75A50223R00003 Amendment 0003.pdf

(x)

75A50223R00003 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

WASHINGTON DC 20201

ASPR-HQ

HEADQUARTERS CONTRACTING

ASST SEC FOR PREPAREDNESS AND RESPONSE

US DEPT OF HEALTH & HUMAN SERVICES

ASPR-HQ

WASHINGTON DC 20201

ASPR-ORM-HQ

HEADQUARTERS CONTRACTING

ASST SEC FOR PREPAREDNESS AND RESPONSE

US DEPT OF HEALTH & HUMAN SERVICES

ASPR-ORM-HQ

75A50223R0000307/25/20230003

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/25/2023

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of Amendment 0003 is to provide a Questions and Answers (Q&A) document based on questions received in response to the solicitation. Please note that Q&A in reference to the RFP is being provided via two separate Amendments. Q&A Part 1 of 2 was issued via

Amendment 0002. The attached Q&A document provided via Amendment 0003 is considered to be

Q&A Part 2 of 2.

1. Q&A Part 2 of 2 is hereby provided based on questions received in response to the solicitation. Section L.3 Market Sustainable Plan is hereby updated based on the

Government's response to Vendor Question #12 and is incorporated herein.

2. All other terms and conditions remain the same.

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

ROGER N. HENRIQUEZ

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

08/09/2023

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 5

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75A50223R00003/0003

Period of Performance: 09/22/2023 to 09/21/2026

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

Questions and Answers (Q&A) Part 2 of 2 Solicitation 75A50223R00003 Amendment 0003

12. Vendor Question: Under L.3 Market Sustainable Plan under the current version of the RFP, the following requirement appears:

"Attestation and proof that the Offeror currently possesses a 510(k) certification for the production and sale of MMF."

Currently, there is no FDA requirement to have a 510(k) clearance for certain fibers, such as polyester fiber. Given there is no FDA requirement in those instances, what do you suggest the Offeror's response should be to Section L.3's 510(k) requirement?

If the Offeror does not have 510(k) clearance, will the Offeror's eligibility be called into question?

Section L.3 asks for an “Attestation and proof that the Offeror currently possesses a 510(k) certification for the production and sale of MMF.” Please clarify what is meant by “a 510(k) certification for the production and sale of MMF.” We note that the term “510(k)” refers to the type of premarket notification FDA requires for certain finished class II medical devices (See 21 C.F.R. Part 807, Subpart E.)

FDA will “clear” a class II medical device for marketing if the 510(k) notification demonstrates that the device meets the requirements for clearance (See 21 CFR 807.100.)

Govt. Response: Attestation and proof of 510(k) certification is not required and the RFP associated language is being removed in its entirety.

As a result of the answer to this question, the RFP language under L.3 Market Sustainable Plan, in page 34, under bullet 4 is removed:

· Attestation and proof that the Offeror currently possesses a 510(k) certification for the production and sale of MMF.

13. Vendor Question: Section L.3 of the RFP references a requirement for Offerors to have a 510(k) clearance from the FDA for production and sale of MMF. However, 510(k) premarket clearance is not required by the FDA to manufacture or sell man-made fibers (MMF), which are considered raw materials and not finished medical devices. Given this, can USG please remove the 510(k) requirement and amend the RFP.

Govt. Response: See Gov’t response to question 12 above.

14. Vendor Question: Could you please confirm the type and level of medical fabric that the government is seeking to receive?

Govt. Response: A key raw material for PPE manufacturing is man-made fiber (MMF). MMF comprises the suite of staple fiber and filament yarn that are the feedstock for wovens, non-wovens (e.g., spunbond, meltblown, spunbond-meltblown-spunbond (SMS), or similar material) produced by extrusion of polymer resin, variations of, or novel fiber technology.

Will this involve woven or non-woven textiles?

Govt. Answer: See Gov’t response to question 14 above.

Are gowns categorized as Level 1, 2, 3, or 4?

Govt. Answer: Not relevant to the requirement of the solicitation.

Are masks categorized as Level 1, 2, or 3?

Are head and shoe covers categorized as Level 1, 2, 3, or 4?

Are surgical drapes categorized as Level 1, 2, 3, or 4?

Are coveralls categorized as Type I, II, or III?

15. Vendor Question: Can you also provide clarification on the ramp-up period for each requested material? The government aims to more than double its fabric production within 120 days. This would necessitate awardees to have cold lines with the capacity to rapidly scale up in-house. There is another section referring to the procurement of machinery, which suggests an expectation of manufacturing expansion, a process that typically takes up to 5 years to fully implement. How has the government determined ownership in the context of outsourcing for this expansion?

Govt. Answer: Clarification on the ramp-up. The Contractor should already be producing MMF and have the capability to increase production when requested by the Gov’t within 120 days after notification. The period of performance (PoP) for this contract is 36 months after contract award with no option periods. If there is a need to extend the PoP, it will be on a case-by-case basis coordinated by and through the Contracting Officer. The Gov’t is seeking the Contractor to have the capability to produce the required amount without outsourcing for the expansion.

16. Vendor Question: In section 1.2.4.11, there is a mention of operational agreements with foreign suppliers. Does this imply that leveraging overseas manufacturing partners is obligatory during the ramp-up period? Would this waive the requirement for ownership of the machinery?

Govt. Answer: During the contract award, if raw materials are not sourced within the United

States, then, pending the Gov’t decision, the contractor of said raw materials will have the opportunity to be outsourced via waiver. This would not waive the requirement for ownership of the machinery.

17. Vendor Question: Is there an interest in pursuing an eco-friendly fabric option?

Govt. Answer: Section 1, paragraph 2 mentions sustainability, biodegradability, and innovation.

18. Vendor Question: Are there designated delivery locations outlined in this bid?

Govt. Answer: No, as this is capability expansion designated delivery locations outlined in this proposal. Place of Performance is required to be expanded within the 50 United States, or the U.S.

Territories.

19. Vendor Question: Would HHS Contract Officer award a contract to a qualified Small Business, without manufacturing capabilities itself, but who has supply chain partners capable of supporting this HHS requirement?

Govt. Answer: The Gov’t is seeking the Contractor to have the capability to produce the required amount without outsourcing for the expansion.

20. Vendor Question: The capital equipment scope offered for this RFP largely depends on the type(s) of PPE and Medical Supplies desired to be produced from the installed MMF capacity. Please provide guidance on the PPE desired and percentage split of the desired PPE types?

Govt. Response: At this time, the Gov’t has no desire to purchase MMF or end products currently or in the near feature. MMF comprises the suite of staple fiber and filament yarn that are the feedstock for wovens, non-wovens (e.g., spunbond, meltblown, spunbond-meltblown-spunbond (SMS), or similar material) produced by extrusion of polymer resin, variations of, or novel fiber technology.

21. Vendor Question: What is the annual usage per PPE item by government pre pandemic / during pandemic / and post pandemic?

Govt. Response: According to Gov’t research, North America produces domestically and export 68.78K MTA and import 85.6K MTA. April 2023 assessment revealed North America uses 154K MTA of

MMF.

22. Vendor Question: What aspects of the total bid price does the 40% set-aside pertain to?

Govt. Response: The Government intends to ensure that at least 60 metric tons is provided by a small business.

23. Vendor Question: Would alternate green methodologies for finished goods sterilization converting of

Surgical products be considered for this proposal?

Govt. Response: See Gov’t response to question 17.

24. Vendor Question: What is governments intended pay structure for post contract award?

Govt. Response: Payments will be firm fixed price based on the payable milestone structure proposed by the Contractor and accepted by the Government.

25. Vendor Question: Will HHS be notifying other Gov't agencies of awardees and their awarded capacity and capabilities for future government needs?

Govt. Response: Post-award notifications will be posted on Sam.gov and USAspending.gov.

26. Vendor Question: With regard to the volume expressed in the RFP, “60k to 150k MTA”, there is also a 40% set-aside for small businesses. Since 60k MTA is exactly 40% of the 150k MTA maximum, could you please clarify if the small business set-aside shall be 60k MTA (40% of 150k), or 24k to 60k MTA (40% of 60k to 150k)?

Govt. Response: See Gov’t response to question 22.

L.3 Market Sustainable Plan A comprehensive capacity/capability operating and sustainment plan that, at minimum, includes the following:

· A strategy to source all raw materials, supplies, equipment, and reagents required for MMF production from domestic sources to the extent feasible.

· A strategy to recruit, train and maintain a skilled domestic workforce.

· A strategy to ensure that the newly established MMF manufacturing capacity meets all FDA requirements and guidelines for MMF to be used in production of PPE.

· Attestation and proof that the Offeror currently possesses a 510(k) certification for the production and sale of MMF.

· A strategy to ensure planning, permits, execution and activities required to obtain all required certifications and validation of the MMF manufacturing capacity and ensure that all work performed is in compliance with federal, state and local regulations.

· A strategy to insure, maintain, operate and service all equipment and tooling acquired by the Offeror to produce MMF.

· A strategy for the newly established/expanded MMF production capacity to accommodate any surge capacity that may be needed for a period of 10 years from the date of contract award.