RFP 75N98023R00014 Questions and Answers Amendment 11 Final.docx

RFP 75N98023R00014 Questions and Answers Amendment #11 Answers to Questions are in bold.

1. Are the gloves for the Animal Labs the only gloves in this bid? What about the rest of NIH?

No. The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include ALL domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. The Amendment to Attachment 2 identified a known, unique salient characteristic for animal lab facilities. Because the attribute of 5mil vs. industry standard of 4mil for gloves was an important consideration specifically unique to a component organization, we highlighted it for consideration for those companies that offer this product. Companies may offer any or all IIJA compliant PPE that they are willing and able to provide the Government.

2. What color are the [nitrile and latex] gloves?

PPE being offered under this RFP should be IIJA compliant and meet the FDA, CDC and relevant certification standards identified in Attachment 2. The PPE that is being requested under the anticipated resultant IDIQ, is a comprehensive array, to include multiple salient characteristics and AQLs for the Government. Please provide the products you offer that meet IIJA compliant PPE and identify the colors, attributes, salient characteristics, including AQL’s your company is offering for sale to the Government.

3. Do you require a 510(k) for the [nitrile] gloves?

The determination of when a 510(k) is required is determined by the FDA and dependent upon what medical device is being offered to the Government. For example: because of the risks inherent to surgeon’s gloves and patient examination gloves the potential magnitude of the diseases being prevented to preserve healthy and safety of personnel and patients, for example, gloves with product codes LYY, LYZ, OIG, OPC, OPH, LZC, and OPA require a 510(k) clearance Manufacturers of one or more offerings under Class I and Class II devices should consult FDA website: Premarket Notification 510(k) | FDA. Please see also Q&A #1 Answer posted on August 9, 2023

4. What is the number of [nitrile] gloves that are in the current packaging? 100 per box or more? 10 boxes in a case?

Utilization estimates are listed on Attachment 2, page 4, Table 1. Quantities requested will be determined at the order level. Offerors should provide quantity and packaging in accordance with normal sales unit, packaging and manufacturing that occurs in the normal course of production.

5. Do they [nitrile gloves] have beads?

Please see Answer #2 above.

6. What is the estimated annual usage [ for nitrile gloves, latex gloves, safety goggles, lab coats]?

Utilization estimates are listed on Attachment 2, page 4, Table 1.

7. Are they [the PPE listed in Attachment 2] used in one location or multiple locations?

The PPE utilized by the animal facilities that were highlighted in Amendment #8 are utilized in a multiple building, but single campus location. Because it is a comprehensive, multiple organization usage contemplated under the resultant IDIQ, the consumers of the PPE will be housed in multiple locations.

8. What is the number of [latex] gloves that are in the current packaging? Are they single pair packed? How many in a case?

Please see Answer #4 above.

9. Are they [latex gloves] hand specific (left/right)?

Please see Answer #2 above.

10. Are the latex gloves surgical gloves? Sterile?

Please see Answer #2 above.

11. The original version of the solicitation listed certification level options for the Clear Mask as ASTM F2100, 16 CFR Part 1610, and 42 CFR 84. According to Amendment #8, the Clear Mask now requires only 42 CFR 84 certification, which is a certification for Respirators (including N95s). By eliminating the ASTM F2100 and 16 CFR Part 1610 certification options, no clear earloop mask in existence will meet the 42 CFR 84 certification standards as these standards are for respirators.

Clarification to Attachment 2 has been made under Amendment #11. The PPE that is being requested under the anticipated resultant IDIQ, is a comprehensive array, to include multiple salient characteristics and AQLs for the Government.

12. The surgical mask requirements for masks and clear masks changed to only 42 CFR 84. This CFR refers to Respirators. The correct CFR is 21 CFR 878.4040 Please see Amendment #11 for updated Attachment #2.

13. Are proposed items required to comply with all of the Certification Levels listed in the table on page 3 of Attachment 2?

The PPE that is being requested under the anticipated resultant IDIQ, is a comprehensive array, to include multiple salient characteristics and AQLs for the Government. Please provide the products you offer that meet IIJA compliant PPE and identify the colors, attributes, salient characteristics, including AQL’s your company is offering for sale to the Government.

14. Are contractors required to offer all sizes listed on page 5 of Attachment 2?

No. There is no mandate for what may be offered to the Government, only that any IIJA compliant PPE being offered to the Government, meet the required certification standards specific to the product being offered. The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. The Amendment to Attachment 2 identified a known, unique salient characteristic for animal lab facilities. Because the attribute of 5mil vs. industry standard of 4mil for gloves was an important consideration specifically unique to a component organization, we highlighted it for consideration for those companies that offer this product. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government.

15. Below this (ADDITIONAL COMPOSITION STANDARDS - Animal Lab Facilities) provision, there are salient properties listed for PPE used in this area. Does this mandate apply to all awarded contractors or just to those supplying PPE that will be used in the animal facilities?

No. The Amendment to Attachment 2 identified a known, unique salient characteristic specific to animal lab facilities. There is no mandate for what may be offered to the Government, only that any PPE being offered to the Government, meet the required certification standards specific to the product being offered. The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government.

16. Regarding the NFPA requirement sizes XS thru 6XL, what percentage of your overall glove usage is in sizes 3XL thru 6XL?

The range of lab gowns for animal lab facilities were for sizes 3XL through 6XL. Glove usage range across HHS is primarily XS through 2XL. The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1.

17. If NIH really wants to buy in accordance w/the Make PPE in America Act, would you consider a manufacturer/bidder if they currently only have glove formers (formers are the molds used to manufacture gloves) in sizes XS thru 2XL. Understand that the only thing needed to make sizes 3XL thru 6XL is procuring formers that size. With such small usage (less than 5% and likely less than 2% of NIH’s total usage) why force yourself into using Chinese or Malaysian product overall for such a small percentage of your volume?

Glove usage range across HHS is primarily XS through 2XL. The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. Non-domestically sourced, domestic component PPE is not being considered at this time.

18. We note that you are allowing bidders to propose isolation gowns. Can you provide specifications including: Desired fabric weight, Cuffs: Elastic, Knit, or thumbhole, Finished dimensions. We note that your specifications for surgical gowns do not specifically require a 510k, and do not specifically require sterilization. Can you confirm that you will accept surgical gowns that are not made under a 510k, and are not sterilized, if they pass AAMI level 4 barrier testing?

Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government. Please list all of the standards and certifications that your PPE offered meets.

19. Will 4 mil thickness gloves be given equal consideration given all other salient physical property characteristics are met for said glove? Or is the requirement strictly for a 5 Mil glove?

The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. The Amendment to Attachment 2 identified a known, unique salient characteristic for animal lab facilities. Because the attribute of 5mil vs. industry standard of 4mil for gloves was an important consideration specifically unique to a component organization, we highlighted it for consideration for those companies that offer this product. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government.

20. Does this requirement apply to PPE (glove) manufacturers? Resellers as well?

The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. The Amendment to Attachment 2 identified a known, unique salient characteristic for animal lab facilities. Because the attribute of 5mil vs. industry standard of 4mil for gloves was an important consideration specifically unique to a component organization, we highlighted it for consideration for those companies that offer this product. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government.

21. Would the NIH consider amending the certification level options for the Clear Mask to the original version ASTM F2100, 16 CFR Part 1610, and 42 CFR 84? By eliminating the ASTM F2100 and 16 CFR Part 1610 certification options, no clear earloop mask in existence will meet the 42 CFR 84 certification standards as these standards are for respirators.

Clarification to Attachment 2 has been made under Amendment #11. The PPE that is being requested under the anticipated resultant IDIQ, is a comprehensive array, to include multiple salient characteristics and AQLs for the Government.

22. For thickness: 5mil, is this fingertip, palm, or cuff?

The PPE that is being requested under the anticipated resultant IDIQ, is a comprehensive array, to include multiple salient characteristics and AQLs for the Government.

Nitrile gloves are commonly available in different thicknesses, measured in mils (thousandths of an inch). In reference to the 5mil glove as a need specific to animal lab facilities, the term "5 mil" refers to the average thickness of the glove material. However, this thickness is usually not evenly distributed across the entire glove. The distribution of thickness among the fingertips, palm, and cuff can vary depending on the manufacturer and the specific design of the gloves. In a typical nitrile glove with a thickness of 5 mils:

Fingertips: The fingertips of the gloves are usually thinner than the rest of the glove to provide better sensitivity and dexterity for tasks that require precision. The fingertip thickness might be around 3-4 mils.

Palm: The palm area is where the main protection is needed. The palm thickness is often close to the overall glove thickness, so in a 5-mil glove, the palm thickness might also be around 5 mils.

Cuff: The cuff is the part of the glove that covers the wrist. It is usually thicker and more robust than the fingertips to provide extra protection and prevent tearing during donning and doffing. The cuff thickness can vary, but it might be around 6-7 mils in a 5-mil glove.

It is important to note that these thickness values are approximate and can vary between different manufacturers and glove models. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government. Please list all of the standards and certifications that your PPE offered meets, including mil thickness.

23. What AAMI protection levels must the SMS Lab Coats pass to be considered?

To ensure that the Government has the best possible protective equipment to carry out their duties effectively, AAMI Level 4 protection for lab coats is requested. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government. Please list all of the standards and certifications that your PPE offered meets.

24. Would NIH consider allowing submissions without samples, and allowing winning bidders to submit samples for approval post-award? This would expedite and simplify the bid process.

Per the solicitation, Offerors must provide samples to be considered. Samples are due when proposals are due, not post award.

25. Other than looking at the PPE Contractor’s records, what is the nature and frequency of the inspections at a Contractor’s PPE facility, as stated in NIH STD12008b, paragraphs 3.1 Personnel, 3.7 Plant Sanitation, 3.8 Quality Control of the Feed Manufacturing Process, 3.9 Feed Ingredient Quality, and 4.1 Inspection?

The Government reserves the right to inspect facilities, upon award, to ensure they meet the requisite standards at least annually thereafter, or more frequently as may be necessary to meet quality assurance.

26. If a PPE Contractor’s plant is ISO 9001 certified, does NIH accept this or any other ISO certification(s) in lieu of the training records and quality assurance/management requirements and reports as stated in NIH STD12008b paragraph 3.1 Personnel, 3.2 Pest Management, 3.5 Equipment and Machinery, and/or 3.9 Feed Ingredient Quality?

The Government places emphasis on comprehensive compliance and adherence to its standards, which might encompass additional aspects not covered by ISO 9001 certification alone. NIH maintains its standards and requirements outlined in NIH STD12008b.

27. Is it NIH’s expectation that PPE Contractors flow down to the Contractor’s transportation or third part logistics providers the paragraph 3.2 Pest Management paragraph, or at minimum its requirements for a pest management control program and reports/records, as stated in NIH STD12008b?

NIH holds a proactive stance on maintaining the highest standards of safety and quality throughout the supply chain. While NIH recognizes the need for flexibility in the management of various aspects of operations, including pest management, it is strongly encouraged that PPE Contractors demonstrate a commitment to ensuring the integrity of their products and services, even beyond their immediate control. Specifically, the flow-down of pest management requirements to transportation or third-party logistics providers aligns with NIH's overall goal of safeguarding both human and environmental health.

In the context of paragraph 3.2 Pest Management of NIH STD12008b, which addresses the establishment of pest management control programs and the maintenance of relevant records and reports, NIH recommends PPE Contractors to consider extending these requirements to transportation or third-party logistics partners. By doing so, PPE Contractors can ensure that the same rigorous standards and protocols for pest management are upheld throughout the entire supply chain, from production to delivery. This practice not only enhances the overall quality and safety of the products being delivered but also reinforces the PPE Contractor's commitment to transparency, accountability, and continuous improvement. Collaborating closely with transportation or third-party logistics providers to ensure consistent adherence to pest management protocols is a proactive approach that aligns with NIH's dedication to excellence in all aspects of its contracted services.

While it may not be a strict mandate, NIH's expectation is that PPE Contractors recognize the benefits of extending the requirements outlined in paragraph 3.2 Pest Management of NIH STD12008b to their transportation or third-party logistics providers. This collaborative approach fosters a culture of shared responsibility and commitment to meeting the highest standards of quality, safety, and environmental protection.

28. Does NIH require new, unused pallets, as stated in NIH STD12008b, paragraph 4.0 Transportation?

Paragraph 4.0 Transportation within NIH STD12008b underscores NIH's commitment to ensuring the integrity of products and materials during their transportation. This includes the use of pallets, which play a crucial role in maintaining the quality and safety of goods throughout the supply chain.

NIH recognizes the importance of utilizing new, unused pallets in various scenarios. The use of such pallets helps minimize the risk of cross-contamination, allergen transfer, and pest infestations. Additionally, new pallets are less likely to have been exposed to potentially hazardous materials, residues, or contaminants that might compromise the safety of the products being transported. While NIH STD12008b does emphasize the use of new, unused pallets, it's important to acknowledge that the specific context and requirements of each situation may vary. There might be cases where reusing pallets is acceptable, provided that thorough cleaning, disinfection, and inspection processes are implemented to ensure that the pallets are free from contaminants and pose no risk to product quality.

While NIH does emphasize the use of new, unused pallets in accordance with paragraph 4.0 Transportation of NIH STD12008b, it's crucial to consider the specific circumstances of each case and take measures to ensure the cleanliness, safety, and quality of any pallets used. The intention behind this requirement is to maintain the highest standards of product safety and integrity throughout the transportation process.

29. For the reports required in NIH STD12008b, Pest Management paragraph 3.2.b.4 Quality Assurance and 3.2.b.5 Service Reports, and 3.5 Equipment and Machinery, does NIH expect the Contractor to provide these reports to NIH once after contract award or, if instead on a recurring basis, how frequently? What are the specific requirements (e.g., content, format, etc.) for these reports?

NIH expects these reports to be provided on a recurring basis. The specific frequency can vary based on the scope of work and the risk factors associated with the environment. It is recommended that PPE Contractors discuss and establish a reporting schedule with NIH to align with the unique needs of the facility.

Regarding the content and format of these reports, NIH STD12008b does not provide specific details. However, it is anticipated that these reports should include, but are not limited to:

Pest Management Reporting

· Summary of pest management activities conducted during the reporting period

· Pest identification and location of activity

· Details of corrective actions taken

· Any changes or modifications to the pest management program

· Documentation of inspections and outcomes

· Signature and credentials of responsible personnel

Equipment and Machinery Reporting (3.5 Equipment and Machinery): The content and format of equipment and machinery reports should encompass essential information such as:

· List of equipment and machinery used

· Maintenance and service schedules

· Inspection outcomes and findings

· Any repairs or adjustments made

· Records of training and certification for personnel operating the equipment

· Updates on equipment upgrades or replacements.

NIH expects PPE Contractors to provide reports on a recurring basis for both pest management and equipment and machinery, as per the requirements specified in NIH STD12008b. While the standard does not outline detailed content and format requirements, it is crucial to provide comprehensive and accurate information in a manner that reflects professionalism and transparency. Collaborating closely with NIH to establish a reporting schedule and address any specific content expectations will contribute to the successful fulfillment of these reporting obligations.

30. Amendment 8, page 11 indicates, “Suppliers must meet the standards for personal protective equipment (PPE) found here:” The document then goes on to list text and refers to various standards, guides and guidelines. The link to NIH Standard 12008b is listed as only applicable to Laboratory Animal Feed Processing and Mill Sanitation. In reading the document there are no standards for personal protective equipment (PPE) found in the document. What PPE standards is the Government referring to within this document? The standard does refer to clothing when it says, “Wearing clean uniforms in a manner that protects against the contamination of feed, feed-contact surfaces, or feed packaging materials.” Is the requirement to wear uniforms applicable to PPE manufacturers even though our PPE factory does not contain feed, feed-contact surfaces or feed packaging materials? Please clarify that NIH is not indicating PPE manufacturers need to meet the requirements in NIH Standard 12008b, but rather, as written later in that paragraph, a PPE manufacturer, as the Awarded Contractor, is required to only: 1) “provide (upon award) the name of the firm that provides vermin and pest control services as well as a description of their pest control program” and 2 “provide, upon award, a copy of the pesticides used, program for maintaining the stored product(s) free of pesticide residues, facility map, and the latest quality assurance report and service report and provide the regularly scheduled and documented program of manufacturing, storage, control and monitoring that exist.”

The specific requirements for a PPE manufacturer, as the Awarded Contractor, are as follows:

Provide the name of the firm responsible for vermin and pest control services, along with a description of their pest control program, upon award.

Submit a copy of the pesticides used, a program for maintaining stored products free of pesticide residues, a facility map, the latest quality assurance report, and service report upon award. Additionally, provide a regularly scheduled and documented program of manufacturing, storage, control, and monitoring.

It is important to note that these requirements focus on the aspects directly related to maintaining quality assurance, vermin control, and the safe production and storage of PPE. The specific PPE standards referenced in the document, which were not included in the text, should be interpreted in line with the specialized nature of PPE manufacturing.

31. Amendment 8, page 11 indicates, "Awarded Contractor(s) shall also provide, upon award, a copy of the pesticides used, program for maintaining the stored product(s) free of pesticide residues, facility map, and the latest quality assurance report and service report and provide the regularly scheduled and documented program of manufacturing, storage, control and monitoring that exist.” Does NIH expect the Contractor to provide these reports to NIH once after contract award or, if instead on a recurring basis, how frequently?

Please see below:

Copy of Pesticides Used: This requirement involves submitting a copy of the pesticides used in your operations. The expectation is to provide this information upon contract award. It is a one-time submission and serves to inform NIH of the specific pesticides used in your manufacturing processes.

Program for Maintaining Pesticide Residue-Free Storage: Similar to the previous requirement, this information is expected to be provided upon contract award. It offers insight into how you maintain your stored products free of pesticide residues and ensures that proper practices are in place from the beginning of the contract.

Facility Map: Providing a facility map allows NIH to understand the layout and arrangement of your manufacturing, storage, and control areas. This, too, is expected as a one-time submission upon contract award.

Latest Quality Assurance Report and Service Report: These reports offer a snapshot of the quality assurance efforts and services carried out. As these documents provide a current overview of your operations, they should be provided upon contract award and kept up to date whenever a new report becomes available.

Regularly Scheduled and Documented Program: This program outlines your procedures for manufacturing, storage, control, and monitoring. It is expected to be provided upon contract award and serves as a foundational document that reflects your commitment to maintaining high standards throughout the life of the contract.

In summary, the majority of the documentation is expected to be submitted once upon contract award. However, documents like the latest quality assurance report and service report should be updated whenever new versions are available to ensure NIH has current and accurate information about your operations.

32. In review of pages 21, 22 and 141 in the National Research Council (2011). Guide for the Care and Use of Laboratory Animals, 8th Edition. Pages 21, 22, 141. Institute of Laboratory Animal Resources, Commission on Life Sciences, does not make reference to the manufacturing facility of PPE. It also does not impose any obligation on a manufacturer of PPE or require the flow down of any part of this Guide to a PPE manufacturer. Rather, all references to PPE are regarding the health and safety of personnel working with the animals, in the work environment, and to an animal facility. Please confirm, therefore, that no obligations are imposed upon the Contractor related to respirator manufacturing, arising out of these pages. Alternately, please specifically identify what NIH is stating are the requirements of a PPE manufacturer.

Per the Guide for the Care and Use of Laboratory Animals, 8th Edition, Pages 21, 22, and 141 do not convey any requirements or obligations related to the manufacturing of respirators or other PPE. Therefore, there are no direct implications arising from these pages for PPE manufacturers in the context of respirator manufacturing.

The Guide's references to PPE are centered on ensuring the safety of personnel and the well-being of animals. While PPE manufacturers play a vital role in supporting these goals, the Guide does not impose requirements specific to PPE manufacturing.

To further confirm, NIH does not assert any obligations upon Contractors related to respirator manufacturing based on the pages referenced. The obligations outlined in NIH documents are distinct and focused on other aspects of quality assurance, vermin control, and the safe production and storage of PPE.

33. Do the requirements and items (Lab coats. Coveralls etc.) mentioned under ADDITIONAL COMPOSITION STANDARDS - Animal Lab Facilities (Pg 11-14) constitute additional binding requirements? i.e., do we have to fulfill them in addition to the previous requirements for each PPE item or can we proceed with our previous offerings without the products being animal lab-specific PPE?

The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. The Amendment to Attachment 2 identified a known, unique salient characteristic specific for animal lab facilities. Because the attribute of 5mil vs. industry standard of 4mil for gloves was an important consideration specifically unique to a component organization, we highlighted it for consideration for those companies that offer this product. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government.

The "ADDITIONAL COMPOSITION STANDARDS - Animal Lab Facilities" detailed in the mentioned pages provide guidelines that are specific for PPE items used in animal lab environments. These guidelines address the unique challenges and considerations associated with working in laboratory settings where animals are present and consider factors such as protection against potential contaminants, ease of decontamination, and compatibility with animal research activities. In addressing your inquiry, it is essential to understand that the additional composition standards for animal lab facilities are intended to enhance the suitability of PPE items for such environments. While these standards are recommended to ensure optimal safety and functionality in animal lab settings, they are not mandatory for PPE manufacturers to comply with unless they align with your product development and business goals. Ultimately, the decision of whether to fulfill these specific animal lab-specific PPE standards depends on various factors including market demand, customer requirements, and your organization's strategic direction. If your previous offerings meet the general PPE requirements and align with industry standards, you can proceed with those offerings. It is important to note that compliance with these additional standards could potentially open new avenues for your PPE offerings in the animal lab facilities market segment, showcasing your commitment to addressing the unique needs of these environments.

34. Are we allowed to go over the 55" height for pallet dims to maximize eaches per pallet? If so, what is the maximum allowable above the listed height per pallet?

Pallet maximum is 55” per warehousing configuration.

35. With private labeled products, per the FDA packaging guidelines, the private label will have the required verbiage “Distributed by” listed on the packaging in place of the manufacturers information. Will this packaging be acceptable? If it’s required by NIH, a secondary label with this information along with any additional labeling and barcode requirements will be affixed to the packaging. Will this secondary label be acceptable to meet the additional requirements?

Bar coding for scan capability is a requirement. Barcodes must be affixed to each respective case (at a minimum) for shipments arriving on a pallet. Every individual package shipped to/received by the Government warehouse must have a barcode on its packaging. Barcoding cannot be done by pallet. Related stock numbers will be provided, as necessary, to the contract awardee for appropriate labeling/barcoding. Suppliers must label each package with the NIHSC NSN provided; this is an individually assigned number separate from UPC and any secondary labels applied by the Supplier. Manufacturer inclusion on the NSN, secondary labels applied by Supplier is helpful, but not required.

36. Product Name (under the bar code but not coded in the barcode). What are the 3 of 9 codes acceptable? Will a GUDI be required, or will a UPC-A barcode be acceptable?

Bar coding for scan capability is a requirement. Related stock numbers will be provided, as necessary, to the contract awardee for appropriate labeling/barcoding. NIH’s system of record (NBS) is currently unable to use manufacturer barcodes; suppliers must label each package with the NIHSC NSN provided.

37. With the continued extensions, are we allowed to continue to send samples for our submission package?

Samples may be sent up until the time of Proposal due date. See also Answer 24 above.

38. Are the products & their respective specifications on the last 2 pages (12 13) of the document destined specifically for Animal Lab Facilities, as per the highlighted title ''ADDITIONAL COMPOSITION STANDARDS - Animal Lab Facilities''? We want to understand if these changes only affect the PPEs used for Animal Lab Facilities, or the PPE used as a whole in all departments (including hospitals, clinics, etc.)

Yes, the portion of Attachment 2 identified as “ADDITIONAL COMPOSITION STANDARDS – Animal Lab Facilities” is specific to Animal Lab facilities. The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. The Amendment to Attachment 2 identified a known, unique salient characteristic specific for animal lab facilities. Because the attribute of 5mil vs. industry standard of 4mil for gloves was an important consideration specifically unique to a component organization, we highlighted it for consideration for those companies that offer this product. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government.

39. Could we get a more detailed list of the PPEs you are looking to procure for each of the PPE categories? For example, in the ''PPE Gloves'' category, it is impossible to tell what exact gloves specifications you are looking to acquire. The characteristics, certifications & protective attributes all refer to a very large number of different types of gloves. Could you make a list of the products with their specific requirements so that we can have a better time offering a product?

The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. The Amendment to Attachment 2 identified a known, unique salient characteristic for animal lab facilities. Because the attribute of 5mil vs. industry standard of 4mil for gloves was an important consideration specifically unique to a component organization, we highlighted it for consideration for those companies that offer this product. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government.

40. Page 10 includes the following table about levels of protection. Can you provide more information about these levels of protection? Are there supporting documents or regulations we can refer to? Where should this information be included in our technical response?

Please see Amendment #11, which amends Attachment 2 to clarify references to levels of protection based on usage. The purpose of this Request for Proposal and resultant vehicle, is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Companies may offer any or all IIJA compliant PPE that meet the respective, requisite certification standards, that Offerors are willing and able to provide the Government. Companies should reference the relevant standards and certification specific to the IIJA compliant PPE they are offering the Government within their technical proposal.

41. Regarding Attachment #8, a specification with measurements titled “Salient Characteristics for Spun Bound Melt-Blown Synthetic (SMS) Lab Coats:” was given on page 12 of the document titled “IIJA Compliant PPE Specifications, Certification Levels, and Attributes” dated August 14 2023. We are looking for clarification on Point of measure for the sleeve opening, sleeve out seam and arm pit. Can the NIH please provide a Point of Measure guide that clearly spells out from where on the garment these measurements are to be taken from?

Measurement points will be familiar to established manufacturers and align with industry standards. The specifications detailed in "Salient Characteristics for Spun Bound Melt-Blown Synthetic (SMS) Lab Coats" should reflect widely accepted industry standards for SMS Lab Coats production. If your lab coats are already being manufactured in line with these established standards, then the expectation is that you are fulfilling the specified requirements without the need for additional guidance. We encourage you to continue your efforts in maintaining the high quality and safety standards that are expected in producing SMS Lab Coats.

42. Bar Coding Requirements – I assume most are in the same boat, but are we expected to unpack our current inventory to support the NSN and barcoding requirements outlined? This would require re-labeling and changing our packaging artwork to accommodate, which is possible, but I want to understand if that is a strict requirement. Currently, we have a UPC barcode on the product that scans and gives you the information on the product, but does not have NSN information, etc.

Bar coding for scan capability is a requirement. Related stock numbers will be provided, as necessary, to the contract awardee for appropriate labeling/barcoding. NIH’s system of record (NBS) is currently unable to use manufacturer barcodes; suppliers must label each package with the NIHSC NSN provided.

43. Does the expiration date have to be printed on the mask boxes? This is not an FDA requirement for masks, so it has not been historically included. Also, does the manufacturers name have to be on the box? Our line is a private label and only includes our brand name. Right now, our boxes will have date of manufacturing, lot number, etc. Alternatively, we could put the expiration date on the outside of the wrapped pallet. Would that suffice?

Clearly identifying the expiration date per sales unit is imperative to quality control. Expiration date must be clearly marked on outer package.

44. As all products must be shipped on a pallet, does NIH intend to only purchase by the pallet or is the request to order by case? It would not be economical to only ship 5 cases on 1 pallet as currently our manufacturer places 60 cases (600 boxes/24,000 pieces) per pallet.

The Government is not prescribing how companies conduct their standard business operating procedures. Responsive offerors should present pricing data based on articulated assumptions for volume savings. To re-emphasize, the resultant vehicle is for HHS agencies potential consumption, inclusive of NIH. See also, Answers to #45 to the RFP above. Offerors should demonstrate the ability “meet and sustain” product shipments on a recurring monthly basis, and up to twice weekly as required for inventory replenishment.

45. Is this contract for “regular” NIH orders or is this contract geared towards a “pandemic-type crisis” or “special” situations?

Proposed Utilization Estimates are listed on Attachment 2 of the RFP/Solicitation and are intended for anticipated use for the duration of the awarded contract for “normal”/non-emergency usage. This includes requirements estimated across HHS subagencies, inclusive of NIH.

46. The RFP states, "No more than one sample per contract line item proposed shall be submitted to the Government". Should we send just one sample or one box of each line item? In my understanding, the Federal Government has a review panel composed of several individuals, each of whom evaluates, handles, and tries on the sample. My recommendation is to send one box of each item. Can you please provide further guidance?

Samples provided should follow the instructions within the RFP/solicitation. For each PPE offered, a sample needs to be provided (including 1/size offered). All samples must be provided in the by sales unit and within original packaging with manufacturer and product details. No more than one sample per contract line item proposed shall be submitted to the Government to determine whether items meet specifications for anticipated use. Samples must be sent in the packaging that will be sold to and by the NIHSC. This is critical to the packing validation that characteristics are MADE IN USA markings are on every material. Information concerning submitting samples are detailed further in Page 18 of the solicitation.

47. What quantity do you need for the [masks, face shields]?

Proposed Utilization Estimates are listed on Attachment 2 of the RFP/Solicitation. This includes requirements estimated across HHS subagencies, inclusive of NIH.

Utilization estimates are listed on Attachment 2, page 4, Table 1. Under an IDIQ, quantities for specific PPE requested will be determined at the order level. Offerors should provide quantity and packaging in accordance with normal sales unit, packaging and manufacturing that occurs in the normal course of production.

48. The pallet size stated in the instructions is size 42x40 4 way. Please confirm if this is correct. If this is the case, the pallets will be a special size request therefore increasing the price.

Both standard pallet dimensions (48” x 40”) and 42” x 40” pallets will be accepted.

49. Special delivery options of overnight or expedited shipping. As we know, shipping large pallets overnight is extremely expensive. What is the average in the past in which the Government required overnight shipping?(100%, 80%, or 25%) Proposed Utilization Estimates listed on Attachment 2 of the RFP/Solicitation are intended for anticipated use for the duration of the awarded contract for “normal”/non-emergency usage, which should not require overnight shipping if contractor can demonstrably meet the ability to sustain product shipments on a recurring monthly basis, and up to twice weekly as required for inventory replenishment. Expedited shipping or other special delivery options, if any, will be determined at the order level.

50. CLIN 3 Lab Coats and/or Jackets; CLIN 5 Surgical Gowns - Required certifications are clear however please provide salient characteristics of garment9s).

PPE being offered under this RFP should be IIJA compliant and meet the FDA, CDC and relevant certification standards identified in Attachment 2. The PPE that is being requested under the anticipated resultant IDIQ, is a comprehensive array, to include multiple salient characteristics and AQLs for the Government. Please provide the products you offer that meet IIJA compliant PPE and identify the colors, attributes, salient characteristics, including AQL’s your company is offering for sale to the Government.

51. CLIN 4 Coveralls – Please provide the build model i.e. with or without attached hood? With or without attached booties/socks?

PPE being offered under this RFP should be IIJA compliant and meet the FDA, CDC and relevant certification standards identified in Attachment 2. The PPE that is being requested under the anticipated resultant IDIQ, is a comprehensive array, to include multiple salient characteristics and AQLs for the Government. For example, animal lab facilities requirements may include attached hood and booties, whereas other labs and facilities would not. Please provide the products you offer that meet IIJA compliant PPE and identify the colors, attributes, salient characteristics, including AQL’s your company is offering for sale to the Government.

52. Amendment 0002 was issued to include potential HHS use. Since HHS had a requirement for Level 2 disposable isolation gowns (proposals were due in Nov 2022) and never proceeded with a contract award, will the NIH solicitation be further amended to include Level 2 disposable isolation gowns?

This RFP/Solicitation always contemplated and considered enterprise HHS use to include all types of domestically sourced and component PPE. Amendment #2 added additional language to further underscore this. Per the RFP/Solicitation, page 2, the anticipated contract type is “a multiple award indefinite delivery/indefinite quantity (IDIQ) type contract in accordance with FAR Part 16.504.” Because it is an IDIQ, the Government does not presently have a definitized quantity requirement for this specific PPE. However, the purpose of the resultant vehicle is to comprehensively include all domestically sourced, domestic components PPE as defined under the IIJA for use by all of HHS agencies. Utilization estimates are listed on Attachment 2, page 4, Table 1. If isolation gowns are something your company offers to the Government, please offer it under CLIN 5.