2120-XXXX alternative pilot physical examination and education requirements supporting statement

Department of Transportation

Federal Aviation Administration

SUPPORTING STATEMENT

Alternative Pilot Physical Examination and Education Requirements

2120-XXXX

INTRODUCTION

This information collection is submitted to the Office of Management and Budget (OMB) to fulfill the requirements of section 2307 of Public Law 114-190.

Part A. Justification

1. Circumstances that make collection of information necessary. 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.

Section 2307 of Public Law 114-190, medical certification of small aircraft pilots, provides that, within 180 days of enactment of Public Law 114-190, the FAA Extension, Safety and Security Act of 2016, the Administrator of the FAA shall issue or revise regulations to ensure that an individual may operate as pilot in command of a covered aircraft if certain provisions stipulated in the Act are met. The Act was enacted July 15, 2016. Those provisions include requirements for the individual to:

• Possess a valid driver’s license;

• Have held a medical certificate at any time after July 15, 2006;

• Have not had the most recently held medical certificate denied, revoked, suspended, or (if authorized under special issuance provisions) had the authorization withdrawn;

• Have taken a medical education course within the past 24 calendar months;

• Have completed a physical examination within the past 48 months;

• Be under the care of a physician for certain medical conditions;

• Have been found eligible for special issuance of a medical certificate for certain specified mental health, neurological, or cardiovascular conditions;

• Consent to a National Driver Register check;

• Fly only certain small aircraft, at a limited altitude and speed, and only within the United States;

• Not fly for compensation or hire.

The use of section 2307 by any eligible pilot is voluntary. Persons may elect to use these alternative pilot physical examination and education requirements or may elect to continue to operate using a third-class or higher medical certificate (information collection 2120-0034).

This information collection reflects the burden and costs associated with completion of the medical education course and attestations every 24 calendar months, the National Driver Register check every 24 calendar months, and the physical examination every 48 months.

2. How, by whom, and for what purpose is the information used. 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 FAA is establishing two forms to fulfill the requirements of this information collection:

• FAA form 8700-2, Comprehensive Medical Examination Checklist

• FAA form 8700-3, BasicMed Online Course Certifications

The FAA will use this information to determine that individual pilots have met the requirements of section 2307 of Public Law 114-190. It is important for the FAA to know this information as the vast majority of pilots conducting operations described in section 2307 of Public Law 114-190 must either hold a valid medical certificate or be conducting operations using the requirements of section 2307 as an alternative to holding a medical certificate.

3. Extent of automated information collection. 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.

As required by section 2307 of Public Law 114-190, the FAA has worked with nonprofit and not-for-profit general aviation stakeholder groups to develop medical education courses for pilots wishing to use section 2307 as an alternative to holding a medical certificate. Those medical courses will be provided free of charge on the Internet, as required by section 2307. Course providers will transmit course completion information to the FAA, which will retain the information as part of its airmen registry records.

Section 2307 requires that pilots maintain the medical checklist completed by the pilot and the physician in the pilot’s logbook (section 2307(b)(3)). Section 2307(c)(10)(A) requires pilots to maintain a certification of completion of the medical education course, which shall be printed and retained in the individual's logbook and made available upon request. Section 2307(c)(10)(E) requires pilots to be provided with a statement, which shall be printed, and signed by the individual certifying that the individual understands the existing prohibition on operations during medical deficiency by stating: “I understand that I cannot act as pilot in command, or any other capacity as a required flight crew member, if I know or have reason to know of any medical condition that would make me unable to operate the aircraft in a safe manner.” The FAA is permitting these written statements, once signed, to be retained electronically.

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.

There is no duplication. The FAA is the agency solely responsible for certificating pilots for civil operations in the United States.

5. Efforts to minimize the burden on small businesses. 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.

This rule is voluntary for pilots, who are individuals. Pilots choosing to use BasicMed must receive a medical examination conducted by any State-licensed physician. Any State-licensed physician, who could be (but is not required to be) an Aviation Medical Examiner, will complete the physician portion of the Comprehensive Medical Examination Checklist. Because Aviation Medical Examiners could choose to complete the physician portion of the Comprehensive Medical Examination Checklist in their capacity as a State-licensed physician, there is no impact on small businesses.

6. Impact of less frequent collection of 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.

The relief provided by section 2307 of Public Law 114-190 is voluntary. A pilot may choose to use this relief or may continue to hold a medical certificate appropriate to the operation being conducted (information collection 2120-0034). If a pilot chooses to use this relief, the statute requires that a medical education course be taken every 24 calendar months, a National Driver Register check be conducted every 24 calendar months, and a physical examination be conducted every 48 months. These are statutory requirements over which the FAA has no discretion.

7. Special circumstances. Explain any special circumstances that would cause an information collection to be conducted in a manner:

• Requiring respondents to report information to the agency more often than quarterly;

• Requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• Requiring respondents to submit more than an original and two copies of any document;

• Requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• In connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• Requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

• That includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• Requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

There are no special circumstances for this information collection.

8. Compliance with 5 CFR 1320.8. Provide an electronic copy and identify the date, volume number and page number of the publication in the Federal Register of the agency's notice (for a 60-day and a 30-day 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 those comments. Specifically address comments received on cost and hour burden.

• Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and record keeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

• Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years--even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

The FAA published the 60-day notice for this information collection December 27, 2016. 81 FR 95265. The FAA published the final rule Alternative Pilot Physical Examination and Education Requirements to implement section 2307 of FESSA on January 11, 2017. 82 FR 3149.

The FAA received one comment to the 60-day notice, and one comment to the Advisory Circular supporting implementation of the final rule that related to this information collection request. The comment received in response to the 60-day notice was received from the Division of Preventive, Occupational & Aerospace Medicine, Mayo Foundation for Medical Education and Research. The comment received in response to the Advisory Circular was received from the Aircraft Owners and Pilots Association (AOPA).

Mayo supported the inclusion of the attestation statement in the medical examination checklist, noting that without the attestation statement, there is no way to establish that the detailed physical examination and review of medications being taken has actually occurred.

FAA Response: The FAA has included on the form the language from section 2307 of FESSA regarding the attestation. The FAA does not have discretion to revise or amend this language as it comes directly from FESSA.

Mayo recommended that since physicians who are not familiar with the FAA aeromedical certification process will be asked to complete the Comprehensive Medical Examination checklist, it would be useful to include a short preamble that concisely outlines the purpose of the examination, as well as what obligations are placed upon the examiner who elects to sign off on the assessment.

FAA Response: The FAA agrees and has included a discussion of requirements for the State-licensed physician in the instructions for the FAA Form 8700-2, Comprehensive Medical Examination Checklist, and plans to add this information to the advisory circular accompanying the final rule.

Mayo stated that there appears to be relatively little space available on the document itself for physicians to enter the details of a specific medical condition if an abnormality is identified in the physical examination portion of the assessment. Mayo also noted that there is no place for the physician to record the presence or absence of medical conditions obtained during the process of reviewing the pilot’s medical history. Mayo believed that the medical history is a necessary portion of all medical examinations and is typically the most important aspect of any regulatory surveillance examination. At a minimum, the form should include instructions that will inform the state-licensed physician to use additional space if needed to clearly document any potential medical conditions.

AOPA questioned the FAA’s inclusion of a Yes/No box and a Comments box next to each element the State-licensed physician is required to examine on the FAA form 8700-2, Comprehensive Medical Examination Checklist. AOPA indicated these fields were not required by statute and should not be included in the form 8700-2.

FAA Response: After consideration of Mayo’s and AOPA’s concerns, the FAA has removed the Yes/No and Comments boxes from the FAA form 8700-2, Comprehensive Medical Examination Checklist. AOPA is correct that section 2307(b)(2)(C) requires that the checklist include a section, for the physician to complete, that instructs the physician to perform a clinical examination of 22 elements as part of the physical examination of the pilot. FESSA does not indicate that information regarding the physician’s findings is to be included on the Comprehensive Medical Examination Checklist. While the FAA has determined that FESSA does not include the latitude for the FAA to include Yes/No boxes or comment fields as part of the Comprehensive Medical Examination Checklist, the FAA notes that the non-inclusion of such information does not relieve a State-licensed physician from conducting a medical examination in accordance with well-understood medical requirements and otherwise meeting his or her responsibilities as a physician.

A revised version of the FAA Form 8700-2, Comprehensive Medical Examination Checklist, without the Yes/No boxes and Comment boxes will be included when the first revision of the Advisory Circular is made available.

Mayo believed that there is no place on the form to record that a reconciliation of medications has been performed and no place for pilots or physicians to list what medications the airman is actually taking.

FAA Response: Section 2307 of FESSA requires that boxes 3 through 13 and 16 through 19 of the FAA Form 8500-8 be included on the Comprehensive Medical Examination Checklist and be completed by the pilot. Included in that information is a list of the medications being taken by the pilot. The FAA cannot request information beyond that which is included in section 2307 of FESSA.

Mayo recommended that the electronic forms are “writable,” so that physicians completing the form could do so on-line and enter the data electronically in a legible form prior to printing and signing the document.

FAA Response: The FAA is working to ensure that forms may be completed electronically. However, the FAA notes that the FAA Form 8700-2, Comprehensive Medical Examination Checklist, must first be completed by the pilot and then provided to the State-licensed physician. Therefore, as two persons are completing different sections of the same form, it may be difficult to ensure that the physician is provided with an electronic document to complete. Also, the FAA notes that the revised FAA Form 8700-2 will have no fields for the physician to complete, other than the signature of the attestation, so the need for legibility Mayo mentions is lessened.

Mayo emphasized that the medical community at large will need to have significant education to perform FAA BasicMed examinations as intended by the legislation. Mayo suggested that to minimize overall burden, clear communication on the FAA web site and on the checklist document itself will be necessary to minimize unnecessary lost time.

FAA Response: The FAA has included frequently asked questions on its www.faa.gov/go/basicmed/ webpage. The FAA Office of Aerospace Medicine will add a chapter to the Advisory Circular with information for State-licensed physicians, and that Office will educate FAA Aviation Medical Examiner designees on BasicMed. The FAA also plans to reach out to State licensing authorities as the effective date of the final rule approaches to provide general information regarding BasicMed.

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

No gifts or payments are provided to respondents.

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

The Privacy Act System of Records Notice DOT/FAA ### Name, provides notice to the public of the agency’s privacy practices regarding the collection, use, sharing, safeguarding, maintenance, and disposal of information that affects individuals and their personally identifiable information (PII). The SORN identifies the routine uses for the PII collected. The current version of the SORN may be found in the Federal Register at.

11. Justification for collection of sensitive information. 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.

This information collection does not collect information of a sensitive nature.

12. Estimate of burden hours for information requested. Provide estimates of the hour burden of the collection of information. The statement should:

• Indicate the number of respondents, frequency of responses, calculation for the individual burdens and for the total annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hour for customary and usual business practices

• If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in item 13 of OMB form 83-I.

• Provide estimates of annualized cost to respondents for the hourly 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. Instead, this cost should be included in item 14.

Pilots operating under APPEER are required to complete Section 1 of the Medical checklist every 48 months, regardless of age, and they must also complete the online medical education course every 24 months. A state-licensed physician is required to complete the rest of the Medical checklist. Costs are estimated over 10 years from 2017 to 2026.

Paperwork Burden and Costs to Pilots and State-licensed Physicians (Year 2017 to 2026)

Form	# of Applications	Hours Per Application	Total Hours	Hourly Wage	Total Cost (millions)	PV at 7% (millions)	Annualized at 7% (millions)
Medical Checklist (Physician)	1,238,192	0.25	309,548	$135.151	$41.8	$30.2	$4.0
Section 1 of the Medical Checklist (Pilot)	1,238,192	0.5	619,096	$25.00	$16.8	$12.1	$1.7
Medical Education Course (Pilot)	2,063,554	0.75	1,547,666	$25.00	$42.0	$30.0	$4.3
Total			2,476,310		$100.6	$72.3	$10.0

Note: Form 8500-8 is currently completed by all pilots that are required to hold a medical certificate to fly. These pilots may fly for personal use or for compensation or hire. However, this rule will only impact pilots flying for leisure therefore the FAA used $25.00 as the hourly rate for a pilot’s leisure time per the revised Departmental of Transportation’s “Guidance on Valuation of Travel Time in Economic Analysis.”

The average of those 10 years is estimated in the following table:

Average Yearly Applications

Form	# of Applications	Hours Per Application	Total Hours	Hourly Wage	Total Cost (millions)
Medical Checklist (Physician)	123,819	0.25	30,955	$135.152	$4.2
Section 1 of the Medical Checklist (Pilot)	123,819	0.5	61,910	$25.00	$1.7
Medical Education Course (Pilot)	206,355	0.75	154,767	$25.00	$4.2
Total			247,631		$10.1

13. Estimate of total annual costs to respondents. Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the costs of any hour burden shown in items 12 and 14).

• Include a breakdown for total capital/start-up costs and operation/maintenance. The cost estimates should be split into two components: (a) a total capital and start-up cost component (annualized over it expected useful life); and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major costs factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

• If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

• Generally, estimates should not include purchases of equipment or services, or portions thereof, made (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

The Aircraft Owners and Pilots Association (AOPA) and Experimental Aircraft Association (EAA), in their petition for exemption, created and offered to host the medical education course at no charge. As the course has already been created, the FAA assumes no cost to establish the course and minimal costs for updates.

14. Estimate of cost to the Federal government. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate costs, which should include quantification of hours, operational expenses such as equipment, overhead, printing, and support staff, and any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from items 12, 13, and 14 in a single table.

The FAA anticipates a one-time cost in 2017 of 30 hours for a CAMI physician³ at $140.99 (hourly wage of $139.59 in 2016 increased by 1.0 percent) and 30 hours for a Program Manager⁴ at $75.08 (hourly wage of $74.34 in 2016 increased by 1.0 percent) to initially approve and add the link for the course to the FAA website. This one-time cost sums to $6,482. The course will be reviewed and updated in a timely manner to reflect the most up-to-date medical protocols as needed however the FAA envisions these updates being minimal cost for both the FAA and third party providers.

FAA Cost for Medical Education Course (Year 2017 to 2026)

CAMI physician; $140.99 x 30 hours	$4,230
Program Manager Wage; $75.08 x 30 hours	$2,250
Total	$6,482
Annualized at 7%	$863

Currently pilots consent to an NDR check, thru the MedXpress application, every 5 years for pilots under age 40 and every 2 years for pilots age 40 and over. Under this rule all pilots will consent to an NDR check every 24 calendar months, regardless of age, when they complete the online medical education course. For pilots 40 years of age and older, with or without a special issuance medical certificate, the NDR check continues to occur every 2 years so there are no additional costs associated with these pilots. The FAA also continues to assume that active pilots age 40 and under without a special issuance will elect not to use this medical alternative. Therefore, the increase in NDR check will only impact pilots with active and expired special issuance medical certificates under age 40.

The 3% of pilots that require additional review is multiplied by the hourly wage for a special agent who verifies each identified record at an estimated 40 hours per record.⁵ The hourly wage plus fringe benefits is $53.49 in 2016 and increases by 1.0 percent per year. Total cost sums to $7.4 million.

FAA Cost for NDR Check (Years 2017 to 2026)

Form	# of Applications	Hours Per Record	Total Hours	Cost/ Hours	Total Cost (millions)	PV at 7% (millions)	Annualized at 7% (millions)
NDR Check	3,312	40.00	132,480	$53.49	$7.4	$5.5	$0.8

The total paperwork cost to FAA is estimated at $7.4 million over 10 years.

15. Explanation of program changes or adjustments. Explain the reasons for any program changes or adjustments reported.

This is a new information collection.

16. Publication of results of data collection. 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.

The results of this information collection will not be published.

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

The FAA is not seeking approval not to display the date of expiration of this information collection.

18. Exceptions to certification statement. Explain each exception to the certification statement identified in question 19, "Certification for Paperwork Reduction Act Submissions" (attached).

There are no exceptions to the certification statement for this information collection.

1 Family and General Practitioners Mean Hourly Wage, Occupational Code 29-1062. Bureau of Labor Statistics

May 2015. http://www.bls.gov/oes/current/naics4_621100.htm#29-0000 : included fringe benefits. Volpe Memorandum, Estimating Total Cost of Compensation Based on Wage Rate or Salaries, Jan. 30, 2014

2 Family and General Practitioners Mean Hourly Wage, Occupational Code 29-1062. Bureau of Labor Statistics

May 2015. http://www.bls.gov/oes/current/naics4_621100.htm#29-0000 : included fringe benefits. Volpe Memorandum, Estimating Total Cost of Compensation Based on Wage Rate or Salaries, Jan. 30, 2014

3 2016 General Schedule (GS) Locality Pay Tables; GS-11 Step 5 locality pay The REST OF UNITED STATES; https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2016/RUS_h.pdf ; plus fringe benefits; http://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2008/m08-13.pdf

4 FAASTeam Program Manager: (GS-14 Step 5) with DC, MD, and VA locality pay plus Fringe Benefits. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2016/general-schedule/

http://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2008/m08-13.pdf; the 2016 hourly wage of $74.34

5 Special Agent: Oklahoma City; I Band with Rest of US locality plus fringe benefits. https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2016/general-schedule/

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