Amnd 0001_S.pdf

(x)

75N95022Q00498 x x 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

NINDS

Bethesda, MD 20892-7511 Disorders and Stroke National Institute of Neurological National Institutes of Health

08/11/20220001

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

08/11/2022

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 this Amendment is to: 1) Post responses to submitted questions and 2) Extend the quotation submission due date to August 25, 2022 at 9:00 AM ET.

Please see the Continuing Pages for more details.

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)

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 .

Evan C. Feely

Questions and Answers

Request for Proposals (RFP) Number: 75N95022Q00498

Project Title: Biological Therapeutics Bioassay Subject Matter Expert Consulting Services to Support the Development of Therapeutic Biotechnology Products (Biologics)

Question Number Question and Answer

1.

Question: Was this previously competed; is this a recompete?

Answer: This is a new requirement.

2.

Question: What is the type of contract being awarded? CPFF, FFP, T&M, etc.?

Answer: As stated on page 1 of the Combined Synopsis-Solicitation, the Government anticipates awarding one or more Labor-Hour type purchase orders.

3.

Question: No Key Personnel were listed. Can you validate that this is indeed true, and provide the purpose of Key Personnel during the evaluation?

Answer: As stated on page 5 of Attachment #3 - Statement of Work, “key personnel” refers to the Contractor-proposed subject matter experts that will potentially perform NINDS’ specific requirements.

4.

Question: Past Performance evaluation was listed as a factor, but according to the FAR, Past Performance cannot be used against performer selection. How will the Government’s evaluate responses with no Past Performance?

Answer: There is no FAR provision that prohibits the evaluation of relevant past performance, however, Quoters without relevant past performance will not be evaluated favorably or unfavorably against this factor.

5.

Question. I’m not sure that my personal computer meets the requirements of encryption and traceability, in which case would the government provide a computer for me to use?

Answer: NINDS does not anticipate providing Government-Furnished Equipment for performance of this requirement. If necessary, however, clarification regarding the information-security provisions

Questions and Answers

Request for Proposals (RFP) Number: 75N95022Q00498

Project Title: Biological Therapeutics Bioassay Subject Matter Expert Consulting Services to Support the Development of Therapeutic Biotechnology Products (Biologics)

Question Number Question and Answer

(Attachment #7) can be provided after award.

6.

Question: How many assay development consultants is NINDS looking for? Do consultants need to be registered in Sam.gov already?

Answer: NINDS requires 1-3 assay development SMEs for support of its’ biologics programs. Any organization that wishes to be considered for award must have an active SAM registration prior to submitting a quotation.

7.

Question: Is there a preferred format and method of submission?

Answer: The completed Reps and Certs (Attachment #3) should be submitted as a separate PDF and the completed price template (Attachment #4) should be submitted as a separate Excel spreadsheet. Otherwise, all applicable documents listed on pages 5-6 of the solicitation can be submitted a single PDF.