NIH Updates

Last updated on November 1, 2019

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.

Below is a list of Notices that are relevent to UCSF faculty and staff:

2018:
June, July, September, October, November, December,

2019:
JanuaryFebruary, March, April, May, June, July, August, September, October

 


October 2019

NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-20-003 announces that the Department of Health and Human Services (HHS), including NIH, operates under the "Continuing Appropriations Act, 2020 and Health Extenders Act of 2019" (Public Law 116-59) signed by President Trump on September 27, 2019. The Continuing Resolution continues government operations through November 21, 2019 at 99.3209% of the FY 2019 enacted level.

Continuing the procedures under NOT-OD-19-131 and consistent with NIH practices during the Continuing Resolutions of FY 2006-2019, NIH will issue non-competing research awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Upward adjustments will be considered after FY 2020 appropriations are enacted.

All FY 2019 legislative mandates (NOT-OD-19-030), salary cap (NOT-OD-19-099), and predoctoral and postdoctoral stipend levels and tuition and fees (NOT-OD-19-036) remain in effect under this Continuing Resolution.

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GUIDANCE ON POSTING INFORMED CONSENT FORMS FOR AHRQ-FUNDED CLINICAL TRIALS: NOT-HS-19-023 provides guidance to AHRQ grant applicants on posting clinical trial informed consent forms, as required by the Final Rule. The HHS Office of Human Research Protections (OHRP) has identified ClinicalTrials.gov and Regulations.gov as the publicly available federal websites that will satisfy the consent form posting requirement.

To fulfill the requirement, recipients conducting AHRQ-funded clinical trials must submit one IRB-approved version of a consent form that has been used to enroll participants to either ClinicalTrials.gov or Regulations.gov. AHRQ recipients submitting informed consent forms to Regulations.gov should maintain a copy of their receipt and tracking number. Additional instructions are available at: https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/.

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NIH EXTENDS EXLIGIBILITY WINDOW FOR PATHWAY TO INDEPENDENCE AWARDS (K99/R00): NOT-OD-20-011 serves to update the NIH extension policy on the eligibility window for PIs to apply for a K99/R00 Pathway to Independence Award.

Applicants for the K99 awards listed in the Notice must have no more than 4 years of postdoctoral research experience at the time of application. NIH considers requests for extension of the eligibility window on a case by case basis for reasons including medical concerns, disability, family care, extended periods of clinical training, natural disasters, and active duty military service.

Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI), effective immediately, NIH will approve an extension of one year for childbirth within the 4 year K99 eligibility window. Applicants must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the FOA at least 12 weeks before submitting an application.

  • For the March 12, 2020 deadline, requests must be received by the week of December 9, 2019
  • For the July 12, 2020 deadline, requests must be received by the week of April 13, 2020
  • For the November 12, 2020 deadline, requests must be received by the week of August 10, 2020

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September 2019

  (no policy/procedure changes to post)

August 2019

NIH ANNOUNCES NEW CENTRALIZED NOTIFICATIONS FOR UNFUNDED APPLICATIONS: NOT-OD-19-133 introduces a new centralized, streamlined process for official NIH notification of unfunded applications.

  •  NIH will begin sending centralized, automated notifications of unfunded applications via the eRA system approximately 14 months after the application’s council date
  • Notifications will be sent to the AOR/SO listed in the grant application and to the Notice of Award email address
  • PIs and individuals with privileges to view Status will also be able to see if an unfunded application notification has been sent for a specific application in eRA Commons
  • Funding decisions are specific to the applications included in the email and have no impact on subsequent submissions/resubmissions. There is no change to NIH’s application submission/resubmission policy as outlined in NOT-OD-18-197
  • More information is available in the FAQs and the eRA Online Help webpage.

 For technical assistance contact the eRA Service Desk.

Questions regarding this policy should be directed to [email protected].

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REPORT ON REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS: ANIMAL CARE AND USE IN RESEARCH: NOT-OD-19-136 announces the publication of Reducing Administrative Burden for Researchers: Animal Care and Use in Research, a report by NIH, USDA and FDA, resulting from Title II, Section 2034(d) of the 21st Century Cures Act (P.L. 114-255), enacted December 13, 2016. With regard to the regulations and policies for the care and use of laboratory animals in research, the Act instructs NIH to:

  1. Seek the input of experts
  2. Identify ways to ensure applicable regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative
  3. Take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies
  4. Take other actions, as appropriate to improve the coordination or regulations and policies with respect to research with laboratory animals

Implementation of the planned changes in policies, guidance, or regulations are expected to begin within the next two years to accommodate time needed for the public engagement processes.

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CLARIFYING COMPETING APPLICATION INSTRUCTIONS AND NOTICE OF PUBLICATION OF FAQs REGARDING PROPOSED USE OF HFT IN RESEARCH: NOT-OD-19-137 provides clarification of competing application instructions referenced in NOT-OD-19-128 and announces the publication of Frequently Asked Questions (FAQs) regarding the proposed use of human fetal tissue from elective abortions in extramural applications for grants, cooperative agreements, and R&D contracts.

Clarifications from this Notice have been incorporated into guidance provided on the Human Fetal Tissue Research (HFT) - NIH Requirements page of the OSR website.

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SEXUAL AND GENDER MINORITY PROPULATIONS IN NIH-SUPPORTED RESEARCH: NOT-OD-10-139 announces the revision of the definition of Sexual and Gender Minority (SGM) populations for research purposes at NIH. NIH is releasing the updated SGM definition to foster and expand inclusion of SGM individuals in health research. Please see the Notice for the full revised definition.

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July 2019

REQUIREMENT FOR ORCID iDs FOR INDIVIDUALS SUPPORTED BY RESEARCH TRAINING, FELLOWSHIP, RESEARCH EDUCATION, AND CAREER DEVELOPMENT AWARDS BEGINNING IN FY2020NOT-OD-19-109 announces the NIH/AHRQ/CDC requirement that individuals supported by research training, fellowship, research education, and career development awards, have an Open Researcher and Contributor Identifier (ORCID). The requirement will be implemented through the appointment process in the xTrain system commencing October 2019 and through the application process commencing with applications due January 25, 2020. Prospective applicants/appointees should follow the ORCID link from their Personal Profile in the eRA Commons to create and link or link the ORCID profile back to their eRA Commons Personal Profile. Please see NOT-OD-19-109 for details and specific activity codes affected.

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REMINDERS OF NIH POLICIES ON OTHER SUPPORT AND ON POLICIES RELATED TO FINANCIAL CONFLICTS OF INTEREST AND FOREIGN COMPONENTS: NOT-OD-19-114 reminds the extramural community of the need to report foreign activities through documentation of other support, foreign components, and financial conflict of interest. There is no change to the policies, the notice highlights several points summarized below:

Other Support:

Report all current projects and activities that involve senior/key personnel including all resources, funded or in-kind (e.g. lab space, equipment, supplies, employees) in support of and/or related to all of their research endeavors regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant.

Foreign Component:

NIH requires recipients to determine if supported activities include a foreign component, defined as: the existence of any “significant scientific element or segment of a project” outside of the United States. For example:

  • Work performed by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended
  • Work performed by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended

Conflict of Interest

FCOI regulation specifies the minimum requirements for investigators to disclose to their institution their significant financial interests including financial interests received from a foreign entity.

For details and FAQs, please refer to NOT-OD-19-114.

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NOTICE OF SYSTEM CHANGE AND PROCEDURE FOR REQUESTING AN EXTENSION TO EARLY STAGE INVESTIGATOR (ESI) STATUS: NOT-OD-19-125 serves to inform the extramural community of a change in the procedure for requesting an extension of early stage investigator (ESI) eligibility.

NIH defines ESI as a Program Director/Principal Investigator (PD/PI) who has completed their terminal research degree or post-graduate clinical training within the past 10 years who has not previously competed successfully as PD/PI for a substantial independent NIH research award. Some investigators may experience a lapse in their research/research training or less than full-time effort during the 10 year ESI period. NIH will consider requests for extension the ESI period for reasons such as family care responsibilities, medical concerns, disability, natural disasters, and active duty military service.

Effective August 22, 2019, the ESI Extension request button will be available in the Education section of the PD/PI’s Personal Profile in the eRA Commons. If selected, the system will provide text fields for justification of the extension request and the ability to upload PDFs of supporting documentation. If the request is approved after review by the ESI Extension Committee, a new ESI end date will appear in the Education section of the PD/PI’s Personal Profile.  With the introduction of the new ESI Extension process, the prior Extension Request form and portal will be retired.

Note: other aspects of the ESI Extension process remain unchanged. See Early Stage Investigator FAQs for more information.

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EXTENSION OF CERTAIN FLEXIBILITIES FOR PROSPECTIVE BASIC EXPERIMENTAL STUDIES WITH HUMAN PARTICIPANTS: NOT-OD-19-126 announces the delay of the enforcement of the NIH Policy on the Dissemination of NIH funded clinical trial information for Basic Experimental Studies with Human Subjects (BESH) through September 24, 2019.

Points to be considered:

NIH recognizes that registering and reporting results in ClinicalTrials.gov for BESH studies can pose a challenge

  • NIH is extending the delayed enforcement of this reporting requirement originally announced in NOT-OD-18-212 through September 24, 2019
  • This delayed enforcement is only applicable to BESH studies submitted to FOAs designated as “basic experimental studies with humans” in the title
  • During this time NIH expects registration and results reporting using alternative publicly available platforms
  • Plans for meeting NIH reporting expectations using an alternative platform should be described at the time of application in the Dissemination Plan Attachment
  • Funded awardees for applications to BESH-specific FOAs who are not using ClinicalTrials.gov, should provide in their annual progress reports the unique identifier assigned by the alternate platform (if available) and a link to the report (e.g. page or record) in the alternate platform

 NOTE:

  • NIH will not extend leniency for applications submitted to incorrect FOAs based on the study-type designation.
  • Commencing with due dates on or after September 25, 2019, applications submitted to an incorrect FOA based on study-type designation (e.g. clinical trial submitted to a “clinical trial not allowed” FOA) may be withdrawn.
  • See clinical trial-specific FAQs.

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CHANGES TO NIH REQUIREMENTS REGARDING PROPOSED HUMAN FETAL TISSUE RESEARCH: NOT-OD-19-128 announces the upcoming HHS requirements and review considerations for NIH research applications (e.g. grants, cooperative agreements, and R&D contracts) that involve the proposed use of human fetal tissue obtained from elective abortions (HFT). Changes will apply to competing grant applications submitted for due dates on or after September 25, 2019 and in response to R&D contract solicitations published on or after September 25, 2019.  Information on the changes are posted on the Human Fetal Tissue Research (HFT) - NIH Requirements page of the OSR website.

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 June 2019

NIH EXPANDING USAGE OF NOTICES OF SPECIAL INTEREST: NOT-OD-19-107 alerts the extramural community that NIH has been updating the format of the Weekly NIH Funding Opportunities and Notices to include a special section highlighting Notices of Special Interest (NOSI) since early May.

NOSIs highlight a specific topic of interest, e.g. a specific area of research or program and direct applicants to use one or more active Funding Opportunity Announcements (FOAs), often parent announcements, for submission of applications for the initiative described in the NOSI. These Notices of Special Interest will replace the non-parent announcements (PAs) that have standard submission and review requirements, which will be phased-out to streamline how NIH announces areas of interest.

NIH will continue to post full FOAs for Requests for Applications (RFAs), program announcements with special receipt/referral/review considerations (PARs), and program announcements with set-aside funds (PASs).

Applicants must always follow guidance found in the FOA used for submission and the How to Apply – Application Guide as well as any additional submission guidance described in the NOSI. Applicants are encouraged to contact the Program Official listed on the NOSI for clarification prior the submission. Applicants will be required to include the notice number in the Agency Routing Identifier field (4b) of the SF424 (R&R) form at the time of submission. 

For more information, please visit the Applying Electronically FAQs, Section II Funding Opportunities.

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NOTICE OF INTENT TO PUBLISH FUNDING OPPORTUNITY ANNOUNCEMENT TO DEVELOP STATE-LEVEL CAPACITY FOR DISSEMINATION AND IMPLEMENTATION OF PATIENT-CENTERED OUTCOMES RESEARCH INTO PRIMARY CARENOT-HS-19-019 announces that the Agency for Healthcare Research and Quality (AHRQ) intends to publish a Request for Application (RFA) to disseminate and implement patient-centered outcome research (PCOR) findings into primary care practices, with a focus on improving heart health and developing sustainable, primary care quality improvement (QI) capacity within states.

Additionally, this notice is intended to inform potential applicants of the expectation to establish multi-organizational partnerships that will support AHRQ’s role to disseminate and implement patient-centered outcomes research.

 See NOT-HS-19-019 for more information.

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NOTICE OF DATA SHARING POLICY FOR THE NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH): NOT-MH-19-033 notifies the research community of NIMH’s Data Sharing Policy.

NIMH has established an informatics infrastructure to enable responsible sharing and use of data collected from and about human subjects by the research community. This data archive provides the infrastructure and support to enable mental health researchers to deposit their data and share that data with the research community. Consistent with the authorities under the 21st Century Cures Act, researchers funded by NIMH are required to deposit all raw and analyzed data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) from experiments involving human subjects into this infrastructure.

This policy applies to all grant applications that involve human subject research submitted to NIMH and FOAs that NIMH participates in after January 1, 2020. This policy does not apply to the following types of applications:

  • Fellowship (F)
  • Research Career Development (K)
  • Training (T)
  • Small Business (SBIR/STTR)
  • Small Grants (R03)
  • Education (R25)
  • Awards related to AIDS applications

 The NIMH Data Sharing Policy does not supersede the general NIH Genomic Data Sharing Policy (NOT-OD-14-124); however, it does mandate that the NIMH Data Archive (NDA) serve as the repository for genomic data resulting from NIMH funded research unless NIHM agrees to a different data archive during the negotiation of the award terms and conditions. Awardees who are measuring human genomic data will register with dbGaP. After registration, all data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) will be deposited in the NDA and a link to the NDA collection will be added to the dbGaP registration. Computational credits may be applied for to do facilitate the re-analysis of aggregated data in the single cloud based data archive. All data associated with new projects at the NIMH Repository and Genomics Resource will be deposited in the NDA and then appropriate data will be transmitted to the NIMH Repository and Genomics Resource.

See NOT-MH-19-033 for details and additional information concerning Proposal and Post Award requirements.

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May 2019

NIGMS-managed HIV/AIDS RESEARCH PORTFOLIO TRANSITIONING TO NIAID: NOT-GM-19-039 announces 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.

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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.

Please see NOT-OD-19-100 for more information (please note estimated award and start dates).

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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.

Please see NOT-OD-19-104 for more information (please note estimated award and start dates).

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REQUIRED USE OF THE xTRACT SYSTEM TO PREPARE DATA TABLES FOR TRAINING GRANT RPPRs IN FY 2020NOT-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.

Please see NOT-OD-19-108 for more information and specific details.

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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.gov 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.

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April 2019

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.

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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 grants, 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, see the NIH Salary Cap Summary page.

For University-specific guidance, please see the May 1, 2019 issue of the Controller's Newsletter.

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 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.

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March 2019

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 improving 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.

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.

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February 2019

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 Emergency Plan for AIDS Relief (PEPFAR). This requirement is effective January 3, 2019 for new awards and contracts 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 family 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 NOT-OD-19-083 for full provisions of the requirement. 

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.

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January 2019

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.  See the HRPP Common Rule webpage 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 January 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 8.1.2.5).

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, UC has a separate campus-wide Letter of Support for the prevention of harassment and other discriminatory actions. The link to this letter is posted on the OSR webpage for Regulatory/Compliance Requirements.  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.

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December 2018

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 include them. Applications for research involving human subjects must address the age-appropriate inclusion or exclusion of individuals in 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. 

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November 2018

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 conduct 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 will 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 on the NIH Funding Strategies webpage.
  • 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 - equivalent 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 on the NIH Funding Strategies webpage.

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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.

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 October 2018:

REINSTATEMENT OF NIH SBIR DIRECT-TO-PHASE II AUTHORITY: NOT-OD-19-019 announces the reinstatement of the NIH SBIR Direct Phase II provision through FIscal Year 2022. Please refer to the notice for exceptions.

COMMUNICATING RESEARCH MISCONDUCT TO NIHNOT-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.

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September 2018: 

2018 BAYH-DOLE ACT FINAL RULENOT-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 AWARDSNOT-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 UPDATESNOT-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 UPDATESNOT-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.

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July 2018:

SUBMISSION/RESUBMISSION POLICYNOT-OD-18-197 consolidates the policy onto one notice and rescinds prior notices. Use this notice when referring to the policy.

UPDATES TO RPPRNOT-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 RULENOT-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 STUDIESNOT-OD-18-212 announces delayed enforcement and short-term flexibilities for some requirements affecting Basic Science Studies with Human Participants.

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June 2018:

CONTINUOUS SUBMISSIONNOT-OD-18-178 reminds the research community of the application deadlines based on Council Round assignment.

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