Air Force Medical Support Agency (AFMSA) Bacteriophage Therapy RFI (Research and Development )
All information included in this RFI is confidential and only for the recipient knowledge. No information included in this document or in discussions connected to it may be disclosed to any other party.
With this RFI, we request information regarding your company and your products/services to determine capability. The same information will be gathered from different companies and analyzed against the requirements. In accordance with (IAW) Federal Acquisition Regulation (FAR) 15.201(e), "Responses to these notices are not offers and cannot be accepted by the Government to form a binding contract."
Specific information is requested according to the forms below. Please complete as much information as possible.
AFMS: Air Force Medical Services
AFMSA: Air Force Medical Support Agency
AFMESA: Air Force Medical Evaluation Support Activity
APA: Additional Performance Attributes
CDD: Capabilities Development Document
DOD: Department of Defense
FDA: U.S. Food and Drug Administration
FHP: Force Health Protection
KPP: Key Performance Parameters
KSA: Key System Attributes
MTF: Medical Treatment Facility
NMRC-NAMD: Naval Medical Research Center - Naval Advanced Medical Development
RFI: Request for Information
TED: Troop Equivalent Dosing
To answer this RFI, please fill in the attached forms (RFI response Form #1 and #2 [attached Excel requirements spreadsheet]).
The contact person listed below is available for assistance, if needed.
The answers to this RFI will be evaluated by staff from different functions in AFMSA.
Response to this RFI must be submitted via email to Major Rodney Ho, Test Director, AFMSA.SG5T.Market@us.af.mil. Email responses should be no larger than 10 MB in size. If larger attachments are required, please notify AFMSA at the above listed e-mail address. Please include a point of contact, phone number, e-mail address, website information, and indicate whether the company is a foreign or domestic entity in the contents of the e-mail. Each RFI response will receive a confirmation e-mail; if a confirmation is not received, please call 301-619-8600.
The Government will not pay for any information submitted, or for any costs associated with providing the information.
How to deliver the answer
Send the attached forms (format unchanged) by email to: AFMSA.SG5T.Market@us.af.mi
Contacts
For questions regarding this RFI, you are welcome to contact:
Major Rodney Ho
Chief, Clinical Systems Evaluation
Air Force Medical Evaluation Support Activity
1270 Montevue Lane (Area B)
Fort Detrick, MD 21702
301-619-8600
AFMSA.SG5T.Market@us.af.mil
This is the timeframe for Q&A's and responses
2 July 2019 - The RFI is sent out
17 July 2019 - Last date for questions & answers
1 Aug 2019 - Last date for response
Currently, the standard of care is to treat bacterial infections with antibiotics, either topically (i.e., ointments or creams) or systemically (i.e., oral or intravenous). In some cases, such as treatment of abscesses, antibiotic treatment is usually preceded by incision and drainage. With an increase in drug-resistant bacteria, the Naval Medical Research Center - Naval Advanced Medical Development (NMRC-NAMD) is looking at acquiring and fielding solutions that (a) have the ability to effectively treat patients with drug-resistant infections while having minimal impacts on human cells or the normal bacterial flora and (b) do not lead to an increase in antibiotic-resistant strains of bacteria. The treatment would be provided at a fixed facility (Role 4) such as a Medical Treatment Facility (MTF).
NMRC-NAMD is interested in identifying a bacteriophage therapy capability that will be used to treat patients with complicated and/or drug-resistant bacterial infections that can be administered via a general bacteriophage cocktail and/or a personalized/precision therapeutic. Bacterial pathogens relating to sepsis and urinary tract infections, such as Staphylococcus aureus, Escherichia coli, and Klebsiella pneumonia, present a threat to the health and operational effectiveness of the United States military as it requires effective treatments that contribute to the overall cost of miltary health care.
The response should describe the company's capability to provide, field, and sustain the treatment as characterized by the requirements addressed in this RFI. If unable to provide a treatment capable of meeting all requirements, the respondent should provide trade-off considerations to meet the requirements addressed in this RFI.
The requirement below is a mandatory Key Performance Parameter (KPP) of the Bacteriophage Therapy capability, taken from the NMRC-NAMD Bacteriophage draft capabilities development document (CDD):
Food and Drug Administration (FDA) Licensure- i.e., FDA Approval, with use for treatment described in the FDA-approved labeling of the drug. The FDA will be the approving authority for the use of this drug. All drugs used in U.S. military personnel for Force Health Protection (FHP) must be FDA licensed as it is a regulatory requirement for routine Department of Defense (DOD) use, and thus, is Federal law. The FDA does not specify actual performance required. However, in order to use a product in humans, the FDA requires that manufacturers demonstrate levels of safety, chemical composition, and efficacy that are consistent with the wording in the product label. Moreover, the FDA review includes manufacturing processes and procedures which assure consistent manufacture of a high quality product that will perform as described in the label. While manufacturing standards are specified by the FDA, DOD does not set them. Thus, FDA licensure implies a spectrum of manufacturing, documentation, quality assurance, and product performance assuring that the product will perform as labeled when marketed for use by consumers.
Seven Additional Performance Attributes (APAs) were identified. APAs are considered lower priority than KSAs. The KSA and APAs are notional.
The KPP and APAs are listed in the attached document (Form #2).
Manufacturers are encouraged to submit a response to this RFI, even if a
system does not meet all the requirements at this time. For requirements that are not met, responses will still be reviewed.
Major Rodney Ho, Test Director, Phone 301-619-8600, Email AFMSA.SG5T.Market@us.af.mil - Christal Jackson, Contracting Officer, Phone 2103959383, Email christal.jackson.6@us.af.mil
