QA- 75A50322R00008_IsolationGowns_update2_072922.pdf

Combined Synopsis/Solicitation

Combined Synopsis/Solicitation #75A50322R00008 Domestic Isolation Gowns Questions and Responses

No. Question Response Solicitation Revision

1 What is the difference in size from Large to X-Large?

Large and extra-large gown sizes should reflect dimensions currently available in the commercial market. Examples of approximate gown dimensions include chest width:

large 27 inches and extra-large 30-31 inches; sleeve length: large 22-23 inches and extra-large 24 inches; and gown length 46 inches.

N/A

2 Do they need to be a certain percentage larger?

Reference Question #1. N/A

3 How will this need to be submitted?

Technical responses are to be documented and substantiated in the response. N/A

4 Page 2, of the Solicitation page 2 states, “The offeror’s complete proposal (including all information required to be submitted as part of the offeror’s Volume A -Technical Proposal, and Volume B – Price/Business proposal)”.

Volume A – Technical Proposal and Volume B – Price/business proposal are to be labeled as such and submitted separately by established deadlines.

N/A

5 Do we need to label it Volume A or Volume B?

Yes. N/A

6 RFP 75A50322R00008 went inactive after posting. Do you expect this RFP to be reactivated soon? If not, can you share any timeline?

The RFP is active. N/A

7 Is the Solicitation RFP 75A50322R00008 active?

8 How can we better track information on Sam.gov?

Contact www.sam.gov for tracking options. N/A

9 Is there past awarded pricing for this item?

There is no previous or historical pricing available. N/A http://www.sam.gov/

10 What are the outlying areas regarding place of manufacturing?

Contractor must provide items compliant with the IIJA/Make PPE in America Act. The goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components. “Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations. Reference H.5 – Domestic Manufacturing for definition of outlying areas.

N/A

11 We are a Canadian company that has facilities in NY and USA that make the gowns. Can we bid on the requirement?

See response to question # 10. N/A

12 For the technical reports, can we use our nonwoven fabric suppliers for the biocompatibility?

No. Biocompatibility testing shall be conducted on the final finished gown at a US independent ISO 17025 accredited laboratory, with each biocompatibility test (irritation, sensitization, and cytotoxicity) being within the scope of the laboratory’s accreditation.

N/A

13 Would we be allowed to show the required Subfactor 8 test reports on our TAA-compliant Cambodian and/or Chinese gowns that have an identical manufacturing process?

Contractor must provide items compliant with the IIJA/Make PPE in America Act. The goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components.

“Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations. Test reports must be conducted and provided on the offered full finished gown which is manufactured and sourced in the US. Test results from a foreign laboratory is not acceptable.

14 Will the solicitation result in multiple contracts awarded to multiple offerors, or a single contract awarded to a single offeror?

The Government reserves the right to make multiple awards under this solicitation. N/A

15 May we request the previous bid tabulation and contract pricing?

See response to question # 9. N/A

16 RFP which was issued on June 27, 2022, is this active or has it been rendered inactive shortly after it was issued?

The RFP is active. N/A

17 Regarding the language found on pg.38, L.3 Addendum to FAR 52.212-1 within the attached combined synopsis solicitation. Does DHHS consider electronic signatures to be valid?

Yes, electronic signatures are acceptable. N/A

18 The proposal must be signed by an official authorized to bind your organization?

19 Please clarify the type of audit found on pg.44, section (b) Business Proposal Cover Sheet within the attached combined synopsis solicitation?

Section L.6 Business Proposal Instructions, (b) Business Proposal Cover Sheet – the listed information is requested “as applicable”. The Government is not requesting a specific type of audit.

20 Our gown is individually packed with polybag, for the inner label, can we place it on that polybag, or we need to place it onto the gown?

It is not required to place labeling on individual gowns.

Isolation gowns must be packaged and labeled in inner packaging within the outer case.

Labeling must be applied to the inner packaging, such as a polybag and the outer case.

Isolation gowns case labeling and inner packaging labeling must comply with ASTM F3352-19 Section 11.1 and 11.2 Labeling Requirements, FDA’s general device labeling requirements per 21 CFR Part 801, and other applicable guidance.

Change for clarity: add first sentence to Section M – Evaluation Factors For Award, (1) Technical Evaluation Criteria, Subfactor 3:

Labeling

“It is not required to place labeling on individual gowns.”

See page 46

21 Domestic component: the elastic band supplier claims their band is made in USA with globally sourced materials, will that component

Reference H.5 – Domestic Manufacturing Contractor must provide items compliant with the IIJA/Make PPE in America Act. The goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are

(elastics band) count as a 100% domestic component?

grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components. “Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations.

22 Will you please disclose the funding level that is currently available for this procurement?

Funding levels will be made available at the base year and upon award.

23 If additional funding is needed, what is the pathway to obtain that funding?

See response to question #22.

24 Will the agency establish accelerated payments to small businesses with a goal of 15 days or less? Will the agency consider contract financing such as advance payments given the potential high volume of product?

That’s a lot in carrying costs for small businesses to absorb.

Yes, accelerated payments are considered in accordance with FAR 52.232-25. N/A

25 Section IV talks about up to 75,200,000 Level 2 gowns “manufactured in the U.S.” PLUS an optional quantity of 150,400,000 that are 100% domestic components.

C.2 Talks about the purpose in establishing Level 2 disposable “domestically manufactured” gowns.

Domestically manufactured could imply some components sourced elsewhere Section H.5 only talks about Make PPE in America act – so is H.5 only applicable to the optional quantity or ALL delivered product?

All delivered product. H.5 is applicable to components and delivered product. N/A

26 Is H.5 clause the reason Trade Agreements 52.225-5 is not checked? Trade agreements could apply vis-a-vis by dollar threshold reached under an awarded contract.

Trade Agreement does not apply to this award. The components must be 100 domestically sourced in accordance with H.5.

N/A

27 Label: Our gown is individually packed with polybag, for the inner label, can we place it on that polybag, or we need to place it onto the gown?

See comments on question #20. N/A

28 domestic component: the elastic band supplier claims their band is made in USA with globally sourced materials, will that component (elastics band) count as a 100% domestic component ?

Reference H.5 – Domestic Manufacturing goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components. “Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations.

N/A

29 Regarding the language found on pg.38, L.3 Addendum to FAR 52.212-1 within the attached combined synopsis solicitation.

Does DHHS consider electronic signatures to be valid "original" signatures (i.e.: DocuSign)? “The proposal must be signed by an official authorized to bind your organization.”

Yes N/A

30 Does HHS have a preference or position on build quality conforming to industry standard characteristics?

For instance, are seams allowed to be left exposed on the outside of the gown or is the industry standard of all seams being turned to the inside of the gown preferred?

Gown design and construction must meet standards listed in Section C.3 Open Seams of the RFP. Seams must conform to industry standards. and may not be exposed on the outside of the gown.

31 Will gowns with knitted cuffs be given preference over elastic cuffs?

Knitted cuffs have advantages over elastic cuffs, including a more comfortable fit, better protection over gloves, and are generally more accepted in the commercial marketplace. However, they have a higher cost than elastic cuffs. So it is valuable to know if knitted cuffs are preferred or if they are viewed as an equal replacement option?

Elastic wrist and knitted cuffs will both be considered. Both costs must be separately provided under 1 submission.

N/A

32 Is rubber thread allowed for the cuffs or is the industry standard elastic ribbon preferred?

Gown material shall be consistent with industry standards. Elastic wrist and knitted cuffs will both be considered. Rubber thread is not acceptable.

N/A

33 How do you submit bids for two different part numbers? For instance, one for a gown with knitted cuffs and one for a gown with elastic cuffs. Does this require two separate submissions, or is it different CLINs?

Multiple gowns may be submitted under the same proposal. Each different gown type/part number submitted would require the full required package of information, testing results, labeling etc.

N/A

34 Because of the limited time period before submissions are due, would we be allowed to show the required Subfactor 8 test reports on our TAA-compliant Cambodian and/or Chinese gowns that have an identical manufacturing process, design, attributes, and gram weight of material, knowing that the production product upon award would come from our USA factory with solely domestic components?

Contractor must provide items compliant with the IIJA/Make PPE in America Act. The goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components.

“Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations.

Test reports must be conducted and provided on the offered full finished gown which is manufactured and sourced in the US. Test results from a foreign laboratory is not acceptable.

Biocompatibility reports are now required as a contract deliverable within 30 days from award. The solicitation has been updated to reflect this change, Change: Section C.6 Deliverables

See pages 15-16, 41 including the evaluation factors.

35 For points 1, 3, 4, 5, 6, 8 and 10 can the Government please clarify on whether it expects these on the outer carton, inner packaging, both or neither? We recognize these have to be on the “deliverable” based on the wording in the RFP. Should these be on the outer carton and inner packaging as well?

For Section D.2. Markings points 1-12, the following items shall be listed on both the inner packaging and the outer case: Description of product, manufacturer name and address, lot numbers, quantity, date of manufacture or expiration date, and part number. All other information required in Section D.2. Markings shall be, at a minimum, listed on the outer case.

Additionally, isolation gown case labeling and inner packaging labeling must comply with ASTM F3352-19 Section 11.1 and 11.2 Labeling Requirements, FDA’s general device labeling requirements per 21 CFR Part 801, and other applicable guidance.

36 It references ‘“Component” means an article, material, or supply incorporated directly into an end product. Would the Government like to see packaging materials, US labor cost, logistics and rent included in this calculation, especially given that US labor is the largest percentage of cost?

Page 41-42

Section B – Supplies or Services and prices/Costs require all costs to be rolled up into a cost per each unit. The Offerors shall provide a breakdown of the end product demonstrating that the cost of domestic components and material is 100% of the cost of all the components. For the technical proposal, this information must be expressed in terms of percentages. Also reference directions under (b) Business Proposal Cover Sheet regarding costs reporting. The Offerors shall provide a breakdown of the end product demonstrating that the cost of domestic components and material is 100% of the cost of all the components and material. For the technical proposal, this information must be expressed in terms of percentages. Offerors will be evaluated based upon the percentage of domestic components; vendors who provide less than 100% of domestic components will not be considered.

N/A

37 What is the minimum and maximum number of volume pricing steps/tiers that the Government will allow? In the example there is 4 volume ranges.

Page 7-8

B.4 Volume Discounts states Vendors must provide a volume-based pricing table.

Example provided below; vendors may update these volume ranges. No Minimum or Maximum requirement is listed.

N/A

38 Will the government please confirm that the requirement for this RFP is that the raw material must be sourced from the United States and the labor must be performed within the United States?

goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components. “Component” means an article, material, or supply incorporated directly into an end product. A “domestic component” means one that is manufactured/sourced in the United States, its territories, or tribal locations.

N/A

39 If a contractor manufactures in California and is asked to deliver to New York, their delivered price is

Products shall be shipped FOB Destination. The address(es) will be provided by the COR after award and will be to a Government designated location within the very different from a manufacturer based in New Jersey that is asked to deliver to New York. Can HHS / ASPR provide an assumed delivery location for the sole purpose of evaluating pricing on a level playing field across all vendors so that all vendors can have same delivery location assumption when creating a delivered price for the government?

continental United States (CONUS). Contractor should calculate FOB destination costs based on multiple geographic locations across the CONUS.

40 Will the contract include a separate CLIN for shipping at the time it is awarded?

Yes. Transportation (Time and Material) CLIN 1003 & 2003 have been added for Shipping Cost. There is now a total of three (3) CLINs in the RFP in Section B.1 Contract Line Items for both Base Quantity and Optional Quantity.

Change: add CLIN 1003 & 2003 in Section B – Supplies or Services and Price/Costs, B.1 Contract Line Items, Base Quantity and Optional Quantity

See pages 4-5

41 Will small business offerors with a longer ramp-up time be disqualified from receiving an award?

No. N/A

42 Will HHS prioritize awards to contractors who demonstrate their product can meet level 3 standards?

No. The RFP is for Level 2 disposable medical isolation gowns and must be labeled as such. However, gowns that meet increased standards will be considered as long as they are labeled as a Level 2. Medical gowns that are Level 1 disposable isolation gowns, reusable isolation gowns, reusable surgical gowns, disposable surgical isolation gowns, disposable surgical gowns, gowns made of film (e.g., polyethylene), over the head gowns, open back gowns, gowns that contain antimicrobial or antiviral agents, and gowns containing nano materials do not meet the technical requirements for this SOW.

Level 3 gowns will not be considered.

N/A

43 Will HHS / SNS prioritize awards to manufacturers who demonstrate scalability and quality assurance through technological innovations that can be applied broadly to the industrial base?

HHS will only prioritize awards as described in RFP. N/A

44 How many gowns are required per bag? Across many manufacturers, 10

Industry standard of individually wrapped gowns or 10 gowns per bag is acceptable.

Inner packages of greater than 10 gowns per bag will not be considered. No partial case or package quantities will be accepted unless approved by SNS in advance.

gowns per bag is the industry standard.

45 Will the government allow deliveries to be scheduled one month in advance?

Contractor shall contact designated POC (for the respective address where items are being delivered to) to schedule delivery appointments NLT 48 hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM –

3:30 PM.

N/A

46 How many bags are required per carton? Across many manufacturers, 10 bag per carton (100 gowns per carton) is the industry standard.

Industry standard of individually wrapped gowns or 10 gowns per bag with a total of 100 gowns to a carton/case is acceptable. Cartons/case of greater than 100 gowns will not be considered. No partial case or package quantities will be accepted unless approved by SNS in advance.

47 How many cartons per pallet?

No Requirement is listed in RFP. No partial case or package quantities will be accepted unless approved by SNS in advance. All pallets are to have the identical TI-HI stack pattern except for the final pallet. All product to be delivered on standard 48” by 40” pallet, not to exceed 60” in height, stretch wrapped, and secured to pallet for safe transport.

N/A

48 The RFP states that there shall be one lot number per pallet. Can there be multiple pallets with the same lot number?

49 Does the contract officer expect to make awards to small businesses with the intent of expanding and diversifying the domestic industrial base?

This is a full and open competitive requirement. N/A

50 In order to meet the 10-page, 2MB submission limit, is a summary of lab testing conducted acceptable to the contract officer?

The technical proposal shall be no more than 10 pages in length, excluding product literature/information documents. Summary of lab testing if not contained in information documents may be summarized or attached separately.

N/A

51 Foreign labs have a history of providing fake documentation throughout the COVID-19 pandemic and often fail to keep up with their scope of accreditation under ISO 17025. Accepting foreign lab reports would create a situation where the US government has very little ability to verify veracity of the testing protocol, ability to verify chain of custody, and increase liability to the US taxpayer. Will the government

Contractor must provide items compliant with the IIJA/Make PPE in America Act.

The goods must be manufactured in the U.S. or its possessions, which means items for personal protective equipment, including the materials and components thereof, that are grown, reprocessed, reused, or produced in the United States, resulting in an end product where the cost of domestic components is equal to 100 percent of the cost of all the components. Gown testing shall be conducted on the final finished gown at a US independent ISO 17025 accredited laboratory, with each performed test being within the scope of the laboratory's accreditation. Test results from a foreign laboratory is not acceptable.

please confirm that lab testing from outside the United States is not acceptable for submission? All lab testing must be from US-based labs with ISO 17025 accreditation?

52 Will the government take time to come tour the manufacturing locations once a contract is awarded?

This would help to diversify and expand the industrial base through government-contractor interactions and awareness. We are proud of our workforce and would like to showcase these facilities to the government.

USG reserve the right to visit manufacturing facilities post award. No

53 Will subcontracting plans including a VOSB or SDVOSB meet the HHS current large business subcontracting goal for economically disadvantaged businesses?

Yes. HHS Subcontracting goals is in accordance with FAR 52.219-9 Small Business Subcontracting Plan (Nov 2021). This FAR clause date is hereby updated in the RFP.

HHS current small business goals has been updated to the following:

Small Business (SB) – 22.85% Small Disadvantage Business (SDB) – 4.49% Women-owned Small Business (WOSB)– 1.77% HUBZone (HZ)– 1.29% Service-disabled Veteran-owned Small Business (SDVOSB) – 2.64%

Change: provided current HHS subcontracting goals section L.6 Business Proposal Instructions and updated the clause date.

See page 42

54 Should a large business’s subcontracting goal be insufficient, will HHS give an opportunity to the large business to work with others who have responded to this RFP in order to meet the HHS subcontracting plans?

It is up to the discretion of the industry to engage in such partnerships. N/A

55 Is the government asking for a delivered price per gown to their SNS warehouses all around the country? Or an ex-works price per gown to be picked up by a third party from the offeror?

Products shall be shipped FOB Destination. The address(es) will be provided by the COR after award and will be to a Government designated location within the continental United States (CONUS). Contractor should calculate FOB destination costs based on multiple geographic locations across the CONUS.

56 The Contract Officer selected 52.219-8, Utilization of Small Business Concerns on Page 28. And FAR Subpart 19.7 However, on page 42, two socio-economic categories are missing. What is the prescribed Service-Disabled Veteran Owned Small Business (SDVOSB) sub-contracting goals for HHS this fiscal year? What are the prescribed HUBZone sub-contracting goals for HHS this fiscal year? Will the government please amend page 42 to include SDVOSB and HUBZone sub-contracting goals?

See response to question #53. Yes

57 Are small businesses required to fulfill small business sub-contracting goals?

No. N/A

58 Do the guidelines of FAR 19.1307 apply to this solicitation when evaluating a HUBZone Small Business offeror’s response as compared to a large business?

No. N/A

59 Who will be responsible for conducting quality checks and assurances at the delivery HHS ASPR delivery point/warehouse?

ASPR/DSNS personnel or its contractors will conduct visual checks for external case/package damages at point of delivery.

N/A

60 Can the Government provide clarification on what is deemed as acceptable supporting documentation to support an offeror’s shelf-life claim?

Sub-Factor 7: quality Control & Assurance states Offerors shall provide the expected remaining shelf-life for product at time of delivery. At time of delivery, product shall have been manufactured within the prior 3 months. The Government’s overall best value determination will consider the cost of the product as it relates to the shelf-life at time of delivery and the best value determination will also consider the time, effort, and cost to sustain product with lesser shelf-life. Offerors shall provide a shelf-life claim for their product in accordance with FDA shelf-life policy regulations and standards.

Sufficient documentation to support the claim is required. If available, accelerated aging and real-time testing reports could be provided to validate shelf-life claims.

N/A

61 Can the Government confirm that product samples utilized for testing or any other supporting documentation that substantiates

Gown testing shall be conducted on the final finished gown at a US independent ISO 17025 accredited laboratory, with each performed test being within the scope of the laboratory's accreditation.

shelf-life claims must be finished products that are equivalent to the isolation gowns offered?

62 For best value determination as it relates to shelf life, is there a shelf-life ceiling the Government intends to apply during evaluations that aligns with the anticipated storage time of isolation gowns in the stockpile? i.e., the value in a longer shelf life is factored into evaluations up to X number of years after which no additional value will be applied to shelf life exceeding this ceiling.

There is no shelf-life ceiling. Offers shall provide a shelf-life claim for their product in accordance with FDA shelf-life policy regulations and standards. Sufficient documentation to support the claim is required. If available, accelerated aging and real-time testing reports could be provided to validate shelf-life claims.

63 We understand you cannot provide exact delivery/warehouse locations for delivery. In order to provide a more accurate transportation estimate could you provide the anticipated regions for delivery (ie: Northwest, Northeast etc)?

Products shall be shipped FOB Destination. The address(es) will be provided by the COR after award and will be to a Government designated location within the continental United States (CONUS). Contractor should calculate FOB destination costs based on multiple geographic locations across the CONUS

N/A

64 Is a cover page included in the 10-page limit for the technical proposal?

65 Section B.5 Delivery Schedule Milestones: The tables are confusing.

a. Under B.5.B, the table for Optional CLIN, Year 1 appears to be the surge quantities for additional gowns not included in Table B.5.A for the base year.

b. Under B.5.B, the table for Option CLIN, Year 2 (Delivery Period: 5 August

B.1 Contract Line Items are provided in Section B – Supplies or Services and Prices/Costs. Base Quantity and option year quantities are outlined by Item # within B.1, B.2 for Option for Increased Quantity – Separately Priced Line Items and B.3 Increased Quantity Limitations and B.5 Delivery Schedule Milestones. B.5.C states Offerors shall provide a breakout detailing the “ramp” timeframe(s) for the optional quantities, required to manufacture and deliver additional quantities. (Which table should be labeled B.5.C). An example is provided below B.5.C.

2023 - 4 August 2024 (Optional CLIN, Year 2) appears to have Optional CLIN, Year 1 embedded in it as well. Should the first 3 lines of that table be deleted so a table showing Aug 23 - Jul 24 table requires completion?

c. Under B.5.C, it appears an additional table is required to show surge quantities for each of the years. Is this the case?

66 I recommend the government structure the CLINS as follows, with 2 tables per year to show the base quantities and surge quantities, respectively, by month that should also illustrate ramp-up. Structuring it in this manner might clear up confusion, simplify the submission / evaluation, and eliminate the need for an additional table under B.5.C.

1. Base year ( 5 Aug 2022 - 4 Aug 2023)

2. CLIN 0001 - Isolation Gown, L

3. CLIN 0002 - Isolation Gown, XL

4. CLIN 0003 - Isolation Gown, L Surge Quantity

5. CLIN 0004 - Isolation Gown, XL Surge Quantity

6.

7. Option Year 1 (5 Aug 2023

- 4 Aug 2024)

8. CLIN 1001 - Isolation

Gown, L

RFP Requirements are listed in B.1 Contract Line Items are provided in Section B – Supplies or Services and Prices/Costs. Base Quantity and option year quantities are outlined by Item # within B.1, B.2 for Option for Increased Quantity – Separately Priced Line Items and B.3 Increased Quantity Limitations.

9. CLIN 1002 - Isolation Gown, XL

10. CLIN 1003 - Isolation Gown, L Surge Quantity

11. CLIN 1004 - Isolation Gown, XL Surge Quantity

3. Option Year 2 (5 Aug 2024

- 4 Aug 2025)

4. CLIN 2001 - Isolation Gown, L

5. CLIN 2002 - Isolation Gown, XL

6. CLIN 2003 - Isolation Gown, L Surge Quantity

7. CLIN 2004 - Isolation Gown, XL Surge Quantity

67 Subfactor 1 - Manufacturer/Producer: What does the government mean by "...providing authorization letters for subcontracting partner..."? Please explain what is required for this subfactor.

Offerors shall be the manufacturer/producer or sole authorized reseller to HHS of the proposed isolation gown and provide evidence, including the location of manufacturing and a signed statement that you are the manufacturer or a letter of exclusivity from the manufacturer indicating you are the sole authorized reseller of this product to HHS.

Multiple awards for the same manufactured product will not be considered. In the event that a proposal from the manufacturer is received, no other proposals for that manufacturer’s product will be considered. If multiple proposals contain a sole authorized reseller letter for the same manufacturer’s product, and the manufacturer does not propose, the product with the multiple sole authorization letters will not be considered.

N/A

68 Subfactor 3 - Labeling: Must each disposable gown inside a polybag be individually labeled or is it sufficient to have the labels with all required information on each gown's polybag, as has been acceptable in the past?

Note that having to label each gown individually will add time, labor, and cost.

See response provided for question #20. N/A

69 Subfactor 3 - Labeling: Offerors are required to provide "...(1) images

The government does not expect offerors to affix six labels on the cartons (e.g., one on each side) and labels on both sides of a polybag; however, the government requires of all 6 sides of the outer case, (2) images of all sides of the inner packaging, and (3) front and back gown images..." Does the government expect offerors to affix six labels on the cartons (ie, one on each side) and labels on both sides of a polybag? Further, pursuant to past government contracts, if there is not a requirement for labeling each gown, why would front and back gown images be required? And, if the government requires offerors to label each gown individually in addition to the polybag label, wouldn't an image of the gown label suffice?

images of all 6 sides of the outer case and all sides of the inner packaging (e.g., polybag) to assist with evaluating labeling requirements (e.g., labeling may extend to the actual packaging beyond an affixed label). Labeling cannot be determined and confirmed without images of all sides of the case and inner packaging (e.g., polybag). A front and back gown image is required to determine if the gown design, material, color, etc. is met.

70 Subfactor 5 - Catalog and Literature: Is product catalog information required if a technical package containing all of the specification sheets is provided? See Section L, Subfactor 5.

71 Subfactor 8 - Test Reports: This subfactor requires a description of the device and components tested "...(including the manufacturer part/model number)...." Is the product description sufficient (style, color, description)?

Test reports must include a description of the test device and components tested (including the manufacturer part/model number), sample preparation, test procedure and/or the standard followed result values, averages, and appropriate sampling size to meet the specific standard. Test reports must align with the offered gown(s). Identifying information on test reports shall include, but are not limited to, manufacturer name, product name/description, style/part/model #, lot #, gown material, and gown color.

N/A

72 Cartons / shipping: The government specified pallet dimensions but no other shipping criteria. Is there a preferred or max

Industry standard of Individually wrapped gowns or 10 gowns per bag with a total of 100 gowns to a carton/case is acceptable. Cartons/case of greater than 100 gowns will not be considered.

See response provided for question #46 and 47 number of gowns per carton and/or cartons per pallet?

73 Material: If gowns can be made of both blue and yellow SMS material and the gowns otherwise have the exact same specifications with the only difference being the color, will the government accept both colors with test reports that list only one color?

Barrier Protection, Physical Strength, and Flammability test reports for two gowns that have same exact specifications, process, geometry, etc, but are different colors may be considered, if the Offeror can illustrate the two gowns are the same and the gown description (e.g., style/part/model #, product description, etc) in the test reports similarly match, less the gown color.

However, biocompatibility testing (irritation, sensitization and cytotoxicity) must be performed on the final finished gown for each gown color.

N/A

74 Federal statute 19 U.S.C. 1307 prohibits the importation of merchandise produced, wholly or in part, by convict labor, forced labor, and/or indentured labor, including forced or indentured child labor. Due to the rise of forced labor and child labor in the geographic regions where much of the subject products are manufactured, will the government consider requiring certification of compliance with FAR 52.222-18 (Certification Regarding Knowledge of Child Labor for Listed End Products) as well as certification that contractor is not at risk for violating FAR 52.222- 18 in other procurements and thus inducing such contractor to debarment proceedings?

75 Will the Government consider awarding this acquisition to a contractor with a recent history of product seizures as the result of the use of forced and/or child labor?

The Government will not make award to any vendor that is debarred, suspended, or ineligible as described in FAR 9.4 - Debarment, Suspension, and Ineligibility.

76 At least two interested vendors for this solicitation are listed in SAM as being foreign owned. Will the government confirm prioritization of US-based small business over foreign owned companies or companies with foreign beneficiaries?

Refer section H.5 – Domestic Manufacturing. N/A

77 Is the government aware that Airboss Defense Group was attempting to fulfill an HHS/ASPR Contract 75A50121C00027 for PPE when several million boxes of their nitrile gloves were seized at port through a WRO from the Customs and Border Patrol that alleged forced labor, indentured labor, and child labor?

Is the government aware that Airboss Defense Group is now being sued by FedEx Trade Networks for $26 million in relation to the performance of an HHS/ASPR Contract for PPE 75A50121C00027?

This is not relevant to this RFP. N/A

78 Is the government aware that Airboss Defense Group is being sued by FedEx for $26 million (case 1:2022cv01313, filed June 1, 2022) to recoup shipping and logistics fees related to the transportation of gloves needed to fulfill a HHS/ASPR Contract for nitrile gloves?

This is not relevant to this RFP. N/A

79 Is the government aware that Airboss Defense Group had several million boxes of medical products seized at port and is now being sued by FedEx for $26 million because of how Airboss operated under HHS/ASPR contract 75A50121C00027?

This is not relevant to this RFP. N/A

80 Are we required to list the GSM of the material on all of the lab testing reports?

This information can be included but is not a requirement to be included in the test reports.

N/A

81 Must all of the lab reports show the same exact model number of the isolation gown?

Test reports must reflect testing on the final finished gown made in the US and the style/part/model number that corresponds to the US-made gown being offered in the proposal. Also, see response to question # 71.

N/A

82 Will the government confirm that lab testing from within the United States going back to March of 2020 is acceptable? For example, a lab test will not be disqualified if it is from 2+ years ago?

Lab test reports from 2020 is allowable. N/A

83 Why did the Contract Office decide not to make this a small business set-aside, even though more than 125 million gowns were successfully delivered by small business throughout the pandemic to a variety of federal government agencies?

The is a full and open requirement, small businesses will be considered. N/A

84 The following contracts were performed by small business during the pandemic for PPE and Isolation Gowns: (1) Parkdale Advanced Materials, (2) Unifire, (3) First Aid and Survival Technologies, (4) Beachley Medical, (5) Coulmed Products Group, (6) JL Kaya, (7) Health Supply US, (8) Marena Group, (9) Wise Manufacturing, (10) Wildcat Technologies, (11) American Purchasing Services, (12) Texas Medical Technology. Given

The is a full and open requirement, small businesses will be considered. N/A the ability for small business to perform this requirement’s work, will the government please consider making this a small business set aside given the pre-existing capabilities and performance of the small business industrial base?

85 Given the small business capability listed up above, will the government please reserve 80% of these contract awards for small business?

86 Should the receiving warehouses be unable to accommodate delivery, will the manufacturer be held liable for delivered goods not meeting the stated shelf-life requirement?

Contractor shall contact designated POC (for the respective address items are being delivered to) to schedule delivery appointments NLT 48 hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:30

PM

ASPR/SNS encourages contractors to make delivery appointments early in advance to avoid delivered goods to be out of compliance to the stated shelf-life requirement.

N/A

87 Will responses provided by large businesses with existing contracts for receiving and storing HHS/SNS medical products be allowed to compete in this RFP given their unique advantage and associated conflicts of interest?

Yes. These businesses are not given a unique advantage or have a known associated conflict of interest.

N/A

88 Will contractors supplying the gowns be allowed to inspect the delivery location to ensure property custody and care of the product prior to HHS’s acceptance inspection?

89 Will the government prioritize US-based small companies over large companies?

No. N/A

90 Given that this is US taxpayer money being used to support the United States, will the government prioritize US-based companies that do not have foreign parent companies?

See section H.5 – Domestic Manufacturing. N/A

91 Will the government disqualify vendors that have previously used suppliers and factories that were found to be in violation of FAR 52.222-18 (Certification Regarding Knowledge of Child Labor for Listed End Products), 52.222-50 Combating Trafficking in Persons, and/or had a Withhold Release Order issued against their imports for violating forced labor statues from the CBP?

The Government will not make award to any vendor that is debarred, suspended, or ineligible as described in FAR 9.4 - Debarment, Suspension, and Ineligibility.

N/A

92 Are there any requirements for the manufacturers to have cGMPs in place or any 3rd party certifications (such as ISO 13485)?

Offerors shall provide their Quality Control Plan that addresses the appropriate controls (e.g., process controls, lot release testing) are implemented within their Quality System as, for example, seam strength and integrity may vary across different lots and lot release testing may help ensure product quality and consistency to meet specifications.

N/A

93 Are there any specific material requirements for the Isolation Gown (i.e. SMS)?

Material made of woven fabric, non-woven fabric, and composites will be considered. Medical gowns that are Level 1 disposable isolation gowns, reusable isolation gowns, reusable surgical gowns, disposable surgical isolation gowns, disposable surgical gowns, gowns made of film (e.g., polyethylene), over the head gowns, open back gowns, gowns that contain antimicrobial or antiviral agents, and gowns containing nano materials do not meet the technical requirements for this SOW.

94 Isolation Gowns are exempt from FDA review, how will SNS ensure the Isolation Gowns meet the quality standards as companies are responsible for their own quality assurance? The recent study by Scientific American states that Isolation Gowns let to much liquid through and often do not provide enough protection.

(https://www.scientificamerican.com /article/disposable-hospital-gowns-

Offerors shall provide their Quality Control Plan that addresses the appropriate controls (e.g., process controls, lot release testing) are implemented within their Quality System as, for example, seam strength and integrity may vary across different lots and lot release testing may help ensure product quality and consistency to meet specifications.

Test reports shall be provided to ensure the offered gown(s) meet the required standards (AAMI, ASTM, ISO, CPSC). See Subfactor 8: Test Reports.

N/A https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.scientificamerican.com%2Farticle%2Fdisposable-hospital-gowns-could-expose-health-workers-to-infection%2F&data=05%7C01%7CSherica.Teshome%40hhs.gov%7C854d21fe4fde422cd7ce08da641c0476%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C637932368742295977%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fihPeai4k7RKSJQTQ0YpYfVSeD%2BUGf5VMplefQzdT3U%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.scientificamerican.com%2Farticle%2Fdisposable-hospital-gowns-could-expose-health-workers-to-infection%2F&data=05%7C01%7CSherica.Teshome%40hhs.gov%7C854d21fe4fde422cd7ce08da641c0476%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C637932368742295977%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fihPeai4k7RKSJQTQ0YpYfVSeD%2BUGf5VMplefQzdT3U%3D&reserved=0 could-expose-health-workers-to-infection/)

95 Why are Isolation Gown being procured at this quantity when it was proven throughout the pandemic that Surgical Gowns were preferred and more effective?

The SNS stockpiles PPE, including isolation gowns, that can be used for multiple threats.

N/A

96 Given the large amount of information solicited, it is reasonable to expect a long review time, contrary to the HHS stated award timing. Does this mean that HHS already have awardee(s) in mind? Why is HHS planning to award this so quickly (less than a week based on the stated start date of August 2022)?

No. The August start date is an anticipated date. The start date has been revised to October and reflected in the solicitation.

Change:

See pages 1,4,5,6,7

97 The documents required in this solicitation (barrier protection, biocompatibility, flammability, etc.)

take longer than the time allotted for completion due to the laboratory requirements. Please extend the due date of the solicitation to give a reasonable amount of time to allow for fair competition.

The due date has been extended to July 29 August 3, 2022. Change:

See pages 2,3,38

98 How will HHS ensure the integrity of the paperwork submitted since SMS Isolation Gowns are not historically made in the US, with 100% of the cost coming from US domestic components? (i.e. the properly tested isolation gowns will need to be exactly the same as the ones going to be delivered, not from

Offerors shall provide test reports (e.g., AATCC 42) that must be conducted at a U.S.

independent ISO 17025 accredited laboratory, with each test performed being within the scope of the accreditation.

Also see response in Question #71.

N/A https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.scientificamerican.com%2Farticle%2Fdisposable-hospital-gowns-could-expose-health-workers-to-infection%2F&data=05%7C01%7CSherica.Teshome%40hhs.gov%7C854d21fe4fde422cd7ce08da641c0476%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C637932368742295977%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fihPeai4k7RKSJQTQ0YpYfVSeD%2BUGf5VMplefQzdT3U%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.scientificamerican.com%2Farticle%2Fdisposable-hospital-gowns-could-expose-health-workers-to-infection%2F&data=05%7C01%7CSherica.Teshome%40hhs.gov%7C854d21fe4fde422cd7ce08da641c0476%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C637932368742295977%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fihPeai4k7RKSJQTQ0YpYfVSeD%2BUGf5VMplefQzdT3U%3D&reserved=0 another source; laboratories do not certify this but only test what they are supplied; e.g. a company may have made a Barry compliant polyethylene isolation gown and submit that paperwork to try to certify its gown as compliant).

Material made of woven fabric, non-woven fabric, and composites will be considered. Medical gowns that are Level 1 disposable isolation gowns, reusable isolation gowns, reusable surgical gowns, disposable surgical isolation gowns, disposable surgical gowns, gowns made of film (e.g., polyethylene), over the head gowns, open back gowns, gowns that contain antimicrobial or antiviral agents, and gowns containing nano materials do not meet the technical requirements for this SOW.