Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Administrative Supplements to NCI-Funded Research Projects: Funding to Advance Research on Cancers in Women (Admin Supp)
Activity Code	Administrative Supplement Additional funds may be awarded as supplements to parent awards using the following Activity Code(s): P01 Research Program Projects P50 Specialized Center U10 Cooperative Clinical Research Cooperative Agreements U19 Research Program Cooperative Agreements U54 Specialized Center- Cooperative Agreements UM1 Multi-Component Research Project Cooperative Agreements R00 Research Transition Award R01 Research Project Grant R03 Small Grant Program R15 Academic Research Enhancement Award (AREA) R21 Exploratory/Developmental Research Grant Award R33 Exploratory/Developmental Grants Phase II R37 Method to Extend Research in Time (MERIT) Award R41 Small Business Technology Transfer (STTR) Grant - Phase I only R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II R42 Small Business Technology Transfer (STTR) Grant - Phase II only R43 Small Business Innovation Research (SBIR) Grant - Phase I only R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II R44 Small Business Innovation Research (SBIR) Grant - Phase II only U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	PAR-13-067
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393; 93.394; 93.395; 93.396; 93.399
Funding Opportunity Purpose	The National Cancer Institute's Office of Science Planning and Assessment, in conjunction with the NCI Women's Health Officer and the Women's Health Activities Committee, announces an Administrative Supplement opportunity to expand and/or enhance research on cancers in women, which include both non-sex-/gender-specific cancers and sex-/gender-specific cancers. The overall goal of these Administrative Supplements is to advance cancer research that is pertinent to distinct characteristics of women s health. It is also expected that these efforts will facilitate translational applications of relevant findings to benefit specifically women’s health.

Posted Date	December 21, 2012
Open Date (Earliest Submission Date)	January 28, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	February 28, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Not Applicable
Advisory Council Review	Not Applicable
Earliest Start Date	June 2013
Expiration Date	March 1, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The National Cancer Institute (NCI) Office of Science Planning and Assessment (OSPA), in conjunction with the NCI Women’s Health Officer and the Women’s Health Activities Committee, announces an Administrative Supplement opportunity to expand and/or enhance biomedical, epidemiologic, behavioral, and social research on cancers in women, which include both non-sex-/gender-specific cancers and sex-/gender-specific cancers, in eligible active NCI-funded grants and cooperative agreements (see Section III.3. below). The overarching purpose of these supplements is to move forward cancer research that is relevant to health characteristics unique to women. In addition, funded projects are expected to facilitate translation of relevant findings to applications that benefit women's health specifically.

Although major progress has been made in some cancers affecting women (e.g., breast and cervical cancer), advances in a number of other relevant cancers (most notably lung and some gynecological cancers) have been less significant. Furthermore, knowledge of the cancer burden in some subpopulations of women is limited; epidemiological studies have primarily focused on racial and ethnic disparities with little attention to other under-represented minorities including lesbian, bisexual, transgender, and intersex (LBTI) populations. Even though data may be extrapolated to these populations, the disparities regarding care, treatment, and quality of life largely remain unaddressed. The overall goal of these administrative supplements is to advance cancer research that is pertinent to distinct characteristics of women’s health. It is also expected that these efforts will facilitate translational applications of relevant findings to benefit specifically women’s health.

Support through this administrative supplement program is expected to enhance biomedical, epidemiologic, behavioral, and social research as related to cancer.

Research of particular interest includes projects focused on:

• Gynecological cancers including cervical, ovarian, uterine, vaginal, and vulvar cancers;
• Cancers in members of lesbian, bisexual, transgender, and intersex (LBTI) populations;
• Cancers in members of unrepresented and underrepresented minority groups, including those in low socio-economic status, underinsured, and racial minority groups; and/or
• Cancer as a global health issue, particularly in low-resource countries.

Activities proposed for the Administrative Supplements may include:

• Additional, enhanced, and/or accelerated analyses relevant to cancers in women; and/or
• Pilot studies that address specific aims from the parent grant in a new way addressing aspects directly pertinent to cancer in women.

The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant or cooperative agreement. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

Funding Instrument	The funding instrument will be the same as the parent award.
Application Types Allowed	Non-competing Administrative Supplements
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The NCI intends to commit up to $250,000 for FY 2013 funding.
Award Budget	Application budgets are limited to $50,000 in total costs, and must reflect actual needs of the proposed project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.
Award Project Period	The project and budget periods must be within the currently approved project period for the existing parent award. Although a project period of up to 2 years may be proposed (provided the parent grant remains active), the entire budget request can be for no more than 1 year, based upon the current budget period of the parent grant.

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.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov (required for all electronic application submissions)
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are invited to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

Applicants may submit more than one application but only if the parent grant has multiple projects that meet the criteria. In such a case, awardees must submit separate requests that clearly identify the individual project for which they are seeking supplemental funds. Note, however, that regardless of scoring, a maximum of one supplement per parent grant may be funded. Additionally, each PD/PI may not submit more than two supplement requests in total.  

Because applications in response to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply.

The topic of the administrative supplement must be related to the stated Scientific Priorities of this Administrative Supplement Program.

Current NCI awardees with active R00, R01, R03, R15, R21, R33, R37, R41, R42, R43, R44,
P01, P50, U01, U10, U19, UM1, and/or U54 grants and/or cooperative agreements pertinent to cancer in women may apply for an administrative supplement provided that the following conditions are met:

• The parent research projects are either already explicitly focused on cancer in women or have a broader focus that can be enhanced by addressing certain aspects specific to cancer in women; and
• The topic of the administrative supplement must be related to the stated Scientific Priorities of this Administrative Supplement Program but must also remain within the general scope of the original parent award.

Given that the above conditions are met, there are no further limitations regarding the nature of the eligible projects, which may range from basic research through translational studies to clinical research (e.g., ancillary studies) and population studies.

No other funding mechanisms are eligible.

Please contact the Program Director assigned to the parent grant or cooperative agreement for questions related to scientific or programmatic content and to determine if the supplement fits within the approved scope of the project. 

Applicants are required to prepare applications according to the current application forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

All forms should be completed for the supplemental activities only and should not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• Introduction: Limit 1 page
• Specific aims: Limit 1 page
• Research Strategy: Limit 3 pages
• Timeline: Limit 1/2 page
• Biographical Sketch for all key personnel: Limit 2 pages per biosketch

The process for submitting an application varies depending on whether the activity code of the parent award requires electronic submission (as of the submission date of the supplement application). Visit the list of Activity Codes Processed Electronically by eRA to determine if the activity code of the parent award has transitioned to electronic submission.

• If the parent award’s activity code has not transitioned to electronic submission, then you may use the PHS 398 Application Forms and follow program-specific instructions provided in this announcement.
• If the parent award’s activity code has transitioned to electronic submission, then you may either: (1) electronically submit using the PHS 398 Application Forms and Grants.gov/Apply; (2) electronically submit using the streamlined submission process of eRA Commons; or (3) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Component. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some components marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional components.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available.

Include the Research Strategy, Cover Letter, and any other required documentation (described below) as a PDF file using the Add Other Attachments function. Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, and two signed photocopies in one package to:

Genevieve A. Medley
Deputy Women's Health Officer
Science Planning and Coordination Branch
Office of Science Planning and Assessment
National Cancer Institute
6116 Executive Boulevard, Suite 205
Rockville, MD 20852
Phone: 301-594-9979
Email: [email protected]

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

Cover Letter

Applications must include a cover letter, citing this FOA, signed by the authorized organizational representative (AOR)/institutional official. The signature of the AOR must be clearly visible. The letter must cite FOA number PAR-13-067 and the FOA title, Administrative Supplements to NCI-Funded Research Projects: Funding to Advance Research on Cancers in Women, and it must contain the following information:

• Principal Investigator(s) name(s);
• Title of proposed project;
• Complete parent grant number, title, and end-of-funding date;
• Name of NCI Program Officer for parent award;
• Requested period of supplemental support (up to 2 years) -- The parent grant must be active through the entire period requested for the supplemental funding;
• Total amount of the requested supplement, including direct and indirect costs;
• Name and title of the institutional official; and
• Telephone, email, and address information for both the PI and institutional official.

The cover letter must also include the following information:

• Cancer Type. Indicate the cancer type(s)/site(s) most relevant to the proposed project: bladder, breast, cervical, colon and rectal, endometrial, leukemia, lung, melanoma, non-Hodgkin lymphoma, ovarian, pancreatic, renal cell, thyroid, uterine, and/or other.
• Scientific Area. Indicate the scientific area(s) most relevant to the proposed project: biology; etiology (causes of cancer); prevention; early detection, diagnosis, and prognosis; treatment; cancer control, survivorship, and outcomes research; and/or scientific model systems.
• In any case where instructions provided in the PHS398 Application Guide differ from those provided herein (e.g., page limits), instructions stated in this Notice shall supersede those in PHS398.

A cover letter template is available at http://www.novaresearch.com/cancersinwomensupplements/.

Application Forms

In any case where instructions provided in the PHS398 or SF424 Application Guide differ from those provided herein (e.g., page limits), instructions stated in this FOA shall SUPERSEDE those in the PHS 398 or SF 424 application guides.

• On the Face Page: Title of Project refers to the title of the parent grant.
• On the Face Page: Program Director/Principal investigator items 3a-3h refer to the PD/PI of the parent grant; remaining items refer to the proposed supplement project.
• On the Face Page: Skip items 7a and 7b.
• Omit the following: Multiple PDs/PIs list, Project Summary, Relevance, and Project/Performance sites.
• Under Research Plan, include the elements described below, noting page limits indicated in the Page Limitations section above.
• Unless the proposed project DIFFERS from the parent grant regarding the inclusion of women, children, or minorities, you may omit the following: Inclusion Enrollment Report, Inclusion of Women and Minorities, Targeted/Planned Enrollment Table, and Inclusion of Children.
• Unless the proposed project DIFFERS from the parent grant regarding inclusion of Select Agents, you may omit the Select Agent Research section.
• Do not use the mailing address for application page in the PHS 398. The NIH Center for Scientific Review (CSR) is NOT involved in receipt and processing of these requests.

The application should include a brief proposal describing the supplemental research activities, including:

Introduction describing how the proposed supplemental activities relate to the parent award.

Specific aims for the supplement, including a brief statement of expected impact and scientific relevance of the supplemental research on cancer in women to the overall goals of this Administrative Supplements Program. Specify the general scientific priority (i.e., previously listed in this FOA under General Scientific Priorities) that is most relevant to the proposed project.

Research Strategy

Describe the proposed research, explaining how it relates to the priority areas defined for this Administrative Supplements Program. Explain how the proposed supplemental activities will enhance research conducted under the parent award. If the parent grant is a U01 cooperative agreement award, outline how the supplemental project will fit within the terms and conditions of the cooperative agreement award. The Research Strategy should contain sufficient detail to allow assessment of the scientific merit of the proposed plans and the appropriateness of the request for supplemental funding in the context of the priorities of this Administrative Supplement Program. 

Timeline

Bibliography and References Cited

Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

List the PD/PI as the first person (regardless of their role on the supplement activities). List all other Senior/Key Personnel; include a biographical sketch for each. Follow all instructions in the Application Guide.

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

All instructions in the Application Guide must be followed, with the following additional instructions:

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

• If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications as described above. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

This initiative is not subject to intergovernmental review.

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 only as described in the NIH Grants Policy Statement.

Applications must be submitted using the instructions specified above

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

NIH Staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

• Importance of the project to a specific problem or critical barrier to progress in the field of women’s health research.
• Uniqueness of the application to women’s health research.
• Potential of the project to fill a gap in women’s health research.
• Potential of the proposed project to add significantly to the scientific knowledge and increase awareness of either non-sex/gender-specific cancers or sex-/gender-specific cancers.

Additional selection factors include:

• Relevance of the proposed activity to the parent grant.
• Adequate progress of the parent grant appropriate to the current stage of the project.
• Appropriate and well-described plan to accomplish goals within the timeframe proposed
• Expertise of the research team proposed to conduct and achieve the goals of the supplemental study.
• Appropriateness of the budgets in consideration of the study proposed and the research environment for the scientific projects.
• Relevance of the proposed project to one or more of the scientific priority areas stated in this FOA.
• Feasibility of the project as proposed.
• Suitability of the investigators, collaborators, and other researchers to the project. If early-stage investigators or new investigators are involved, they must have appropriate experience, training, and mentorship.

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, NIH staff will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

NIH Staff 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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

NIH Staff 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.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. The progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Non-Competing Grant Progress Report, PHS 2590 or RPPR, and financial statements as required in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Genevieve A. Medley
Deputy Women's Health Officer
Science Planning and Coordination Branch
Office of Science Planning and Assessment
National Cancer Institute
Telephone: 301-594-9979
Email: [email protected]

NOTE: An informational website for these administrative supplements is available at http://www.novaresearch.com/cancersinwomensupplements/. The site includes a cover letter template, submission checklist, and answers to frequently asked questions (FAQs).

Not Applicable

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
Telephone: 301-496-8634
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.