The Office of Chief Health and Medical Officer (OCHMO), within the National Aeronautics and Space Administration (NASA) as part of its continuing effort to reduce public burden and maximize the utility of government information, provides the general public and other Federal agencies the opportunity to comment on an information collection project, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection project titled, “Electronic Medical Record for Implementation of TREAT Astronaut Act.” The TREAT Astronaut Act is subsection 441 within the National Aeronautics and Space Administration Transition Authorization Act of 2017 (115th Congress, https://www.congress.gov/115/plaws/publ10/PLAW-115publ10.pdf).
The goal is to maintain digital medical records of routine health care, emergency treatment, and scheduled examinations for active or retired astronauts in order to develop a knowledge base and address gaps in services in support of medical monitoring, diagnosis and treatment of conditions associated with human space flight as stated in Public Law 115-10.
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All comments should be submitted within 60 calendar days from the date of this publication.
You may submit comments by any of the following methods:
Federal eRulemaking Portal: http://www.Regulations.gov. Follow the instructions on-line for submitting comments.
Mail: Gatrie Johnson, National Aeronautics and Space Administration, 300 E Street SW, Washington, DC 20546-0001.
Instructions: All submissions received must include the agency name. NASA will post, without change, all relevant comments to Regulations.gov.
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FOR FURTHER INFORMATION CONTACT:
To request additional information or to obtain a copy of the information collection plan and instruments, contact Gatrie Johnson, National Aeronautics and Space Administration, 300 E Street SW, Washington, DC 20546-0001.
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Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
The project includes standard use of Electronic Medical Records (EMR) under NASA 10 HIMS regulations at Johnson Space Center (JSC) Occupational Health Branch (OHB) by authorized healthcare providers assigned to, employed by, contracted to, or under partnership agreement with the JSC, OHB. This EMR will be used in support of the TREAT Astronaut Act to generate medical records of medical care, diagnosis, treatment, surveillance examinations (e.g., flight certification, special purpose and health maintenance), and exposure records (e.g., hazardous materials and ionizing radiation).
Background and Brief Description
Management and utilization of the EMR at JSC, OHB clinics will be carried out in support of the TREAT Astronaut Act. 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.
In order to implement the necessary supportive clinical services, accurate digital medical records will be established in the EMR for each visit to the OHB clinics. The legal medical record is the documentation of health care services provided to an individual; it is used for clinical decision making, following accurate recording of observations, actions and analysis of diagnostic tests. The legal medical record in this instance is digital recorded data collected and used for providing healthcare at the OHB Clinics. Additionally, the medical record is used as a tool for evaluating the adequacy, appropriateness and quality of care.
The OHB clinics at JSC will create, maintain and securely archive digital medical records and physical examination records of Astronauts and payload specialists. Such records shall contain standard clinical information resulting from physical examinations, laboratory and other relevant diagnostic tests, and medical history surveys; screening examination results; immunization records; administration of medications prescribed by private/personal or NASA flight surgeon physicians; consultation records; and hazardous exposure as well as other health hazard/abatement data.
NASA collects, archives, and secures information from individuals visiting the OHB clinics requiring routine medical examination in compliance with the following regulations:
- 2015 Joint Commission (JC) Standards for Ambulatory Care IM.01.01.01, IM.02.01.03, IM.02.02.01, IM.02.02.03
- NASA Procedural Requirements, NPR 1800.1C.
- NASA Records Retention Schedules NRRS 1441.1
5 U.S.C. 552a, Privacy Act, 1974
42 U.S.C. 2472; 44 U.S.C. 3101; Public Law 92-255
- NIST SP 800-53 revision 4, Recommended Security Controls for Federal Information Systems
- NIST SP 800-53A, Techniques and Procedures for Verifying the Effectiveness of Security Controls in Federal Information Systems
- NPR 2810.1, Security of Information Technology
II. Method of Collection
Electronic and paper.
Title: Electronic Medical Record for Implementation of TREAT Astronaut Act. (Pub. L. 115-10).
OMB Number: 2700-xxxx.
Type of Review: New Clearance.
Affected Public: Astronauts and payload specialists.
Average Expected Annual Number of Activities: 36,840.
Average Number of Respondents per Activity: 36,840.
Annual Responses: 36,840.
Frequency of Responses: 1.
Average Minutes per Response: 0.5 hours.
Burden Hours: 18,420.
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total responses||Response time||Respondent burden hours|
|Burden Calculation—Estimation of Respondent Burden Hours|
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responses||Response time||Respondent hourly wage||Labor burden per response||Total labor burden|
|Burden Calculation—Labor Cost of Respondent Burden|
IV. Requests for Comments
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information will have practical utility;
2. Evaluate the accuracy of NASA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Ways to enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including automated, electronic collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
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NASA PRA Clearance Officer.
[FR Doc. 2018-27594 Filed 12-20-18; 8:45 am]
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