FDA Response to Questions for RFP 75F123R00038.pdf

QUESTIONS FOR SOLICITATION #75F123R00036

Question #1:

Based on the referenced RFP sections and MCA below, could HELP, which is the current subcontractor, be awarded the contract as the Primary Contractor should the current Primary Contractor (MT DPHHS) be unwilling to directly employ the PC and BPC as requested in the RFP? It is our understanding that it may not be feasible for MT DPHHS to employ the PC and BPC while subcontracting with HELP as has been done successfully under previous contracts. Montana Code allows DPHHS to contract inspections. HELP is currently considered the sole source for contracting tobacco inspections for MT and would seem to have authority to continue conducting inspections under agreement with DPHHS.

RFP page 3 Section B.1 A. Background paragraph 2:

“To the extent feasible, FDA will contract with the state or territory to conduct compliance check inspections of tobacco retailers, as required under 21 U.S.C. 372(a)(1)(B)(i).”

RFP page 11 Section C.1.1 C. Key Personnel paragraph 3:

“The PC and BPC must be employed directly by the Prime Contractor and shall not be employed by a subcontractor.”

Montana Code Annotated (MCA) 2021

16-11-309. Inspection and notification of violation required. (1) The department of public health and human services shall conduct inspections of persons selling or distributing tobacco products, alternative nicotine products, or vapor products to determine compliance with 16-11- 303, 16-11-304, 16-11-305(1), 16-11-306, and 16-11-307. Inspections may be conducted directly by the department of public health and human services or may be provided for by contract let by the department of public health and human services.

FDA Response: The PC and BPC must be employed directly by the Prime Contractor and shall not be employed by a subcontractor.

Question #2

HELP currently uses off-duty or retired law enforcement officers, the state program officer, program coordinator, or back-up program coordinator as part-time FDA Commissioned officers for conducting inspections. Would these criteria for inspectors continue to be acceptable under the RFP? Is that acceptability contingent upon MTDPHHS or HELP being the Primary Contractor? The relevant past contract, current contract and RFP sections are included below.

https://leg.mt.gov/bills/mca/title_0160/chapter_0110/part_0030/section_0030/0160-0110-0030-0030.html https://leg.mt.gov/bills/mca/title_0160/chapter_0110/part_0030/section_0030/0160-0110-0030-0030.html https://leg.mt.gov/bills/mca/title_0160/chapter_0110/part_0030/section_0040/0160-0110-0030-0040.html https://leg.mt.gov/bills/mca/title_0160/chapter_0110/part_0030/section_0050/0160-0110-0030-0050.html https://leg.mt.gov/bills/mca/title_0160/chapter_0110/part_0030/section_0060/0160-0110-0030-0060.html https://leg.mt.gov/bills/mca/title_0160/chapter_0110/part_0030/section_0070/0160-0110-0030-0070.html

Contract HHSF22301510101C pg. 10 C. Inspectors The contractor shall conduct compliance check inspections through any health, food, or drug officer/employee of any State, Territory, or political subdivision thereof. These individuals must be United States citizens and be able to be commissioned as officers of the United States Department of Health and Human Services (HHS), Food and Drug Administration, under the authority of the FD&C Act.

Current Contract HHSF22301810079C pg. 9 C. Inspectors The Contractor shall conduct compliance check inspections through any health, food, or drug officer/employee of any State, Territory, or political subdivision thereof. These individuals must be United States citizens and be able to be commissioned as officers of the United States Department of Health and Human Services (HHS), Food and Drug Administration, under the authority of the FD&C Act.

RFP page 11 Section C.1.1 D. Inspectors:

“…which includes any health, food, or drug officer/employee of the State, Territory, or political subdivision thereof.”

FDA Response: All inspectors must be a current health, food, or drug officer/employee of any State, Territory, or political subdivision thereof. The determination if an individual meets these requirements must be made by the contractor prior to submission and will be reviewed on a case-by-case basis during the commissioning review.

Question #3

If HELP, with the agreement of MTDPHHS, applies to become the Primary Contractor for the FDA in MT, would we need to provide a Technical Proposal in addition to the Business Proposal as we technically already have a contract with the FDA for providing tobacco inspections?

FDA Response: The proposed contract action is for services for which the Government intends to solicit and negotiate with ONLY state organizations under the authority of 41 U.S.C.

3304(a)(5).

Question #4

Does the 40 page limit include any exhibits that are supporting documentation referenced throughout the Solicitation and under Section L.4 I (Additional Documentation to be Submitted with Business Proposal?

FDA Response: Yes, the 40-page limit includes any exhibits that are supporting documentation referenced throughout the Solicitation and under Section L.4 I (Additional Documentation to be Submitted with Business Proposal.)

Montana Code Annotated (MCA) 2021