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[December 15, 2016] What post-submission materials are allowed for NIH applications? The NIH has updated their Policy on Post-Submission materials for grant applications (NOT-OD-16-130), which will be implemented for submissions due on or after January 25, 2017. Under the new policy, the only post-submission materials that will be accepted for most applications are those resulting from an unforeseen event. Allowable Post-Submission Materials are:
•    Revised budget page(s) (due to new funding or institutional acquisition of equipment)
•    Biographical sketches (due to the hiring, replacement, or loss of an investigator)
•    Letters of support or collaboration due to the hiring, replacement or loss of an investigator
•    Adjustments resulting from natural disasters (e.g. loss of an animal colony)
•    Adjustments resulting from change of institution [e.g. Principal Investigator (PI) moves to another university]
•    News of professional promotion or positive tenure decision for any PI or Senior/Key Personnel
•    Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application (see NOT-OD-12-111)
•    Videos that demonstrate devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change.  Applicants must follow the directions in NOT-OD-12-141 for submitting videos to accompany grant applications
•    Other post-submission materials specified in the Funding Opportunity Announcement (FOA) for which the application was submitted or in a special Guide Notice.
•    News of an article accepted for publication since submission of the application, which must include only:
o    List of authors and institutional affiliations
o    Title of the article
o    Journal or citation (if available)
Certain applications (such as institutional training grants, fellowships, and career development awards) allow additional materials; see NOT-OD-16-130 for details.

As with the current policy, post-submission materials must be received by the NIH Scientific Review Officer (SRO) no later than 30 calendar days prior to the peer review meeting.  Post-submission materials will not be accepted if fewer than 30 calendar days remain before the peer review meeting, unless specifically stated otherwise in the FOA for which the application was submitted or in a special Guide Notice. The Authorized Organization Representative (AOR) must send the materials directly to the SRO.  A communication from the PI only or with a "cc" to the AOR will not be accepted. More >> [Faculty, Postdocs and Resadmin 12/15/2016]

[November 17, 2016] What appendix materials are allowed for NIH applications? The NIH has announced a new Policy on Appendices to grant applications (NOT-OD-16-129), which eliminates most appendix materials for submissions due on or after January 25, 2017. Under the new policy, the only allowable appendix materials are:
• Clinical trial protocols
• Investigator's brochure from Investigational New Drug (IND), if relevant
• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments
• Funding Opportunity Announcement (FOA)-specified items.

Applications will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed in the above list or specified in the FOA. More >> [Faculty, Postdocs and Resadmin 11/17/2016]

[October 20, 2016] Is permission needed for NIH grant applications requesting $500,000/year or more (direct costs)?
Yes. An applicant planning to submit a grant proposal (new, resubmission, revision, or supplement) with $500,000/year or more in annual direct costs, even if only in one year, must contact program staff in writing at least 6 weeks before the submission deadline. The NIH supports research projects with large budgets, however, if program staff is contacted less than six weeks before submission, there may be insufficient time to evaluate the request prior to the intended submission date. If the requested dollars are significantly greater than $500,000/year, then approval should be sought even earlier. This prior acceptance policy does not apply to applications submitted in response to RFAs (Request For Applications) or other program announcements that include specific budgetary limits. More>> [Faculty, Postdocs and Resadmin 10/20/2016]

[October 20, 2016] What is the process for requesting permission for a budget over $500,000/year in direct costs?
An applicant planning to submit a grant application with $500,000 or more in direct costs for any year (excluding consortium F&A costs) is required to contact in writing or by telephone NIH program staff. If the Program Official (PO) determines that they wish to receive the request through an electronic process, they will initiate an invitation to the Principal Investigator (PI) using the Prior Approval module of the eRA Commons. The PI will receive an email notifying them of the invitation. The PI will complete the form and submit it to the initiating PO for review. Regardless of how the request is made, the PI must include a cover letter with the application, identifying the PO contacted and the Institute or Center that has agreed to accept assignment of the application. It is recommended that PIs include the official communication from the NIH PO as part of the cover letter. More>> [Faculty, Postdocs and Resadmin 10/20/2016]

[September 22, 2016] What resources are available for NIH’s new policy on Rigor and Reproducibility?
The NIH has provided a summary of Rigor and Reproducibility resources that include FAQs, blog posts, and examples. This information is intended to help investigators determine how and where to address the four focus areas (Scientific Premise, Scientific Rigor, Biological Variables and Authentication) in their grant applications.

If using biological or chemical resources that will be obtained from an RU Resource Center, please consult with the director of the Resource Center. The University has arranged for access to STR service from the MSKCC Genomics Core Lab at the internal price of $36/sample. This covers the assay and delivery of raw .fsa files, PDFs of each sample’s fluorescence peaks with allele calls, and a table of the genotypes and raw data, along with a genotype quality score, for each locus. If you need assistance with locating commercial sources, please contact Chris Keogh.

See also previous Rigor and Reproducibility tips from March 17, 2016. [Faculty, Postdocs and Resadmin 9/22/2016]

[September 15, 2016] What are the new NIH font guidelines for applications? The list of allowable fonts was recently expanded, and the following fonts are now acceptable for NIH grant applications:
• Arial
• Garamond
• Georgia
• Helvetica
• Palatino Linotype
• Times New Roman
• Verdana
Please Note: OSPA has reviewed several grants under the new guidelines, and recommends Arial as a preferred font. It most consistently adheres to the type density and line spacing requirements listed below.

The application text must also follow minimum requirements:
• Font size: must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%)
• Type density: must be no more than 15 characters per linear inch (including characters and spaces)
• Line spacing: must be no more than six lines per vertical inch
• Text Color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable as long as it is legible)

Applications that do not conform to the minimum requirements listed above may be withdrawn from consideration. [Faculty, Postdocs and Resadmin 9/15/2016]

[July 21, 2016] How do I ensure that my NIH biosketch is compliant? The NIH biosketch format was updated in 2015. All biosketches included in NIH applications must be formatted per the instructions in the SF424 application guide, including:
•    Completing each section (A - Personal Statement; B – Positions and Honors; C – Contributions to Science; D – Research Support or Scholastic Performance)
•    Including no more than 5 contributions to science with no more than 4 citations per contribution
•    Ensuring that, if you include the optional link to a full list of your published work, the URL is .gov (i.e., a site such as My Bibliography)  
•    Refraining from including information, such as preliminary data, that belongs elsewhere in the application
•    Following NIH guidance on font type, font size, paper size, and margins (see Format Attachment instructions)
•    Limiting the length of your biosketch to 5 pages or less
Failure to follow the policy means NIH may withdraw your application from consideration (NOT-OD-15-095). More>> [Faculty, Postdocs and Resadmin 7/21/2016]

[June 16, 2016] What are the acceptable post-submission materials to the NIH? Per NIH Notice NOT-OD-13-030, acceptable post-submission materials include:
- Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)
- Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)
- Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator
- Adjustments resulting from natural disasters (e.g., loss of an animal colony)
- Adjustments resulting from change of institution (e.g., PI moves to another university)
- News of an article accepted for publication (a copy of the article should not be sent)
- News of a professional promotion or positive tenure decision for any Program Directors/Principal Investigators and Senior/Key Personnel.
[Faculty, Postdocs and Resadmin 6/16/2016]

[June 16, 2016] How are post-submission materials submitted?
Post-submission materials must be submitted as a PDF by the Authorized Organization Representative to the Scientific Review Officer one month (30 calendar days) prior to the peer review meeting. Page limitations apply, and post-submission materials must conform to NIH policy on font size, margins, and paper size. Additional form pages such as budget, biographical sketches, and other required forms must follow NIH standards for required NIH form pages. If you have any questions, contact Your GMS for more information. [Faculty, Postdocs and Resadmin 6/16/2016]

[May 19, 2016] What is the difference between Research Support and Other Support, and when is each requested?
 From the NIH Grant Application Instructions Guide:
Though they sound similar, these parts of the application are distinctly different. As part of the biosketch section of the application, Research Support highlights the scientific accomplishments of  you and your collaborators. This information is provided BEFORE submission and will be used by the reviewers in the assessment of each individual's qualifications for their specific role in the proposed project, as well as to evaluate the overall qualifications of the research team.
Other Support information is required for all applications that are selected to receive grant awards and includes details on direct costs and individual effort in calendar months. NIH staff will request complete and up-to-date "Other Support" information AFTER peer review. This information will be used to check that the proposed research is not already funded through other sources. More in Section 4.6 of Instructions for Preparing an Application. [Faculty, Postdocs and Resadmin 5/19/2016]

[May 19, 2016] What should I list in my Other Support, and when?
Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards (i.e., training grants), prizes, or gifts do not need to be included.

For Just in Time, provide Active and Pending support. See NIH example.  

For Progress Reports, provide only Active support for all new senior/key personnel, and provide updated Active and Inactive support for any senior/key personnel for whom there has been a change since the last reporting period. See progress report form sample. [Faculty, Postdocs and Resadmin 5/19/2016]
[April 21, 2016] What do the various characters in my NIH application/award number represent? The application identification number refers to (example from the NIAID Glossary):
Application type – Activity code – Institute – Serial no. – Suffix Year – Amendment – Supplement
1– R01 – AI – 83723 –  01 – A1 – S1
The first number indicates the type of application (e.g. “New” = Type 1; “Renewal” = Type 2;  “Non-competing continuation” = Type 5). The following three-characters indicate the activity code (i.e. funding mechanism). The NIH Institute or Center to which an application/award is assigned is represented by a two-letter organization code. Next is the unique serial number assigned by the Center for Scientific Review (CSR), which is retained by the application/award throughout its lifetime. The two-digit suffix year that follows indicates the budget period of the award.  The last two fields – Amendment and Supplement - indicate a supplement (S1), resubmission (A1), or a fellowship's institutional allowance, and are used only when applicable. [Faculty, Postdocs and Resadmin 4/21/2016]

[April 21, 2016] Are eRA Commons IDs required on NIH Research Performance Progress Reports (RPPRs)? When submitting an RPPR, the NIH requires an eRA Commons ID for the Principal Investigator (PI) and all individuals in trainee roles (postdoc, graduate, and undergraduate student) who participated in the project for at least one-person month during the reporting period, whether or not paid by the award. In addition, all students and postdocs completing an NIH Commons Personal Profile are now required to answer certain demographic questions, e.g. date of birth and gender. This information is required as part of the NIH initiative to improve data on the biomedical research workforce, including NIH-supported trainees. It is important to note that an error will be generated and the RPPR will not be accepted by the NIH unless all postdocs and students listed as participants on the project have an NIH eRA Commons ID and a complete Commons profile. More>> [Faculty, Postdocs and Resadmin 4/21/2016]

[March 17, 2016] What is the new NIH policy on authentication of key resources, and what does it mean for my grant submission? The NIH has updated their application instructions and review criteria to enhance the reproducibility of research findings through increased scientific rigor and transparency. If you are submitting an NIH research or career development application and plan to propose the use of key biological and/or chemical resources, then your application should address how these resources will be authenticated. The authentication plan should be included in your proposal as an additional attachment (not as part of the research strategy) and it should be brief – no more than one page is suggested. The plan should include a description of the methods proposed to authenticate key resources prior to use and at regular intervals, if appropriate. Key resources include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. If these resources will be obtained from an RU Resource Center, please consult with the director of the Resource Center. The University is currently exploring both commercial and in house options for STR services. More information on that will be forthcoming from Research Support. If you need assistance with locating commercial sources, please contact Chris Keogh. If you do not propose the use of key biological and/or chemical resources, then a plan for authentication does not need to be included. More>> [Faculty, Postdocs and Resadmin 3/17/2016]

[March 17, 2016] Do I need to include information in my Research Strategy to address the NIH’s new guidance on increased scientific rigor and transparency? Yes. For most research and career development applications, the NIH has provided new guidance for the Significance and Approach sections of the Research Strategy component. The Significance section should include a description of the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application. The Approach section should include a description of the experimental design and methods proposed and how they will achieve robust and unbiased results, as well as a discussion of how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. We suggest that you consult with the directors of the RU Resource Centers regarding descriptions of methods utilized by the centers for any services you plan to obtain from the Centers. More>> [Faculty, Postdocs and Resadmin 3/17/2016]
[February 18, 2016] What is required for a resubmission application? Resubmissions, like first-time submissions, are required to be accurate and current, and to fully meet sponsors' and institutional requirements.  As with brand new applications, materials prepared for resubmission must be up-to-date before a resubmission application may be reviewed and approved by the institution (details on SR-PD Application Review page). This includes the following updated materials: research plan, references, CVs/biosketches, budget and budget justification, description of resources and facilities, letters of support, new sponsors’ prior approvals if applicable, a new institutional Routing Form, compliance verification, and more. Before moving forward with a resubmission, applicants are strongly encouraged to contact program staff for their advice. More on NIH resubmission and on NSF resubmission processes and requirements. [Faculty, Postdocs and Resadmin 2/18/2016]

[February 18, 2016] Is there a cap on budget requests for NIH Renewal applications? There may be. Policies that limit how much of a direct cost increase may be requested for NIH competing renewal applications vary amongst NIH Institutes and Centers (ICs). Terms and conditions specified in the active award’s Notice of Award would often indicate whether any such cap applies and ways to calculate allowable budget levels. Additionally, applicants are urged to speak to their Program Official early in the planning stage of their renewal application (at least 60 days prior to the intended submission) to discuss available options and to verify the maximum budget permissible/feasible for their award renewal. The NCI, and NIAID are among the ICs requiring a cap on budget requests for NIH competing renewals. More on ‘Dealing With a Budget Cap’. [Faculty, Postdocs and Resadmin 2/18/2016]
[January 21, 2016] What is the NIH viewing window for electronic applications? Applicants who submit in advance of the deadline have two business days to view their assembled application in the eRA Commons. This viewing window enables applicants to verify that their application is viewable correctly and, if not, to work with an institutional Signing Official to reject, modify, and resubmit it.  However, any modifications or corrections must be completed PRIOR to the due date. Applicants are strongly advised to submit early and to allow enough time for an adequate review in order to ensure the successful submission of their applications. In general, SR-PD will only reject and resubmit applications for reasons such as missing documents, illegible figures, and validation warnings. More>> [Faculty, Postdocs and Resadmin 1/21/2016]  
[January 21, 2016] What type of NIH supplement programs are available? Administrative supplements are used to provide additional funds to an existing grant or cooperative agreement to support efforts that fall within the scope of that award but were not anticipated at the time of the competing submission. Principal Investigators are encouraged to speak to their Program Official before applying to discuss eligibility, need for the supplement, availability of funds and application procedures. Requests for administrative supplements are reviewed internally by NIH program staff and do not normally require peer review.

The NIH also offers competitive revisions, which are supplements to existing awards for activities that are beyond the scope of the original project. Competitive revisions are peer-reviewed and are submitted using the forms, instructions, and guidelines detailed in the parent grant’s originating Funding Opportunity Announcement. More>> [Faculty, Postdocs and Resadmin 1/21/2016] 

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