources already available within a Cancer Center.

Costs for participation of members of underserved and/or minority populations in the proposed study (e.g., travel expenses, patient navigators, case managers, and/or translators), are allowable and encouraged.   Requests to support the partial salary and/or research activities of a junior clinical investigator are also encouraged.

An applicant may request a project period of 1 or 2 years (but must have at least the same amount of time of active funding remaining on his/her associated parent grant award during the requested time period of any supplement award).

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Eligible institutions or organizations are the current NCI Cancer Center Support (P30) awardees (institutions/organizations).

All NCI-designated Cancer Center investigators are eligible to apply, so long as the criteria in regard to project responsiveness are met.  However, anticipated funding period of the Avon-NCI award should not extend beyond the end date of the 5-year parent P30 project period.  Likewise, if investigators from other SPOREs (P50)/ NCI-designated Cancer Centers are included in the application as subcontractors, the funding period of these subcontractors should not exceed their respective parent P30/P50 project period.  Applications exceeding this time limit will not be accepted.

1.B. Eligible Individuals

Principal Investigators (PIs/Directors) of all eligible active NCI Cancer Center Support (P30) grants.

2. Cost Sharing or Matching

Not applicable.

3. Other-Special Eligibility Criteria

Not applicable.

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 Grants Info -- 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 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 announcement (FOA) must be typed on line 2 of the face page of the application form and the YES box must be checked.

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(s): March 27, 2007; October 15, 2007.
Application Receipt Date(s): April 27, 2007; November 15, 2007.
Peer Review Date(s): June/July 2007; February/March, 2008.
Council Review Date(s): August2007; May 2008.
Earliest Anticipated Start Date(s): September 24, 2007; July 24, 2008.

3.A.1. Letter of Intent

Prospective applicants are encouraged 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 NCI staff members to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Jaswant S. Bhorjee, Ph.D.
Cancer Centers Branch
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Blvd, Suite 700, MSC 8347
Bethesda, MD 20892-8341 (for U.S. Postal Service express and regular mail)
Rockville, MD 20852-8345 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8531
Fax: (301) 402-0181
Email: bhorjeej@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application form found in the PHS 398 instructions for preparing and submitting a research grant application. One-sided original and three exact copies of the application should be submitted to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; 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 the appendix materials, if any, in pdf format should be sent to:

Referral Officer                 
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8042, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD  20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email:  ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.).  If an application is received after that date, it will be returned to the applicant without review.  Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.

Information on the status of an application should be checked by the PI 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 http://grants.nih.gov/grants/policy/policy.htm.

6. Other Submission Requirements

Application Details

Applications must follow instructions for the standard (non-modular) format of the PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).  For Item 1 on the face page of the PHS 398 form provide the generic title: “Avon-NCI PFP Program,” followed by a short informative title.  Total title length should not exceed 81 characters.  Total costs in Items 7 and 8 should not exceed those stated under Section II.2 above.

The Research Plan – Sections A-D, which is limited to 10 pages maximum, should contain:

When applicable, clinical protocols, patient consent forms, institutional review board (IRB) approvals, protocol review and monitoring system approval(s), data and safety monitoring plans (DSMPs), verification of investigational new drug (IND) applications, certificates of training in protection of human research participants, letters of collaboration, manuscripts, and authorization to share materials pertaining to Avon-NCI PFP application with the Avon Foundation should be included in the Appendix. Application may still be considered for an award even if no authorization to share with the Avon Foundation is submitted.  Submission of manuscripts in the appendix is now limited and should follow rules and requirements described in new instructions to form PHS 398.

For applications involving subcontractors, the lead institution is required to submit full information that details the overall goal of the study, project activities performed at its site, the first-year budget, the overall budget, and other documentation.  All documentation of participating institutions (i.e., as subcontractors), including clinical protocols (if it differs form the leading institution), budgets, IRB approvals, etc., should be submitted by the leading institution as a part of its application.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy  expects that grant 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 at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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.  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


1. Criteria

The proposed project should support interventions and/or studies that advance knowledge in the field(s) of prevention, detection, diagnosis, and/or treatment of breast cancer.  Projects considered to be responsive include phase I, II, or I/II treatment trials with any novel or previously approve agent; risk assessment or prevention studies involving humans; validation testing of a biomarker (s) in human subjects (retrospective or prospective trials); and imaging studies in early detection, treatment monitoring and response to therapy.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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 in breast cancer prevention, detection, diagnosis, and/or treatment?  If the aims of the research proposed in 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 application 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 1 or 2 years of support in relation to the proposed research.  The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

NIH policy expects that grant 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 at http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and at 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

It is the intent to select meritorious applications for funding within 4-5 months of the application receipt date based on the recommendations by the NCI.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the 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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 (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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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.

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:

Jaswant S. Bhorjee, Ph.D.
Cancer Centers Branch
Office of Centers, Training and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 700, MSC 8347
Bethesda, MD 20892-8341 (for U.S. Postal Service express and regular mail)
Rockville, MD 20852-8345 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8531
Fax: (301) 402-0181
Email: bhorjeej@mail.nih.gov

2. Peer Review Contacts:

Referral Officer     
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8042, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD  20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email:  ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Eileen M. Natoli
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Phone: (301) 496-8791
Fax: (301) 496-8601
Email: natolie@mail.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); and 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 institutional review board (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.

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 at http://grants.nih.gov/archive/archive/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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH.  The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies.  The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings.  Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 funding opportunity 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 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 2 years to the research.  For further information, please see http://www.lrp.nih.gov.


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