Stony Brook University Office of Research Services
Category: NIH

Notice of Clarification of 4-Year Limit of Postdoctoral Research Eligibility for K99 Applicants for PA-14-042 “NIH Pathway to Independence Award (Parent K99/R00)”

NOT-OD-15-013

The purpose of this Notice is to clarify the eligibility requirement that K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial application or resubmission or revision.  Specifically, this Notice describes situations in which time is not counted against the 4-year limit.

Part 2. Section III. Eligibility Information

1. Eligible Applicants

Currently reads:

Eligible Individuals (Program Director/Principal Investigator)

K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

Modified to read:

Eligible Individuals (Program Director/Principal Investigator)

K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

Parental leave or other well-justified leave for pressing personal or family situations of generally less than 12 months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 4-year eligibility limit. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. Only time dedicated to research activities would count toward the 4-year limit.

Additional clarifications are provided under Frequently Asked Questions. Potential candidates are encouraged to discuss their individual situation with an NIH Institute or Center Scientific Program Contact before applying.

Inquiries

Please direct all inquiries to:

Henry Khachaturian, Ph.D.
Acting NIH Research Training Officer
NIH Office of Extramural Programs
Telephone: 301-451-4225
Email: NIHTrain@mail.nih.gov

Notice of Revised NIH Definition of “Clinical Trial”

NOT-OD-15-015

The purpose of this Notice is to inform the research community that NIH has revised its definition of “clinical trial.”  The revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.  It is not intended to expand the scope of the category of clinical trials. No changes have been made to the NIH definition of a “Phase III clinical trial.”  

In addition, because clinical trials are subject to additional oversight, a clearer definition will help investigators ensure that they are meeting all of their obligations, and it will help NIH ensure that the additional oversight is occurring when it is needed.  For example, NIH policy requires clinical trials to be monitored, and applicants and offerors seeking NIH support are expected to describe their plans for data and safety monitoring in their applications and proposals.  Final data and safety monitoring plans must be approved by the NIH prior to award.  In addition, throughout the life of the award, NIH staff monitors the clinical trial’s progress to ensure that milestones are met and that any safety concerns are addressed.

The revised definition will replace the current clinical trial definition in relevant extramural and intramural NIH policies, guidance, and instructional materials. It will apply to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates and contracts proposals that are submitted to NIH on or after January 25, 2015.

The revised NIH definition of clinical trial is:

A research study in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5


1See Common Rule definition of research at 45 CFR 46.102(d).

2See Common Rule definition of human subject at 45 CFR 46.102(f).

3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4An intervention is defined as a manipultion of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

NIH Biosketch

NIH is in the process of piloting new five page biographical sketches (biosketch), for release in FY 16 this would be around October 2015.  Although this change is over a year away it will have far reaching implications as most foundation and smaller sponsors defer to this biosketch format.  Attached is a sample of what the current version of the new format looks like, the basic change is the allow researchers to describe up to five of their most significant contributions to science along with historical background that framed their research.

This description can outline the central finding(s) of their work, the influence of those finding(s) on their field and how those findings may have contributed to improvements in health or technology.  For those involved in team science, it will allow the investigator to describe their specific role in the described work.  Each of these descriptions can be supported by listing up to four, relevant peer-reviewed publications.  In addition to the descriptions of their contributions, researchers will be able to include a link to a full list of their published work as found in a publicly available digital database such as MyBibliography or SciENcv.

Unless your program announcement is part of the pilot you are not permitted to use the longer format until it is rolled out next year.  If you do include a longer bio during this pilot you will only get a warning and not an error message. But your proposal will be found non-responsive once reviewed. 

As updates become available they will be passed along.  If you have any questions please contact your Grants Administrator within OSP.

NIH Commons: User IDs

Starting in October 2014, Commons User IDs will be required for all project personnel including, students (under graduate and graduate), and Post Docs and Research Support personnel. NIH will not accept RPPRs or PHS 2590s that do not have this information.

To avoid delays as you hire people to work on your project you should make sure that they have a Commons ID.  If they do not you should have one created for them.  To do this contact you the Grant Administrator assigned to your department with the following information:

  • New Personnel’s Complete Name
  • Email address
  • Phone and Fax
  • Two choices for user ID*

*Please keep in mind that this ID will be with the person for their entire research life in association with NIH projects.    

Once this id is create an email will be sent to the address given for that person. It is up to the new personnel to populate their profile once the ID is created.

NIH Announces Updated Policy for Application Submission

The National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) announce a change in policy on application submissions. Effective immediately, for application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate due date. The NIH and AHRQ will not assess the similarity of the science in the new (A0) application to any previously reviewed submission when accepting an application for review. Although a new (A0) application does not allow an introduction or responses to the previous reviews, the NIH and AHRQ encourage applicants to refine and strengthen all application submissions.”

For additional information:

Policy:  http://1.usa.gov/P8caVG

Blog:    http://1.usa.gov/1gDtcCO

If you have questions regarding this new policy, contact your Program Official.

NIH Will Open the Research Performance Progress Report (RPPR) for All Type 5 Non-SNAP Progress Reports on April 25, 2014

Notice Number: NOT-OD-14-079

Key Dates
Release Date: April 15, 2014

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) will open the Research Performance Progress Report (RPPR) for all type 5 non-SNAP progress reports following the April 24, 2014, eRA release.

Background

NIH requires use of the RPPR module to submit progress reports for Streamlined Non-competing Award Process (SNAP), fellowship, and multi-year funded awards.  NIH is continuing efforts to implement the RPPR module for non-SNAP awards; please see details below.

RPPR for Non-SNAP Progress Reports
Federal Demonstration Partnership (FDP) institutions currently may opt to to submit type 5 non-SNAP progress reports using the RPPR and NIH encourages FDP institutions to continue to do so.     

On April 25, 2014, NIH will expand to all institutions the ability to submit type 5 non-SNAP progress reports using the RPPR.  NIH encourages all institutions to use the RPPR to submit type 5 non-SNAP progress reports when access is available.  While non-FDP institutions cannot submit type 5 non-SNAP progress reports using the RPPR until April 25, 2014, for institutions interested in learning more about non-SNAP RPPRs, an archive of a recent training session is available on the NIH RPPR webpage.  Beginning on April 25, 2014, all institutions may use the RPPR for type 5 non-SNAP progress reports. 

Non-SNAP progress reports not submitted using the RPPR must be submitted using the PHS 2590. 

NIH anticipates requiring all grantee institutions to use the RPPR for non-SNAP progress reports beginning on October 17, 2014; however, a separate Guide Notice announcing the requirement will be issued on a future date.  Note also, that NIH continues development of the RPPR for final progress reports and for administrative extensions (Type 4s; e.g., SBIR/STTR Fast-Track Phase II application).  NIH will update the community as progress is made.  

Additional information and resources on the RPPR, including the current RPPR Instruction Guide and training archives, can be found at: http://grants.nih.gov/grants/rppr/ .

Inquiries

General questions concerning using the eRA Commons and RPPR functionality should be directed to the eRA Commons Helpdesk at:

eRA Commons Help Desk
Web : http://grants.nih.gov/support/index.html
(Preferred method of contact)
Toll-free: 1-866-504-9552
Telephone: 301-402-7469
TTY : 301-451-5939

General inquires about this Notice may be directed to: 

Division of Grants Policy
Office of Policy for Extramural Research Administration

National Institutes of Health (NIH)
Telephone: 301-435-0938
Email: GrantsPolicy@od.nih.gov

eRA Information: eRA Commons and ASSIST Will Be Offline Memorial Day Weekend

In the interest of giving you as much advance notice as possible for planning purposes, we would like to let you know about an extended downtime that eRA has currently scheduled for the Memorial Day weekend in May 2014.

All systems, including eRA Commons and ASSIST will be offline while our systems are upgraded and the information in the databases will be converted to support Unicode compatible data.

Unicode is a computing standard that allows systems to handle virtually any type of text expressed in the world’s writing systems.  As a result of this upgrade, eRA systems will be able to accept Greek characters as they appear in the original scientific text submitted by grantees. For instance, Greek characters will now appear in progress reports without resulting in garbled text.

We will share more details about the downtime in May as the date approaches.

We are sorry for any inconvenience this may cause.

eRA Communications

Division of Communications and Outreach

NIH Office of Extramural Research

Questions? Please contact the eRA Help Desk. Check out self-help resources on the Help pagebefore submitting an online ticket; or call Toll-free: 1-866-504-9552, Phone: 301-402-7469, TTY: 301-451-5939; or email helpdesk@od.nih.gov. The Help Desk hours are Mon-Fri, 7 a.m. to 8 p.m. ET

eRA Information: New Videos on Navigating Status Available

NIH has announced that there are three new tutorial videos available for viewing to help you navigate the Status screen in eRA Commons.  These videos are the first three in a series that will look at the Status option in detail.

Status Screen Overview (tutorial #1) goes through the steps of how to get to the Status search options if you are a Signing Official (SO) or a Principal Investigator (PI); it outlines the importance of the Status screen; it also highlights some of the critical actions that must be taken to manage a grant application from submission to award to closeout.

Signing Official: Finding Information (tutorial #2)  is focused on the tools available to a Signing Official.  The video reviews the three ways an SO can search for a grant application, and the various other search options available to them.

Status Search Results (tutorial #3) covers the results of a search. The video highlights how search results are displayed and organized and the importance of checking the items listed in the Action column.

Additional Clarification on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations

Notice Number: NOT-OD-14-014

Key Dates
Release Date: October 29, 2013

Related Announcements
NOT-OD-14-002
NOT-OD-14-003
NOT-OD-14-006
NOT-OD-14-007

Issued by
National Institutes of Health (NIH)

Purpose

This Notice provides additional clarification to the guidance on resumption of NIH extramural activities following the recent lapse in appropriations (NOT-OD-14-007).

  • All standard due dates in October have been rescheduled for November. The R21/R33 activity code was inadvertently missed in prior guidance. New R21/R33 applications originally due on October 16, 2013 are now due on November 18, 2013.
  • The statement ‘Make the refreshed application a “new”, “resubmission” or “renewal” to match the withdrawn application.’ should have also included “revision”.
  • Applicants should designate ‘Changed/Corrected Application’ as the Type of Submission on the SF424 R&R cover form of their refreshed applications.

We continue to expand our FAQs and web page of consolidated information as we encounter additional questions from applicants.

Inquiries

Please direct all inquiries to: 

NIH Grants Information
Telephone: 301-435-0714
Email: grantsinfo@od.nih.gov

Interim Guidance on Resumption of NIH Extramural Activities

Notice Number: NOT-OD-14-002

Key Dates
Release Date: October 17, 2013

Issued by
National Institutes of Health (NIH)

Purpose

NIH is working to reestablish dates for grant and contract submissions, determine how to handle missed review meetings, and reschedule dates for training and other activities that were scheduled to occur during and immediately following the period of the government shutdown.

As of today, we can confirm that we will be rescheduling all October grant application submission deadlines to the November timeframe (specific dates to be announced in a future Notice). By delaying due dates that occurred both during the lapse in funding and in the week following, applicants will have access to NIH staff and the help desks as they develop their applications.

Peer review meetings that were due to be held between October 1 and October 17 have been cancelled and are being rescheduled.

We expect the eRA Commons will be available for public access on Monday, October 21.

NIH will provide additional information, including a Notice on NIH operations during a continuing resolution, as soon as it is available.

Information for the NIH Extramural Grantee Community During the Lapse of Federal Government Funding

Notice Number: NOT-OD-13-126

Key Dates
Release Date: October 1, 2013

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

The Government Fiscal Year (FY) 2013 ended on September 30, 2013 at midnight EST and an Appropriation Act for FY2014 has not been passed leading to a lapse in Federal funding.  We are providing the following information to answer questions you may have on the impact this lapse in appropriation will have on your grant/cooperative agreement or the availability of NIH’s systems and services.

RESUMING OPERATIONS

You are encouraged to stay tuned to the national media to determine when the Federal Government will resume operations.  Depending on the length of the funding lapse, once NIH non-excepted staff are authorized to resume operations it will take time for full operations to be resumed.  Depending on the length of the funding lapse, the eRA system may require at least one business day after operations resume.   We ask for patience when trying to contact NIH staff once operations resume since there will be a backlog of information to process.

CONTACT WITH NIH STAFF

E-mail, Phone, Fax, and Postal Mail Contacts:  For the duration of the funding lapse, NIH extramural employees will be prohibited from working (remotely or in the office).  Consequently, there will be no access to voice mail, e-mail, fax, or postal mail during this period.  Mail requiring someone to sign/accept may not be received.  All other postal mail, fax, and voice mail communications will not be acted upon until after operations resume. It is recommended that you delay sending such communications until after operations resume.

Help Desk Support:  For the duration of the funding lapse, all help desks, central e-mail boxes, and web ticketing systems for questions related to NIH grants policy and electronic grants systems will not be available, including the eRA Helpdesk and Grants Information Services.   

In the event of an emergency involving human safety, please contact Dr. Sally Rockey at rockeysa@od.nih.gov

SUBMISSION OF GRANT APPLICATIONS

For the duration of the funding lapse, applicants are strongly encouraged not to submit paper or electronic grant applications to NIH during the period of the lapse.  Adjustments to application submission dates that occur during the funding lapse will be announced once operations resume.  For any applications submitted immediately prior to or during the funding lapse, here is what will happen.

For electronic submissions through Grants.gov: Grants.gov will be open and can accept electronic applications.  However, applications will not be processed by NIH until the eRA Systems are back on-line.  NIH will ensure that all applications submitted within the two business days before or during the funding lapse will receive the full viewing window once the systems are back on-line.  

For electronic submission of multi-project applications through NIH’s ASSIST system: The ASISST system will not be available until NIH systems are back on-line.

Paper Submissions: Staff will not be available to receive paper applications during a funding lapse. 

The safest course is to wait to submit any application to NIH until after operations resume and a Notice in the NIH Guide concerning adjusted submission dates is posted.

PEER REVIEW AND COUNCIL MEETINGS

Initial Peer Review Meetings:  For the duration of the funding lapse, the NIH will not be able to conduct initial peer review meetings – whether in-person or through teleconferences or other electronic media. Also during this time, the NIH staff will not be able to send or receive email messages, or update website information, and NIH computer systems that support review functions will not be operational.  When operations resume, those meetings will be re-scheduled and the pending applications will be processed and reviewed as soon as possible.  

Also, the results, including final impact scores and summary statements, of some peer review meetings that took place prior to the orderly shutdown of operations may not be available until operations resume.  Therefore, applicants with applications going through the peer review process should stay tuned to the national news to determine when operations of the government resume, and then check the NIH website for information on any review meetings that may have been extended or re-scheduled.  The results of meetings held prior to a potential funding lapse will be released as soon as possible after resumption of operations.

Individuals who had agreed to serve on NIH review panels (”study sections”) that were scheduled to meet during the funding lapse will not be able to access the Internet Assisted Review (IAR) site or other NIH web-based systems during that time. Reviewers who were scheduled to travel for a review meeting on a day when operations are down will not be able to board a plane or train, and will be sent instructions on how to handle their reservations.  Reviewers who are attending an NIH review panel on the day of orderly shutdown will be able to change their travel plans and return home.  Therefore, peer reviewers should stay tuned to the national news to determine when operations of the NIH will resume, and then check the NIH website for information on meetings that have been re-scheduled.   As soon as possible after operations resume, the NIH Scientific Review Officer in charge of the review meeting will contact those reviewers with more detailed information.

Advisory Council Review: The NIH will not be able to conduct Advisory Council review meetings – whether in-person or through teleconferences or other electronic media – during the funding lapse.  Also during this time, the NIH staff will not be able to send or receive email messages, or update website information, and NIH computer systems that support review functions will not be operational.  Therefore, no applications will be processed for Council review or be taken to Council meetings during that time.  When operations resume, those pending applications will be processed, and meetings will be re-scheduled as soon as possible.  

Applicants with applications pending Council review during that time should check the NIH website for information after operations resume.  Advisory Council members should stay tuned to the national news to determine when operations of the government will resume, and then check the NIH website for information on Council meetings that have been re-scheduled.   As soon as possible after operations resume, the NIH Executive Secretary in charge of the Council meeting will contact those Council members with more detailed information.

AWARDED GRANTS

Currently Active Grant Awards:  For the duration of the funding lapse, all work and activities performed under currently active NIH grant awards may continue.  However, see below for limits on performing many of the reporting requirements associated with NIH grant funding.  

Progress Reports

Electronically Submitted Progress Reports:  For any progress reports due during the funding lapse, the eRA Commons will not be accessible.  Users will need to wait until the eRA Commons is back on-line before these progress reports can be submitted. 

Paper Submitted Progress Reports:  No NIH staff will be available to receive paper progress reports. Therefore, institutions are encouraged to delay mailing all paper progress reports due during the funding lapse until after operations resume.  

Notice of Awards (NoAs):  No NIH grant awards will be processed for the duration of the funding lapse.  For any awards processed before the funding lapse that have an issue date during the funding lapse, the awards will not be sent to the grantee on the issue date.  Once operations resume, all pending NoAs will be sent.  This will not affect the start date nor the issue date of these awards; it just affects the date the award document is actually sent to the grantee and available for access in the eRA Commons.  In the absence of actually receiving the NoA, institutions may use pre-award costs authority at their own risk.  

No-cost Extension Notifications:   The eRA Commons will not be accessible during the funding lapse.  Further, no-cost extension notification cannot be submitted via the Commons once the expiration date of the grant has passed.  For any grants due to expire during the funding lapse that plans to be given a no-cost extension, a paper notification to the IC will be required after operations resume.  

General Access to eRA Commons and Other OER-Supported Systems:  The eRA Commons will not be accessible during the funding lapse.  Therefore, no user will be able to access the Commons for viewing electronically submitted applications, accessing Internet Assisted Review, or processing such actions as Commons Registration, FSRs/FFRs, xTrain documents, Closeout documents, and/or FCOI notifications etc.  Further there will be no ability to access Commons for query or other purposes.  There also will be no access to the Interagency Edison or Electronic Council Books systems.

Prior Approval Requests and Other Communications:  NIH extramural employees will have no access to voice mail, e-mail, fax, or postal mail during the funding lapse.  All prior approval requests and other communications will not be received until operations resume.  It is recommended that you delay sending such communications until after operations resume.

Access to HHS Payment Management System (PMS):   For the duration of the funding lapse, the HHS PMS will be open; however, no Federal staff will be available to assist or process any requests.  Therefore, drawdowns (payments) on accounts can be processed as long as no Federal staff action is required to finalize the payment.  For most NIH grantees, this means drawdowns should be possible.  However, if a particular grant is on a reimbursement basis for withdrawing funds or otherwise restricted, then these requests cannot not be processed until after Federal Government operations resume.

ANIMAL WELFARE

The Office of Laboratory Animal Welfare (OLAW) business processes are funded by annual appropriations and are not designated as excepted activities under the Antideficiency Act. No activities associated with the OLAW mission will continue for the duration of the funding lapse.

For the duration of the funding lapse, PHS-funded institutions are encouraged to delay sending all Assurance documents, preliminary or final reports of noncompliance or IACUC suspensions as required under the Public Health Service Policy on Humane Care and Use of Laboratory Animals IV.F.3, or other correspondence due to OLAW during the funding hiatus period until after operations resume. OLAW will extend deadlines for all reporting activities as necessary to compensate for the period of the lapse in funding and the unavailability of the website and OLAW operational support.

Institutions are reminded that their obligation under their Animal Welfare Assurance to ensure ongoing local support and oversight, and to address and correct all situations that affect animal welfare and compliance with the PHS Policy continues during this period.

Informal Notice about Potential Lapse in Appropriated Funds

September 26, 2013

Dear Grantee: 

As you are aware, the Government Fiscal Year (FY) 2013 ends on September 30, 2013 and an Appropriation Act for FY2014 has not yet been passed.  The Administration strongly believes that a lapse in appropriations should not occur, and that there is enough time for Congress to act to prevent a lapse.  However, prudent management requires that we prepare for an orderly execution of contingency plans in the unfortunate event of a lapse.  In the event a continuing resolution or a FY2014 budget is not passed and a lapse of funding occurs, I wanted to provide you with information related to our grant administration processes.

Your particular grant program is funded by appropriations that will be affected by a government shutdown.  As a result, if there is a lapse in funding, HHS’ NIH staff will not be available to provide routine administrative support services.  HHS will, however, maintain the Payment Management System in an operational status to continue processing grant drawdown requests. Given that you have received your award prior to the gap in funding, you may be able to continue drawing funds from prior awards during an appropriations lapse.  If you received your notice of grant award with restrictive terms and conditions, or if your drawdown request triggers one of the Payment Management System edit checks and/or the drawdown limit controls, you will not be able to drawdown funds. 

If you are considering submitting an application for additional HHS federal assistance funding, please be advised that the Grants.gov system will be operational during a lapse in funding and will be accepting applications from prospective grantees.   However, for NIH applications the Grants.gov system will only accept and store applications. Applications will not be processed further until such time as the authority and funding to return to normal business operations are restored.

Please check the website at www.hhs.gov for updates.  Thank you for your assistance with this period of a potential government shut-down and your ongoing support of the NIH.

Sally J. Rockey, Ph.D.

NIH Deputy Director for Extramural Research

rockeysa@od.nih.gov

Extension of eRA Commons User IDs to Individuals in Graduate and Undergraduate Student Project Roles with Measurable Effort on an NIH Annual Progress Report (PHS2590 & RPPR)

Notice Number:  NOT-OD-13-097 

Purpose

Over the next year the NIH will start requiring an eRA Commons ID for all individuals in graduate and undergraduate student roles who participate in NIH-funded projects for at least one person month or more.  That information will appear on NIH progress reports, including those submitted on paper using the DHHS Public Health Service Grant Continuation Progress Report (PHS2590, rev. 8/2012), and electronically using the Research Performance Progress Report RPPR, rev. 08/2012).  Beginning on October 18, 2013 a warning will be generated when an RPPR is submitted that lists individuals in a graduate or undergraduate student role who have not established an eRA Commons ID.   Then beginning in October 2014, RPPRs lacking the eRA Commons ID for Graduate and Undergraduate Students will receive an error and the RPPR will not be accepted by the NIH without this information. 

The NIH PHS 2590 and RPPR forms will be modified to prompt for this information beginning on October 18, 2013.  Also beginning on that date, graduate students and postdocs who complete their eRA Commons Profile will be required to answer certain demographic questions related to their date of birth, gender, race, ethnicity, disabilities, US citizenship status and country of citizenship; and where applicable, they will need to indicate their highest educational degree and the institution where it was earned, in order to complete the data collection.  For items that request information on gender, race and ethnicity, and disability one of the acceptable responses will be ”I Do Not Wish to Provide”.

Once phased in, this new policy will extend the existing eRA Commons ID requirement for Program Directors/Principal Investigators (PDs/PIs) and postdoctoral researchers.  In addition to providing information on PD/PIs and those in the training phases of their careers, grantee institutions will be encouraged to create an eRA Commons Account for all other personnel listed on the All Personnel List of the PHS 2590 or in the Participant Section (D.1) of the RPPR. This new collection will provide more comprehensive information about the size and nature of the biomedical research workforce. Entering an eRA Commons ID in the Participant Section of the RPPR will pre-populate other components of this form reducing some of the burden associated with annual progress reporting. 

The newly revised instructions and forms will be available on October 18, 2013 at http://grants.nih.gov/grants/forms.htm.  And, the following tools for creating eRA Commons Accounts are now available:

Background

Consistent with reporting requirements from the NIH Reform Act of 2006 (P.L. 109-482, “NIH Reform Act”), NIH has collected identifying and demographic information, facilitated by eRA Commons Registration, for individuals designated in applications as the  PD/PI(s) and any individual with a postdoctoral role who participates in a NIH-funded project for at least one person month.   In addition, NIH maintains a comprehensive data collection on students and postdoctoral researchers supported by the Ruth L. Kirschstein National Research Service Award (NRSA) programs.   The inclusion of all individuals in a graduate or undergraduate student role who participated in a project for at least one person month or more will enhance the NIH’s ability to describe these populations in detail and to conduct comprehensive workforce and career outcome studies and analyses, consistent with the NIH Reform Act requirements. 

In addition to this statutory directive, the requirement for eRA Commons IDs for students responds to recommendations on the Biomedical Research Workforce  from the NIH Advisory Committee to the Director:

The NIH should ensure that all students and postdoctoral researchers supported by the NIH on both research grants and research training grants are identified and the necessary variables are collected to assess the impact of NIH funded experiences on their subsequent careers.  

Further, the NIH solicited input from the community in a Request for Information (RFI) that was issued in the NIH Guide for Grants and Contracts on February 21, 2013.   The RFI included questions specifically about the plan to gather information about students on research grants by requiring eRA Commons accounts.  In general, individuals who responded to the RFI supported the concept that the NIH should identify and track those who receive NIH support from any source during the training phases of their careers.   Some of the respondents expressed concern about burden, duplication of current data, privacy, confidentiality and security.   Some suggested close coordination with the federal scientific profile system, Science Experts Network curriculum vitae (SciENcv) that will be launched as a public beta version later this summer.  In response to the concerns raised in the RFI, all eRA Commons information will continue to be stored in a database protected by the Privacy Act.   To reduce respondent burden, information collected in the eRA Commons will be available to pre-populate the on-line SciENcv to permit users to easily generate biosketches associated with federal grant applications and progress reports.  

Implementation

Beginning this summer, on August 15, the NIH will make undergraduate, graduate student, and other project personnel roles available in the eRA Commons.   At that time, grantee Commons Account Administrators should begin working with individuals in those and other roles at their institution to establish eRA Commons accounts and to populate their profiles.  Various components of these requirements will become available at different times, as shown below:

eRA Commons Accounts: Beginning on August 15, Grantee Commons Account Administrators should start encouraging graduate and undergraduate students and others to establish eRA Commons Accounts.   All individuals establishing Commons Accounts should be encouraged to complete all requested fields.  Beginning on October 18, 2013, warnings will appear in the eRA Commons screens to alert individuals identified as undergraduate students, graduate students, and postdoctoral researchers that the following fields should be completed:  date of birth, gender, race, ethnicity, disabilities, US citizenship status and country of citizenship.  For those who have completed undergraduate or graduate degrees (graduate students and postdoctoral researchers), the highest educational degree, the degree date, and the institution where it was earned also should be completed.   Beginning on October 1, 2014, those fields in the eRA Commons screens will be required for individuals identified in any of those three roles. 

Progress Reports:  On/after October 18, 2013, all graduate and undergraduate students reported on the All Personnel Form in the PHS2590 or the Participants Section (D.1) in the RPPR should have eRA Commons IDs in addition to the current requirement for postdoctoral researchers.  A warning will be issued for all graduate and undergraduate students listed on the Participant List of the RPPR who do not have an eRA Commons ID.  Beginning October 2014, RPPRs lacking an eRA Commons ID for graduate and undergraduate students will receive an error and the RPPR will not be accepted by the NIH without this information.   eRA Commons IDs will be encouraged for all other individuals listed on the All Personnel Form or the Participants sections of those reports. 

NRSA Fellows and Trainees: Please note that these new eRA Commons roles should NOT be used for individuals submitting Individual NRSA Fellowship applications.  The PD/PI role will continue to be used for those submissions.  These roles also should not be used for individuals being reported in xTrain or on a Statement of Appointment Form (PHS2271); the Trainee Role must be used for that reporting requirement.

Inquiries

Please direct all inquiries to: 

Grants Info
Office of Extramural Research
National Institutes of Health
Telephone: 301-435-0714
TTY: 301-451-5936
Email: Grantsinfo@nih.gov
User support is provided at http://ithelpdesk.nih.gov/eRA/.

NIH Pioneer Award Program (DP1) – RFA-RM-13-006

Sponsor

National Institutes of Health (NIH)

Sponsor Announcement Web Location

http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-13-006.html

Synopsis

The NIH Pioneer Award initiative complements NIH’s traditional, investigator-initiated grant programs by supporting individual scientists of exceptional creativity who propose pioneering and possibly transforming approaches to addressing major biomedical or behavioral challenges that have the potential to produce an unusually high impact on a broad area of biomedical or behavioral research. To be considered pioneering, the proposed research must reflect substantially different scientific directions from those already being pursued in the investigator’s research program or elsewhere.

There is no limit to the number of applications an institution may submit. Individuals may submit only one application as a PD/PI in response to this FOA.

Areas of Interest

The NIH Pioneer Award initiative is part of the NIH Common Fund (formerly known as the NIH Roadmap), which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The NIH Pioneer Awards initiative is a component of the Common Fund High-Risk Research Program that also includes the NIH Director’s New Innovator Awards, the NIH Transformative Research Awards, and the NIH Director’s Early Independence Awards.

To be considered pioneering, the proposed research must reflect ideas substantially different from those being pursued in the investigator’s research program or being pursued elsewhere. The program is not intended to expand a current research program’s funding in the area of the proposed project. While the research direction may have as its foundation the applicant’s prior work and expertise, it cannot be an obvious extension or scale up of a current research enterprise which could be anticipated to be competitive as a new or renewal R01 application. Rather, the proposed project must reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally innovative approaches and/or from the posing of radically unconventional hypotheses. Applications for projects that are extensions of ongoing research should not be submitted.

Pioneer awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Pioneer Award research project. Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. Applicants with current research commitments exceeding 49% must provide a detailed explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Pioneer Award project. Applicants who will not be able to meet this requirement should not submit applications.

Deadline Details

Application Due Dates:

October 18, 2013, October 10, 2014, and October 9, 2015, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Award Amount

$2,500,000

Award Details

The NIH intends to commit approximately $5,000,000 for approximately 7 awards in each fiscal year 2014 – 2016.

Award Budget
Awards will be for $500,000 Direct Costs each year for five years, plus applicable Facilities and Administrative (F&A) costs to be determined at the time of award.

Award Project Period
The maximum project period is 5 years.

Applicant Type

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

Agency Contact

Ravi Basavappa, Ph.D.
Office of the Director
Telephone: 301-435-7204
Email: PioneerAwards@mail.nih.gov

NOT-OD-13-091: Now Available: PHS 398 Application Forms and Instructions for Application Due Dates on or after September 25, 2013 and Updated Application Guides for Electronic Application Forms

This Notice announces the availability of new application instructions and forms for paper-based PHS 398 applications (http://grants.nih.gov/grants/funding/phs398/phs398.html) and also the availability of new Application Guide instructions for electronic SF 424 (R&R) applications (http://grants.nih.gov/grants/funding/424/index.htm). The new application instructions and forms must be used for applications intended for due dates on or after September 25, 2013.

All Applicants

These instructions incorporate numerous clarifications, updates and policy announcements that have appeared in the NIH Guide for Grants and Contracts (aka Guide) since the 06/2009 revision of the PHS 398 application guide and the 06/2012 revision of the SF424 (R&R) Application Guide for NIH and Other PHS Agencies. Since the Guide also publishes multiple funding opportunity announcements, the Office of Extramural Research posts Policy Notices, clarifications and other updates on this webpage: NIH Policy Notices. Applicants are expected to be aware of any relevant Notices that appear in the Guide.

Changes of note include:
Supplemental Grant Application Instructions 
Parts II (Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan and Policies) and III (Policies, Assurances, Definitions, and Other Information) of the instructions are now located in a separate “Supplemental Grant Application Instructions” document.  Parts II and III have therefore been removed from the PHS398 Application Instructions and the general Application Guides for Forms-B and Forms-C application packages.  

Notice of Proprietary Information
Clarification of policy regarding the final determination of whether an application contains proprietary information and that a positive finding of proprietary information does not automatically shield the information from release in response to a Freedom of Information Act (FOIA) request should the application result in an award.

Biographical Sketch
“Patent Citations” have been added as part of section C, Selected Peer Reviewed Publications.

Research Plan
In the Research Strategy, Section C Approach, if research on Human Embryoinic Stem Cells (hESCs) is proposed but an approved cell line from the NIH hESC Registry cannot be identified, applicants must provide a strong justification for why an appropriate cell line cannot be chosen at the time of application.

Letters of Support
There are clarifications regarding the content.

Appendix
Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Strategy.

PHS 398 Applicants

  • All PHS 398 paper application submissions intended for due dates on or after September 25, 2013, must use the 8/2012 version of the PHS 398 instructions and forms (http://grants.nih.gov/grants/funding/phs398/phs398.html). The 06/09 version of the form remains available at this time for use in responding to FOAs that have due dates prior to September 25, 2013.
  • In addition to the changes outlined above, in the Research Plan, Inclusion Enrollment Reports have been renamed and modified and are now “Planned Enrollment Report” and “Cumulative Inclusion Enrollment Report”. See NIH Guide Notice NOT-OD-13-092 “Modifications to NIH’s Planned and Cumulative Inclusion Enrollment Forms”.

SF 424 (R&R) Applicants

  • As announced in Notice NOT-OD-13-074, applications using electronic forms will transition to new forms identified with a Competition ID of FORMS-C.  Application instructions for FORMS-C are now available. Applicants MUST return to the FUNDING OPPORTUNITY ANNOUNCEMENT (FOA), or the reissued Parent Announcement, to download the new application forms for due dates on or after September 25, 2013
  • Added a new Chapter 9. Supplemental Instructions to the SF 424 (R&R) for Preparing a Multi-Project Application
  • At this time the general Application Guide for Forms-B and Forms-C have been revised. The anticipated posting dates for the SF424 (R&R) Individual Fellowship Application Guide for NIH and AHRQ and the SF424 (R&R) SBIR/STTR Application Guide for NIH and Other PHS Agencies are Late Fall 2013 and Spring 2014, respectively.  As those Application Guides are revised, the above changes, including the use of the separate Supplemental Grant Application Instructions will be applicable. 

Important Note

Any application submitted using incorrect application forms (including applications that have an incorrect mix of old and new forms) may be delayed and may not be reviewed.

Inquiries

Questions should be directed to grantsinfo@od.nih.gov.