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NOTICE OF INTENT TO ISSUE AN ORDER/CONTRACT. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC), National Center for Occupational Safety and H... NOTICE OF INTENT TO ISSUE AN ORDER/CONTRACT. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC), National Center for Occupational Safety and Health (NIOSH), hereby announces its intent to issue a sole source order/contract to Battelle Memorial Institute, 505 King Ave, Columbus, OH 43201-2696. The NAICS code for this acquisition is 541380 Testing Laboratories, with a size standard of $16.5 million. _______DRAFT SOW________ Title: Assessing Garment Performance Against Fentanyl and Fentanyl-Related Liquid Compounds. SECTION 1 – BACKGROUND The National Personal Protective Technology Laboratory (NPPTL) of NIOSH conducts personal protective equipment (PPE) research and evaluations on respirators, protective clothing, gloves, surgical gowns, etc. With the increase in in opioid sales on the illicit drug market and overdoses, an increase in exposure and risk has been identified for first responders and law enforcement officers. NIOSH seeks to assess the permeation of fentanyl solution through a variety of clothing materials. Testing and evaluation of these clothing materials will help in recommending adequate PPE protection to first responders. The permeation of fentanyl solution is commonly assessed used an industry consensus standard for evaluation of chemotherapy drugs and thus a test method to assess fentanyl permeation through protective clothing does not need developed. SECTION 2 – PURPOSE First responders rely on PPE—including respirators and protective clothing — when there is a possibility of contact with opioids, such as fentanyl and its analogs. The purpose of this contract is for NIOSH to receive empirical data for the effort of evaluating clothing performance when exposed to fentanyl and a fentanyl analog solution. Protective clothing will be assessed that vary in material, thickness, structure, etc. NIOSH seeks to work with a vendor to complete this work at a laboratory with extensive experience working with this hazardous narcotic. NIOSH will benefit from these results to assist with the validation of PPE recommendations to ensure the safety of law enforcement officers and first responders when in contact with fentanyl or similar narcotics. SECTION 3 – SCOPE OF WORK Both liquid and solid forms of fentanyl are hazardous to first responders and law enforcement officers; in this work, the liquid form of fentanyl and its analogs will be assessed for permeation through clothing materials. Fentanyl permeation will be assessed in accordance to ASTM D6978: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs which in turn references ASTM F739 “Standard Practice for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact,” Procedure A. To support NIOSH with testing this hazardous narcotic, a DEA-registered laboratory with experience handling fentanyl and its analogs is being sought. The protective clothing samples will be purchased on the open market by NIOSH. The contractor must furnish all fentanyl, analog, and surrogate materials. The contract will continue from August 1st, 2021 – August 31st, 2022. SECTION 4 – TASKS TO BE PERFORMED To fulfill the objectives of this contract, the contractor must complete each task list below. Kick-Off meeting: The contractor must partake in a Kick-Off meeting held via conference call at the beginning of the Period of Performance. NIOSH will schedule the meeting. During this meeting, NIOSH and the contractor shall discuss the overall objective of the contract, a summary of each Task, and a detailed discussion pertaining to all described Tasks. Base Period for Tasks 1-7: August 1st, 2021 – August 31st, 2022. Task 1: Testing fentanyl permeation through protective clothing: 10 different protective clothing models should be tested in accordance with ASTM Test Method D6978 (see Section 8: Reference Materials) which in turn references ASTM F739 “Standard Practice for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact,” Procedure A. For each clothing model, 3 tests shall be conducted at the continuous regions and 3 tests shall be conducted at the seam regions (except model #1 and 2). Thus, a total of 6 permeation tests will be conducted by the contractor for each model. Only continuous regions will be tested for Model #1 and #2. The contractor shall supply the fentanyl/fentanyl analogs and must adapt the ASTM D6978 test method to determine the appropriate fentanyl challenge concentration (e.g., representative of that found illicitly in the field) and detection methodology. Task 2: A Draft Task 1 Report (i.e. Draft Report 1) of the permeation testing and evaluation results should be written and submitted within 30 calendar days upon completion of Task 1 (See Deliverables for more detail). The contractor must partake in a conference call meeting to discuss any clarifications regarding Draft Report 1 (Task 2) and discuss Task 3. The contractor must address any comments or clarifications in the Draft Report 1 and submit the document as a Final Task 1 Report within 14 calendar days of the scheduled conference call. NIOSH will schedule this conference call meeting. Task 3: Testing fentanyl analogs permeation: 3 different protective clothing models should be tested in accordance with ASTM Test Method D6978 (see Section 8: Reference Materials) which in turn references ASTM F739 “Standard Practice for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact,” Procedure A. NIOSH will work with the contractor to determine which fentanyl analog(s) should be tested (e.g., carfentanil). The total number of permeation tests will not exceed 18; this is calculated by testing 3 different protective clothing models x 2 Regions/Model x 3 Specimens/Regions. The contractor must supply the fentanyl (and its analogs) used for this Task. The contractor shall supply the fentanyl/fentanyl analogs and must adapt the ASTM D6978 test method to determine the appropriate fentanyl challenge concentration (e.g., representative of that found illicitly in the field) and detection methodology. Task 4: A Draft Task 3 Report (i.e. Draft Report 2) of the permeation testing and evaluation results should be written and submitted within 30 calendar days upon completion of Task 3 (See Deliverables for more detail). The contractor must partake in a conference call meeting to discuss any clarifications regarding Draft Report 2 (Task 3) and discuss Task 5. The contractor must address any comments or clarifications in the Draft Report 2 and submit the document as a Final Task 3 Report within 14 calendar days of the scheduled conference call. NIOSH will schedule this conference call meeting. Task 5: A Final Report of all methodology and test data for Tasks 1 and 3 should be written and submitted within 30 calendar days upon completion of Task 3. Optional Tasks Optional Task 1: Evaluation and testing of penetration properties of fentanyl powder and the selected fentanyl surrogate(s) through garment materials. One report SECTION 5 – GOVERNMENT FURNISHED MATERIALS NIOSH will supply all protective clothing samples (in whole sample form) to the contractor. SECTION 6 – PERIOD OF PERFORMANCE The period of performance will be August 1st 2021 – August 31st, 2022. SECTION 7 – DELIVERABLES/REPORTING SCHEDULE A summary of deliverables Deliverable 1: Task 1 Report Report should detail the results of testing 10 protective clothing models (54 tests in total) against fentanyl permeation in accordance with ASTM D6978. The report should detail all raw data: protective clothing that passed or failed in accordance to the developed pass/fail criteria), as well as include the selected challenge concentration of fentanyl, and the concentration of fentanyl that permeated the protective clothing (if applicable). 1 electronic copy (Word or PDF format), January 31st 2022. Deliverable 2: Task 3 Report Report should detail the results of testing 3 protective clothing models (18 tests in total) against fentanyl analog permeation in accordance with ASTM D6978. The report should detail all raw data: protective clothing that passed or failed in accordance to the developed pass/fail criteria), as well as include the selected challenge concentration of fentanyl, and the concentration of fentanyl that permeated the protective clothing (if applicable). 1 electronic copy (Word or PDF format), April 30th 2022 Deliverable 3: Final Report Report should detail all raw data and the results of Tasks 1, and 3. The report should detail all necessary details to capture the findings of this work, including the testing methodology and parameters, instrument specification, and data on all protective clothing permeation tests. 1 electronic copy (Word or PDF format), September 1st 2022 SECTION 8 – REFERENCE MATERIALS The industry-accepted test method in Task 1 and 3 shall use ASTM D6978: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. ASTM D6978 references ASTM F739 “Standard Practice for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact,” Procedure A for permeation. Links to these test methods can be found here: https://www.astm.org/Standards/D6978.htm and https://compass.astm.org/download/F739.14035.pdf . NIOSH will provide the contractor with a PDF copy of this test method. SECTION 9 – ADDITIONAL APPLICABLE REQUIREMENTS Indicate which elements listed below apply to the project by checking the appropriate blocks. If applicable, provide the necessary clearance/approval documentation, if available; otherwise, indicate when the clearance/approval will be provided. 1. Performance-Based Requirements. Performance-based contracting techniques will be applied to task orders issued against the BPA to the extent practicable. For task orders that are awarded on a PBSC basis, the following will be provided with applicable task order requisition packages: (a) The Performance Work Statement defines the work in measurable, mission-related terms; (b) Performance standards (i.e., quality, quantity, timeliness) tied to the performance requirements; (c) A Quality Assurance Surveillance Plan (QASP) or other suitable plan that describes how the Contractor’s performance will be measured against the performance standards or service level agreements (SLAs); 2. HSPD-12. Applicable when the task order requirement involves or requires contractor access to HHS-controlled facilities, information technology systems, sensitive data, or any combination thereof. 3. EIT. Applicable when the task order involves the delivery of IT services or reports intended to be published for NIOSH staff or the public. Approval of the OPDIV/OS Section 508 Official or designee is required when claiming an exception to Section 508 of the Rehabilitation Act (see HHS Section 508 policy at http://508.hhs.gov/). 4. HIPPA. Indicate if HIPAA covered information will accessed so that appropriate contract clauses protecting the privacy of individually identifiable health information can be incorporated into the individual task order. 5. Conference Approval. Indicate of the work under the task order will involve a function meeting the definition of an event requiring CDC conference approval. 6. Human Subjects. See 45 CFR part 46 and HHSAR 370.301. 7. Animal Welfare. See the Public Health Service Policy on Humane Care and Use of Laboratory Animals, Revised 1986, and HHSAR 370.401 SECTION 10 – POINT OF CONTACT INFORMATION The Technical Point of Contact (POC) for this procurement is: Selcen Kilinc-Balci Centers for Disease Control and Prevention Patriots Plaza, Suite 9200, 395 E St., SW Washington, DC 20201 jcq8@cdc.gov; 412-386-4086 Preferred method of communication: email or telephone SECTION 11 – MINIMUM LABORATORY QUALIFICATIONS At minimum, the contracted laboratory must have the following currently in place: 1) appropriate DEA registration for handling fentanyl (and its analogs); 2) appropriate safety, security, and storage procedures for fentanyl (and its analogs); 3) ISO 9001 certification; 4) subject matter expertise and historic testing and evaluation experience of fentanyl (and/or its analogs) against various types of PPE; 5) appropriate analytical detection methods for detecting fentanyl and its analogs; and 6) appropriate equipment to characterize particles (e.g., particle size) 7) appropriate experience with synthesizing fentanyl and its analogs. SECTION 12 – TECHNICAL PROPOSAL INSTRUCTIONS Technical Proposal Instructions Offerors should note that a technical proposal is required for the Performance Work Statement as described under Section C of the Request for Task Proposal (RFTP). (a) Proposals which merely offer to conduct a program in accordance with the requirements of the Government’s Performance Work Statement will not be eligible for award. The technical proposal should be in as much detail as considered necessary to reflect a clear understanding of the nature of the work being undertaken. (b) The technical proposal must not contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that the offeror’s understanding of the work can be evaluated. (c) Offerors provide at a minimum of two page synopsis of the ability to conduct the work described within the Tasks of this contract. This should include qualifications and experience of personnel and the laboratory as it pertains to this contract, experience working with handling fentanyl (e.g., synthesizing, characterizing, detecting, testing PPE, etc.), and transfer and aerosolization studies that the contractor has conducted in their laboratory. The technical proposal should also include a sound approach to the completion of each task. Lastly, the technical proposal should include the proposed key professional personnel needed to complete each task, and the percentage of time each individual should be allocated to the task order. A price analysis of the quote will also be conducted to determine the reasonableness of the Contractor’s price. SECTION 14 – TECHNICAL EVALUATION TEAM Based on a sole source requirement, it is unnecessary to create have a review team. The PI will evaluate the technical criteria provide by the contractor: Selcen Kilinc-Balci (412-386-4086) Special Considerations: HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. (b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm. (c) The Section 508 accessibility standards applicable to this contract are: 1194. 205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services? In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508. In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues. ? (d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense. ? (e) Electronic content must be accessible to HHS acceptance criteria.? Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. ? _____________________________ A determination by the Government not to compete this proposed action will be based on responses to this notice and is solely in the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All vendors must be registered in the System for Award Management (SAM) at www.sam.gov , prior to an award of a federal contract. This action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C. 2304(c)(1). Interested persons may identify their interest and capability to respond to the requirement or submit quotations. This is not a request for competitive quotations; however, the Government will review any/all product, capabilities, and pricing information submitted prior to the closure of this notice. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responsible sources that believe they possess the expertise and capabilities identified above are hereby afforded the opportunity to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement and pricing information in the format they choose, not to exceed 10 pages. Please forward product and pricing information to Stephanie Reid, Contracting Specialist, CDC, OAS, through email at SReid@cdc.gov. Any responses should be emailed to Stephanie Reid at SReid@cdc.gov@cdc.gov by March 17, 2021 at 12:00 P.M. ET.