RFP_75N94022R00001_CSF_Amendment_0001_05-13-2022_0001.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

PAGE

OF

PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

05/13/2022

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. ((if aapplicable)

6. ISSUED BY CODE 7. ADMINISTERED BY ((If other than Item 5) CODE

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch 6710B Rockledge Drive

BETHESDA MD 20892

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

TO ALL POTENTIAL OFFERORS

( ) 9A. AMENDMENT OF

SOLICITATION NO.

RFP 75N94022R00001 X

9B. DATED ((SEE ITEM 11)

05/13/2022

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE FACILITY CODE 10B. DATED ((SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

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 Items 8 and 15, and returning __1___ copy of the amendment in your business proposal; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA ((if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

( ) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO FAR 52.243-2. THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract

ARTICLE B.4.

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor __ is not, X is required to sign this document and return 1 copy in your business proposal to the issuing office.

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

PURPOSE: To amend Request for Proposals (RFP) No. 75N94022R00001, entitled, “Chemical Synthesis Facility” and provide responses to questions received regarding this RFP.

DUE DATE: Until June 17, 2022, 4:00 PM Local Time (Eastern Standard Time (EST) (Changed).

Questions must be submitted in writing via e-mail by May 27, 2022 (Unchanged).

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

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

Alice Pagán Pereira

NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

BY ________________________________________

(Signature of Contracting Officer)

16C.DATE

SIGNED Alice M. Pagan Pereira

-S Digitally signed by Alice M. Pagan Pereira -S Date: 2022.05.13 20:28:57 -04'00'

RFP No. 75N94022R00001 AMENDMENT NO.: 0001 CONTINUATION PAGE Page 2 of 3

A. As a result of this Amendment 1, the Request for Proposals (RFP) is revised as follows:

1. SECTION A – SOLICITATION/CONTRACT FORM (page 1), subsection 8: Proposal Submission Deadline specified time is changed to 4:00 pm (EST).

2. SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, subsection c, Business Proposal Instructions, item 7. Small Business Subcontracting Plan (page 69) first paragraph is hereby revised to read as follows:

7. Small Business Subcontracting Plan

If the proposed contract exceeds a total estimated cost of $750,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the Solicitation, See SECTION J - LIST OF ATTACHMENTS, BUSINESS PROPOSAL ATTACHMENTS of this RFP for an example of such a plan.

3. SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, subsection c, Business Proposal Instructions, item 7. Small Business Subcontracting Plan (page 71) is hereby revised to add item 12 to subparagraph d as follows:

Offerors shall include a list identifying proposed Small Businesses: Provide the name(s) of the proposed small businesses, addresses, points of contact, e-mail addresses, and phone numbers. The information below shall be provided in the following format to demonstrate that the small business is small in relation to the NAICS appropriate for the work it will be performing under the contract:

Subcontractor Name Address

Point of Contact Information

NAICS, Size & Socioeconomic

Status as applicable

Work to be Performed

Total Amount Proposed

Describe the Extent of Offeror’s Commitment to Use Small Businesses: Commitment should be as specific as possible. Provide copies of documents demonstrating this commitment (e.g., draft subcontracting agreements, letters of commitment, teaming arrangements, etc.). The documents provided shall describe the work that will be performed by the small business subcontractors (documents may be provided as an attachment).

4. SECTION M – EVALUATION FACTORS FOR AWARD (pages 78-79), subsection 6. Technical Evaluation Factors is removed in its entirety and replaced with Attachment No. 1 of this Amendment.

B. Additional Proposal Instructions:

1. To assist offerors in the preparation of the proposal, the Government’s estimated effort is provided below:

Total number of hours per year is estimated to be approximately a Minimum of 4700 hours and a Maximum of 9400 hours.

RFP No. 75N94022R00001 AMENDMENT NO.: 0001 CONTINUATION PAGE Page 3 of 3

For budget purposes, offerors should assume the following:

i. Synthesize approximately: Minimum of 10-24 and Maximum of 48 - laboratory-scale small molecules with > 95% purity per year, depending on the complexity of the chemical synthesis per year.

ii. Synthesis of approximately: Minimum of up to 1 and Maximum of 2 - cGMP lot(s) with > 99% purity per year.

This information is furnished for the offerors' information only and is not to be considered restrictive for proposal purposes.

C. This Amendment provides answers to questions received regarding this RFP. Please note that individual questions may have been combined or reworded. The responses are provided for information only as guidance to potential offerors and do not supersede any terms of the RFP, and do not revise or become part of this RFP.

1. Questions: Please confirm your position on potential service providers that do not have current Good Manufacturing Practices (cGMP) in-house capabilities.

Answer: As stated in the Technical Evaluation Factors (See Attachment 1 of this Amendment), the cGMP manufacture and facility can be provided by the prime contractor or a subcontractor. The technical proposal must present sufficient information to demonstrate the offeror and/or the proposed subcontractor’s cGMP manufacturing capabilities.

RFP NO. 75N94022R00001

AMENDMENT NO. 0001

AMENDMENT NO. 0001

ATTACHMENT NO. 1

RFP NO. 75N94022R00001

“Chemical Synthesis Facility”

6. TECHNICAL EVALUATION FACTORS

The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed in the order of relative importance with weights assigned for evaluation purposes. Subfactors are listed in order of relative importance.

Evaluation Factors Technical Factors Weighted Percentage

1 Facilities and Equipment 50% 2 Personnel 35% 3 Organizational Experience 15%

1. Facilities & Equipment

a. Adequacy of required facility and infrastructure, including but not limited to, all chemical equipment, hardware, software, and instrumentation to carry out multistep synthesis, purification, and characterization of small molecules and specific compounds including, but not limited to steroids, steroid analogues, unnatural amino acids, natural products, natural product analogues, and heterocycles on a laboratory mg scale and on a large scale up to 10 kg under current Good Manufacturing Practice (cGMP). The cGMP manufacture and facility can be in-house or subcontracted. All work must be under Occupational Safety and Health Administration (OSHA)’s compliance. Offerors must demonstrate compliance with all applicable OSHA standards and provide documentation of the current Food and Drug Administration (FDA) Drug Establishment Registration Number.

b. Adequacy of documentation that the Chemical Synthesis Facility (offeror) has federal, state, and all applicable local licenses required for high potency and controlled substances:

i. Proper identification and determination of the required purity of the compounds produced.

ii. Stability testing of cGMP manufactured drug substances, including stability chamber.

iii. To perform analytical work for the assessment of purity compounds.

c. Adequacy of documentation, including capacity and capability that the offeror or proposed subcontractor has a cGMP facility with a recent audit by the FDA capable of manufacturing up to 10 kg of clinical grade chemical agent.

RFP NO. 75N94022R00001

AMENDMENT NO. 0001

2. Personnel

a. Principal Investigator:

i. Demonstrated GMP experience and expertise in multistep synthesis, purification, and characterization of small molecules and specific compounds, including but not limited to steroids, steroid analogues, unnatural amino acids, natural products, natural product analogues, and heterocycles on a laboratory scale and on a large scale of up to 10kg.

ii. Understanding of the issues and problems involved in the maintenance and operation of a chemical synthesis facility in accordance with the objectives and requirements of the Statement of Work

(SOW).

iii. Experience with overseeing cGMP facility performing work with a similar size and scope to this project.

iv. Experienced process chemist for multistep synthesis of new chemical entities (NCEs) for which routes of synthesis are not documented.

b. Technical Personnel

i. Synthetic chemists with GMP experience and with the ability to carry out multistep synthesis, purification, and characterization of small molecules and specific compounds including, but not limited to, steroids, steroid analogues, unnatural amino acids, natural products, natural product analogues, and heterocycles on a laboratory scale and on a large scale up to 10 kg.

ii. Experienced process chemist for multistep synthesis of NCEs for which routes of synthesis are not documented.

iii. Demonstrate training and certification of personnel for cGMP manufacture of chemical agents.

iv. Demonstrate training of personnel in quality control (QC) and quality assurance (QA).

3. Organizational Experience with cGMP and Regulatory Support

a. Adequacy of documentation of the offeror’s capacity to perform short- and long-term drug substance stability tests under GMP protocol as required by the FDA.

b. Adequacy of the documentation of the offerors’ previous experience in submitting Drug Master Fire (DMF) and regulatory documents, including but not limited to Certificate of Analysis, Chemistry Manufacturer and Control Document, and stability data for Investigational New Drug, New Drug Applications, and/or supplemental New Drug Applications (sNDAs) associated with the active pharmaceutical ingredient (API) manufacture as required and acceptable by the FDA. This includes an understanding of the interactions and communications with regulatory agencies and issues of regulatory compliance as it applies to clinical trials.