sub-study for EIAP Applications

Mini Supporting Statement A

Early Investigator Advancement Program (EIAP) Applications

(National Cancer Institute)

Sub-study under,

“Generic Clearance for Application Information for

Fellowship, Internships, Training Programs, and Specialty Positions

(National Cancer Institute)”

OMB# 0925-0761,

Expiration Date: 7/31/2025

Date: July 19, 2022

Federal Government Employee Address:

Name: Samson Gebreab

Address: 9609 Medical Center Drive, MSC 9746 Rm 6W236, Rockville, MD 20892

Telephone: 240-276-6177

Fax: 240-276-7862

Email: [email protected]

List of Attachments

Attachment 1: EIAP Application

Attachment 2: Request for Reference Letter

Attachment 3: Privacy Act Memo

A.1 Circumstance Making the Collection of Information Necessary

The Early Investigator Assistance Program (EIAP) fulfills the requirements of the National Cancer Institute (NCI) training authority as established under Section 413 (b) (3) of the Public Health Service Act, 42 USC 285a-2 (b) (3), as amended pertaining to the NCI, which states that the NCI Director, in carrying out the National Cancer Program . . . shall . . . "support appropriate programs of education and training (including continuing education and laboratory and clinical research training).” In addition, enhancing the diversity of the cancer research workforce in the nation, especially at the early investigator career level, is an NCI priority.

The cancer research enterprise needs a continuous flow of talent through the research career pipeline to thrive. One critical juncture is the transition from junior investigator to independent investigator. This is arguably the most challenging step, made more by the lack of consistent and structured support. While challenging for all, the obstacles in this critical transition can be particularly exacerbating for junior investigators from underrepresented populations.

An essential element of a successful transition to an independent investigator is a competitive R01 or R01-equivalent grant application. Currently, a significant underrepresentation of diverse populations exists in the ranks of R01-equivalent scientists (Guers et al., 2017, Valantine, 2016, Ginther, 2011). Increasing the number of underrepresented R01-equivalent scientists will require an increase in applicants, increase the resubmission rate and enhance the competitiveness of submitted applications. While some institutions offer training opportunities that help potential applicants in professional development and grantsmanship, many do not. This variability in training can be especially detrimental for under-resourced institutions that often support under-served populations.

Gaining grant preparation skills is not the only essential ingredient to research independence. Effective mentoring is critical to career advancement, yet underrepresented faculty often experience a lack of access to mentors (Zambrana et al., 2015, Beech et al., 2013). In addition, feelings of belonging and social connectedness are vital to underrepresented scientists (Fisher et al., 2019, Walton et al., 2007). Promoting the transition of underrepresented junior investigators to independent investigators needs a program that can integrate these mission-critical components through deliberate planning.

With the support of the NCI Equity Council, the Center to Reduce Cancer Health Disparities (CRCHD) is launching the EIAP to facilitate the advancement of scientists from diverse backgrounds to independent investigators through:

1. Educating EIAP participants via monthly webinars

2. Assisting EIAP participants in building grant writing skills and producing a grant application

3. Providing mentors and a professional network to EIAP participants

4. Providing EIAP participants with a virtual hub with helpful information.

The EIAP will establish one cohort of 70 participants each year. Outcomes for a successful participant will include:

• Completing an R01 grant proposal

• Becoming part of a group of peers with similar career goals

• Engaging with mentors who are established, investigators

• Becoming familiar with job and funding opportunities

• Developing professional and management skills critical to growing a research group.

A successful EIAP candidate holds an investigator-level position, is capable of obtaining an R01, and can submit an R01 upon completion of the program. In addition, EIAP candidates should not have previously received an NIH R01 or equivalent grant. This collection of information is critical in assessing the eligibility and qualifications of applicants and helping in the recruitment and selection process of EIAP participants.

A.2 Purpose and Use of the Information Collection

The purpose of the proposed information collection activity is to:

• Assure that prospective applicants to the EIAP meet basic eligibility requirements.

• Assess their potential to submit an R01 grant proposal upon program completion.

• Make decisions regarding which applicants will be selected to participate in the EIAP.

In each case, completing the application is voluntary, but to receive due consideration, the prospective awardee is encouraged to complete all relevant fields. The information is for internal use to make decisions about prospective candidates who could benefit from the EIAP program. The EIAP has been approved for funding by the NCI Equity Council.

Participants in the EIAP must be U.S. citizens, non-citizen nationals, or legal permanent residents. The EIAP will include participants who are currently at an institution, hold an investigator-level position, are capable of obtaining an R01, can submit an R01 by the completion of the program, and have not previously received an NIH R01 or equivalent grant. Individuals from groups identified in the Notice of NIH’s Interest in Diversity (NOT-OD-20-031) as underrepresented in the biomedical, clinical, behavioral, and social sciences are particularly encouraged to apply.

The EIAP application includes a cover letter with a personal statement, the applicant’s NIH bio-sketch, a letter of support from the institution, a letter of support from a mentor at the applicant’s current institution, and at least one letter of recommendation from any current or previous research mentor or collaborator (Attachment 2).

A.3 Use of Information Technology and Burden Reduction

Applicants for EIAP must apply directly to CRCHD (Attachments 1 and 2). Information that comes now to CRCHD will be collected by email submission. CRCHD is developing an electronic application system and expects to launch the application system shortly.

The NCI Privacy Act Coordinator was consulted and determined that a Privacy Impact Assessment (PIA) is not needed.

Applicants voluntarily submit their information to CRCHD by email. Information collected is only made available through encrypted emails or folders with restricted access to NIH account holders who are NCI or NIH scientific and program officials who recommend or approve fellowship awards and to administrative, human resources, and financial officials who prepare the necessary documentation to arrange for stipend payments and to activate approved awards. These authorized individuals will access their emails or folders with restricted access through NIH credentials. Applications not selected for EIAP support will be kept for three years; applications selected for EIAP support will be held for up to 15 years.

The applications, including applicant data, are stored on government-issued desktop computers and information systems protected at all entry points by firewalls and intrusion detection devices.

A.4 Efforts to Identify Duplication and Use of Similar Information

The primary purpose of the EIAP is to promote the transition of junior investigators to independent investigators while furthering NCI’s commitment to diversity. The EIAP will help enhance professional skills, guide the construction of an R01 grant application, provide a mentoring and peer network and build a diverse community of emerging independent investigators.

While there are webinar series and professional development activities offered by NIH to the extramural communities, there is currently no other program at NCI or NIH like the EIAP. No existing application system is ideally situated to help identify junior investigators in cancer research from diverse backgrounds who are ready and qualified to apply for an R01.

A.5 Impact on Small Businesses or Other Small Entities

No small businesses or other small entities will be impacted.

A.6 Consequences of Collecting the Information Less Frequently

Without approval to collect applications specific to the program’s needs, the EIAP would be compromised in its ability to identify highly qualified applicants.

A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances for this information collection request relating to guidelines of 5 CFR 1320.5.

A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency

N/A

A.9 Explanation of Any Payment of Gift to Respondents

Neither payments nor gifts will be provided to respondents who complete the application.

A.10 Assurance of Confidentiality Provided to Respondents

There is no assurance of confidentiality provided to the applicants. However, their information will be kept private to the extent provided by law.

The NIH Privacy Act Officer was consulted and determined the information collected is covered by the NIH Privacy Act Systems of Records Notice (SORN) is #09–25–0014, “Clinical Research; Student Records, HHS/PHS/NIH/OD/OIR/OE” (Attachment 3).

A.11 Justification for Sensitive Questions

The EIAP application will collect information on race, ethnicity, gender, disability, and socioeconomic status. This will help CRCHD staff assess the effectiveness of the EIAP in reaching its primary goal of advancing underrepresented scientists to independent investigators. This information will be used solely to help evaluate outcomes of the EIAP and identify gaps to be addressed.

A.12 Estimates of Hour Burden Including Annualized Hourly Costs

The EIAP plans to collect application and reference letters to help evaluate the merits of candidates and their potential match for the EIAP. The EIAP anticipates receiving 70 applications per year from early-career scientists. The Program expects to receive two additional reference letters to support the candidates. The annual burden estimate is expected to be 280 hours for 210 individuals (Table A.12-1). The annual respondent costs are $13,843.20 (Table A.12-2).

A.12-1 Estimated Annualized Burden Hours

Form Name	Category of Respondent	Number of Respondents	Number of Responses per Respondent	Average Time Per Response (in hours)	Total Burden Hour
EIAP Application	Individuals -Applicant	70	1	3	210
Reference Letter	Individuals - PIs, Professors, and Supervisors	140	1	30/60	70
Totals			210		280

A.12-2 Annualized Cost to the Respondents

Category of Respondent	Total Burden Hours	Hourly Respondent Wage Rate*	Respondent Cost
Individuals	280	$49.44	$13,843.20
Totals			$13,843.20

*The hourly wage rate for the PIs, professors and supervisors was calculated using the BLS wage rate for Medical Scientists (19-1040), https://www.bls.gov/oes/2021/May/oes_nat.htm#19-1040.

A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no capital, operating, or maintenance costs to report.

A.14 Annualized Cost to the Federal Government

The annualized cost to the Federal Government for the proposed data collection effort is estimated to be approximately $36,682.30 (Table A.14-1). This includes the responses to potential candidates’ requests for reference letters, tracking the applications, the evaluation and analysis of completion of the applications, and monitoring the overall process. The Federal oversight amounts to $10,682.30, and the contractor costs are $26,000.00.

A.14-1 Annualized Cost to the Federal Government

Staff	Grade/Step	Salary***	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
HSA	13-1	$ 106,823	10%		$ 10,682.30
Contractor Cost					$26,000.00
Travel					$0
Other Cost					$0
Total					$ 36,682.30

**The salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/22Tables/html/DCB.aspx

A.15 Explanation for Program Changes or Adjustments

This is a mini–Supporting Statement for a generic information collection.

A.16 Plans for Tabulation and Publication and Project Time Schedule

There are no plans for tabulation or publication since this is a request for applications. The applications will be used for annual program assessments and reviews and to assess an applicant's appropriateness for the EIAP.

The application period will open upon receiving OMB clearance and remain open for one month. The future year application period will be October through November (Table A.16-1).

Table A.16-1. Project Time Schedule: Application Opening and Closing Dates

Training Program	Application Opening Date	Application Closing Date
EIAP 2021	Upon receiving clearance	One month after opening
EIAP 2022 and following years	October	November

A.17 Reason(s) Display of OMB Expiration Date is Inappropriate

There is no request for exemption from displaying the expiration date of OMB approval.

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the Certification for Paperwork Reduction Act Submissions.