Administrative Supplements to NCI-funded Research Projects: Funding to Advance Research on Cancers in Women

Notice Number: NOT-CA-12-001

Release Date: October 14, 2011
Receipt Date: by December 19, 2011
Earliest Anticipated Start Date: April 1, 2012

National Cancer Institute (NCI)

The National Cancer Institute’s (NCI) Office of Science Planning and Assessment (OSPA) represented by the NCI Women’s Health Officer in conjunction with the Women’s Health Activities Committee announce an Administrative Supplement opportunity to expand and/or enhance research on cancers in women, which include both non-sex-specific cancers (cancers that affect both women and men) and sex-specific cancers (cancers that affect only women). These Administrative Supplements are available to specific types of NCI-funded research projects that are relevant to cancer in women (see details below in the Eligibility section).

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 gynecological cancers) have been less significant. Epidemiological studies have primarily been focused on mortality in women with little attention on quality-of-life issues. Even in areas in which progress has been achieved, improvements are often not consistent in all populations, creating large disparities among groups of women. The overall goal of these Administrative Supplements is to advance cancer research that is particularly 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.

Outside of the discipline of reproductive medicine, women s health has been rarely a focus of medical research. In a recent report (http://www.iom.edu/Reports/2010/Womens-Health-Research-Progress-Pitfalls-and-Promise.aspx), the Institute of Medicine (IOM) noted that the advances over the past 20 years have been uneven across pathological conditions that affect women, including cancers. The IOM report recommends focusing research efforts on those pathologies that: are specific to women; are more common or more serious in women; have distinct causes or manifestations in women; have different outcomes or treatments in women; and/or have high morbidity or mortality in women. NCI supports the IOM recommendation and encourages research in both sex-specific cancers and non-sex-specific cancers to understand how cancer affects women.

Support through this administrative supplement program is expected to enhance the following priority areas for research on cancer in women:

• Biomedical, epidemiologic, behavioral, and social research on sex and gender differences as related to cancer;
• Disparities in cancer diagnosis and treatment affecting pre- and post-puberty females;
• Cancer in women across their lifespan, including aspects relevant to pregnancy and other fertility-related issues as well as aging process;
• Cancer prevention, including research relevant to Human Papilloma Virus (HPV) infections and research on behavior and diet;
• Effective translation and dissemination of research findings related to women’s health and cancer; and
• Research on triple-negative breast cancer including awareness, prevention, detection, diagnosis, care, and treatment.

Current NCI awardees with active R01, R37, R21, P01, P50, and/or U01 grants/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;
• 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; and
• 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).

No other funding mechanisms are eligible.

Activities proposed for the Administrative Supplements may include:

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

To be eligible, the parent grant must be active through the entire time period of the supplement, and the research proposed in the supplement must be accomplished within the competitive segment. No-cost extensions cannot be used to accommodate this requirement. The proposed supplement must be within the general scope of the peer-reviewed activities and aims approved within the parent grant.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant 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 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. Please contact the Program Director assigned to the parent grant for questions related to scientific or programmatic content and to determine if the supplement fits within the approved scope of the project.

Approximately five awards of up to $50,000 (total costs) each are anticipated in FY 2012, contingent on the availability of funds and receipt of sufficiently meritorious requests. Administrative supplement requests may not exceed $50,000 in total costs. Although a project period of up to 2 years may be proposed (provided the parent grant remains active), the entire budget request must be for year 1 of the supplement. These administrative supplements are non-renewable.

Applicants may submit more than one application but only if the parent grant has multiple projects related to cancers in women. In such a case, awardees must identify the individual project for which they are seeking supplemental funds. However, separate supplement request letters must be submitted for individual components of the parent grant. Additionally, each PD(s)/PI(s) may not submit more than two supplement requests in total. 

Requests should use the PHS398 Application Guide forms, as indicated below. Font size and other formatting rules apply as designated in the instructions. Please note: In any case where instructions provided in the PHS398 Application Guide differ from those provided herein, instructions stated in this Notice shall supersede those in the PHS398 Application Guide.

Include in the request the following elements:

1. Cover Letter, citing this Notice, signed by the authorized organizational representative/institutional official, and containing the following information:

• Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) name.
• Parent grant number, title, and end-of-funding date.
• Requested period of supplemental support (up to 2 years). The parent grant must be active through the entire period requested for the supplemental funding.
• Amount of the requested supplement, including direct and indirect costs. Use the indirect cost rate appropriate to the mechanism of the parent grant.
• Name and title of the institutional official.
• Telephone, e-mail, and address information for both the PD/PI and institutional official.

2. PHS 398 Form Page 1 (Face page) MS Word PDF

• Title of project (Box 1) should be the title of the parent award.
• Cite this Notice number [NOT-CA-12-001] and title, Administrative Supplements to NCI-funded Research Projects: Funding to Advance Research on Cancers in Women in Box 2 and check the yes box.
• Complete the remaining items on the face page in accordance with the PHS 398 application instructions.

3. PHS 398 Form Page 2 MS Word PDF

• The project summary is that of the administrative supplement, not the parent grant.

4. A brief proposal describing the supplemental research activities, including:

A. Introduction (limit 1 page) describing how the proposed supplemental activities relate to the parent award.

B. 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 (limit 1 page).

C. Research Strategy (limit 3 pages, see details below).

Research Strategy.

Describe the proposed research explaining how it relates to the priority areas defined for this Administrative Supplements Program. Explain also 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. 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. 

5. Itemized Budget for the Supplement.

Budgets for Administrative supplement requests may not exceed $50,000 in total costs. Although the project period of up to 2 years may be proposed (provided the parent grant remains active), the entire budget request must be for year 1 of the supplement. Use the standard PHS 398 Form pages 4 and 5 for itemized budget, including justification and Facilities and Administrative costs. 

6. Biographical Sketch for all personnel, including those who are additions on the supplemental project.

7. Human Subjects/Vertebrate Animal documentation (if applicable).

• Include a current Human Subjects/Institutional Review Board (IRB) or Vertebrate Animals/Institutional Animal Care and Use Committee (IACUC) approval letter, if available. Otherwise, this documentation will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
• Any differences in the involvement or use of human subjects or specimens, or in the use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.
• As appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.

This Notice is a one-time announcement, and formal requests must be received on or before 5 p.m. EST December 19, 2011. The request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO).

Applicants are strongly encouraged to submit requests electronically as an e-mail attachment in PDF format; however, the signature of the AOR must be clearly visible. 

The e-mail should be directed to Genevieve Medley at medleyge@mail.nih.gov.

Applicants may also submit applications in paper format (original and one copy) to:

Genevieve A. Medley
Health Science Analyst
Science Planning and Implementation Branch
Office of Science Planning and Assessment
National Cancer Institute
6116 Executive Boulevard, Suite 205
Rockville, MD 20852
Phone: 301-594-9979

NOTE: The NIH Center for Scientific Review (CSR) is NOT involved in receipt and processing of these requests.

All administrative supplement requests submitted in response to this Notice will compete for available funds. The following items will be considered in funding decisions:

• Outcome of administrative review by NCI staff;
• Relevance of the proposed project to one or more of the scientific priority areas stated in this Notice;
• 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-specific cancers (cancers that affect both women and men) or sex-specific cancers (cancers that affect only women);
• Feasibility of the project as proposed; and
• 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.

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

Direct program/scientific-related questions or inquiries to the NCI Program Director listed as Program Official on the parent award or to:

Genevieve A. Medley
Health Science Analyst
Science Planning and Implementation Branch
Office of Science Planning and Assessment
National Cancer Institute
6116 Executive Boulevard, Suite 205
Rockville, MD 20852
Phone: 301-594-9979
E-mail: medleyge@mail.nih.gov

Direct all financial and grants management-related questions or inquiries to:

Crystal Wolfrey
National Cancer Institute
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
E-mail: crystal.wolfrey@nih.gov