The NIH Guide for Grants and Contracts is the official publication for NIH medical and behavioral research Grant Policies, Guidelines and Funding Opportunities.
In an effort to provide a mechanism to locate specific NIH guide notices that are relevent to UCSF faculty and staff, this page was developed with a library of current relevant NIH policy and guide notices that can be located by searching for key words/topic. While on the page strike CTRL-F and enter a key word or topic of the Notice. Each month the page will be updated. If a notice is not listed that you would like to keep for reference, please email a request to post the guide notice (NOT-OD-18-XXX) on the OSR NIH UPDATES page.
NIGMS-managed HIV/AIDS RESEARCH PORTFOLIO TRANSITIONING TO NIAID: NOT-GM-19-039 anounces that effective immediately the National Institute of General Medical Sciences (NIGMS) is transferring its HIV/AIDS portfolio and associated funds to the National Institute of Allergy and Infectious Diseases (NIAID). This portfolio is funded from the HIV/AIDS budget, which is separate from the general NIGMS appropriations. The transfer will be coordinated by the NIH Office of AIDS Research (OAR).
Also, effective immediately, HIV/AIDS applications will no longer be accepted by NIGMS. This applies to FOAs issued by NIGMS, FOAs in which NIGMS participates, and NIH Parent Announcements.
Affected grantees will be contacted by NIGMS and NIAID staff with further information including Program Official and Grants Management Specialist assignment.
NOTICE OF INTENT TO PUBLISH A FUNDING OPPORTUNITY ANNOUNCEMENT FOR MAXIMIZING TH SCIENTIFIC VALUE OF EXISTING BIOSPECIMEN COLLECTIONS: NOT-OD-19-100 announces the intent of the NIH Tobacco Regulatory Science Program (TRSP), participating NIH ICs, and FDA Center for Tobacco Products (CTP) to promote a new initiative through an R21 Funding Opportunity Announcement (FOA). The FOA will solicit applications for research that will stimulate exploratory research relevant to the mission of the FDA CTP using existing (publicly available) biospecimen currently stored in repositories in the United States. This will included (but not limited to) collections associated with:
- Population Assessment of Tobacco and Health (PATH) Study
- National Health and Nutrition Examination Survey (NHANES)
- NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC)
- Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial
Short Turnaround: Estimated FOA publication – August 1, 2019. First estimated Application due date – October 8, 2019.
Click here for more information (please note estimated award and start dates).
NOTICE OF INTENT TO PUBLISH A FUNDING OPPORTUNITY ANNOUNCEMENT FOR SECONDARY ANALSES OF EXISTING DATASETS OF TOBACCO USE AND HEALTH: NOT-OD-19-104 announces the intent of the NIH Tobacco Regulatory Science Program (TRSP), participating NIH ICs, and FDA Center for Tobacco Products (CTP) to promote a new initiative through an R21 Funding Opportunity Announcement (FOA). The FOA will solicit applications for research proposing innovative analysis of existing (publicly available) nationally representative U.S. cross-sectional and longitudinal data to investigate novel scientific ideas and/or to generate new models, systems, tools, methods, or technologies that have the potential for significant impact on biomedical or biobehavioral research in areas relevant to the FED CTP.
Short Turnaround: Estimated FOA publication – August 1, 2019. First estimated Application due date – October 8, 2019.
Click here for more information (please note estimated award and start dates).
REQUIRED USE OF THE xTRACT SYSTEM TO PREPARE DATA TABLES FOR TRAINING GRANT RPPRs IN FY 2020: NOT-OD-19-108 announces the requirement to use the xTRACT feature in the eRA Commons to prepare the required data tables for Research Performance Progress Reports (RPPRs) of institutional research training awards (T15, T32, T90/R90, and TL1). Beginning with RPPRs due October 1, 2019, system validations in the RPPR module will check to ensure that the uploaded data tables were created using xTRACT.
This requirement is not mandatory for new and renewal institutional research training awards (T15, T32, T90/R90, and TL1) in FY 2020; however, this may become a requirement in future years.
Other types of predoctoral, postdoctoral, and career-level training, education, and career development awards that currently use training data tables (T37, R25, K12/KL2) will not be required to use xTRACT to prepare tables for RPPRs in FY 2020. Recipients of these awards may wish to wait for future editions of xTRACT, which are expected to include features and instructions tailored to these specific programs.
Click here for more information and specific details.
GUIDANCE ON POSTING INFORMED CONSENT FORMS FOR NIH-FUNDED CLINICAL TRIALS: NOT-OD-19-110 provides guidance regarding where to post clinical trial informed consent forms, as required by Section 46.116(h) of the Revised Common Rule (Subpart A of 45 CFR 46). The Revised Common Rule requires Federally-supported clinical trial (as defined in 45CFR46.102(b)) recipients to post an IRB-approved consent from on a public federal website designated for posting such consent forms.
NIH-funded recipients should submit IRB-approved English-language informed consent forms to ClinicalTrials.gov, following the instructions. Note: ClinicalTrails.gove does not support non-English documents.
NIH-funded recipients using only non-English informed consent forms to enroll participants should submit IRB-approved informed consent forms to Docket ID: HHS-OPHS-2018-0021 on the Regulations.gov website following the instructions provided by the Office for Human Research Protections.
See NOT-OD-19-110 for specific details.
REQUEST FOR INFORMATION (RFI) - TISSUE SOURCE OPTIONS FOR GENERATING HUMAN IMMUNE SYSTEM (HIS) MICE: NOT-OD-19-093 announces that NIAID and ORIP plan to collect information on which tissues and sources are deemed important by the biomedical research community as potential alternatives to the use of fetal tissue to conduct detailed characterization, direct comparisons and further development of HIS mouse models. Responses will be accepted through May 29, 2019. Please see the notice for specific details.
NIH SEXUAL & GENDER mINORITY RESEARCH OFFICE (SGMRO) ANNOUNCES SOUTHERN REGIONAL WORKSHOP ON SGM-RELATED RESEARCH: NOT-OD-19-097 announces a regional workshop in Sexual and Gender Minority (SGM) health research to build capacity within the extramural research community. Free workshops will be hosted by Emory University on May 31 and June 1. Click here to register.
NOTIFICATION OF CHANGE IN FEDERAL-WIDE UNIQUE ENTITY IDENTIFIER REQUIREMENTS: NOT-OD-19-098 alerts NIH recipients of the Federal-wide transition from the Data Universal Numbering System (DUNS) to a new Government-owned Unique Entity Identifier (UEI). Effective December 2020, the System for Award Management (SAM) will be the central repository for the new SAM Managed Identifier (SAMMI) that will be incorporated into an institution’s SAM registration and will not impact the Institutional Profile File (IPF) generated by the eRA Commons. Details related to full implementation will be provided to agencies by December 2020.
FY 2019 SALARY LIMITATION FOR GRANTS & COOPERATIVE AGREEMENTS: NOT-OD-19-099 announces that effective January 6, 2019, the salary limitation for Executive Level II increased from $189,600 to $192,300. The salary limitation applies to NIH grantsa, cooperative agreements and extramural research and development contract awards. Existing awards may adopt the new salary cap through rebudgeting; however, no additional funds will be provided by the sponsor. For a historical record of the salary cap including effective dates, click here.
For University-specific guidance, please see the May 1, 2019 issue of the Controller's Newsletter.
PUBLICATION OF REVISED NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES: NOT-OD-19-106 announces the update of the NIH Guidelines to eliminate duplicative review and reporting requirements for human gene transfer protocols and describes NIH’s efforts to refocus the role of the NIH Recombinant DNA Advisory Committee (RAC) to be closer to its original mandate. The RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC). Please see the Notice for links to the final revisions.
IMPORTANT NOTE: Though NIH is streamlining individual protocol reporting requirements, robust oversight over gene therapy trials will continue as Federal and local oversight must continue to review and approve these trials before any research with human participants can be initiated.
NOTICE OF SPECIAL INTEREST: DEVELOPMENT OF CRYOGENIC OR OTHER LONG-TERM PRESERVATION AND REVIVAL METHODS FOR DROSOPHILA AND ZEBRAFISH GENETIC STOCKS: NOT-OD-19-089 announces that the Office of Research Infrastructure Programs (ORIP) is interested in receiving grant applications for hypothesis-driven research projects through PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) aimed at developing or inproving cryogenic or other long-term preservation and revival methods of either Drosophila or zebrafish genetic stocks. Submission should indicate that they are in response to NOT-OD-19-089 in Field 4.b. on the SF 424 form. Interested Principal Investigators are encouraged to contact scientific contacts listed on the Notice to be advised on the appropriateness of the intended research project, competitiveness of a potential application, and alignment with ORIP's program priorities. Please see the Notice for areas of high priority.
NIH OFFICE OF DISEASE PREVENTION (ODP) ANNOUNCES THE PATHWAYS TO PREVENTION WORKSHOP: NOT-OD-19-090 announces that NIH is hosting the Pathways to Prevention Workshop: Achieving Health Equity in Preventive Services, focused on three leading causes of death in the United States (cancer, heart disease, and diabetes) to assess the available scientific evidence on achieving health equity in the use of clinical preventive services in a health care setting. The workshop will be held: June 19-20, 2019, Natcher Conference Center, NIH Main Campus, Bethesda, MD. See the notice for more registration information and how to watch the workshop live online.
CLARIFICATION REGARDING THE SUBMISSION OF BIOSKETCHES FOR PA-18-906: NOT-OD-19-091 informs potential applicants using the eRA Commons for electronic-based submissions for PA-18-906 “Research Supplements to Promote Diversity in Health-Related Research (Admin Supp-Clinical Trial Not Allowed)” that biosketch information for the candidate, any mentors, and any senior or key persons directly involved in the activities related to the supplement should be included. Biosketches for mentors and other senior and key persons should provide evidence of past mentoring experience.
REQUEST FOR INFORMATION (RFI) ON THE REVISED DEFINITION OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH (BSSR): NOT-OD-19-032 NIH seeks comments on the following:
- Is the definition clear? If not, suggest language to improve
- Does the definition capture the full range of health-related BSSR? If not, suggest modifications
- How well does the definition distinguish BSSR from other disciplines of research? If not well, suggest modification
Submit responses no later than February 22, 2019 through the OBSSR crosdsourcing IdealScale website.
FUNDS AVAILABLE FOR REVISION APPLICATIONS FOR RESEARCH CENTERS FOCUSED ON CHRONIC DISEASE AND REDUCTION OF HEALTH DISPARITIES: NOT-OD-19-070 solicits competitive revision applications to support the expansion of existing P30, P50 or U54 cores and/or pilot project programs of NIH-supported chronic disease research centers (P30, P50, U54). Participating NIH ICs: NCI, NHLBI, NIAMS, NIDDK, NINDS, and NIMHD. Competitive revision applications must be submitted by March 28, 2019, please see the notice for details.
REVISED GUIDANCE ON PROTECTING LIFE IN GLOBAL HEALTH ASSISTANCT: NOT-OD-19-079 extends the applicability of the PLGHA policy (see NOT-OD-17-083) to the foreign non-governmental organizations (NGO) who are subrecipients (and their vendors) of US State or local governmental entities including state universities that receive US global health assistance from the President's Emergbency Plan for AIDS Relief (PEPFAR). This requirement is effective January 3, 2019 for new awards and contracts and and existing awards and contracts when amended to add new funding. The term will appear in Section IV: Special Terms and Conditions of the Notice of Award, below is an example of the term:
In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organizations (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award either as a prime recipient or subrecipient of a US NGO are strictly prohibited regardless of the source of funds, from performing abortions as a method of famiuly planning or engaging in any activity that promotes abortion as a method of family planning or engaging in any activity that promotes abortion as a method of family planning or to provide financial support to any other foreign NGO that conducts such activities. Please refer to the full provisions of the award here.
UPDATE TO NIH/AHRQ/NIOSH POLICY ON POST-SUBMISSION MATERIALS: NOT-OD-19-083 updates and clarifies the NIH, AHRQ, and NIOSH policy for post-submission materials for applications submitted on or after May 25, 2019.
What will change: for Training Grant (T series) applications submitted on or after May 25, 2019, a list of publications up to 3-pages will be accepted as post-submission materials. This replaces the former 1-page limit.
Clarifications: Preprints and Other Interim Research Products are not accepted as post-submission materials - they do not represent unforeseen events. Missing or corrected materials are not accepted unless specifically listed in this Notice as post-submission materials. Materials resulting from change of institution or change of PD/PI that occurs between application submission and peer review must first be sent to the SRO managing the review with a copy to the Division of Receipt and Referral ([email protected]), and after review materials should be sent to the Grants Management Specialist listed in eRA Commons for that application.
See the Notice for Allowable Post-Submission Materials for All Applications.
NIH IMPLEMENTATION OF THE FINAL RULE ON THE FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS (COMMON RULE): NOT-OD-19-050 announces the NIH implementation of the Final Rule amending the Federal Policy for the Protection of Human Subjects (Common Rule). Several provisions in the Revised Common Rule resulted in changes to NIH policies and procedures. From an application submission perspective, the most notable changes are: 1.) Changes to categories of research qualifying for exemptions (FAQs) and 2.) Use of new exemptions 7 and 8, when applicable.
UCSF HRPP hosted two Town Hall meetings on January 14-15, 2019, to discuss the changes to the federal policy for research involving Human Subjects. The sessions were live-streamed and recorded. Click here for more information and resources.
NIH POLICY FOR REVIEW AND RESUBMISSION OF NEW INVESTIGATOR R01 APPLICATIONS: NOT-OD-19-053 provides an update of review and resubmission of New Investigator (NI) R01 applications, commencing with R01 applications submitted for due dates on or after Janaury 25, 2019. NIH has prioritized funding of meritorious R01 applications (NOT-OD-17-101) and will continue to make a special accommodation for NI R01 applications by retaining clustered review and preferential release of summary statements. The special NI deadline for next round resubmission of A1 R01 applications will be eliminated.
REMOVAL OF REQUIREMENT FOR IRB REVIEW OF NIH GRANT APPLICATIONS & CONTRACT PROPOSALS: NOT-OD-19-055 provides guidance on the implementation of revisions to the Final Rule on the Federal policy for the Protection of Human Subjects (Common Rule). Effective January 21, 2019 and forward, NIH will no longer require IRB review of the entire grant application or contract proposal. NIH will continue to require certification that all NIH-supported, non-exempt human subjects research protocols have been reviewed and approved by an IRB and the date of final IRB approval provided at Just-In-Time. The notice further provides a reminder that any changes to peer reviewed protocols or the addition of new study protocols require NIH prior approval (NIH GPS 184.108.40.206).
CLARIFICATION REGARDING HARASSMENT AND DISCRIMINATION PROTECTIONS IN NIH TRAINING (T) APPLICATIONS: NOT-OD-19-056 provides clarification that this policy allows for a single letter, on institutional letterhead, signed by a key institutional leader with institution-wide responsibilities. The letter provides the institution's commitment to the planned program and includes its commitment to prevent discriminatory harassment and other discriminatory practices through proper policies, procedures, and oversight; appropriately responding to such allegations; and following NIH prior approval procedures if there is a change in the status of NIH-supported Senior/Key Personnel as a result.
Please note, UCSF has a seperate campus-wide Letter of Support for the prevention of harassment and other discriminatory actions that is posted on the OSR webpage for Regulatory/Compliance Reqirements. The campus-wide letter and the program specific letter should be included in the single pdf for the Letters of Support on the PHS 398 Research Training Program Plan form for T applications due on or after January 25, 2019. Also, consult specific instructions provided by individual NIH Institutes and Centers.
REVISION: NIH POLICY AND GUIDELINES ON INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN IN RESEARCH INVOLVING HUMAN SUBJECTS: NOT-OD-18-116 replaces NOT-98-024 revising the NIH Policy and Guidelines on the Inclusion of Children. Now individuals of all ages are expected to be included in all NIH-defined clinical research unless there are scientific or ethical reasons not to includle them. Applications for research involving human subjects must address the age-appropriate inclusion or exclusion of individuals inn the Inclusion of Women, Minorities, and Children section of the proposed research project.
CHANGES TO NIH ACADEMIC RESEARCH ENHANCEMENT AWARD R15 PROGRAM: NOT-OD-19-015 announces the rebranding of the "NIH Research Enhancement Award." The R15 activity code will include two programs: 1.) Academic Research Enhancement Award (AREA) for Undergraduate-Focused institutions and 2.) Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools. The ineligible institution list will no longer be maintained, instead an institution letter verifying eligibility is required with criteria listed in the funding opportunity announcement.
ADVANCE NOTICE-STREAMLINING THE CERTIFICATIONS AND REPRESENTATIONS PROCESS AND PHASING OUT THE SF-424B: NOT-OD-19-043 announces that effective January 1, 2020, the System for Award Management (SAM) will become the central repository for common government-wide certifications and representations (assurances) required by NIH. This action will reduce the duplicative practice of Federal-awarding agencies requesting these assurances with the submission of each Federal financial assistance application and will phase-out the use of the SF-424B.
UPDATE TO NIH MANAGEMENT OF GENOMIC SUMMARY RESULTS (GSR) ACCESS: NOT-OD-19-023 provides an update to the NIH Genomic Data Sharing (GDS) Policy, which implements data management procedures for GSR access. Investigators proposing to donduct GDS Policy applicable research will be expected to indicate in their genomic data sharing plans (in grant or contract proposals) if a study should be designated as "sensitive" for the purposes of access to GSR.
HARASSMENT AND DISCRIMINATION PROTECTIONS IN NIH TRAINING APPLICATIONS: NOT-OD-19-029 announces that NIH training (T) applications due on and after January 25, 2019 lwill require an additional letter of support describing the institutional commitment to prevent discriminatory harassment and other discriminatory practices. NOTE: Resources and guidance are under development for the January 25, 2019 due date.
LEGISLATIVE MANDATES IN EFFECT FOR FY 2019: NOT-OD-19-030 provides current requirements that limit or conditions the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2019, under the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 (Public Law 115-245), signed into law on September 28, 2018.
NOTICE OF FISCAL POLICIES IN EFFECT FOR FY 2019: NOT-OD-19-031 summarizes NIH fiscal policies instituted in FY 2019:
- FY 2019 Funding Levels - non-competing continuation awards will generally be issued at the commitment level indicated in the Notice of Award. Out-year commitments for continuation awards remain unchanged. NIH awarding ICs will post their individual fiscal policies here.
- Kirschstein-NRSA - stipends will increase by approximately 2% on average (see NOT-OD-19-036).
- Next Generation Researchers Initiative Policy - NIH will prioritize meritorious R01 - exuivalent applications for Early Stage Investigators (ESI) per the policy established in FY 2017 (see NOT-OD-17-101).
- Salary Limits - salaries paid through extramural mechanisms (e.g. grants) shall not exceed Executive Level II, currently $189,600.
- Other Legislative Mandates - other statutory requirements are described in more detail in NOT-OD-19-030.
- Additional Information - details on Fiscal Operations and IC-specific funding strategies will be posted here.
KIRSCHSTEIN-NRSA STIPENDS AND OTHER BUDGETARY LEVELS (FY 2019): NOT-OD-19-036 establishes stipend levels for fiscal year (FY) 2019 Kirschstein-NRSA awards for predoctoral and postdoctoral trainees and fellows. Budgetary categories described in this notice apply only to Krischstein-NRSA awards made on or after October 1, 2018 with FY 2019 funds. All FY 2019 awards previously issued using budgetary levels publsihed in NOT-OD-18-175 will be revised to adjust funding to the FY 2019 levels.
NOTE: Additional information regarding UC scale from HR is forthcoming. OSR to concurrently release additional guidance.
CORRECTION-KIRSCHSTEIN-NRSA INDIVIDUAL PREDOCTORAL FELLOWSHIP TO PROMOTE DIVERSITY IN HEALTH-RELATED RESEARCH: NOT-OD-19-039 informs prospective applicants that the Certification Letter required in PA-18-666 should avoid revealing sensitive personal information, such as the candidate's specific racial/ethnic background or type of disability. The certification letter must be on institutional letterhead and scanned so that an institutional official signature is visible. The letter should be uploaded to the "Other Attachments" section in the Research & Related Other Project Information Form.
REINSTATEMENT OF NIH SBIR DIRECT-TO-PHASE II AUTHORITY: NOT-OD-19-019 announces the reinstatement of thie NIH SBIR Direct Phase II provision through FIscal Year 2022. Please refer to the notice for exceptions.
COMMUNICATING RESEARCH MISCONDUCT TO NIH: NOT-OD-19-020 reminds recipient institutions of their responsibilities in handling research misconduct (suspected or confirmed) in NIH-funded research. The notice also clarifies the requirement of recipient and subrecipient institutions (foreign or domestic) to hold assurances with HHS Office of Research Integrity (ORI) and outlines procedures to communicate matters related to research misconduct proceedings to the NIH and ORI.
REVISED NIH GRANTS POLICY STATEMENT (NIHGPS): NOT-OD-19-021 announces publication of the revised NIH Grants Policy Statement (NIHGPS. Rev. October 2018). This revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018 and supersedes, in its entirety, NIHGPS. Rev. October 2017 as a standard term and condition of award.
NEW FUNDING OPPORTUNITY ANNOUNCEMENTS (FOAs) TARGETING BASIC EXPERIMENTAL STUDIES WITH HUMANS: NOT-OD-19-024 announces the intent to publish new R01 Parent Announcements identified as Basic Experimental Studies with Humans, which focus on applications that propose clinical trials that also meet the definition of basic research. Pay close attention to participating Institutes and Centers and any restrictions posted in the Related Notices section of each FOA. Applications proposing basic experimental studies involving humans may also be submitted to opportunities which allow clinical trials.
2018 BAYH-DOLE ACT FINAL RULE: NOT-OD-18-233 implements the new final regulations of the Bayh-Dole Act (rights to Federally-funded inventions and licensing of government-owned inventions), which applies to all NIH new (including renewals) and continuation awards beginning on or after October 1, 2018.
FIXED AMOUNT AWARDS: NOT-OD-18-222 provides clarification of the definition of “fixed amount” subawards, specifically when used for human subject studies, e.g. clinical trials and other types.
FELLOWSHIP APPLICATION UPDATES: NOT-OD-18-227 announces planned updates to the application instructions and review criteria for fellowship grant applications for due dates on or after January 25, 2019.
RESEARCH APPLICATION UPDATES: NOT-OD-18-228 announces planned updates to the application instructions and review criteria for research grant applications for due dates on or after January 25, 2019.
CAREER DEVELOPMENT AWARD APPLICATIONS: NOT-OD-18-229 announces planned updates to the application instructions and review criteria for career development award applications for due dates on or after January 25, 2019.
SUBMISSION/RESUBMISSION POLICY: NOT-OD-18-197 consolidates the policy onto one notice and rescinds prior notices. Use this notice when referring to the policy.
UPDATES TO RPPR: NOT-OD-18-202 announces update to the delegation feature of the final and interim RPPR to align with the annual RPPR. Now, PIs can delegate initiation of any RPPR to the ASST role. Also, RPPR forms include decimals in the effort being reported.
2018 COMMON RULE: NOT-OD-18-211 announces NIH implementation of the 3 burden reducing provisions during the 6 month delay. UCSF has decided not to implement to provisions and is working on campus-wide training materials for the January 21, 2019 compliance date.
BASIC SCIENCES HS STUDIES: NOT-OD-18-212 announces delayed enforcement and short-term flexibilities for some requirements affecting Basic Science Studies with Human Participants.
CONTINUOUS SUBMISSION: NOT-OD-18-178 reminds the research community of the application deadlines based on Council Round assignment.