New Forms and Instructions for NIH applications

The National Institutes of Health has issued New NIH “FORMS-G” Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022 (NOT-OD-22-169).

For a transition period, both FORMS-F and FORMS-G application packages will be active simultaneously. Applicants must choose the appropriate application package for their due date when presented with both FORMS-F and FORMS-G application packages on the same FOA.

See the tables in New NIH “FORMS-G” Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022 (NOT-OD-22-169) and in Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available (NOT-OD-22-018) for additional guidance.

Note: All FORMS-F application forms packages will be updated with a close date of January 24, 2022.

Application due dates remain unchanged. Applicants must refer to the FOA for key date information.

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September 3, 2021 Research Advocate: NIH Guidance: Forms-G Required on or After January 25, 2022

NIH: Trainee Childcare Costs and Move to Passphrases

The National Institutes of Health recently issued two messages:

1. Announcement of Childcare Costs for Ruth L. Kirschstein National Research Service Award Institutional Research Training Awards

NIH will now begin providing childcare cost support to full-time predoctoral and postdoctoral trainees appointed on NRSA institutional research training awards. This is anticipated for awards made beginning in the first quarter of Fiscal Year 2022. The NRSA childcare costs apply to each full-time predoctoral or postdoctoral NIH-NRSA-supported institutional research training award appointment. Each trainee is eligible to receive $2,500 per budget period for childcare costs provided by a licensed childcare provider.

2. Replace eRA Commons Password with Passphrase, Starting Sometime in November

While eRA has been transitioning users of eRA Commons, Commons Mobile, ASSIST and IAR to two-factor authentication using either Login.gov or an InCommon Federated Account that supports NIH’s two-factor authentication standards, users will still need to maintain their eRA Commons username and password for the time being.

So eRA account credential maintenance will continue, at least for now, but not to worry, gone are the days of having to continually change your password every 120 days. NIH is moving from passwords to passphrases — a set of random words or a sentence at least 15 characters long — effective sometime in November (date to be confirmed). Passphrases will only need to be updated annually.

This change is part of a new NIH password policy designed to make passwords easy for users to remember but hard for others to guess. The new policy aims to improve user experience and enhance cybersecurity.

Once this new change is in effect, Commons users will be prompted to change their password to a passphrase when trying user credentials with an expired or forgotten password. Users are advised to avoid words that can be easily guessed, such as family names.

NIH Guidance: Forms-G Required on or After January 25, 2022

The National Institutes of Health published the following guidance in Goodbye FORMS-F, Hello FORMS-G on the Extramural Nexus blog.

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Applicants applying to NIH funding opportunities with due dates on or after January 25, 2022 must use updated application forms and instructions identified with a Competition ID of “FORMS-G.”

Key changes in the FORMS-G update include:

• Transition from DUNS to a unique entity identifier (UEI) issued by SAM.gov as the official identifier for doing business with the federal government (NOT-OD-21-170.) See Goodbye DUNS, Hello UEI.
• Updated biosketch and other support format pages (NOT-OD-21-110.)
• Updated country and state dropdown lists across all forms.
• Increased character limit to 100 characters for “Department” and “Division” fields.
• Expanded requirement for a Commons ID to all senior/key personnel (NOT-OD-21-109.)
• Increased number of “Other” direct cost budget lines from 3 to 10.
• Added “Childcare Costs” section to Fellowship Supplemental Form (NOT-OD-21-074.)
• Added question regarding Technical and Business Assistance (TABA) to the SBIR/STTR Information form (NOT-OD-21-082.)

Application guides for FORMS-G application packages will be posted to the How to Apply – Application Guide page no later than October 25, 2021.

Related resources

• New NIH “FORMS-G” Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022 (NOT-OD-21-169)
• High-level Summary of Form Changes in FORMS-G Application Packages

NIH Biosketch and Other Support Clarifications

The Council on Governmental Relations (COGR) has engaged with the leadership of the National Institutes of Health (NIH) regarding questions that COGR member institutions have raised concerning NIH’s Biosketches and Other Support FAQs.

In response, NIH has updated these FAQs to make the following clarifications:

1. Faculty consulting activities must be reported as Other Support only when the consulting activity involves research and “fall[s] outside of an individual’s appointment” with their home institution.
2. When consulting activities constitute Other Support, they should be reported as estimates of the amount paid, as opposed to an estimate of time and effort.
3. Consulting activities do not count towards the 12 calendar months of effort.
4. NIH will not require the disclosure of completed support (including completed in-kind support) as Other Support, only current and pending support. (FAQs I.B.3 & I.C.5).
5. Institutions need only go back three years in reporting as Other Support materials that were received from external collaborators. (FAQ I.C.7). NIH has provided separate guidance on when data and resources should be acknowledged in grants. [See, FAQs – Communicating and Acknowledging Federal Funding.]
6. Information may not be redacted from contracts, agreements, or other supporting documents that are submitted to NIH. (FAQ I.D.8). [Note that this FAQ differs from some prior NIH verbal statements on this topic.]
7. If a researcher has a foreign appointment, affiliation, and/or employment with a foreign institution, they must provide supporting documentation of that relationship, even if they do not have a formal agreement in place. (FAQ I.D.9).

NIH Grant Applications Fall 2021

The National Institutes of Health has issued Clarification and Guidance for Applicants Preparing Applications for the Fall 2021 Due Dates During the COVID-19 Pandemic (NOT-OD-21-180).

The notice states:

The NIH remains firmly committed to supporting the biomedical research enterprise as the nation implements the President’s Guidelines for Re-Opening America Again. The purpose of this Notice is to clarify the guidance provided earlier (NOT-OD-21-026), for applicants preparing applications for the May 2022 Council round, beginning with the September 25, 2021 due date for Fall 2021 initial peer review meetings.

Reviewers will continue to receive instructions to assume that constraints arising from the COVID-19 pandemic (e.g., lab occupancy restrictions, declines in patient accrual, etc.) will be resolved during the project period and thus should not affect their scores.

Therefore, NIH grant applications should NOT include contingency or recovery plans for problems resulting from the COVID-19 pandemic. However, applicants may address effects due to the pandemic on productivity or other scoreable issues in their Personal Statement in the NIH Biosketch. Reviewers will be instructed to take these pandemic-related circumstances into account when assessing applicants’ productivity and other score-driving factors.

As with previous instructions, if needed, NIH staff will request and assess plans to resolve specific problems arising from the COVID-19 pandemic prior to funding.

Essential Guidance for NIH Project Directors and Principal Investigators

The National Institutes of Health is changing the formats and clarifying the requirements for submitting Biographical Sketches and Other Support. Some of these changes may affect Project Directors and Principal Investigators (PDs/PIs) now and others will impact PDs/PIs as of January 25, 2022.

As of Now:

Supplementary Documentation

It is now possible for NIH to request that PDs/PIs provide supplementary documentation for all foreign activities and resources reported by Senior/Key Personnel under “Other Support” in Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs). Note: After January 25, 2022 this information will be required by NIH.

Supplementary documentation includes copies of contracts, grants or any other agreement specific to Senior/Key Personnel foreign appointments and/or employment with a foreign institution. If the contracts, grants or other agreements are not in English, recipients must provide translated copies. Note: NIH funds cannot be used to translate these documents, but Google translations are acceptable.

Although not a new requirement, PDs/PIs that discover that any Senior/Key Personnel listed in the proposal have failed to disclose this requested or required information at the JIT and/or RPPR stages should notify SPO as soon as possible. SPO will need to submit updated supplementary documentation for Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known.

Other Support

PDs/PIs are reminded that “Other Support” includes all resources made available to a researcher 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. This includes:

1. Consulting agreements, when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities. Note: The definition of what is meant by “research” is important in this context. NIH has indicated that it uses the Common Rule’s definition of “research” [45 CFR 46.102(l)] as a benchmark for determining whether a researcher’s activities constitute research and commented that co-authorship on a publication stemming from activities may be an indicator that the activities constituted research.
2. In-kind contributions, e.g., office/laboratory space, equipment, supplies, or employees or students supported by an outside source. If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates. Note: There is no de minimis dollar or time commitment thresholds that would serve as a trigger for reporting in-kind contributions.

PDs/PIs also are reminded that NIH does NOT require that the following be reported as “Other Support”:

1. Resources and/or financial support for non-research endeavors
2. Non-research consulting activities
3. Training awards, prizes
4. Gifts, but only if the gift is clearly given with no expectation of anything in return
5. Institutional resources, such as core facilities or shared equipment that are made broadly available

Foreign Components

NIH has not changed the definition of a “foreign component.” A foreign component is the performance of a significant scientific element of the NIH-supported project outside of the United States. This includes:

1. Performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended and/or
2. Performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended.

Other indications of a foreign component are:

1. Collaborations with investigators at a foreign site anticipated to result in co-authorship
2. Use of facilities or instrumentation at a foreign site
3. Receipt of financial support or resources from a foreign entity

Note: Foreign travel for consultation is not considered a foreign component.

If a foreign component is to be involved, the PI must attach a justification to the proposal describing why the facilities or other aspects of the proposed project are more appropriate than a domestic setting.

If the PI adds a foreign component after NIH makes the award, NIH prior approval will be required. See: NIHGPS, Section 8.1.2, Prior Approval Requirements. As stated above, a foreign component involves a “significant” aspect of the project. NIH does not specifically define what is meant by “significant.” However, when in doubt, always disclose!

For more information, consult:

1. NIH Grants Policy Statement: 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components) and
2. FAQs on Other Support and Foreign Components

As of January 25, 2022:

There will be changes to the Biographical Sketch and Other Support Format Pages and requirements. NIH encourages PDs/PIs to voluntarily use and become familiar with the new formats now. Failure to follow the appropriate format on or after January 25, 2022 may cause NIH to withdraw applications from or delay consideration of funding.

Changes to Biographical Sketches

1. Personal Statement: Applicants will be allowed to include ongoing and completed research projects from the past three years to draw attention to (previously known as research support).
2. Positions, Scientific Appointments , and Honor should be listed in reverse chronological order all positions and scientific appointments both domestic and foreign, including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
3. Scholastic Performance: “Research Support” will be removed. Section D will be solely present on the fellowship version of the Biosketch and will no longer includes research support, only Scholastic Performance.

Changes to Other Support

1. Each PD/PI or senior/key personnel will need to electronically sign their respective Other Support form as a PDF prior to submission verifying that the information is true and accurate.
2. As described above, the PD/PI will need to provide supplementary documentation in English (i.e., copies of contracts, grants or any other agreement specific to Senior/Key Personnel foreign appointments and/or employment with a foreign institution) for all foreign activities and resources reported by Senior/Key Personnel under “Other Support” in Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs).
3. The format page will be re-organized to separate funded projects from in-kind contributions.

See: Upcoming Changes to the Biographical Sketch and Other Support for more information.

Revised Version of the NSF PAPPG Issued

A message from Jean Feldman, Head of the National Science Foundation Policy Office:

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Dear Colleagues:

We are pleased to announce that a revised version of the NSF Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 22-1) has been issued.

The new PAPPG will be effective for proposals submitted or due on or after October 4, 2021. Significant changes include:

• A new section covering requests for reasonable and accessibility accommodations regarding the proposal process or requests for accessibility accommodations to access NSF’s electronic systems, websites and other digital content;
• A table entitled, NSF Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Current and Pending Support. This table identifies where pre- and post-award current and pending support disclosure information must be provided. Proposers and awardees may begin using this table immediately;
• Increasing the page limit for the biographical sketch from two to three pages;
• Updates to the current and pending support section of NSF proposals to require that information on objectives and overlap with other projects is provided to help NSF and reviewers assess overlap/duplication;
• Adding planning proposals and Career-Life Balance supplemental funding requests as new proposal types;
• Updates to travel proposals will require that AORs certify that prior to the proposer’s participation in the meeting for which NSF travel support is being requested, the proposer will assure that the meeting organizer has a written policy or code-of-conduct addressing harassment.

You are encouraged to review the by-chapter summary of changes provided in the Introduction section of the PAPPG.

NSF plans to conduct a webinar covering these changes. Visit the NSF policy outreach website to sign up for notifications about this and other outreach events.

While this version of the PAPPG becomes effective on October 4, 2021, in the interim, the guidelines contained in the current PAPPG (NSF 20-1) continue to apply.

If you have any questions regarding these changes, please contact the DIAS/Policy Office at policy@nsf.gov.

Regards,

Jean Feldman
Head, Policy Office
Division of Institution and Award Support
Office of Budget, Finance & Award Management

NSF: Disaster Relief Flexibilities

The National Science Foundation implementation of Office of Management and Budget (OMB) Memorandum, M-21-20, “Promoting Public Trust in the Federal Government through Effective Implementation of the American Rescue Plan Act and Stewardship of the Taxpayer Resources, Appendix 3 - Disaster Relief Flexibilities to Reduce Burden for Financial Assistance” dated March 19, 2021 is now available on the NSF Coronavirus Information page.

The exceptions identified by NSF apply to NSF recipients with COVID-19 related federal financial assistance awards. Flexibilities related to NSF’s implementation of OMB Memorandum M-21-20 include:

• Delay of the completion and submission of the Single Audit reporting package
• Extensions of deadlines for certain funding opportunities
• Extension of the biennial physical inventory

For a complete listing see: NSF Implementation of OMB Memorandum M-21-20.

Important Information for NIH PIs

The National Institutes of Health has issued new instructions and requirements for the Biographical Sketch (Biosketch) and Other Support for applications and Research Performance Progress Reports (RPPR) submitted for due dates on or after May 25, 2021. See Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021 (NOT-OD-21-073).

NIH Principal Investigators (PIs) should be aware that additional time and effort may be needed to comply with the following new requirements for reporting “Other Support:”

• If foreign activities and resources are reported under “Other Support,” copies of contracts, grants or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution as supporting documentation must be provided to NIH.
• If these documents are not in English, translated copies must be provided.
• This supporting documentation must be provided as part of the Other Support PDF following the Other Support Format page.
• All principal investigators and other senior/key personnel must electronically sign the Other Support form, prior to its submission to NIH, certifying that the Other Support information is accurate and complete.
• Other Support submissions must be submitted as a “flattened” PDF, after all signatures are obtained. The original electronic signatures must be available upon NIH request.

Unfunded applications submitted prior to May 25, 2021 are not subject to these requirements. The new requirements only apply to RPPRs and to applications submitted on or after May 25, 2021 (including applications submitted early for those due dates).

PIs or other Senior/Key personnel on an active NIH grant who fail to disclose Other Support information outside of Just-in-Time or the RPPR, as applicable, should notify SPO. SPO must provide the updated “Other Support” to the Grants Management Specialist named in the Notice of Award as soon as it becomes known.

See the NIH FAQs on Other Support and Foreign Components for additional information

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March 12, 2021 Research Advocate: NIH: Changes to the Biographical Sketch and Other Support Format Page

NIH: Changes to the Biographical Sketch and Other Support Format Page

The National Institutes of Health has taken steps to align the Biographical Sketch (Biosketch), Other Support format page and Application Form Instructions with the guidance issued by the Office of Science and Technology Policy Joint Committee on the Research Environment.

As a result, NIH has updated its application forms and instructions to support the need for applicants and recipients to provide full transparency and disclosure of all research activities, foreign and domestic.

The updated forms and instructions will be required for use for applications and Research Performance Progress Reports (RPPR) submitted for due dates on or after May 25, 2021.

In addition to the changes to the the Biographical Sketch (Biosketch), Other Support format page and Application Form, note the following new requirements related to Other Support, effective May 25, 2021.

• NIH will require supporting documentation, which includes copies of contracts, grants or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution for all foreign activities and resources that are reported in Other Support. If the contracts, grants or other agreements are not in English, recipients must provide translated copies.
  
  
• If a recipient organization discovers that a PI or other Senior/Key personnel on an active NIH grant has failed to disclose Other Support information outside of Just-in-Time or the RPPR, as applicable, the recipient must submit updated Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known.

See Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021 (NOT-OD-21-073) for more information.

NSF FAQs on Current and Pending Support: Clarification

The National Science Foundation has added some clarifications to its Frequently Asked Questions on Current and Pending Support.

Some highlights:

In-kind contributions that are not intended for use on the project/proposal being proposed to NSF and have no associated time commitment, do not need to be reported.

However, an item or service given with the expectation of an associated time commitment must be reported to NSF in the following manner.

• If the in-kind contribution is not intended for use on the project/proposal being proposed to NSF but has an associated time commitment, the information must be included as part of the current and pending support section of the proposal.  
• If the in-kind contribution is intended for use on the project/proposal being proposed to NSF, the information must be included as part of the Facilities, Equipment and Other Resources section of the proposal and need not be replicated in the individual’s current and pending support submission.

Senior personnel are required to provide the number of person-months (or partial person-months) per year to be devoted to the project by the individual even if this time is not budgeted in the proposal budget. NSF is not asking for information on how much time is budgeted for a particular individual(s), but rather how much time the individual(s) is/are planning to spend to complete the scope of work on the proposed project and/or award.

If a principal investigator or co-PI is not requesting salary support, they should be removed from the budget and their name and the estimated amount of time to be devoted to the project should be identified in the Facilities, Equipment and Other Resources section of the proposal.

If Senior Personnel will be conducting research as part of a consulting agreement, then the consulting arrangement should be specified in the individual’s current and pending support submission.

NIH eRA Commons Modules Will Require Two-Factor Authentication

Although not required until September 15, 2021, the National Institutes of Health is encouraging users of eRA Commons, ASSIST, Internet Assisted Review (IAR), and Commons Mobile to begin their switchover to the new two-factor authentication (2FA) login method (via login.gov) to access eRA modules.

Using login.gov 2FA will be required as of the deadline of September 15, 2021 for all users. The authentication will help ensure the security of personal and confidential information in these systems.

For instructions, frequently asked questions, and other resources, see NIH Extramural News Reminder: Switch Early to the New Secure Two-Factor Authentication Required to Access eRA Modules.

NIH Conference Grants: Focus on Diversity

NIH conference grant applicants (R13/U13) must now include plans to enhance diversity during the selection of organizing committees, speakers, other invited participants, such as session chairs and panel discussants, and attendees. Underrepresented groups include individuals from nationally underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women. See Notice of NIH’s Interest in Diversity (NOT-OD-20-031) for additional details.

A recent NIH Guide notice, Notice of Changes in the Review Criteria for Applications Submitted for NIH Support for Scientific Conferences (R13 and U13) (NOT-OD-21-055), announced that reviewers of scientific conferences (R13 and U13) will be asked to evaluate a diversity plan and factor it into the overall impact score. The diversity plan will be evaluated as an additional review criterion and will not receive a separate criterion score. The new parent conference grant funding opportunity announcement, NIH Support for Conferences and Scientific Meetings (R13) (PA-21-151), published February 10, reflects the new review criteria.

Principal investigators should carefully follow these instructions, Updated Guidelines for Enhancing Diversity and Creating Safe Environments in Conferences Supported by NIH Grants and Cooperative Agreements (NOT-OD-21-053), for developing the diversity plan.

Conference grant awardees also will be required to report on the effectiveness of plans to enhance diversity of underrepresented groups in annual Research Performance Progress Reports (RPPR) and the Final-RPPR.

New Salary Cap: NIH and AHRQ

The National Institutes of Health has released an announcement regarding the new salary cap: Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2021 (NOT-OD-21-057).

Effective January 3, 2021, the salary limitation for Executive Level II is $199,300.

For issued awards that were restricted to Executive Level II (see Salary Cap Summary (FY 1990 - Present)), including competing awards already issued in FY2021, if adequate funds are available in active awards, and if the salary cap increase is consistent with the institutional base salary, recipients may rebudget funds to accommodate the current Executive Level II salary level.

Also of note:

• Updated NRSA stipends: Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2021 (NOT-OD-21-049)
• Agency for Healthcare Research and Quality announcement regarding the new salary cap: Salary Limitation on AHRQ FY2021 Grants, Cooperative Agreements, and Contracts (NOT-HS-21-007)

Statement of Economic Interests (700-U) Form Revised for 2021

The State of California has issued a revised 700-U Statement of Economic Interests for Principal Investigators for immediate use. The revised form, dated 2020/2021, is available on the Conflict of Interest Committee website and is the only version that will now be accepted. The form and requirements are the same as the previous 2020 version, except for an increase in the limit for gifts of travel. Gifts of travel may be subject to a $500 gift limit in 2020. This gift limit has increased to $520 for calendar years 2021 and 2022. Please contact coi-team@berkeley.edu with any questions.

State of California law requires disclosure of financial interest in the sponsor of a research project; the donor of a research gift; and, under certain circumstances, the provider of materials under a Material Transfer Agreement (MTA) when that sponsor, donor, or provider is a non-governmental source. See State of California Financial Disclosure for more information.