****** 01/29/2021 – Uploaded Draft SOW.***** This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Center for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), is seeking information on a potential requirement for “PPE Conformity Assessment-NIOSH Pittsburgh” The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the NAICS code 541690 for the potential acquisition. See Draft Sample Work Statement. 1 Background and Need – Conformity assessment (CA) is the demonstration that a product meets specified requirements. CA procedures evaluate whether the products, services, or systems produced or operated have the required characteristics and whether these characteristics are consistent from product to product, service to service, or system to system. CA includes sampling and testing, inspection, supplier’s declaration, certification, and quality and environmental system assessment and registration. It also includes accreditation of the competence of the provider of those activities by a third party and recognition of an accreditation program's capability. In the U.S., CA schemes are commonly referred to as CA programs. Both public agencies and private organizations operate such programs. A program consists of rules, procedures, and management requirements related to assessing conformity with a set of specified requirements. The National Framework for Personal Protective Equipment Conformity Assessment – Infrastructure provides a Framework to assist in developing, structuring, and managing conformity assessment for personal protective equipment used in American workplaces. The Framework serves as foundational principles for conformity assessment programs. At NPPTL, the respirator conformity assessment core function consists of those activities performed to ensure that all respiratory protective devices (RPDs) used in American workplaces conform to established standards and provide the defined level of respiratory protection. The primary purpose of this action is to fully align NIOSH’s Respirator Conformity Assessment Core Function with the principles outlined in the National Framework for PPE CA. A secondary purpose is to similarly align NIOSH’s non-respiratory PPE and non-traditional RPDs efforts with the Framework. 2 Project Objective – The following objectives are established for the contractor to provide the minimum services: Identify practices from private sector CA programs that may offer enhancements to the respirator conformity assessment core function activities Assist NIOSH in ensuring that the findings and recommendations of the ad hoc committee are made actionable and successfully incorporated into its Respirator Conformity Assessment activities. Explore technologies and approaches currently being used and developed. Explore Conformity Assessment requirements needed, including CA activities and gaps in standards related to face masks, face shields, ensemble combinations of protections. Develop a strategy for NIOSH to incorporate the use of third-party test laboratories into the RAP and Post Market Evaluation activities. Define a system that allows Approval Holders to upload and identify the relevant documents and their status changes and identify the regulatory updates needed. Develop a sustainable strategy for improving respirator approval turn-around times. Develop a strategy for considering the implications of modifying an STP that would cause respirators that have been previously approved to not meet the requirements under a modified STP. Review the NIOSH STPs to determine the abilities of the current test methods to effectively evaluate the appropriateness of a product to meet performance requirements, as well as a strategy to prioritize the STPs to be updated. Assess the various performance requirements of 42 CFR Part 84 for appropriateness in modern workplaces, as well as for workplaces of the future. Develop a strategy to incorporate issues that are identified during the RAP activity’s initial, engineering, and quality reviews and recommend a feedback loop to better evaluate products at an increased frequency. Identifying gaps for the healthcare and EMS community, including respirator decontamination and outward leakage from exhalation values Identify gaps in approaches and develop strategic direction for Conformity Assessment of nonregulated devices intended to provide respiratory protection and barrier face coverings. Anticipated period of performance. Two (2) years of the effective date of the contract. The contractor may propose an accelerated schedule based on concurrent performance of some or all of the effort Capability statement /information sought. Respondents who believe that they possess the expertise and experience to meet the government’s needs as described above are invited to submit technical and management capabilities addressing those requirements. These may include but are not limited to: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information . Respondent must indicate in your capability statement: Organization name, Address, DUNS number, Business size Classification (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code of 541690 Other Scientific and Technical Consulting Services size standard which is $16.5 million . Points of contact, Email, Telephone number, Page Limitation: No more than five (5) pages, 8 ½ x 11. Response Due Date: Submit information above to Stephanie Reid, Contracting Specialist,
[email protected]. Reference: HHS-CDC-NIOSH(SR)-SBSS-21-52153 . Responses are due no later than 12:00pm, February 10, 2021 Eastern Time. Any information received by the government will not be returned. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be posted on Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).