TREAT Astronaut Act Supporting Statement Parts A_Final

Information Collection for NASA TREAT Astronauts Act

Support Statement for Information Collection Requirements

Information Collection for NASA TREAT Astronauts Act

Form name: Electronic Medical Record

TYPE OF ACTION: NEW

OMB Control Number: 2700-XXXX

Part A. Justification

1. Need for the Information Collection: Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The National Aeronautics and Space Administration’s (NASA) Office of Chief Health and Medical Officer (OCHMO), in conjunction with Johnson Space Center (JSC), Flight Medicine Clinic (FMC) is implementing the National Aeronautics and Space Administration Transition Authorization Act of 2017 the TREAT Astronauts Act, noted in subsection 441. (https://www.congress.gov/115/plaws/publ10/PLAW-115publ10.pdf).

The approved PUBLIC LAW 115–10 states:

This law authorizes the National Aeronautics and Space Administration (NASA) to provide for:

• the medical monitoring and diagnosis of a former United States government astronaut or a former payload specialist for conditions that the Administrator considers potentially associated with human space flight; and

• the treatment of a former United States government astronaut or a former payload specialist for conditions that the Administrator considers associated with human space flight, including scientific and medical tests for psychological and medical conditions.

Implementation of this act necessitates the collection of information from former astronauts and/ or former payload specialists at the JSC FMC in order to provide treatment. Additionally, the information collected will develop a knowledge base on the effects of spaceflight; and identify any gaps in services that support medical monitoring, diagnosis and treatment of conditions associated with human space flight.

2. Use of this Information: Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

The purpose for this information collection is to support the approved TREAT Astronauts Act for former astronauts and/ or former payload specialists. This information is collected with electronic forms built into the Electronic Medical Records (EMR) software in operation at the JSC, FMC.

The EMR is governed by NASA’s Health Information Management System (10 HIMS) and NASA’s Privacy Act System of Records Notice (SORN) regulations. This information is collected by authorized healthcare providers assigned to, employed by, contracted to, or under partnership agreement with the JSC, FMC. The purpose of the information collected using the EMR electronic form is for evaluating the adequacy, appropriateness and quality of care used for clinical decision making.

3. Use of Information Technology: Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

The form in this collection is electronic within the clinic’s Electronic Medical Records (EMR) software at Johnson Space Center (JSC) Flight Medicine Clinic (FMC). Authorized healthcare providers at JSC FMC conduct the collection of information into the EMR. There is no automated technique for collecting or obtaining clinical information.

4. Efforts to Identify Duplication: Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

The information that NASA collects is unique to the respondent and is not available from any other source. Information collected previously during the course of the former astronaut’s career at NASA is also part of the EMR and prevents any duplication of information collected. This allows NASA to avoid recreating health histories or collecting relevant information previously produced by or for NASA.

5. Burden on Small Business: If the collection of information impacts small businesses or other small entities (Item 5 of OMB Form 83-I), describe any methods used to minimize burden. If the collection does not have a significant impact on small business, you may state something to the effect that “Collection of this information does not have a significant impact on small businesses.”

The collection of this information does not have a significant impact on small businesses or other small business entities.

6. Consequences of Not Collecting the Information: Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

If accurate information of former astronauts and/ or payload specialists is not collected or was collected less frequently, clinical decision making and treatment for former United States government astronaut or a former payload specialist would be compromised. This would negatively impact the authorized treatment of all former astronauts or former payload specialists for conditions that the NASA Administrator considers associated with human space flights.

7. Special Circumstances: Explain any special circumstances that would cause an information collection to be conducted in a manner: (Exceptions/special circumstances must be explained if the collection of information is not conducted in a manner consistent with the guidelines for PRA in 5 CFR 1320.6” below)

The collection of information in the EMR is necessary as a critical component of supportive clinical services required for the monitoring, diagnosis and treatment of spaceflight associated conditions in compliance with federal regulations noted above. Collection of relevant information is determined by clinical necessity, and may occur more frequently than quarterly.

8. Consultation and Public Comments: If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

60-day FRN: Federal Register Volume _83_, Number _245_, on December, 21, 2018. No comments were received.

30-day FRN: Federal Register Volume __84__, Number _58__, on March 26, 2019. /No comments were received.

9. Payments to Respondents: Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

No payments or gifts will be provided to the respondents.

9. Assurance of Confidentiality: Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

Confidentiality of all information collected within the EMR is maintained in compliance with:

• The Privacy Act of 1974, 5 U.S.C. § 552a,

• NASA System of Records Notice (SORN)10 HIMS

11. Sensitive Questions: Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

Collecting private information of sensitive nature may be a part of routine health monitoring of former astronauts and/ or payload specialists, as appropriate. Inquiry by clinic staff about information of a sensitive nature is relevant for comprehensive health history. The sensitive information can be used to provide comprehensive treatment and allow authorized clinical personnel to provide information necessary for meeting both health treatment goals.

12. Respondent Burden Hours and Labor Costs: Provide estimates of the hour burden of the collection of information.

We estimate that there will be approximately 175 respondents annually for this collection. The completion times vary depending on the activity associated with the clinic visit. At an average, completion time of 0.5 hours per collection, we estimate the annual burden hours to be 87.5. The table below lists the details.

RESPONDENT CATEGORY	NUMBER OF RESPONDENTS	ESTIMATED COMPLETION TIME	ANNUAL BURDEN
Former United States government astronauts or a former payload specialists	175	0.5	87.5
TOTAL	175	0.5	87.5

13. Estimates of Cost Burden to the Respondent for Collection of Information: Provide an estimate for the total annual cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12 and 14).

We estimate the annual cost burden to respondents to be $4,375. We estimate an average of $50.0 per hour for salary based on review of records.

Burden Calculation:  Labor Cost of Respondent Burden
	Number of Total Responses	Response Time	Respondent Hourly Wage	Labor Burden per Response	Total Labor Burden
Survey 1	175	0.50	50	25	4,375

14. Cost to the Federal Government: Provide estimates of annualized costs to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses, and any other expense that would not have been incurred without this collection of information.

The annual cost to the Federal Government for this information collection is approximately $10,325. These costs are primarily for staff time to process clinic visits. We estimate an average of $29.5 per hour for salary. Review/ processing time for information associated with each clinic visit varies from 0.5 hours to 2 hours depending on activity.

Cost to Federal Government:  Annualized Cost
	Number of Total Responses	Average time per Response (hours)	Average Cost (hourly)	Total Cost to Government
Survey 1	175	2.0	29.5	10,325

15. Changes in Burden: Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-I, if applicable.

No program changes or adjustments are applicable.

16. Publication of Results: For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

NASA will not publish results from these information collections.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

NASA will display the OMB control number and expiration date.

18. Explain each exception to the certification statement identified in Item 19, "Certification for Paperwork Reduction Act Submissions," of OMB Form 83-I.

The NASA information collection sponsor (civil service employee) must address the certification below, and enter their name and position title. The NASA Office of the Chief Information Officer must concur on any exceptions requested by the information collection sponsor, or the package will not be forwarded to OMB.

NASA will display the OMB control number and expiration date.

The NASA office conducting or sponsoring this information collection certifies compliance with all provisions listed above.

Name: Dr. Mark E. Mavity, MD, MPH

Title: Director, Health and Medical Systems, NASA Headquarters

Email address or Phone number: [email protected] (202) 358-1794

Date: 30 April 2019

(Certifying individual must be a civil service employee)

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