Final AMSIS RFI Medlist V1.8.11.21.docx

Aerospace Medicine Safety Information System (AMSIS) Market Survey/Request for Information (RFI) Announcement Seeking Generic Drug Monograph Data Supplier The Federal Aviation Administration (FAA or Agency) issues this Market Survey/Request for Information (RFI) in accordance with the FAA Acquisition Management System (AMS) Policy 3.2.1.2.1.

This announcement is a Market Survey/RFI and is not a Screening Information Request (SIR) or Request for Offer (RFO) of any kind. Responses to this Market Survey/RFI will be used primarily for informational purposes. The FAA is not seeking or accepting unsolicited proposals. The FAA will not pay for any information it receives nor vendor costs incurred in preparing the response to this Market Survey/RFI. Any costs associated with this Market Survey/RFI submittal are solely at the interested vendor's expense. The results of the Market Survey/RFI will assist the FAA in selecting a vendor, or vendors, that can best meet the requirements, for a subsequent procurement. An acquisition strategy has not been determined at this time.

I. Introduction

The FAA is currently developing an Aerospace Medicine Safety Information System (AMSIS) which will provide support for the FAA’s AAM organization. As part of the AMSIS system there will be automation and replacement of legacy systems for the purpose of certification and clearance for airmen and Air Traffic Control (ATC) specialists respectively. The Office of Aerospace Medicine (AAM) has created a Medication List for the purpose of determining if medications are allowed or not allowed for use by pilots and air traffic controllers. The current Medication List contains over 1,000 AAM-reviewed medications. Each medication has been updated with specific AAM medical information to help AAM determine if, and when, a medication may be used in conjunction with flying or controlling aircraft. The medications are organized by generic name or, in the case of a combined drug medication, with the concatenated generic names.

The FAA AMSIS Program Office (PO) is searching for a vendor that can, on a regular basis, provide the latest information on medications based on their generic form. This includes an adult drug monograph that has been curated, such that warnings, contraindications, and adverse reactions are tied to the generic name. AMSIS will process the information from this dataset to automatically be alerted to new information that could affect their recommendations.

There are two scenarios in which this data may be used:

1) As a Medication Selection List for applicants to choose medications they are currently taking. This list will allow users to select a medication by either the generic name or a brand name for submission in their application.

2) As a curated Medication List used by AAM to determine if airmen or air traffic controllers may be given certification or clearance. AAM will be able to make a determination on an application when a brand or generic name from the Medication Selection List matches up with a medication in the Medication List.

The Agency is researching the best alternative(s) to meet the requirements for obtaining and maintaining current information on medications to support the AMSIS functionality. The potential industry/public sector solution(s) will need to be inputted and integrated into the AMSIS system and accessed periodically, or as required, to continually meet airmen certification and ATC clearance requirements. The industry inputs may be manually augmented for FAA purposes.

II. Purpose

The purpose of this request for information is to assess the capabilities, availability, and pricing models for industry/public sector medical lists and associated information. The resulting inputs will assist the FAA to ascertain market interest and gain knowledge of potential approaches for meeting AMSIS drug information functionality. Specifically, the purpose is to:

1) Collect market information on functionality and capability that may exist or may be adapted to meet AMSIS AAM requirements;

2) Determine whether there is a single industry or public sector capability that meets all of the basic requirements;

3) Determine whether certain industry and public sector capabilities can meet the additional preferred requirements;

4) Assess whether the entire set of requirements are best met by obtaining and integrating industry/public sector capabilities;

5) Assess the ability of the industry/public sector capabilities to be easily input and integrated into the AMSIS system; and

6) Understand the pricing models available to meet all or a majority of AMSIS Drug information requirements

III. Background

The FAA Office of Aerospace Medicine (AAM) is responsible for a broad range of medical programs and services for both the domestic and international aviation communities. AAM is responsible for advancing the field of study of aerospace medicine and for the medical certification programs and medical surveillance of airmen, Air Traffic Control Specialists (ATCS), and other safety critical personnel.

The AAM Civil Aerospace Medical Institute (CAMI) maintains records on over 450,000 medical certifications conducted each year out of approximately 600,000 active airmen and nearly 17,000 ATCS. CAMI cumulative records total 18,000,000 past medical examinations for airmen and ATCS as part of AAM’s oversight role. The surveillance program for the Drug Abatement Division (AAM-800) oversees 8,097 certificated entities, the Department of Transportation (DOT) administered Internal Substance Abuse Program (ISAP) oversees all FAA employees through random drug testing, and the Aviation Medical Examiner (AME) program surveys approximately 4,250 AMEs both domestically and internationally. For purposes of this RFI, AAM is responsible for the following safety critical medical initiatives:

· Airmen Medical Certification

· Medical Clearance of Air Traffic Control Specialists (ATCS)

IV. Description Supplies/Services

AMSIS will provide an aerospace medical information network that integrates critical, security sensitive medical information generated from geographically distributed national and international locations. AMSIS critical data may be used for regulatory enforcement purposes in addition to interfacing with a variety of agency mission related databases. The AMSIS program provides for the procurement of services for the design, development and deployment of a new information system.

The requested capabilities are characterized by a system that can provide medical data and information that can be used by the FAA and by the AMSIS system to aid in certification and clearance. Rather than writing fixed requirements, AAM has intentionally used the term "criteria" in order to identify the best fit solution for AMISIS. AAM acknowledges there may be alternative solutions and compromises to be made based on the selection of a best-fit data set. The attached Vendor Operational Criteria/ Requirements table (Attachment #2) is a list of the data fields AAM is requesting. The criteria has been divided into two groups for each data field: minimum criteria and preferred criteria. Minimum criteria is the criteria related to the data field. Preferred criteria is criteria that is in addition to, or an enhancement, of the minimum criteria. In the event certain data fields do not have minimum criteria associated, the FAA will determine an alternative if the vendor does not have access to the data.

The AMSIS system will ingest or input this data and process it to provide the information needed in the form that it is needed. Attachment #3, Technical Integration Criteria, Requirements for the Medication Data Source, provides those requirements.

In order to best assess vendor capabilities, AAM has identified a list of twenty medications that are used often and which would require the types of information that is being requested. Attachment #4 provides that list of medications. Interested vendors are requested to provide a sample of the information that could be provided for each of these medications and the format that they might be provided in. Please utilize Attachment #5, Data Evaluation Form, which is the preferred format for providing the comparison of the requested data fields and medications. If a vendor cannot provide data on all of the medications on the list, please explain why data on these medications are not available.

V. Attachments

The following files are attached to this request for information:

(a) Attachment #1: Business Declaration Form

(b) Attachment #2: Vendor Operational Criteria/Requirements

(c) Attachment #3: Technical Integration Criteria, Requirements for the Medication Data Source

(d) Attachment #4: Sample Medication List Data

(e) Attachment #5: Data Presentation Form

VI. Submittal Requirements

In order to be considered responsive to this request for information, respondents must provide the following:

1. A Business Declaration Form (See Attachment #1)

2. Description of capability (not to exceed 5 pages). The vendor must provide a description of the methods (e.g., manual download, Application Programming Interface (API)/On-line, etc.) made available to the Government for accessing the data from the vendor. These methods will be assessed to determine if they can be appropriately integrated into the AMSIS system. The capability description must include descriptions of:

a. the vendor's regular update schedule and a description of the content of the update and the delivery mechanism;

b. procedure and turn-around time for content updates, including procedures and timelines for emergency content updates;

c. process for keeping medication monograph content up to date; and

d. process to keep up with, display, and make editorial decisions about FDA warnings at the monograph level.

3. Matrix that shows capabilities to meet each of the requirements of the Minimum and Preferred Criteria shown in Attachment #2

4. Completed Attachment #5, showing Vendor’s ability to meet the requirements in Attachment #2 for each of the sample medications shown in Attachment #4

5. Matrix that shows Vendor’s capabilities to meet each of the Technical Criteria/Requirements in Attachment #3

6. Describe the data pricing model (e.g., fixed annual fee, License – annual or monthly, pricing based upon access or number of requests) covering the Vendor’s available data access methods. If there are more than one model, please provide each method.

Respondents are requested to provide responses as directed below. The Agency encourages respondents to submit nonproprietary information to the fullest extent possible; however, if proprietary information is submitted, please mark such included information as “Proprietary.” As a follow-up to this request for information, the Contracting Officer (CO) may contact some, all, or none of the respondents for one-on– one meetings to obtain additional information regarding their response.

SUBMISSION FORMAT:

One (1) Electronic copy to: katherine.petito-peverall@faa.gov

Katherine Petito-Peverall Wilbur Wright Bldg. (FOB-10B) FAA National Headquarters 600 Independence Ave., SW Washington, DC 20597

The front cover of any submission must include respondent’s point of contact information including name, telephone number, e-mail, and mailing address.

NOTES: Responses to this market survey shall be submitted via email to the Contracting Officer (CO) katherine.petito-peverall@faa.gov. Electronic submission of the responses should be in either Microsoft Word format or portable document format (PDF). Please note that the FAA e-mail server restricts file size to 10MB per e-mail message; therefore, responses may have to be submitted in more than one e-mail in order to be received.

Any questions must be submitted to the CO by September 8, 2021 and answers will be posted prior to the closing date of this RFI.

All submissions must be received by 2:00 pm ETD on September 17, 2021. For questions or requests for additional information, please contact Katherine Petito-Peverall via e-mail at katherine.petito-peverall@faa.gov.

AMSIS MedList Request for Information Announcement August 2021 5

Attachment #1 Business Declaration Form

Attachment #2 AMSIS MedList Requirements

This attachment/Table provides a list of the data fields AAM is requesting. The criteria has been divided into two groups for each data field: Minimum Criteria and Preferred Criteria. Preferred criteria is in addition to the Minimum Criteria and if the vendor also provides the preferred criteria for the data field the dataset will be richer through the added information.

Table: Vendor RFI Criteria

2) Must be able to be mapped to one or more Brand Names

3) Must be able to identify combi-drugs as a distinct generic name

1) Dataset contains Herbals by generic name

2) Brand name is able to be identified as having been discontinued

GENITOURINARY (GU); CARDIOLOGY (CV); DERMATOLOGY; HEMATOLOGY & ONCOLOGY; VITAMINS; INFECTIOUS DISEASE (ID)

2) Indication associated with generic medication is associated with FDA Approval Date

9/4/2014: for Advanced Melanoma 10/2/2015: for Advanced Non-Small Cell Lung Cancer 3/15/2017: for Classical Hodgkin Lymphoma (cHL) 5/17/2017: for Locally Advanced or Metastatic Urothelial Carcinoma

1) Generic medication's initial FDA marketing approval date is available

2) Data able to be used for computations by system (e.g. determine date medication is able to be reviewed by AAM (approval date +1year))

1) If medication has been pulled from the market, the system should be able to detect it in the data

2) Approval date associated with each indication is available

Oxidation, Reduction, Hydrolysis, Hydration, Conjugation, Condensation, Isomerization.

In most cases, when a drug is metabolized it becomes inactivated.

– recommended dosing for indication

– amount of dosage not to be exceeded amlodipine dosing:

Initial: 2.5 to 5 mg once daily; titrate every 1 to 2 weeks as needed based on patient response; maximum: 10 mg/day

2) Usual dosing by indication is available

precautions Identify and describe a discrete set of adverse reactions and other potential safety hazards that are serious or are otherwise clinically significant because they have implications for prescribing decisions or for patient management.

A boxed warning or “black box warning” is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.

Effects

Endocrine & metabolic: Decreased libido (1% to 11%) Gastrointestinal: Anorexia (4% to 17%), diarrhea (8% to 18%), nausea (12% to 29%), xerostomia (9% to 12%)

2) Percentage of side effects identified (e.g. could be a % Number or could be Very Common, Common, Rarely)

AMSIS MedList Request for Information Announcement August 2021 12

Attachment #3 Technical Integration Criteria, Requirements for the Medication Data Source

The Technical Integration requirements speak to the potential aspects for interfacing from the Vendor’s capability to the FAA AMSIS Systems. For each, the table shows the potential options and the FAA preference. If the vendor uses another option, this may be provided, with explanation as to why this is proposed.

Table: Specific Technical Aspects

API/Online access

API/Online access

JSON

Fixed width data files SQL Server format data files

JSON

XML

Flag on access point to denote updates N/A

Key based authentication Key based authentication to allow programmatic access

AMSIS MedList Request for Information Announcement August 2021 15

Attachment #4 Sample Medication List Data

When assessing the data from a Vendor, the following list of medications would be useful as a demonstration of the results returned for assessment (see Attachment #5 for the form for providing this information. This is the preferred format so that responses can be assessed):

1. pioglitazone + metFORMIN (ACTOplus Met)

2. empagliflozin + metFORMIN (Synjardy)

3. sermorelin (Geref)

4. diphenhydrAMINE

5. doxylamine

6. hyoscyamine + atropine + scopolamine + phenobarbital (Donnatal)

7. riTUXimab (Rituxan)

8. montelukast (Singulair)

9. Varenicline (Chantix)

10. Beovu

11. betahistine (Serc)

12. muraglitazar (Pargluva)

13. olaparib (Lynparza)

14. Dupixient

15. Xeljanz

16. naltrexone

17. domperidone (Motilium)

18. linagliptin + metFORMIN (Jentadueto)

19. gemcitabine (Infugem; Gemzar)

20. Avastin

Attachment #5 Data Presentation Format

Please use the attached Medication Sample Data Comparison spreadsheet for providing the information requested for the medications listed.

image1.emf

Business Declaration Form.pdf

OMB Control No. 2120-0595 FAA Template No. 61 (rev. 10/08)

BUSINESS DECLARATION

1 Name of Firm:

Tax Identification No.:

2 Address of Firm: DUNS No.:

3 a. Telephone Number of Firm:

b. Fax Number of Firm:

4 a. Name of Person Making Declaration

b. Telephone Number of Person Making Declaration

c. Position Held in the Company

5 Controlling Interest in Company (“X” all appropriate boxes)

a. Black American b. Hispanic American c. Native American d. Asian American

e. Other Minority (Specify) f. Other (Specify)

g. Female h. Male i. 8(a) Certified (Certification letter attached) j. Service Disabled Veteran Small Business

6 Is the person identified in Number 4 above, responsible for day-to-day management and policy decision making, including but not limited to financial and management decisions?

a. Yes b. No (If “NO,” provide the name and telephone number of the person who has this authority.)

7 Nature of Business (Specify all services/products (NAIC))

8 (a) Years the firm has been in business (b) No. of Employees

9 Type of Ownership: a. Sole Ownership b. Partnership

c. Other (Explain)

Gross receipts of the firm for the last three years:

a.1. Year

Ending:

b.1. Gross

Receipts a.2. Year b.2. Gross a.3. Year b.3. Gross

Is the firm a small business? a. Yes b. No

Is the firm a service disabled veteran owned small business? a. Yes b. No

Is the firm a socially and economically disadvantaged small business? a. Yes b. No

I DECLARE THAT THE FOREGOING STATEMENTS CONCERNING

ARE TRUE AND CORRECT TO THE BEST OF MY KNOWLEDGE, INFORMATION, AND BELIEF. I AM

AWARE THAT I AM SUBJECT TO CRIMINAL PROSECUTION UNDER THE PROVISIONS OF 18 USCS 1001.

14. a.

Signature

b. Date:

c. Typed

Name

d. Title:

image2.emf

Medication Sample Data Comparison.xlsx Medica

Generic Name Brand Name Other Names # of Meds Therapeutic Class Drug Class Conditions FDA approved Onset of Action Half-Life Metabolism Dosing Dosage forms Mechanism of action Monitoring parameters Contraindications Warnings/ precautions Adverse Reactions/ Effects Revision History

1 pioglitazone + metFORMIN (ACTOplus Met)

2 empagliflozin + metFORMIN (Synjardy)

3 sermorelin (Geref)

4 diphenhydrAMINE

5 doxylamine

6 hyoscyamine + atropine + scopolamine + phenobarbital (Donnatal)

7 riTUXimab (Rituxan)

8 montelukast (Singulair)

9 Varenicline (Chantix)

10 Beovu

11 betahistine (Serc)

12 muraglitazar (Pargluva)

13 olaparib (Lynparza)

14 Dupixient

15 Xeljanz

16 naltrexone

17 domperidone (Motilium)

18 linagliptin + metFORMIN (Jentadueto)

19 gemcitabine (Infugem; Gemzar)

20 Avastin