Final Support_StatementA_2020 for Extension of exp 2-28-2021

Supporting Statement A for

NIH Special Volunteer and Guest Researcher Assignment (OD)

OMB# 0925-0177 Expiration date: 02/28/2021

Date: January 15, 2021

Check off which applies:

• New

• Revision

• Reinstatement with Change

• Reinstatement without Change

X Extension

• Emergency

• Existing

Federal Government Employee Information:

Dr. Arlyn Garcia-Perez

Director of Policy and Analysis, Office of Intramural Research

Office of the Director, NIH

Building 1, Room 160

Bethesda, MD 20892-0140

Phones: (301) 496-1381

Email: [email protected]

Table of contents

A. JUSTIFICATION

A.1 Circumstances Making the Collection of Information Necessary

A.2. Purpose and Use of the Information COLLECTION

A.3 Use of Information Technology and Burden Reduction

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

A.5 Impact on Small Businesses or Other Small Entities

A.6 Consequences of Collecting the Information Less Frequently

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

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

A.9 Explanation of Any Payment of Gift to Respondents

A.10 Assurance of Confidentiality Provided to Respondents

A.11 Justification for Sensitive Questions

A.12 Estimates of Hour Burden Including Annualized Hourly Costs

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

A.14 Annualized Cost to the Federal Government

A.15 Explanation for Program Changes or Adjustments

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

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

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

B. Attachments

1. Form NIH-590, Special Volunteer and Guest Researcher Assignment (OMB # 0925-0177)

2. NIH Special Volunteer Agreement

3. NIH Guest Researcher Agreement

4. NIH sample letter acknowledging expression of interest in the NIH Special Volunteer/Guest Researcher Program and request to provide information for Form 590

A. Justification

The NIH needs to collect information on individuals who wish to volunteer their services (Special Volunteers) or wish to use NIH facilities for part of their research (Guest Researchers) to assess their eligibility and match to existing intramural NIH research programs.

A.1 Circumstances Making the Collection of Information Necessary

42 USC 241 (a) (2) permits the National Institutes of Health (NIH) to make research and study facilities available to qualified health officials, scientists, and engineers for use in the furtherance of their own research investigations. These Guest Researchers are neither employed by, nor do they provide services to, the NIH, but rather pursue their own research interests. Authorities at 42 USC 282 (b) (10) and 42 USC 284 (b) (1) (K) permit NIH to accept volunteer services in support of a wide variety of NIH activities. Individuals providing uncompensated services to the NIH under these latter two authorities are referred to as Special Volunteers. In addition, See 45 CFR Part 9, Use of HEW Research Facilities by Academic Scientists, Engineers, and Students.

This is an Extension of an approved collection, OMB Control #0925-0177, with an expiration date of 02/28/2021. Because data required for these two Programs are similar, a consolidated Form NIH-590 is used (See Attachment 1). This form number and the data collected has not changed from the last approval cycle.

A single Form NIH-590 is completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/her arrival at NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities, or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file.

A.2 Purpose and Use of the Information Collection

Currently, there are approximately 2100 Special Volunteers and 200 Guest Researchers at the NIH. The number of Special Volunteers and Guest Researchers has decreased likely due to stricter NIH rules for access to NIH facilities, including to foreign nationals. Equal to the demand for scientists is the need for Special Volunteers who are able to contribute their expertise and talents in support of NIH’s mission. Approximately 200 Guest Researchers are using NIH’s research facilities to further their research, and by furthering their research, they are indirectly contributing to NIH’s effort to uncover new knowledge that will lead to better health for our nation. Depending upon the Program, the information has been used by Scientific Directors/IC Directors or a delegated official at the Institute/Center level to determine that (1) the volunteer or guest researcher is qualified to do the proposed work; (2) the applicant has sufficient income to support himself/herself during the period of the assignment; (3) the Special Volunteer’s proposed project or activity will provide a needed service to NIH; and (4) the Guest Researcher’s proposed project will not interfere with ongoing Federal projects.

There is no other form or record upon which these decisions could be based. NIH does not solicit or request outside individuals to use its facilities or provide voluntary services, and consequently program announcements are neither appropriate nor are they published. Rather, initial inquiries regarding opportunities to volunteer or to use NIH facilities are initiated by the individuals, based on their knowledge of the NIH mission and ongoing research and research support activities acquired through review of the scientific literature, peer contacts, or word of mouth. Inquiries are made in person, by telephone, or by letter, and do not routinely provide all the necessary information. The form is completed by a designated administrative official and reflects information obtained from the prospective Guest Researcher or Special Volunteer through person-to-person inquires, telephone contacts, or correspondence with these interested parties. The information collection appears to be well received, and Special Volunteers and Guest Researchers have readily agreed to provide the requested information.

A.3 Use of Information Technology and Burden Reduction

The simple form is adequate to record the information with minimum burden. The form is filled by the sponsoring Intramural Division of individual NIH Institutes or Centers with privacy considerations in place. There is no NIH central collection of the form or the information on the form, or central automation of the process or central database with the information, except for Special Volunteers or Guest Researchers who are foreign nationals. In those cases, the Division of International Services, Office of Research Services, NIH, keeps all the foreign national’s information required by the Department of State and the Department of Homeland Security in a database sanctioned by them with all the required securities.

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

No duplicate information exists. All information is in the hands of potential program participants.

A.5 Impact on Small Businesses or Other Small Entities

The information is unique to the individual concerned and not available from other sources. Only individuals are eligible for the Special Volunteer or Guest Researcher Programs. No small businesses will be involved in this collection of information.

A.6 Consequences of Collecting the Information Less Frequently

Information is normally collected only once in a given year, when a non-federal scientist asks to use NIH’s unique research facilities, or when an individual volunteers his/her services in support of NIH’s ongoing activities. Initial assignments may be made for the period based upon individual Institute and Center policy, and may be extended beyond that point upon mutual agreement of the individual and the NIH. Another Form NIH-590 is completed for extensions.

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

This information collection is consistent with these guidelines.

A.8.1 Comments in Response to the Federal Register Notice

This proposed information collection was previously published in the Federal Register on November

13, 2020, pages 72672-72673 (85 FR 72672) and allowed 60 days for public comment. No public

comments were received.

A.8.2 Efforts to Consult Outside Agency

Information is obtained only from the individuals who express interest in participating in the NIH Special Volunteer or Guest Researcher programs. The information is obtained once in a year and subsequently every year of assignment extension.

A.9 Explanation of Any Payment of Gift to Respondents

No gifts or payments will be made to applicants for completing the application forms.

A.10 Assurance of Confidentiality Provided to Respondents

Administrative staff members complete the form and copies of the form are distributed only to servicing human resources offices and the Division of International Services, Office of Research Services, NIH - for foreign Guest Researchers and Special Volunteers only. The information collected is subject to the Privacy Act and is part of records system 09-25-0108, Personnel: Guest Researchers/Student Scientists/Special Volunteers/Scientist Emeriti published in the Federal Register, December 24, 1991, pages 66709-66710. Expressions of interest in these Programs are unsolicited, and originate in person, by letter, or by phone. In each instance, NIH staff members make the inquirers fully aware of the implications of the Privacy Act for the information they provide. This is done by providing the Privacy Act statement or by reading the Privacy Act statement to the individual prior to requesting the information. When inquirers elect to provide the information by letter, the Privacy Act statement is mailed to them with a brief note of acknowledgment of their request. Because each component of the NIH responds separately, no standardized reply is used. A copy of one such letter is attached (Attachment 4).

Copies of Form NIH-590 are stored in locked file cabinets and destroyed by means of shredding and burning 3 years after the Special Volunteer or Guest Researcher departs from the NIH.

A.11 Justification for Sensitive Questions

Information collected is limited to that necessary to determine the individual’s eligibility and qualifications for program participation and the appropriateness of the proposed assignment. With the exception of the following, none of the remaining questions could be considered sensitive.

• Question #6. Citizenship – For non-citizens already in this country, NIH provides data on permanent residence and visa status to the Departments of State or Justice as appropriate, so that the individual’s visa can be transferred, extended, or changed to permit assignment to NIH. For non-citizens still in their home country, NIH completes and forwards the appropriate visa application to the individual, so that he/she may apply for a visa at the nearest U.S. embassy or consulate.

• Question # 10. Date of Birth – This information is required in order to determine whether an applicant for the Special Volunteer Program is a minor, in which case the parent or guardian must sign the NIH Special Volunteer Agreement (Attachment 2).

• Question #15. Health Insurance Coverage – Because many foreign visitors are unfamiliar with the U.S. health care system and high cost of medical services in this country, foreign Guest Researchers and Special Volunteers are required to have health insurance coverage to assure their adequate protection in the event of illness or injury. In addition, NIH policy requires that any individual using NIH facilities who receives fellowship or stipend support from other Federal agencies or non-government organizations must have adequate health benefits coverage.

• Question #16. Source of Salary or Stipend

Question #17. Amount of Salary or Stipend

• Question #18. Outside Sponsor – Salary information is necessary to assure that prospective Guest Researchers and Special Volunteers (if applicable) have sufficient monetary resources to be able to afford to live in the Washington, D.C. metropolitan area during the period of the assignment, without support from NIH. Since past experience has shown that many foreign Guest Researchers and Special Volunteers claim but do not actually have sponsorship, foreign participants must provide proof of funding before the assignment is approved. Proof must be in the form of a letter or other verification from the sponsor certifying as to the funding amount and period of coverage. A copy of the sponsor’s official award notice to the individual is normally provided and is acceptable for this purpose.

A.12.1 Estimates of Hour Burden Including Annualized Hourly Costs

The information collected on the form is of a clear-cut and routine nature and takes approximately 6 minutes to record. Approximately 2300 forms are completed throughout NIH each year with the following estimated annual hour burden. The number of total forms has been reduced due to the decrease in Special Volunteers and Guest Researchers mentioned above.

Table 12-1 Estimated Annualized Burden Hours

Form Name	Type of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Annual Hour Burden Hours
Special Volunteer and Guest Researcher Assignment	Special Volunteers and Guest researchers	2300	2	6/60	460
NIH Special Volunteer Agreement	Special Volunteers	2100	1	5/60	175
NIH Guest Researcher Agreement	Guest Researchers	200	1	5/60	17
	TOTALS	2300	6900		652

A.12-2 Annual Cost to respondent

Table 12-2 Annualized Cost to Respondents

Type of Respondents	Total Annual Burden Hours	Hourly Respondent Wage Rate*	Respondent Cost
Special Volunteers	385	*$23.00	$8.855.00
Guest Researchers	37	*$36.00	$1332.00
TOTAL	422		$10,187

*Bureau of Labor Statistics: The General Public rate was obtained from t https://www.bls.gov/oes/tables.htm#00-0000 (used most current year posted, May 2019)

The Health Professionals wage rate was obtained from https://www.bls.gov/oes/current/oes290000.htm (used most current year posted, May 2019)

Occupation title “Healthcare Practitioners and Technical Occupations”, occupation code 29-0000;

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

There are no Capital Costs, Operating Costs, or Maintenance Costs to report.

A.14 Annualized Cost to the Federal Government

The annualized cost to the federal Government is $38,555. The total cost over a 3-year period is $115,664. Office personnel costs for administration of this data collection activity are calculated based on an estimated annual 50% effort for a GS 11 level FTE, at an estimated total cost of

$ 77,109.00 annually (based on January 2020 locality rates for Washington-Baltimore, DC-MD-VA-WV). Costs of reproducing the form are minimal. This estimate is itemized in the following table.

Cost Descriptions	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Analyst	11/5	$77,109	50%		$38,555
Contractor Cost
Travel
Other Cost
Total					$38,555

A.15 Explanation for Program Changes or Adjustments

This is an Extension of a currently approved information collection request. There are no program changes or adjustments.

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

Upon OMB approval, the extension of the NIH Special Volunteer and Guest Researcher Assignment (NIH Form 590) will continue to be operational in administration of the existing NIH Special Volunteer and Guest Researcher Programs. No results will be published for this collection.

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

The OMB expiration date will be displayed on the data collection instrument.

A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

None