Amendment No. 3 RFP NIH-NICHD-IDD-2021-7 05.21.21.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 4

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

03 05/21/2021 N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) 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, County, State and ZIP: Code) (�) 9A. AMENDMENT OF SOLICITATION NO.

TO ALL POTENTIAL OFFERORS

RFP NIH-NICHD-IDD-2021-7

X 9B. DATED (SEE ITEM 11)

05/03/2021

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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, is not 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 one (1) copy of the amendment; (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 DATA 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 data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

N/A

(�) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) 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).

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

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return electronic copy to the issuing office.

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

PURPOSE: To provide clarifications based on inquiries received regarding RFP NIH-NICHD-NIH-IDD-2021-7 entitled, “Newborn Screening Pilot Studies”.

DUE DATE: July 1, 2021 (Unchanged) TIME: 4:00 PM Eastern Standard Time (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 (Type or print)

Alice M. Pagán Pereira Contracting Officer, NICHD Office of Acquisitions

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

(Signature of person authorized to sign)

BY _____________________________________________

(Signature of Contracting Officer)

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

Amendment No. 03 RFP NIH‐NICHD‐IDD‐2021‐7 Page 2 of 4

Below are the answers to questions received regarding this RFP, please note that individual questions may have been combined or reworded. The responses to inquiries are as follows:

1. Please clarify the different technical parts of the RFP.

Answer: Additional clarifications concerning the different technical components of the RFP are provided below:

a) IDIQ/TOA Technical Proposal – (Six (6) Years ordering period) The Government intends to make multiple IDIQ contract awards under this solicitation to establish a network of contractors capable of serving as one of a pool of high throughput newborn screening laboratories (state or private) with the capacity to screen at least 100,000 newborns in relatively short periods of time as outlined in the IDIQ technical requirements.

To be considered for the Newborn Screening Pilot Studies IDIQ pool of contractors, all offerors must submit a Technical Proposal addressing the Statements of Work and Technical Evaluation Criteria for the IDIQ and TOA‐Core Function Activities. This pool of contractors will have the opportunity to be considered for the TOB‐MPS II award (if the Offeror chooses to propose) and future task orders.

Overall, the Technical Proposal must demonstrate the Offerors’ ability to conduct pilot testing on new conditions for newborn screening panels as outlined in the IDIQ technical requirements (see Statements of Work/Attachments 3a & 4a and Technical Evaluation Criteria/Attachment 6a)

b) Task Order A – “Core Function Activities” – (Base Year and Five (5) Option Years) This task order will allow contractors to provide overall support for the Newborn Screening Pilot Studies related activities and to collaborate with other contractors that are part of this program. The requirements of this task order must be addressed in conjunction with the IDIQ proposal (See IDIQ/TOA Technical Proposal above). The IDIQ awardees that do not receive a TOB‐MPSII award will be issued a TOA‐ Core Function Activities award. (See Statements of Work/Attachments 4a).

c) Optional Task Order B* – “Newborn Screening Pilot Studies for Mucopolysaccharidosis Type II”‐ (Two Years) This task order is for the development, implementation, and provision of proof‐of‐ concept for identification of newborns with MPS II in the newborn screening setting. Offerors that choose to propose must include a separate section clearly identified in the Technical Proposal that demonstrates and evidences their ability to fulfill the requirements listed in the TOB‐MPS II Statement of Work (See Attachment 5a) that is specifically for the pilot testing of Mucopolysaccharidosis Type II. (See also Attachment 6b ‐ Technical Criteria for TOB‐MPS II).

*The RFP was revised to change TOB‐MPII to be an optional task order (see RFP Amendment #2 posted in beta.SAM.gov on May 17, 2021).

2. What paperwork/materials/clearances are necessary to compile before the submission deadline?

Do I need to have state approval for the pilot in hand before applying?

Answer: Offerors do not need state approval at the time of the submission of the proposal for the “Newborn Screening Pilot Studies for Mucopolysaccharidosis Type II” (TOB‐MPS II). However, offerors must demonstrate their ability to obtain all required approvals (e.g., Institutional Review Board, state oversight authorities) and provide estimated timelines for obtaining these approvals in their technical proposal. See below for guidance regarding prior approval requirements.

Amendment No. 03 RFP NIH‐NICHD‐IDD‐2021‐7 Page 3 of 4

IDIQ/Task Order A Core Function Activities (TOA) Technical Proposal:

The following information is provided as guidance for Offerors to document prior approval processes. This list is not intended to be an all‐inclusive list. (See IDIQ and TOA’s Statements of Work/Attachments 3a and 4a and Technical Evaluation Criteria/Attachment 6a for the complete list of requirements):

Document the Institutional Review Board (IRB) process, including the development of the IRB application and provide an estimated timeline.

Describe and document the process of developing the protocol and informed consent form and provide an estimated timeline.

Describe and document the process of approval of a new pilot study with the appropriate oversight authorities and provide an estimated timeline.

Describe how a newborn screening platform is chosen for a new pilot testing paradigm. The Offerors must document their ability to onboard new technologies or test for the designated condition within the 9‐month start‐up period specified.

“Newborn Screening Pilot Studies for Mucopolysaccharidosis Type II” (TOB‐MPS II):

The following information is provided as guidance for Offerors to document prior approval processes. This list is not intended to be an all‐inclusive list. (See TOB‐MPS II Statement of Work/Attachment 5a and Technical Evaluation Criteria/Attachment 6b for the complete list of requirements):

Document the informed consent form (if needed) and protocol development processes. This process should be completed within 6 months, barring unforeseen complications.

Describe the process of approval of the TOB MPS‐II pilot with the appropriate oversight authorities and provide an estimated timeline.

Provide the rationale for how the newborn screening platform was chosen for the TOB MPS II testing paradigm. Offerors must demonstrate the ability to onboard the chosen new technology (testing for MPS II) within the 9‐month start‐up period specified.

3. Do I need to apply to all parts of the RFP?

Answer: All Offerors must submit a Technical Proposal addressing the IDIQ and TOA Statements of Work and Technical Evaluation Criteria in order to be considered for the Newborn Screening Pilot Studies IDIQ pool of contractors. (See response to Question 1 above). However, Offerors are not required to submit a proposal for “Newborn Screening Pilot Studies for Mucopolysaccharidosis Type II” (TOB‐MPSII) as it is an optional task order. The RFP was modified to change this requirement (see RFP Amendment #2 posted in beta.SAM.gov on May 17, 2021).

4. Are these pilot studies required to be done using identifiable newborns/dried blood spots and is informed consent required from each newborn participating in the pilot?

Answer: It depends. The RFP requires Offerors to “Establish and implement a system of referral to an appropriate health care provider and/or specialty clinic for follow‐up and treatment for children

Amendment No. 03 RFP NIH‐NICHD‐IDD‐2021‐7 Page 4 of 4 who have screened positive in order to ensure timely access to the treatment.” Depending on the state, it is possible that Offerors would need to have identifiers associated with dried blood spots in order to refer screen‐positive children for follow‐up; if so, then the use of identifiers would likely bring the pilot under the auspices of human subjects research and would thus require informed consent. Offerors should check with their Institutional Review Board and other appropriate oversight authorities (e.g., state regulations) to determine whether they would require access to identifying information to establish a follow‐up referral system of screen‐positive children.

5. Does this RFP provide support for obtaining FDA approval for MPS II testing, or am I able to use a laboratory developed test during the pilot? If FDA approval is not required before applying, can FDA approval be sought during the contract award period?

Answer: FDA approval is not required before submitting a Technical Proposal. However, as stated in the IDIQ and TOB‐MPS II Statements of Work (see Attachments 3a and 5a), the Contractor must “ensure that the technology developed under this contract satisfies the requirements of applicable FDA statutes and regulations. Additionally, the Contractor shall review and consider recommendations provided in applicable FDA guidance documents.” In addition, the Contractor must: “evaluate and select the entire technology platform or components of a platform needed to embark on screening for the designated condition(s) in a newborn screening environment. The platform may already exist, or the Contractor may need to develop a new testing paradigm that includes analytic performance of the test chosen under the high throughput testing situation.”

6. Do I need to have the entire testing process for MPS II finalized in order to apply (e.g., first‐ and second‐tier testing, known rate of false positives from first‐tier testing method)?

Answer: No. Offerors must provide the rationale for how the newborn screening platform was chosen for the MPS II testing paradigm. The Contractor must demonstrate the ability to onboard the chosen new technology or test for MPS II within the 9‐month start‐up period specified. A proposed workflow diagram of the entire platform must be provided. (See TOB‐MPS II Statement of Work/Attachment 5a and Technical Evaluation Criteria/Attachment 6b).

7. If my state is already screening for MPS II, am I eligible to apply?

Answer: Offerors already screening for MPS II, will not be eligible to receive an award for TOB‐MPS II. However, Offerors may propose to be part of the Newborn Screening Pilot Studies pool of contractors by submitting a Technical and Business Proposal in response to the IDIQ/Task Order A – “Core Function Activities.