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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)

Components of Participating Organizations
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)

Title: NIDCD Research Core Centers (P30)

Announcement Type
New.

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-10-077

Catalog of Federal Domestic Assistance Number(s)
93.173

Key Dates
Release Date: January 6, 2010
Letters of Intent Receipt Date(s): 30 days before application receipt dates.
Application Receipt Dates(s):March 8, 2010, June 1, 2010, October 1, 2010, February 1, 2011, June 1, 2011, September 30, 2011, February 1, 2012, June 1, 2012, October 1, 2012
Peer Review Date(s): June/July; October/November; February/March
Council Review Date(s): October, January, May
Earliest Anticipated Start Date: December, April, July
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: October 2, 2012

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. 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. Resource Sharing Plan(s)
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.

Additional Information: Limited developmental research may be allowed in a research core if it is directly related to enhancing the functioning, utility or methodology of the core. Major multi-user equipment should be requested from the NIH National Center for Center for Research Resources, http://www.ncrr.nih.gov. Applications from institutions that have a General Clinical Research Center (GCRC) funded by the National Center for Research Resources (NCRR) at NIH may wish to identify the GCRC as resource for conducting the proposed research. In such a case, include a letter of agreement from the Program Director of the GCRC with P30 application material in the Administrative Core. Collaborations among other NIH supported P30s are encouraged.

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 announcement (FOA) will use the P30 award mechanism. The applicant 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).

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

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 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. 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.

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

Number of Applications. Only one P30 award is allowed per institution; exceptions may be made with documented prior NIDCD approval for different user groups working in different NIDCD mission areas within the same institution, but no R01 grants may be counted as qualifying for more than one P30.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). 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 are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are 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. Applicants may submit a renewal application, but renewal applications may not exceed the stated caps. Competing revision (supplemental) applications requesting an additional research core to an existing P30 are allowed, but may not exceed the term or the budgetary caps as described for the parent award.

Section IV. Application and Submission Information

1. Address to Request Application Information

The most current 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) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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 must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

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 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, the Research Plan section and the 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

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): 30 days before application receipt dates.
Application Receipt Date(s): March 8, 2010, June 1, 2010, October 1, 2010, February 1, 2011, June 1, 2011, September 30, 2011, February 1, 2012, June 1, 2012, October 1, 2012
Peer Review Date(s): June/July; October/November; February/March
Council Review Date(s): October, January, May
Earliest Anticipated Start Date(s): December, April, July

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.

Christopher Platt, Ph.D.
Division of Scientific Programs
National Institute on Deafness & Other Communication Disorders
6120 Executive Blvd., EPS 400
NIH, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and 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 materials must be sent to:

Melissa Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS 400C
MSC 7180
Rockville, MD 20852
Telephone: (301) 496-8683
FAX: (301) 402-6251
Email: [email protected]

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 CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

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

The following paragraphs describe the Special Requirements for an NIDCD Research Core Centers (P30) application. This paper submission uses the most current PHS 398 instructions cited above (Section IV.1). Applicants may consult with NIDCD staff concerning the technical aspects of preparing the application.

NIDCD P30 Research Core Center Application Components

Core Center applications must address the Research Base, the Administrative Shell, and one or more Research Cores. Present these components in order separately, all using PHS 398 form pages for the required information.

For each component, the Specific Aims section is limited to one page.

For the Research Strategy section of each component the limits are 12 pages for the Core Center Research Base; 6 pages for the Administrative Shell; and 12 pages for each Research Core.

The Biosketches and Budgets are not included in the Research Strategy page limits. In addition to the overall budget included in the Core Center Research Base section, each component requires a separate detailed budget.

Face Page of Form PHS 398: Complete all items on the face page as directed. There is only one Face Page for the entire application; components use individual cover pages. In the title block, item 1, include the words Core Center as part of the title, preferably adding a few descriptive words (e.g., Core Center for Human Communication , Core Center for Sensory Transduction , etc.).

Core Center Research Base (Specific Aims: 1 page; Research Strategy: 12 pages)

Use this section to describe how this overall Core Center will serve its biomedical research base. Include the overall budget, personnel, facilities, research strategy, and the other required points.

Resources: Describe existing environment and facilities briefly in the context of how the Core Center will use or change existing access, space and usage; include space maps as needed, letters of institutional commitment and, if applicable, of the General Clinical Research Center (GCRC) Director, documenting space or cost-sharing arrangements at the applicant institution.

Personnel: Senior/Key Personnel to list are the PI as Core Center Director, any Associate or Co-Director for the Center (if applicable), and each Research Core Director. Biographical Sketches are required for these, and also for each PI holding a qualifying R01 grant listed in the research base. Place individual sketches in alphabetical order. Do not duplicate these pages in the individual research cores. Requests are allowed for technical staff time that is related to effort on the research core, and may include up to 100% salary support from the P30. Requests are allowed for limited support for administrative staff time only when the duties described relate directly to managing the P30 activities.

Budget: Use form pages as directed for the overall Core Center initial year and 5-year plan, with justifications, and do not repeat these elsewhere in the application. Include budget lines for the Administrative Shell and each of the Research Cores. Future year budget requests must not exceed cost escalations specified by the NIH. The sum for all years requested must not exceed the particular 5-year cap determined by the number of qualifying R01 grants in the P30 research base, and no single year may exceed 25% of the 5-year cap without prior NIDCD approval. A modular budget format is not allowed for any of the P30 components.

Travel requests for scientific, technical, or administrative staff are allowed only for training needed specifically to enhance or maintain operations of a research core. This training must take place in a focused, intensive session, course or workshop, as opposed to a session at a national meeting or the equivalent. P30 funds are not for travel for scientific speakers for seminars unless explicitly related to further development of core services.

Multi-user equipment requests generally are not appropriate for the P30, but should use other mechanisms (e.g., NCRR Shared Instrumentation Grant). Some equipment requests are allowed when justified by documenting available equipment within the institution, and by describing clearly how requested equipment will provide core services. In addition, the potential for cost-sharing must be explored before submission and the results of such exploration (i.e., institutional commitment demonstrated through cost sharing) must be stated clearly in the application.

Consortium/Contractual Costs: Funds may be requested for some subcontracts (see NIH notice NOT-OD-05-004 on handling indirect costs), but P30s may not subcontract to foreign organizations.

Funds may not be requested for alteration and renovation, rental space, staff retreats, direct support of individual research projects, direct support for pilot studies, salary and support for central institutional administrative personnel or secretarial support that is usually paid from institutional overhead charges, travel of investigators, or page and publication charges for staff investigators.

Specific Aims (1 page): Concisely state how the goals and objectives of the Core Center will enhance the research base; include potential impact, any areas of special interest, and any research ideas, disease entities, and target populations to be studied.

Research Strategy (12 page limit): Describe how the Core Center will serve its research base, including the required significance, innovation, and approach. Include an overview of the scientific focus of current R01 projects in the research base of the Core Center in sufficient detail to allow reviewers to judge the extent and the interrelationships of ongoing research. How Center members interact, the quality and productivity of the research programs, demonstrated or potential interdisciplinary collaborations, and how establishment of a Core Center will further extend, stimulate and provide added dimensions to the current research activities are all important considerations for review and subsequent funding. Research included in the base should be grouped into aggregates of projects with similar overall goals and objectives since an assessment of the research base is important as a primary criterion in evaluating applications. The qualifying grants have been through peer review already as R01s, establishing the quality of the individual funded projects, so important aspects will be: (1) interactions and interrelationships of the research efforts; (2) uses and benefits of core services; and (3) plans to continue/develop productive collaboration among Core Center investigators. Documentation of a collaborative environment may be included (listing co-authored publications from PIs).

Table of Qualifying R01 Grants (include within the 12 page limit): The required minimum number of qualifying R01 grants in the biomedical research base of a Core Center is described above (Section II.2) for each of three possible levels of budget. Include a table of these grants, listing alphabetically by PI. To qualify, an R01 grant must have at least one year of support remaining at the submission date of the P30 application; grants in no-cost-extensions, and a grant that is not an R01 does not qualify. (In very rare instances, grants equivalent to R01s may qualify, e.g., U24, R37; however, institute approval must be obtained before submission.) Use columns for the PI’s last name, the PI’s % effort on the R01, the grant number (in the form R01DC012345), the project end date (not just the current year of support), the annual direct cost, and the grant title. Use one row for each grant (a PI holding more than one grant will appear on more than one row), and wrapping text within columns is allowed. Provide a total for current year direct costs for all qualifying grants listed for the proposed P30 Core Center. For listed qualifying grants that are not funded by NIDCD, add a justification sentence at the bottom of the table for each, stating how it relates to NIDCD mission areas. If relevant, a second table may be included for Additional Funded Projects planning some use of Research Core facilities; these may be supported by grants other than R01s (e.g., R21, K08), and from agencies other than NIH.

Preliminary Studies/Progress Report (include within the 12 page limit): This part of the Approach for the Core Center Research Base is primarily for competing renewals or competitive revisions; for new applications, this section may be shorter than in an R01 application and may include examples of previous/ongoing services/techniques that have provided increased productivity within the research environment. Renewal applications use this section to document the impact the Core Center has had on research accomplishments, shared resources, new collaborations, and other outcomes enabled by the core. Provide information on core usage and other benefits to the scientific research enterprise, and note any specific problems in core administration and management.

Table of Assurance Documentation (include within the 12 page limit): Include a table listing by PI and grant number the status of human subject (IRB) and animal usage (IACUC) committee approval dates for each relevant research project using the Core Center facilities. In many cases the research cores encompass research supported by grants for which the IRB review of human subjects is already complete or an exemption is already designated. This review or exemption designation is sufficient, provided the IRB determines that the research is not substantially modified by the Core. Otherwise, if a Core has activities not covered in current R01s, follow the PHS 398 Instructions for Protection of Human Subjects in respect to 45 CFR Part 46. Similarly, in many cases the research cores encompass research supported by grants for which IACUC review of vertebrate animal use already is complete. This review is sufficient, providing the research is not substantially modified by the Core. Otherwise, if a core has activities not covered in current R01s, follow the PHS 398 Instructions for Compliance on Animal Welfare.

Administrative Shell (Specific Aims: 1 page; Research Strategy: 6 pages)

Use regular PHS 398 form pages to describe the Administrative Shell that will manage the overall Core Center. For the cover page title use Administrative Shell .

Resources: Include any particular administrative facilities and environment features not covered earlier for the overall Core Center.

Personnel: List administrators and staff for the Core Center (not individual Cores). Do not duplicate Biosketches, which already are provided in the earlier section. If Research Core Directors also help administer the overall Core Center, list them as well.

Budget: Include only the Administrative budgets for the Core Center initial year and for the 5-year plan, with justifications, and do not repeat these elsewhere in the application. Administrative leadership is not expected to require more than 5-10% effort, unless strongly justified by activities that go distinctly beyond usual administrative functions. Budget constraints are the same as given earlier for the Core Center.

Specific Aims (1 page): Describe briefly how the Core Center administration will coordinate and manage activities across the Research Cores, and have an impact on the research infrastructure.

Research Strategy (6 page limit): Describe how the administration of the overall Core Center will enhance the research base activities, including the required significance, innovation, and approach. The PI provides scientific and administrative leadership for the Center, so must have demonstrated ability to coordinate, integrate, and provide guidance in establishing multi-faceted research programs. Describe the administrative framework to manage the Core Center and each core, including the roles of the Center Director and Research Core Directors, the lines of authority and relationship to appropriate institutional officials, how access and utilization of services will be prioritized, how potential disputes will be resolved, and how periodic evaluations will be used to improve the services. Describe how the proposed Administrative Shell will foster developing close interactions among the Core Center Director, Research Core Directors, the PIs of the funded grants utilizing the core, appropriate institutional administrative personnel, and other members of the institution holding the P30.

Research Cores (Specific Aims: 1 page; Research Strategy: 12 pages)

Present each proposed Research Core separately in the regular form 398 format. Give each Core a cover page with a descriptive title of a few words (e.g., Core 1: Imaging , Core A: Human Recruitment , etc.).

Resources: Include any particular equipment or spaces particular to the Research Core not covered earlier in the facilities and environment for the overall Core Center, and describe the convenience, accessibility and distance of Core resource locations from the various core users.

Personnel: The named Core Director of each Research Core is its PI. A Research Core Director must have the scientific expertise and leadership skills necessary to be the primary decision-maker for that core’s management, both technical and administrative, but a Research Core Director is not required to be the PI on a current NIH grant. The requested percent effort is expected to be relatively low (5 to 10%). Any request for a Research Core Director at more than 10% effort must be justified by activities beyond typical administrative functions; institutional commitments for levels beyond 10% that are not requested from the NIDCD should be noted. Include needed support for time and salary of technical personnel or positions to be filled in the Research Core. Do not repeat the Biosketches already presented earlier for the Core Center.

Budget: Use form pages as directed for the initial year and 5-year plan with justifications, and do not repeat these elsewhere in the application. Include any issues of overlap and accounting strategies for future expenses and mechanisms for reimbursing core services, if appropriate.

Supplies: Consumable supplies directly related to the operation of the cores (photographic supplies, electronics parts, machine shop stock, tissue culture media, glassware, chemicals, animals, etc.) are allowed. Some equipment purchases are allowable, including upgrades to obsolescent instruments in the Core, and fabrication of Core-specific instrumentation or devices.

Restrictions on travel, equipment, subcontracts, alterations, pilot studies, and administrative staff remain the same as described above for the Core Center.

Specific Aims (1 page): Concisely describe how this Research Core will provide new services to the individual R01s beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or promote public health advances. Include impact beyond the qualifying users, if applicable to other users of the core.

Research Strategy (12 page limit): Describe how the Research Core facilities or services will enhance research activities of the projects using this core, and add benefits to the research accomplishments; include the required significance, innovation and approach. Include how the Research Core will provide increased or innovative capabilities; facilitate increased productivity or effectiveness through sharing expertise or centralizing labor-intensive tasks; and/or foster collaborative or new research directions, including bridging basic and clinical goals or attracting new investigators into an area. Each proposed technique or service in the Research Core, and its current status of staffing, space and equipment, should be described in enough detail to allow a comprehensive evaluation. Existing methodologies already in use at the institution may be described briefly; methodologies new to the institution need to be described in greater detail and strategies delineated for successful implementation. Include any developmental methods for research or training, if proposed. If applicable, include sections on quality control. A number of NIDCD-funded investigators larger than the required minimum of three using each core to some degree may strengthen the request. The ability to articulate user benefit is a critical factor in review.

Table of the Projected Use: Provide a table listing all R01 projects, by PI name and grant number, with a column showing for each project an estimate of the proportion of Core resource time used by each funded investigator as major (25% or more of the Core’s usage) or minor; no single core may be used more than 50% of the time by a single PI. If a proposed research core is not to be used 100% of the time, explain why.

Include plans for administration, organization and proposed management of the Research Core. Administrative organization is a critical issue in review of the application. Include plans to implement core services, prioritize investigator use among projects competing for core use, and how potential disputes will be resolved. If the core is used to train investigators in special techniques, describe the nature and extent of this training and the qualifications of core personnel to provide and oversee this training. Discuss the potential for budgetary overlap, whether minimal or extensive, between the user R01 projects and the Research Core, including personnel effort as well as other categories. Specifically address the strategies for deciding what expenses will be charged to the P30 versus the participating research grants, and describe how budgetary expenses for the user R01s, or any other funding mechanisms with potential overlap, will or will not be modified upon receipt of the P30 award. If appropriate, provide a strategy for reimbursement of core services. NIDCD program and grants management staff may negotiate with both the P30 Director and R01 PIs who utilize P30 facilities regarding potential budgetary overlap.

Vertebrate Animals and/or Human Subjects: Separate sections must be included as required (see Section VIII and PHS 398). If not applicable, mark them N/A.

Literature Cited, Consortium/Contractual Arrangements: Include as appropriate; if not applicable, mark them N/A.

Appendix: NIDCD P30 applications may include appendix materials; see below for instructions on Appendix Materials CDs.

Application Types: All use the NIDCD P30 special receipt dates noted above.

Renewal (formerly Competing Continuation ) competing applications must document progress for the Core Research Base in the Approach part of the Research Strategy section (within the 12 page limit). Include a Progress Report on the impact the Core Center has had, including evidence of PI interactions with each other and attracting additional investigators to the mission areas of the NIDCD. Also include the following information in a renewal: (a) A summary of major accomplishments that can be attributed to the Core Center program and a brief explanation of how these accomplishments have helped achieve the stated objectives of the grant. Include the significance of the products and services contributed by these individual cores to the research base; evidence that the Core Center shared resources effectively and efficiently; the extent of core use by individual PIs in the research base; effectiveness of the Core Center in facilitating collaborations or helping to attract investigators to communication disorders research; and the ability of the individual cores, and overall Core Center, to provide a qualitative advantage beyond what could practically or efficiently be supported on individual research grants. (b) Any data-sharing activities undertaken as part of the P30. (c) Any other information that is considered directly attributable to the use and conduct of the P30. (d) A list of the publications (do not list manuscripts in preparation or under review) that have resulted specifically from using resources of the Core Center grant (this list is not within the Research Strategy page limit). (c)

Resubmission (formerly Revised ) applications must have an introduction that addresses the criticisms from the previous review and notes changes made in the application. One page is allowed for introduction for the Core Center, and one page for each component of the Core Center. All changes in the research plan must be clearly marked following PHS 398 Instructions.

Revision (formerly Supplemental ) applications requesting the addition of a research core(s) to an existing P30 are allowed, but they may not exceed the term of award of the parent P30, or the appropriate budgetary cap. A Revision requires a one page Introduction. In the Research Strategy section, include a brief overview of the administrative structure and research base of the parent Core Center (this could include passages from the original application), as well as a brief overview of the currently funded individual research cores. Then describe research plans for the new core and how it will be integrated into existing Center activities. Reviewers will evaluate the supplemental core in the context of the overall P30 and the appropriateness of administrative oversight.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.

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. 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: Investigators seeking $500,000 or more in direct costs in any year 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

Review Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCD 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 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.

The review criteria listed below apply to the individual research cores and to the overall Core Center. As part of the initial scientific review, reviewers will rate each individual research core, including its management, as well as the overall Core Center; the scores will appear in the summary statement. The Administrative Shell of the whole Core Center will be rated only as Acceptable or Unacceptable , but the administration quality will be included in the overall score for the Core Center. Since the NIDCD is interested in funding only the best research cores, individual cores of lesser quality might not be funded even if recommended within a strong overall P30 Core Center grant application.

Overall Impact. Reviewers will provide an overall impact/priority 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).

Scored 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? How will the core support and enhance ongoing research projects beyond currently available resources, promote collaborative research and/or attract new investigators to research in communication disorders, provide enhanced or increased efficiency of services, and/or offer services that are new, unique or otherwise unavailable on individual R01s? If present, are translational components well designed to enhance potential collaborations leading to public health advances? How well does each individual core fit in and contribute to the overall Core Center?

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? Do the Core Center Director and key personnel have the training, leadership, commitment and ability to devote the required time and effort to the core?

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? Does the Core Center use innovative ways to communicate, to allocate resources, to promote new cross-departmental or multi-disciplinary collaborations, or to integrate activity among the research cores or across basic and clinical fields?

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? Although they need not share a common theme , are the research cores well integrated into the Core Center? Are there plans to establish and maintain communication and cooperation among the Core Center investigators? Are there adequate administrative management plans for the Core Center and the research cores, including implementation, allocation, user prioritization, quality control and utilization of services? How well do the management plans address accountability, flow of authority, dispute resolution, evaluation and integration with the home institution fiscal and academic administration?

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? Is the institutional commitment appropriate?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

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.

Renewal applications will need to document the impact and outcomes from the cores and the Core Center in the previous funding period, including new collaborations, shared resources, and in general a description of what was done that could not have been done without the P30 support.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Revision ( supplemental ) applications will have an overall Administrative Shell already reviewed, so the review will emphasize the added contribution of the proposed research core(s) to the operation of the Core Center, and how well the new core(s) will be integrated administratively to coordinate with existing research cores.

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/priority score.

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Center Grants: Note that the review criteria must be modified to reflect the Regulations at 42 CFR PART 52a.5 NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

NIH considers the following in evaluating Center grant applications:

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.

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.

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.

2. Administrative and National Policy Requirements

Awards to P30s involving Human Subjects activities beyond those done in the research of participating R01s (see Section IV.2) must follow instructions for Human Subjects reporting, including Human Recruitment tables and Human Enrollment tables. See also Section VIII on Federal Citations.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

When multiple years are involved, 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.

Annual progress reports, submitted as part of the annual noncompeting continuation application are due two months before the anniversary date of the award. Include a detailed summary of each research core, including a listing of the Core Center Director and key personnel with percent effort, budgets, and a description of each core s progress and activities. It is especially important that the significance and utility of each research core be discussed in the summary description. Submit a progress report (PHS Form 2590) containing the following information for the cores and the Core Center:

1. A budget of the requested funds for each research core describing allocations in the usual budget categories (e.g., personnel, supplies) as well as the total expenditures, in conjunction with the programmatic description. Use separate budget pages for each research core in addition to a composite budget for the entire Core Center. With the exception of the Administrative Shell, it is allowable to request a redistribution of funds for individual cores different from plans in the original application. Clearly state and justify such reallocations across cores in the budget section.

2. An updated table (same format as original application) showing all support associated with the Core Center. List columns for the funding mechanism and grant number, funding source (as contained in NIH grant number, as R01DC012345), PI name, grant title, percent effort of the investigator, award duration, and annual support (direct cost). A total current year direct cost dollar amount for research grants in the research base of the P30 must be provided. This table should include all individual research grants, center grants, training grants, National Research Service Awards, career development awards, etc. that are currently users of the core.

3. An overall discussion of the effectiveness of the P30 in furthering the proposed goals. Include a summary of the general accomplishments that can be attributed to the P30, and a discussion of any problems that impeded the accomplishment of the stated goals of the P30. Address the administration and conduct of the P30, and organizational issues within the institution that have impact on the P30, both positive and negative.

5. A summary (equivalent to no more than 4 single-spaced pages) of the goals and significant activities of each individual research core. List specific accomplishments or gains seen from use of the core. List what has been accomplished and what would not have been done without it; e.g., new research findings, new investigators brought to the field, efficiency of services, tables of usage, etc.

6. A list of all collaborative efforts that the Core Center has established and is conducting with other institutions/Core Centers. Include a description of each activity, identification of the other Core Center(s) involved, and any results obtained so far.

7. Other information that, from year-to-year, may be requested by NIDCD staff.

The expanded progress report is in addition to, and does not replace, other management reports required by PHS policy. In addition to the annual progress report, NIDCD program staff may conduct programmatic visits to gain added insight into the various aspects of the P30 operations.

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:

Christopher Platt, Ph.D.
Division of Scientific Programs
National Institute on Deafness & Other Communication Disorders
6120 Executive Blvd., EPS 400
NIH, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: [email protected]

2. Peer Review Contacts:

Melissa Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS 400C
NIH, MSC 7180
Rockville, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6251
Email: [email protected]

3. Financial or Grants Management Contacts:

Christopher Myers
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd., EPS 400B
NIH, MSC 7180
Rockville, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-6251
Email: [email protected]

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.

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/.

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.

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.

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-09-116.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.

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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NIH Funding Opportunities and Notices


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