Supporting Statement A for
PHS Applications and Pre-award Related Reporting [OD/OPERA]
0925-0001
Expiration Date 01/31/2026
Date: August 5, 2024
Check off which applies:
Revision
Name: Kasima Garst
Address: 6705 Rockledge Drive, Bethesda, MD 20892-7974
Telephone: 301-402 2541
Fax: 301-435-3059
Email: [email protected]
Table of contents
A. Justification 3
A.1 Circumstances Making the Collection of Information Necessary 4
A.2 Purpose and Use of the Information Collection 9
A.3 Use of Information Technology and Burden Reduction 12
A.4 Efforts to Identify Duplication and Use of Similar Information 17
A.5 Impact on Small Businesses or Other Small Entities 17
A.6 Consequences of Collecting the Information Less Frequently 18
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 18
A.8.1 Comments in Response to the Federal Register Notice 18
A.8.2 Efforts to Consult Outside Agency 19
A.9 Explanation of Any Payment of Gift to Respondents 19
A.10 Assurance of Confidentiality Provided to Respondents 19
A.11 Justification for Sensitive Questions 20
A.12.1 Estimates of Hour Burden Including Annualized Hourly Costs 20
A.12-2 Annual Cost to respondent 22
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers 23
A.14 Annualized Cost to the Federal Government 23
A.15 Explanation for Program Changes or Adjustments 24
A.16 Plans for Tabulation and Publication and Project Time Schedule 25
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate 26
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions 26
ATTACHMENTS
Attachment 1 - Table of Former and Revised Content of Information Collections
Attachment 2 – Assistance Listing/CFDA List
Attachment 3 - PHS 398 [paper]: Public Health Service Grant Application Forms
Attachment 4 - PHS 398 [paper]: Public Health Service Grant Application Instructions
Attachment 5 - PHS 398/SF424 [electronic]: Public Health Service Grant Application component forms and agency specific instructions used in combination with the SF424 (R&R)
5A: Components of an Application to NIH or Other PHS Agencies
5B: PHS Assignment Request Form Instructions
5C: PHS Assignment Request Form
5D: PHS 398 Cover Page Supplement Form Instructions
5E: PHS 398 Cover Page Supplement Form
5F: PHS Human Subjects and Clinical Trial Information (HSCT) Form (Landing Page, Inclusion Enrollment Form, and Study Record Sections 1-6)
5G: PHS HSCT Form Instructions
5H: PHS 398 Modular Budget Form Instructions
5I: PHS 398 Modular Budget Form
5J: PHS 398 Training Budget Form Instructions
5K: PHS 398 Training Budget Form
5L: PHS 398 Training Subaward Budget Attachment(s) Form Instructions
5M: PHS 398 Training Subaward Budget Attachment(s) Form
5N: PHS 398 Research Plan Form Instructions
5O: PHS 398 Research Plan Form
5P: PHS 398 Career Development Award Supplemental Form Instructions
5Q: PHS 398 Career Development Award Supplemental Form
5R: PHS 398 Research Training Program Plan Form Instructions
5S: PHS 398 Research Training Program Plan Form
5T: Data Management and Sharing Plan Format
5U: PHS Additional Indirect Costs Form
5V: PHS Additional Indirect Costs Form Instructions
Attachment 6 - PHS Fellowship Supplemental Form and agency specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic]
6A: PHS Fellowship Supplemental Form Instructions
6B: PHS Fellowship Supplemental Form
Attachment 7 - PHS 416-1: Ruth L. Kirschstein National Research Service Award Individual Fellowship Application Instructions and Forms used only for a change of sponsoring institution application [paper]
7A: PHS 416-1 Transfer Instructions
7B: PHS 416-1 Face Page 1
7C: PHS 416-1 Face Page 2
7D: PHS 416-1 Face Page 3
7E: PHS 416-1 Face Page 4
7F: PHS 416-1 Checklist Form Page
7G: PHS 416-1 Continuation Page
7H: PHS 416-1 Performance Sites
Attachment 8 – Previously Removed
Attachment 9 - General Biographical Sketch Format Page, Instructions (use also for Fellowship Sponsor/Co-Sponsors), and Samples
9A: General (Non-Fellowship) Biosketch Format Page
9B: General (Non-Fellowship) and Fellowship Biosketch Instructions
9C: NIH Biographical Sketch Supplement (new, to replace NIH Biosketch format effective May 2025)
Attachment 10 - Fellowship Applicant Biographical Sketch Format Page (use only for individual predoctoral and postdoctoral fellowships, dissertation research grants [R36], and Research Supplements to Promote Diversity in Health-Related Research [Admin Supplement]) and Samples
10A: Fellowship Biosketch Format Page
10B: Postdoc Biosketch Sample
10C: Predoc Biosketch Sample
Attachment 11 - Data tables for use with Institutional Research Training grant applications using the SF424 (R&R)
11A: Introduction to the Data Tables
11B: Undergraduate Training Tables
11C: Consolidated Predoc and Postdoc Training Tables
11D: International Training Tables
Attachment 12 - PHS 416-5: Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice
Attachment 13 - PHS 6031: Ruth L. Kirschstein National Research Service Award Payback Agreement
Attachment 14 – Previously Removed
Attachment 15 - eRA Commons Profile Data Elements
Attachment 16 - Certifications for SBIR and STTR applicants to determine eligibility for an SBIR/STTR award. Completed at the time of award.
16A: SBIR Funding Agreement Certification
16B: STTR Funding Agreement Certification
Attachment 17 - Certification for SBIR Applicants that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms
Attachment 18 – Pre-Award eRA Prior Approval Screen Shots
Attachment 19 - Privacy Impact Assessment
Attachment 20 – Other Transaction Application
Attachment Att C - Other Support Format Page
Attachment Att D - Other Support and In-Kind Instructions
The National Institutes of Health (NIH) and other Public Health Service (PHS) agencies currently use the Research and Research Training Grant Applications and Related Forms and Ruth L. Kirschstein National Research Service Award (NRSA) Applications and Related Forms (0925-0001 Expiration Date: January 31, 2026). Effective for due dates on or after January 25, 2025, NIH will be implementing several trans-NIH initiatives to simplify the grants process for applicants and recipients as well as for peer review. NIH will be updating fellowship applications to improve fellowship peer review to facilitate the mission of these programs to identify the most promising candidates and individualized training opportunities that will assist them along their paths to support the advancement of the biomedical research enterprise. NIH will reduce the number of required attachments and updating instructions for the PHS Fellowship Supplemental Form to align with the revised review criteria. NIH will be updating institutional training grant applications, adding a new attachment field to the PHS 398 Research Training Program Plan form for the transparent collection of the Recruitment Plan to Enhance Diversity while also providing additional space for applicants within the Program Plan page limit where this information was previously collected. The Training Data Tables will be updated to reduce burden and promote consistent information collection, including limiting the scope of information collection to data only relevant to the training stage(s) of the proposed program in Table 1 and removing instructions in Table 8 that are reported within the RPPR. Effective for due dates on or after May 25, 2025, NIH will adopt the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum (NSPM)-33. The Common Forms are part of a separate OMB collection, approved under 3145-0279. Elements that will be collected within the Common Forms will be removed from NIH’s current NIH Biosketch and Other Support formats. NIH will continue to collect information not captured on the Common Forms to adhere to the agency’s implementation of the NIH Peer Review Regulations at 42 CFR Part 52 as part of the NIH Biosketch form, to be renamed the NIH Biographical Sketch Supplement, to reflect the supplemental information requested. The application and progress report forms and associated instructions will be updated to align with these new requirements.
Post-award reporting requirements, including the Research Performance Progress Report (RPPR), are similarly consolidated and concurrently submitted under 0925-0002 (expiration January 31, 2026).
PHS 398: The Public Health Service (PHS) Grant Application (PHS 398) is used by applicants to request federal assistance for research and research-related training. The PHS 398 application enables public and private organizations to compete for funds for traditional investigator-initiated research projects appropriated to the various components of the PHS and to request access to databases and other PHS resources. Several PHS agencies make such awards using this application, including the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substance and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and the Indian Health Service (IHS). In addition, two offices within the HHS Office of the Secretary (OS), Office of Population Affairs (OPA) and Office of Family Planning (OFP), are serviced by NIH for grant programs and also use this application. In addition, the Biographical Sketch format page, which is a part of the application, is also used by the Health Resources and Services Administration (HRSA). Participating agencies in the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) grant programs include the Administration for Children and Families (ACF), CDC, and FDA. The Administration for Community Living (ACL) may participate in the near future as well.
The PHS 398 is required at various times and circumstances in the course of activities proposed to be carried out under the range of authorized PHS programs: initial or original requests; competing continuation requests for extension beyond the previously approved award period; supplemental requests for additional funds beyond those approved and awarded for an annual budget period. The awards are authorized under 42 USC 241, 42 USC 216, 42 USC 285, 42 USC 286, 42 USC 300 and 42 USC 288. Information collection requirements are specified in regulations governing the PHS research program, including 42 CFR Part 52, 42 CFR 66.204, and 45 CFR 75.
In addition to the Research Project Grant, the PHS uses these applications for programs such as: Institutional Training Grants, including Ruth L. Kirschstein National Research Service Awards (NRSA) and other specialized training programs, Research Career Development Awards (CDA), Program Project and Center Grants, Conference Grants, Cancer Center Support Grants, Biotechnology Resources Grants, Academic Career Awards, Academic Research Enhancement Awards, and for access to agency sponsored resources. These awards are established under authorities such as 42 USC 241 and 42 USC 288. Applicable regulations include: 42 CFR 52.4 specifying the content of the grant application, 42 CFR 52a.4 specifying the content of the center grant application, and 42 CFR 66.204 specifying the content of the NRSA application. Awards are issued under various NIH programs, which are identified in the Catalogue of Federal Domestic Assistance (Attachment 2).
SF424 (R&R) and PHS 398 Forms: The large majority of award applications to NIH and other PHS agencies are submitted electronically through Grants.gov using the Federal-wide SF424 (R&R) application data set. The SF424 (R&R) is separately approved by OMB under OMB Number 4040-0001 expiration date 11/30/2025. NIH and other PHS agencies also require submission of additional PHS 398 forms for collecting agency-specific data not included in the Federal-wide forms as part of the application data set.
NIH and other PHS agencies are continuing to transition to full electronic submission through Grants.gov and use of the Federal-wide SF424 (R&R) application data set. During the transition period there is a need to maintain essentially dual applications processes: complete PHS 398 forms and instructions for programs that have yet to transition to electronic submission and are submitted in hard copy; and PHS 398 component forms for collecting agency-specific data unique to PHS programs that are not part of the Federal-wide SF424 (R&R) data set. The PHS 398 presented in this clearance package includes the PHS 398 forms that are modified since the last OMB approval (Attachment 3), the entire set of PHS 398 instructions (Attachment 4), and the PHS 398 component forms and agency specific instructions used in combination with the Federal-wide SF424 (R&R) (Attachment 5). A component form entitled “PHS Human Subjects and Clinical Trials Information” was added. Use of the PHS 398 paper application diminishes as programs transition to electronic submission, particularly for complex applications such as Research Program Projects and Centers (see Section 3. Use of Information Technology and Burden Reduction). At this time more than 95% of programs have transitioned to electronic submission that use the SF424 (R&R) and PHS 398 component forms, since all administrative supplement applications are required to be submitted electronically since July 25, 2020.
PHS Fellowship Supplemental Form [electronic]: All new and competing individual fellowship applications to NIH and AHRQ are submitted electronically through Grants.gov using the Federal-wide SF424 (R&R) application data set. However, NIH and AHRQ also require submission of additional Fellowship-specific data not included in the Federal-wide forms. The PHS Fellowship Supplemental Form is the form used to collect such agency and fellowship program specific information. It is used by applicants to request federal assistance for research-related training (see Attachment 6 for forms and instructions). This form is used by NIH and AHRQ. The form is required at various times and circumstances in the course of activities proposed to be carried out under the range of authorized PHS programs: initial or original requests; competing continuation requests for extension beyond the previously approved award period; supplemental requests for additional funds beyond those approved and awarded for an annual budget period. The awards are established under statutory authorities contained in the PHS Act, as amended (42 USC 288) and are authorized in accordance with 42 USC 288 and 42 CFR 66. Information collection requirements specified in the regulations governing the NRSA program, include 42 CFR 66.104 (b) (application requirement), 42 CFR 66.105 (b) (candidate assurance and certification) and 42 CFR 66.110 (service, payback, and recovery requirements). This information collection is currently approved under OMB 0925-0002 (expiration 09/30/2024).
Multiple uses of the PHS Fellowship Supplemental Form: These applications are used for all types of Kirschstein-NRSA Individual Fellowships—Predoctoral, Postdoctoral, and Senior. Special instructions may apply to Predoctoral and Senior Fellowship Applicants. In addition to the Predoctoral and Postdoctoral Individual Kirschstein-NRSA, the PHS uses these applications for other programs including the following: Individual Predoctoral Kirschstein-NRSA for M.D./Ph.D. Fellowships; Kirschstein-NRSAs for Senior Fellows; Minority Access to Research Career (MARC) Kirschstein-NRSA Faculty Fellowships; MARC Visiting Scientists Fellowships; Postdoctoral Medical Informatics Fellowships and Senior Medical Informatics Fellowships.
PHS 416-1: The Public Health Service Grant Application PHS 416-1, Ruth L. Kirschstein National Research Service Award Individual Fellowship Application [paper] is used only for a change of sponsoring institution application (Attachments 7 and 8). NIH is developing an electronic business process for handling change of sponsoring institution applications for all grant mechanisms; thus the use of paper forms will eventually be eliminated.
Biographical Sketch: Grant and cooperative applications require a biographical sketch be completed and uploaded for all senior/key personnel and other significant contributors. There is a General Biographical Sketch Format Page that is available for research grant applications, career development, training grant, and all other non-fellowship application types (see Attachment 9 for format page, instructions, and sample). A Fellowship Sponsor/Co-Sponsor can also use this format page. Individual fellowships, R36 dissertation grants, and diversity supplement applicants should use the Fellowship Application Biographical Sketch Format Page (see Attachment 10 for format page, instructions, and samples). Effective for due dates on or after May 25, 2025, NIH will be adopting the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum (NSPM)-33. The Common Forms are part of a separate OMB collection, currently approved under 3145-0279. To adhere to the agency’s implementation of the NIH Peer Review Regulations at 42 CFR Part 52, NIH will replace the NIH Biosketch form, which will be renamed the NIH Biographical Sketch Supplement, to continue to collect the previously approved information not captured on the Common Forms. The application and progress report forms and associated instructions will be updated to align with these new requirements.
Data Tables: Institutional Research Training grant applications using the SF424 (R&R) must complete applicable data tables (see Attachment 11 for instructions and samples). The Introduction to the Data Tables provides instructions applicable to all tables, specific instructions for each table, and Sample Data Tables. The Sample Data Tables illustrate the kind of data to include in each table for Kirschstein-NRSA training grant applications. These tables include undergraduate training, predoctoral training, postdoctoral training, short-term training, or a mix of these types. Also included is a set of training tables for international programs.
PHS 416-5: Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice (Attachment 12) is used by individuals to indicate the start date of their awards. Individuals have a 6-month period after the initial award is issued to begin training.
PHS 6031: Ruth L. Kirschstein National Research Service Award Payback Agreement certifies agreement to fulfill the payback obligation in service or dollars based on the length and amount of support (see Attachment 13 instructions and form). The PHS 6031 is used by NIH, AHRQ and HRSA.
SBIR/STTR Funding Agreement Certifications: For SBIR and STTR new and competing renewal applications, a funding agreement certification is required to be submitted as part of the NIH Just-In-Time pre-award procedure (see Attachment 16 for instructions and forms). These certifications are necessary to ensure that the applicant meets the Small Business Administration (SBA) size criteria, and that the organization will comply with other program-specific requirements such as all work must be conducted in the United States and that a minimum amount of work be performed by its own employees within its own facilities, before NIH to can issue an award. Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission (see Attachment 17 for instructions and form). This applies to NIH and CDC small business applicants.
Other Transaction (OT) Awards: In addition to grant awards, NIH has Other Transactions Authority (OTA) allowing one or more components of NIH to use the Other Transaction awarding instrument. The awards are authorized under Public Health Service Act (PHSA) sec. 402(n) 42 USC 282(n), PHSA sec. 421(b)(3) 42 USC 285b-3(b)(3), and PHSA sec. 480(e)(3)(C) 42 USC 287a(e)(3)(C). NIH OT applications are required to be submitted through eRA ASSIST.
Information collected is used by Federal agency staff and Public Advisory Committees and National Advisory Boards and Councils as a basis for evaluating applications in light of agency initiatives and programmatic goals in order to carry out Agency missions in a highly competitive fiscal environment, and for program management, planning, budgeting, appraisal of progress, and reporting to Congress and the public. Information received from the current collection enables PHS agencies to continue to receive research and training applications from the research community and to fund new and competing awards.
Since the last OMB approval, NIH has worked on enhancing several key policies, which are necessary to continue enhancing the quality of basic and preclinical research, as well as NIH-funded clinical trials. Some policy updates that are included in the 0925-0001 revision request include the following:
Starting with due dates on or after January 25, 2025, NIH will require applicants for individual fellowship awards to complete an updated version of the PHS Fellowship Supplemental Form as part of the competing application. The PHS Fellowship Supplemental Form has been updated to streamline and simplify the application by consolidating and reducing the number of required attachment fields and updating the form instructions to align with the change and simplified review criteria. These changes will simplify the application by clearly distinguishing between the requirements for the fellowship candidate and the applicant sponsoring institution. These changes will also improve fellowship peer review to facilitate the mission of these programs to identify the most promising candidates and individualized training opportunities that will assist them along their paths to support the advancement of the biomedical research enterprise.
Also starting with due dates on or after January 25, 2025, NIH will update the PHS 398 Research Training Program Plan form to capture the Recruitment Plan to Enhance Diversity as a separate attachment. Currently, when required in a funding opportunity, this recruitment plan information was captured within the content narrative of the Program Plan attachment and relevant page limits. Including the separate attachment field removes this plan content from the Program Plan page limit, providing more space for the Program Plan content, and provides a transparent attachment in the application image as part of the review process. Additional changes to training grant applications will include updates to the Training Data Tables to reduce burden and promote consistent information collection. Changes include including limiting the scope of information collection to data only relevant to the training stage(s) of the proposed program in Table 1 and removing instructions in Table 8 that are reported within the RPPR. As eRA system implementation details of the data tables in xTRACT are being finalized, NIH anticipates that changes may be required in a subsequent submission or change memo. These changes, developed based on feedback from internal and external stakeholders, are aligned within the application and progress reporting tables and associated instructions.
Effective for due dates on or after May 25, 2025, NIH will adopt the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum (NSPM)-33. The Common Forms are part of a separate OMB collection, currently approved under 3145-0279. As such, duplicative elements that will be collected within the Common Forms will be removed from NIH’s current NIH Biosketch and Other Support formats. NIH will continue to collect additional information not captured on the Common Forms to adhere to the agency’s implementation of the NIH Peer Review Regulations at 42 CFR Part 52 as part of the NIH Biosketch form, which will be renamed the NIH Biographical Sketch Supplement to reflect the supplemental information requested. To facilitate the completion of the Common Forms and the NIH Biographical Sketch Supplement, NIH will require the use of the Science Experts Network Curriculum Vitae (SciENcv) to complete and certify the forms electronically. As additional tools (e.g., an Application Programming Interface (API) to reduce the manual burden of completing the forms) and implementation details are being finalized, NIH anticipates that changes may be required in a subsequent submission or change memo. The application and progress report forms and associated instructions will be updated to align with these new requirements.
This clearance package includes the specific PHS companion forms and application instructions that implement these policy changes.
PHS 398 - The PHS 398 comprises the majority of the respondent burden and is used by applicants, staff, and consultants of PHS as follows:
by applicants to compete for funding for research, training, and related activities, and to request access to agency resources;
by recipients to comply with administrative and policy requirements of terms and conditions of award;
by the NIH Center for Scientific Review, Division of Receipt and Referral, to evaluate eligibility of the applicant, completeness of the application, and to determine the appropriate assignment to a Scientific Review Group and PHS awarding component;
by Scientific Review Groups to evaluate the scientific and technical merit of the application in accord with 42 CFR Part 52h;
by the PHS to process awards, manage programs, and analyze agency support of mission critical research activities;
by the PHS to determine fiscal benefits and administer awards in compliance with public and program policies and all award terms and conditions.
PHS Fellowship Supplemental Form and agency specific instructions used in combination
with the SF424 (R&R) forms/instructions for Fellowships [electronic] - The electronic agency-specific component for NRSA and other individual fellowship applications is the PHS Fellowship Supplemental Form. The basic application, which comprises the majority of the respondent burden, is used by applicants, staff and consultants of NIH and AHRQ and fulfills the same purpose as the PHS 398 (identified in the previous section under items i. through vi.) except it is used for NRSA and other individual fellowships.
PHS 416-1 - The paper 416-1 is used only for post-award change of institution (T-7s) and successor-in-interest actions.
PHS 416-5 - The Activation Notice is used by individuals to indicate the start date of their awards. Individuals have a 6-month period after the initial award is issued to begin training. Also the data is used to determine the timing of subsequent actions such as the notification of the progress report by which the individual applies for support for each additional year. The information is used by the PHS awarding component to establish the start date in the record.
PHS 6031 - The 6031 Payback Agreement certifies an individual’s agreement to fulfill a payback obligation.
a. Transitioning to the SF424 (R&R) and Electronic Submission through Grants.gov - PHS is an active participant in Federal-wide electronic grant initiatives to improve efficiencies, harmonize data collection among Federal granting agencies, and provide one simple, unified electronic portal through which applicants may find funding opportunities for, and request Federal support from 26 different grant-making agencies. Grants.gov provides a standardized interface for agencies to announce their grant opportunities, and a single, secure, and reliable source for all grant applicants to find and apply for those opportunities. These efforts ultimately eliminate paper submissions and unnecessary applicant burden.
PHS utilizes Grants.gov Find for posting 100% of all funding opportunities for grants and cooperative agreements; Grants.gov Apply is used for the majority of program opportunities. NIH worked closely with Grants.gov to develop a process for the submission of complex, multi-project applications using existing SF424 (R&R) forms and the PHS 398 forms included in this collection. The new process implemented by Grants.gov, in combination with the Application Submission System & Interface for Submission Tracking (ASSIST) on-line front-end implemented by NIH to support single- and multi-project programs, enabled NIH to accept all competing grant applications electronically through Grants.gov Apply. Use of ASSIST as a submission option to Grants.gov is being expanded to other Public Health Service agencies and programs.
As discussed under A.1. Circumstances Making the Collection of Information Necessary, unique data and information requirements particular to PHS programs are provided through agency-specific PHS 398 data components and instructions to be used in conjunction with the SF424 (R&R). Some post-award applications that have not transitioned to require electronic submission (e.g. change of institution applications) continue to utilize paper applications comprised solely of PHS 398 forms, which are fillable PDF forms and managed electronically upon receipt at NIH. Similarly, the paper 416-1 is used only in a change of institution, whereas, the electronic PHS Fellowship Supplemental Form is used in combination with the SF424 (R&R) forms and instructions for fellowships.
Consolidation of Supplemental Application Instructions - PHS Supplemental Grant Application Instructions will continue to minimize applicant confusion caused by multiple sets of application instructions with similar or identical information. It consolidates the former Parts II and III of each set of application instructions into one document to be used in conjunction with all sets of instructions (398 paper, 398 electronic, Fellowship, SBIR). See Attachment 14 for the “Supplemental Instructions for Preparing the Protection for Human Subjects Section of the Research Plan” and “Policies, Assurances, Definitions, and Other Information.” Changes to these instructions include policy updates related to inclusion, definitions added for key biological and/or chemical resources and scientific rigor, and editorial clarifications.
Electronic Type 3 Submission - to meet NIH and Federal-wide goals for increasing electronic grants processes, the electronic Type 3, administrative supplement, submission has been developed through Grants.gov and the eRA ASSIST. Administrative supplement applications to NIH will continue to be submitted electronically. This has standardized the application process and reduced burden on recipients; reduced costs by standardizing the processing of administrative supplement requests; and systematized data collected on the diversity and reentry programs. NIH is working to develop a process for submission of an electronic Type 3 multi-project application.
Electronic Type 7 Submission - NIH’s ongoing effort for conversion of electronic operations includes transitioning Change of Institution (Type 7) requests, Successor-in-Interest (Type 6) actions, and transfers of Fellowship (Type 7) applications (currently submitted on 416-1). The paper 416-1 is used only for post-award changes of institution (Type 7). NIH is working to develop a process for submission of an electronic Type 6 and 7 multi-project application.
Electronic Complex Application Submission – NIH now requires all competing applications are submitted electronically, and the majority are submitted through Grants.gov. “Complex” applications include multiple independent subprojects with separate budgets, a feature not currently supported by Grants.gov. To meet the goal of receiving all competing applications electronically, NIH has partnered with Grants.gov to develop ASSIST, which accommodates multiple subprojects utilizing the SF424 (R&R) and PHS 398 family of forms. ASSIST is also an option for all single project applications.
There have been significant applicant burden reductions by 1) using electronic systems to eliminate redundant data collections; 2) reducing confusion by using a single form set for all competing applications; and 3) allowing system-to-system users to submit complex applications directly through Grants.gov.
b. eRA Commons - the electronic Research Administration (eRA) Commons is an electronic infrastructure that provides for the secure agency receipt of applications submitted electronically through Grants.gov, and electronic administration by recipients and PHS staff for the complete grant life cycle. It allows recipients to conduct business with PHS electronically, and automatically transfers information to the NIH enterprise database, IMPAC II, for processing. All relevant business areas--application receipt, referral, review, council, grants management, award processing, program and fiscal administration, reporting, and close-out--are accommodated in the eRA Commons. This initiative represents improved administrative operations through information technologies and reengineered business processes. eRA also includes the functionality for the following pre-award grant processes:
1) Just-In-Time (JIT) allows certain data elements required for competing applications to be submitted electronically and later in the review process (after peer review but prior to funding), and only by those applications likely to be funded. In addition to eliminating paper submission and unnecessary agency processing, JIT significantly reduces applicant burden because information is only requested, through centralized system-generated e-mail notifications, when potential funding is anticipated. The JIT module’s capabilities have recently expanded to allow submission of any text attachment collected in a grant application, allowing potential expansion of JIT and additional burden reductions. Electronic submission of JIT materials is mandatory in the eRA Commons.
2) Personal Profile provides principal investigators and reviewers with a secure electronic environment to maintain in the NIH system information concerning degrees, affiliations with institutions, and other professional information, which associates profiles with NIH grant awards. The majority of the data collected is a one-time collection; however profile data and institutional affiliations are updated as necessary. This data is used by the agencies to evaluate demographic information, determine eligibility for programs, and for workforce analysis. It is also used to prepopulate required data in post-award business processes. All of the data elements in the Personal Profile are found in application forms used by the agencies which are already approved for collection under OMB Clearances 0925-0001 expiration date 01/31/2026 and 4040-0001 expiration date 11/30/2025 (see Attachment 15 for the data elements of the eRA Commons Personal Profile).
c. Electronic submission of data tables via xTRACT - xTRACT supports the optional electronic submission of the new data tables to be used for training grants, institutional career development awards, and research education awards. This module efficiently reduces time spent by applicants preparing and submitting these tables. Use of xTRACT is mandatory for most NIH institutional training awards, and its use will continue expanding to other NIH research education and institutional career development awards.
d. User-friendly Forms - where paper applications and forms are still in use, NIH uses fillable Word forms, increasing efficiency while reducing burden on applicants; forms are also available in PDF format.
e. Use of OER Websites - the NIH Office of Extramural Research (OER) public website is used to provide access to all forms, instructions and business processes in an electronic, accessible environment.
f. Prior Approval Requests - the current submission process for prior approval requests is primarily through email. NIH has developed an electronic submission option through the eRA Commons for applicants and recipients to submit these requests directly to the appropriate official. Review and approval will happen within the system, which is currently optional for applicants and recipients. Examples of prior approval requests include, but are not limited to: withdraw an application after it has been submitted; and request direct costs of $500,000 or more in any one year. See Attachment 18 for screen shots of this system.
d. Privacy Impact Assessment (PIA) - NIH grant systems, such as eRA and IMPAC II) are covered by a PIA. See Attachment 19 for the latest copy of NIH’s PIA.
Similar information does not exist, and thus there is no other method for collection. Information requested as part of the competing application process relates to new and unique requests for funding to support work not previously proposed. In accordance with policy, submissions of identical applications to one or more components of the PHS are not allowed, and similar grant applications with essentially the same research focus are not accepted from the same applicant organization.
NIH actively participates in a number of ongoing Federal-wide initiatives that impact forms and datasets, for example the interagency efforts culminating in the development of the Common Forms for Biographical Sketch and Current and Pending (Other) Support. The Federal-wide SF424 (R&R) is intended to coordinate application data requirements across Federal agencies. When the transition to electronic submission is complete, the PHS 398 will consist of only those data elements that are unique to PHS programs (now the 398 component forms). All agency-specific data requirements are shared within the Federal-wide R&R Working Group of 16 research agencies to determine if other agencies have similar data needs. When common needs exist, the data is added to the SF424 (R&R) forms and then also removed from the agency-specific forms. Some of the changes noted in A.15 below are a result of this collaborative process. At this time, other (non-PHS) agencies do not have a need for the 398 specific data components.
The procedures for small businesses and other small entities are the same as for other applicants and recipients. The Small Business Innovative Research and Small Business Technology Transfer (SBIR/STTR) grants were the first NIH programs to transition to electronic submission. The impact on small business or other small entities is anticipated to be negligible.
The basic information in the PHS 416-1 is a onetime collection. PHS 6031, the payback agreement, is required by governing law and regulations. All other forms in this package represent one time information collections. It is not possible to collect the information less frequently.
Per Section 200.335 in OMB’s Uniform Guidance: If paper copies are submitted, the Federal awarding agency or pass-through entity must not require more than an original and two copies. PHS 398 and 416-1 applications will comply with this requirement. Paper copies are extremely rare as all competing applications are required to be submitted electronically. Other post-submission application materials that may be obtained are typically submitted via email if an eRA module for submission is not available.
An announcement was placed in the Federal Register, Vol.89 No.100, pages 45001-45003, on May 22, 2024 for public comment the data collection project, thereby providing the recipient community an active voice in the revision process. No public comments were received.
Comments were solicited from staff within NIH and the on PHS agencies IT services.
Other consultations occur regularly at NIH Virtual Grants Conferences typically held annually. Participation in the Federal Demonstration Partnership (FDP) (http://thefdp.org), and meetings of professional organizations such as the National Council of University Research Administrators (NCURA), Society for Research Administrators (SRA), and the Council on Government Relations also provides an avenue of productive communication with the recipient research community. Such meetings provide for exchange of information on the peer review system, preparation of applications, and other administrative aspects of the PHS programs. All questions, comments and discussions from these meetings and throughout the year are duly noted and considered when modifying grant related information collections.
There are no payments or gifts to respondents.
The Privacy Act applies to this collection. The NIH maintains application and grant records as part of a system of records as defined by the Privacy Act: NIH 09-25-0036, Extramural Awards and Chartered Advisory Committees (IMPAC 2), Contract Information (DCIS), and Cooperative Agreement Information, HHS/NIH: http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm.The SORN was published in the Federal Register on September 26, 2002 (Vol. 67, No. 187). Release of information is fully explained in all grant related information collections. A Privacy Impact Assessment was completed for the databases used in this submission.
The eRA Commons Personal Profile requests the last four digits of the Social Security number (SSN) and date of birth for purposes of accurate identification, referral, and efficient management of PHS grant programs and system records. Provision of the date of birth and abbreviated SSN are voluntary and no individual will be denied any right, benefit, or privilege provided by law because of refusal to disclose the information. This data is not part of the application reviewed by Advisory Committees or the funding component. All analyses utilizing other voluntarily provided data such as month/year of birth, gender, race and ethnicity report aggregate statistical findings only and do not identify individuals. All sensitive data are maintained in a Privacy Act record system (09-25-0036).
This revision request does not include changes to estimates of burden hours. The changes to the PHS Fellowship Supplemental Form, PHS 398 Training Program Plan, and the Training Data Tables are streamlining and clarifying the field elements and instructions but are not inherently changing the overall information being collected. The information collection that will be retained when the NIH Biographical Sketch Supplement replaces the NIH Biosketch format are the narrative portions of that instrument that account for the majority of the burden. The addition of the NIH Biographical Sketch Supplement does not increase the overall burden as it will replace the NIH Biosketch Format upon its implementation. In summary, the overall estimates to burden are not anticipated to change. NIH is engaging in on-going efforts to evaluate the assessment of burden estimates how to improve them.
Table 12-1 Estimated Annualized Burden Hours
Attachment Name/Number |
Information Collection Forms |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Total Annual Burden Hours |
|
PHS 398 - Paper |
4,247 |
1 |
35 |
148,645 |
PHS 398/424 R&R - Electronic |
|||||
|
PHS Assignment Request Form |
37,120 |
1 |
30/60 |
18,560 |
|
PHS 398 Cover Page Supplement |
74,239 |
1 |
1 |
74,239 |
|
PHS 398 Modular Budget |
56,693 |
1 |
1 |
56,693 |
|
PHS 398 Training Budget |
1,122 |
1 |
2 |
2,244 |
|
PHS 398 Training Subaward Budget Attachment(s) Form |
561 |
1 |
90/60 |
842 |
|
PHS 398 Research Plan |
70,866 |
1 |
10 |
708,660 |
|
PHS 398 Research Training Program Plan |
1,122 |
1 |
10 |
11,220 |
|
Data Tables |
1,515 |
1 |
4 |
6,060 |
|
PHS 398 Career Development Award Supplemental Form |
2,251 |
1 |
10 |
22,510 |
|
PHS Human Subjects and Clinical Trial Information |
54,838 |
1 |
13 |
712,894 |
|
Biosketch (424 Electronic) |
80,946 |
1 |
2 |
161,892 |
|
Data Management and Sharing Plan |
73,117 |
1 |
2 |
146,234 |
PHS Fellowship - Electronic |
|||||
|
PHS Fellowship Supplemental Form (includes F reference letters) |
6,707 |
1 |
13 |
87,191 |
|
Biosketch (Fellowship) |
6,707 |
1 |
2 |
13,414 |
|
416-1 |
29 |
1 |
10 |
290 |
|
PHS 416-5 |
6,707 |
1 |
5/60 |
559 |
|
PHS 6031 |
6,217 |
1 |
5/60 |
518 |
|
VCOC Certification |
6 |
1 |
5/60 |
1 |
|
SBIR/STTR Funding Agreement Certification |
1,500 |
1 |
15/60 |
375 |
NIH Other Transaction |
|||||
|
NIH Other Transaction Application Form |
239 |
1 |
11 |
2,629 |
|
Total Annual Burden Hours |
----------- |
486,749 |
------------ |
2,175,670 |
Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here.
Table 12-2 Annualized Cost to Respondents
Information Collection Forms |
Total Annual Burden Hours |
Hourly Wage Rate |
Total Respondent Cost |
PHS 398 - Paper |
148,645 |
$35.00 |
$5,202,575 |
PHS 398/424 - Electronic |
|
|
|
PHS Assignment Request Form |
18,560 |
$35.00 |
$649,600 |
PHS 398 Cover Page Supplement |
74,239 |
$35.00 |
$2,598,365 |
PHS Human Subjects and Clinical Trial Information |
54,838 |
$35.00 |
$1,919,330 |
PHS 398 Modular Budget |
56,693 |
$35.00 |
$1,984,255 |
PHS 398 Training Budget |
2,244 |
$35.00 |
$78,540 |
PHS 398 Training Subaward Budget Attachment(s) Form |
842 |
$35.00 |
$29,470 |
PHS 398 Research Plan |
212,598 |
$35.00 |
$7,440,930 |
PHS 398 Research Training Program Plan (includes data tables) |
3,366 |
$35.00 |
$117,810 |
Data Tables |
6,060 |
$35.00 |
$212,100 |
PHS 398 Career Development Award Supplemental Form |
6,753 |
$35.00 |
$236,355 |
Biosketch |
161,892 |
$35.00 |
$5,666,220 |
Data Management and Sharing Plan |
146,234 |
$35.00 |
$5,118,190 |
PHS Fellowship - Electronic |
|
|
|
PHS Fellowship Supplemental Form (includes F reference letters) |
83,838 |
$35.00 |
$2,934,330 |
PHS Assignment Request Form |
1,677 |
$35.00 |
$58,695 |
Biosketch |
13,414 |
$35.00 |
$469,490 |
416-1 |
290 |
$35.00 |
$10,150 |
PHS 416-5 |
559 |
$35.00 |
$19,565 |
PHS 6031 |
518 |
$35.00 |
$18,130 |
VCOC Certification |
1 |
$35.00 |
$35 |
SBIR/STTR Funding Agreement Certification |
375 |
$35.00 |
$13,125 |
NIH Other Transaction |
|
|
|
NIH Other Transaction Application Form |
2,629 |
$35.00 |
$92,015 |
Total |
|
|
$51,138,518 |
Other annual costs to respondents or record keepers are associated with customary and usual business or practices of organizations applying for PHS funding. There are no additional costs to the respondents.
The estimated annual cost to the NIH is approximately $238,382. This information is calculated based on the NIH Policy Analyst and Health Scientist Administrator’s salary and percentage of effort devoted to preparing this submission. These expenses would not have been incurred without this collection of information.
Annualized Cost to the Federal Government
Staff |
Grade/Step |
Salary |
% of Effort |
Fringe (if applicable) |
Total Cost to Government |
Federal Oversight |
|
|
|
|
|
NIH Systems Policy Analyst |
14/6 |
162,629 |
50% |
|
81,315 |
NIH Supervisory Grants Management Specialist |
15/4 |
180,359 |
50% |
|
90,180 |
|
|
|
|
|
|
Contractor Cost |
|
|
|
|
|
Travel |
|
|
|
|
|
Other Cost |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
171,495 |
**the Salary in table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2024/DCB.pdf.
At a minimum there should be federal oversight costs. Fill others as applicable. Shaded areas are exempt.
This submission represents a program change due to the changes being implemented for institutional training and individual fellowship applications as well as adjustments to align with interagency efforts and NIH’s adoption of the Common Forms for Biographical Sketch and Current and Pending (Other) Support. This revision request does not include changes to estimates of burden hours. The changes to the PHS Fellowship Supplemental Form, PHS 398 Training Program Plan, and the Training Data Tables are streamlining and clarifying the field elements and instructions but are not inherently changing the overall information being collected. The information collection that will be retained when the NIH Biographical Sketch Supplement replaces the NIH Biosketch format are the narrative portions of that instrument that account for the majority of the burden. The addition of the NIH Biographical Sketch Supplement does not increase the overall burden as it will replace the NIH Biosketch Format upon its implementation. In summary, the overall estimates to burden are not anticipated to change.
A Summary Table of Noteworthy Changes or Adjustments:
Form |
Adjustments |
Attachment 3-4: PHS 398 paper application form and instructions |
Updated and further streamlined form and instructions to align with previous clearances and remove all references to mailing in paper applications for competing grants since applicants are required to submit competing applications electronically.
Updated to add instructions to address a Data Management and Sharing Plan if applicable to the project.
|
Attachment 5C: PHS Assignment Request Form |
Removed NOFO number and title and reformatted to a single portrait-orientated page. Reordered “List individuals who should not review your application and why” and “Identify scientific areas of expertise needed to review your application” fields. Streamlined and clarified instructions.
|
Attachment 5E: PHS 398 Cover Page Supplement Form |
Updated labels in item 6 to reflect recipient terminology consistent with 2 CFR 200.
|
Attachment 5R-S: PHS 398 Research Training Program Plan |
Added new item 3. Recruitment Plan to Enhance Diversity attachment and renumbered other sections accordingly. Updated and clarified instructions for item 2. Program Plan which previously contained the approved instructions for the Recruitment Plan to Enhance Diversity.
Updated and clarified other instructions, for example, adding instructions for renewal applications to for item 5. Plan for Instruction in Methods for Enhancing Reproducibility.
|
Attachment 6A-B: PHS Fellowship Supplemental Form and agency specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic] |
Updated the Fellowship Applicant Section label to reflect Candidate Section. Renamed item 2 to reflect Goals, Preparedness, and Potential.
Updated Research Training Plan section attachments to reorganize and streamline. Updated numbering throughout form accordingly. Section reflects attachment items 3-7 as follows:
Updated the Sponsor(s), Collaborator(s), and Consultant(s) Section label to reflect Commitment to Candidate, Mentoring, and Training Environment. Updated attachment for Sponsor and Co-sponsor Statements to reflect Sponsor(s) Commitment.
|
Attachment 7A-H: PHS 416-1 Fellow Change of Sponsoring Institution Application |
Updated and further streamlined Face Page 4 (Attachment 7E) to align with the changes requested on the PHS Fellowship Supplement Form as this is the optional paper application for a change of sponsoring institution. Form label terminology was aligned with references to “candidate” throughout to differentiate from the applicant/sponsoring institution.
|
Attachment 9A_Att A2/9B_Att B: Biosketch (Non-fellowship)
|
Will no longer be used for due dates on or after May 25, 2025. Will be replaced by the Common Form for Biographical Sketch (OMB Number: 3145-0279) and the new NIH Biographical Sketch Supplement form (see Attachment 9C). |
Attachment 9C: NIH Biographical Sketch Supplement and Instructions |
New NIH Biographical Sketch Supplement form and instructions that will replace the current NIH Biosketch format page for both fellowship and non-fellowship applications effective for due dates on or after May 25, 2025 when NIH transitions to the Common Forms for Biographical Sketch and Current and Pending (Other) Support (OMB Number: 3145-0279). This new form will collect a subset of NIH-specific items currently on the NIH Biosketch format page.
|
Attachment 10A_Att A1/10B-C: Biosketch (Fellowship) |
Will no longer be used for due dates on or after May 25, 2025. Will be replaced by the Common Form for Biographical Sketch (OMB Number: 3145-0279) and the new NIH Biographical Sketch Supplement form (see Attachment 9C). |
Attachment 11A-D: Training Data Tables |
Updated table designations and formatting throughout data tables for consistent alignment with predoctoral, postdoctoral, undergraduate, etc.
Removed duplicative information covered in the RPPR.
Updated and clarified instructions. |
There is no tabulation, publication, or project time schedule associated with use of forms.
The OMB number and expiration date will be displayed in all electronic modules and on paper forms.
This project conforms to all of the 5 CFR 1320.9 requirements; no exceptions are requested.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Subject | Supporting Statement A |
| Author | Lopez, Maria (NIH/NICHD) [E] |
| File Modified | 0000-00-00 |
| File Created | 2024-09-26 |