Amendment No. 6 RFP-NIH-NICHD-IDD-2021-7_6.3.21.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 2

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

06 06/03/2021 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 extend the date for questions and provide the presentation slides from the Pre-Proposal Conference held on June 2, 2021 for RFP NIH-NICHD-NIH-IDD-2021-7 entitled, “Newborn Screening Pilot Studies”.

DUE DATE: July 1, 2021 (Unchanged) TIME: 4:00 PM Eastern Daylight 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)

Elizabeth Osinski 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. 06 RFP NIH-NICHD-IDD-2021-7 Page 2 of 2

Request for Proposals No. NIH-NICHD-IDD-2021-7 is amended as follows:

1. Solicitation Section A-Solicitation, Item 13: Deadline for questions has been extended through June 10, 2021.

2. Pre-Proposal Conference slides are attached and thereby posted to SAM.gov:

The slides for the pre-proposal conference that was held on June 2, 2021 from 2:00pm - 3:00pm EDT via Zoom are now posted in SAM.gov. The slides include questions and answers relating to the solicitation that were discussed at this meeting. (see attached)

Newborn Screening Pilot Studies Pre-Proposal Conference

RFP-NIH-NICHD-IDD-2021-7

June 2, 2021

Welcome to the Pre-Proposal Conference for the Newborn Screening Pilot Studies RFP

• All participants will be muted upon entry. Please remain muted until the questions/discussion period.

• Questions may be submitted via the chat box at any time. Please direct your questions privately to Megan Phillips in the chat. Questions will be held for discussions at the end of the webinar.

• Additional questions after this webinar can be emailed to angela.wish@nih.gov and alice.pagan@nih.gov.

• Webinar slides and answers to questions received during this webinar will be posted in an amendment on the SAM.gov website following this event.

• This webinar will be recorded for program staff use only, to ensure all questions are captured.

Agenda Welcome and NICHD Team Introductions

Program Overview

Solicitation Overview

Questions & Answers

Reminders & Closing Remarks

NICHD Program Team Introductions

Melissa Parisi, Chief IDD Branch, NICHD

Megan Phillips, Program Analyst IDD Branch, NICHD

Mollie Minear, Program Official IDD Branch, NICHD

Alice Kau, Program Official IDD Branch, NICHD

Angela Wish, Contract Specialist NICHD Office of Acquisitions

NICHD Contracts Team Introductions

Alice Pagán, Contracting Officer NICHD Office of Acquisitions

Theresa Ranjit, Contracting Officer NICHD Office of Acquisitions

Elizabeth Osinski, Contracting Officer NICHD Office of Acquisitions

Disclaimer

The information contained in this presentation is for informational purposes only.

Remarks and explanations at this webinar shall not qualify the terms of the solicitation. Terms of the solicitation and specifications remain unchanged unless the solicitation is amended in writing.

Program Overview

• Newborn screening (NBS) programs screen > 4 M infants per year to identify infants at risk for congenital disorders

• Early interventions and treatments can reduce morbidity and mortality

• A federal advisory committee (Advisory Committee on Heritable Disorders in Newborns and Children; ACHDNC) recommends conventional newborn screening for at least 35 core and 26 secondary conditions, part of the Recommended Uniform Newborn Screening Panel (RUSP).

• The Newborn Screening Saves Lives Reauthorization Act of 2014 mandates an NICHD research program in newborn screening to "continue carrying out, coordinating, and expanding research in newborn screening (to be known as the 'Hunter Kelly Newborn Screening Research Program') including…”

• 42 U.S. Code 300b-15-Hunter Kelly Research Program.

The NICHD and Newborn Screening

Hunter Kelly Newborn Screening Research Program

Newborn Screening Research Supported by NICHD

• Newborn Screening Translational Research Network (NBSTRN) facilitates research on genetic or congenital disorders through an infrastructure that provides the research community access to robust newborn screening resources

• Investigator-initiated research projects

• Newborn Screening Pilot Studies for conditions recently added to or recommended for the Recommended Uniform Screening Panel (RUSP): Pompe Disease, X-ALD, MPS Type I, Spinal Muscular Atrophy (SMA), Proximal Urea Cycle Disorders, Expanded Homocystinurias

Why Mucopolysaccharidosis Type II (MPS II) as the next pilot condition?

• MPS II (Hunter syndrome) is an X-linked recessive condition:

deficiency of the enzyme iduronate-2-sulfatase

• A closely related disorder, MPS Type I, is a part of the RUSP

• Newborn screening programs: Illinois and Missouri

• Available treatment options:

• Enzyme replacement therapy

• Hematopoietic Stem Cell Transplantation

• Nominated for the RUSP

• ACHDNC voted to move for formal evidence review at May 2021 meeting

National MPS Society https://online.fliphtml5.com/qbhon/xtc d/#p=4

Solicitation Overview Purpose:

• This solicitation and resultant contracts support the development and implementation pilot screening for new conditions designated by the government in the newborn screening setting.

• Establish a pool of contractors with the ability and capacity required to perform the requirements of this project.

*See RFP NIH-NICHD-IDD-2021-7 for the complete scope of this project.

Contract Mechanism:

• Allows for the establishment of a network of readily available contractors/sites to perform Newborn Screening Pilot Studies as needs arise

• New pilots for selected conditions will be competed within the pool of selected contractors to develop and implement novel technologies in newborn screening on a task order basis.

Indefinite Delivery, Indefinite Quantity (IDIQ)

IDIQ Mechanism: Umbrella Contract

Task Order A Core Function

Activities

Task Order B NBS Pilot Studies for

MPS II screening

IDIQ OPTIONAL

ProposalNBS Pool of Contractors

Future Task Orders Future pilots for new conditions

How to respond to this RFP?

Section 1 (Required)

IDIQ

Task Order A Core Function

Activities

Section 2 (Optional)

Task Order B

MPS II

Technical Proposal

Technical Proposal

• IDIQ Contract/Task Order A Core Function Activities:

All offerors must submit a Technical Proposal for the IDIQ/ Task Order A to be considered for award selection

• Task Order B Mucopolysaccharidosis II Pilot Studies (MPS II) (optional):

Offerors have the option to propose for Task Order B MPS II

IDIQ Contract “Newborn Screening Pilot Studies”

• Allow the establishment of a network of contractors capable to serve in a pool of high throughput newborn screening laboratories capable of screening at least 100,000 newborns in relatively short period of time.

• All the general requirements of this project and terms and conditions of the contract are included. The IDIQ terms and conditions flow down to any TO written off the IDIQ.

• Offerors must demonstrate and document their abilities to develop and implement pilot screening for new conditions.

Task Order A "Core Function Activities”

• Contractors will provide overall support for the Newborn Screening Pilot Studies-related activities and collaborate with other contractors who are part of this program

• Statement of Work:

• Establish and coordinate an External Expert Panel

• Annual meetings with NICHD, External Expert Panel, and other contractors within the IDIQ pool

• Annual reports about status of NBS in their state

Task Order B (Optional): “Newborn Screening Pilot Studies for Mucopolysaccharidosis Type II”

• Allows the contractor to support the development, implementation, and provision of proof of concept for identification of newborns with MPS II in the newborn screening setting

• Objectives of TOB:

• Provide validation of testing strategies for MPS II in a high throughput newborn screening environment

• Perform confirmatory testing with sensitive and specific diagnostic tests

• Refer infants who screen positive to an appropriate healthcare provider and/or specialty clinic for treatment and provide follow-up

*Please refer to Attachment 5a for the full Statement of Work for TOB

Timeline for Task Order B: MPS II Screening

Months 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Start-up Period

Screening of 100,000+ newborns for

MPS II

• Obtain all required state, IRB, and other applicable regulatory approvals (3-6 months)

• Develop assay using dried blood spots in the newborn screening environment (6-9 months)

• Validate MPS II testing strategies for MPS II

• Perform confirmatory diagnostic testing

• Refer infants who screen positive for treatment and provide follow-up

Eligibility for Task Order B MPS II Pilot Screening

• If a state/lab is already conducting screening for MPS II, then they would not be eligible to receive this specific Task Order award – but they could be considered for other possible future task orders for other conditions by submitting a proposal for the IDIQ/Task Order A

• If a state/lab chooses not to propose for MPS II then they can still be considered for the overall pool of contractors for other conditions by proposing to the IDIQ/Task Order A

Evaluation Factors for Award

• External Peer Review will evaluate each technical proposal based on the Technical Evaluation Criteria included as part of Section M of the RFP.

• The technical factors* are of paramount consideration in the award of the IDIQ contract (including Task Order A) and Task Order B MPSII awards. Past performance and cost/price will also be considered into the overall award decision.

*See Section M, Attachments 6a and 6B for Technical Evaluation Criteria

Technical Evaluation Criteria for IDIQ & TOB

Criterion Score

1. Technical Approach 40 points

2. Qualifications, Experience, and Availability of Personnel 30 points

3. Experience and Capabilities of the Organization 15 points

4. Facilities and Resources 15 points

TOTAL 100 points

The IDIQ does not have any funding associated with it, so no business proposal is needed.

Task Order A Core Function Activities: The Government’s estimated effort is around 13 hours per year. This Task Order will consist of a Base period of 1 year and 5 option periods of 1 year.

Task Order B MPS II (Optional): Offerors must provide 2 cost estimates with their Business Proposal:

• Estimate 1 (minimum): Assume screening 100,000 newborns and include the cost per screening.

• Estimate 2 (maximum): Total number of newborns that can be screened for MPS II for a period of 2 years and specify the cost per screening.

Business Proposal

Estimated Number of Awards

• The Government intends to make an award(s) to that offeror whose proposal provides the best overall value to the Government.

• The Government anticipates approximately 5 IDIQ awards will be made under this solicitation:

• Task Order A Core Function Activities: Approximately 4 offerors will be selected to receive a Task Order A award to be in the general pool of contractors

• Task Order B MPS II (Optional): From those offerors selected to receive an IDIQ award, the Government estimates that at least 1 offeror will be selected to receive a Task Order B award. Offerors must be selected for the IDIQ pool in order to be considered for this MPS II task order.

Key Dates

Activity Date

Written Questions Due June 10, 2021

Proposal Deadline July 1, 2021 *no later than 4:00 P.M. EDT

Negotiations Anticipated: 08/10/2021 – 09/07/2021

IDIQ and Task Order Award Date Anticipated: September 24, 2021

*Via the NIH electronic Contract Proposal System (eCPS) https://ecps.nih.gov/

What documentation is required to be complete before the RFP submission deadline?

IDIQ/TOA Technical Proposal:

• IRB process documentation

• Informed consent process documentation and timeline

• New pilot study approval documentation and timeline

• Description of choosing a newborn screening platform for the new pilot testing paradigm

• Documentation of ability to onboard new technologies or test for the condition within the

9-month start-up period

TOB Technical Proposal (Newborn Screening Pilot Studies for MPS II):

• Informed consent and protocol development process documentation

• Description of the MPS II pilot approval process and timeline

• Rationale for choosing the newborn screening platform for the MPS II testing paradigm. Demonstration of the ability to onboard the chosen new technology or test for MPS II within the 9-month start-up period.

Do I have to apply to all parts of the RFP?

• All offerors must apply to the IDIQ/TOA Technical Proposal in order to be considered for the Newborn Screening Pilot Studies IDIQ pool of contractors.

• Offerors are not required to apply for the Newborn Screening Pilot Studies for MPS II task order; it is optional.

Is informed consent required for each newborn screened in the pilot?

• RFP requirement: “Establish and implement a system of referral to an appropriate health care provider and/or specialty clinic for follow-up and treatment for children who have screened positive in order to ensure timely access to the treatment.”

• Establishing a referral and follow-up system for screen positive children may require access to the personal identifiers attached to dried blood spots, depending on the state.

• The use of personal identifiers would likely bring the pilot under the auspices of human subjects research and would thus require informed consent.

Therefore, offerors should check with their Institutional Review Board and other appropriate oversight authorities (e.g., states) to determine whether they would require access to identifying information to establish a follow-up referral system of positive screen children.

What FDA approvals must be in place before applying to the RFP?

• FDA approval is not required before submitting a technical proposal.

• The contractor must:

• Ensure that the technology developed under this contract satisfies the requirements of applicable FDA statutes and regulations.

• Review and consider recommendations provided in applicable FDA guidance documents.

• 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.

Is the entire MPS II screening process required to be finalized in order to apply to this RFP?

• Requirements

• Rationale for how the newborn screening platform was chosen for the MPS II testing paradigm

• Demonstrate the ability to onboard the chosen new technology or test for MPS II within the 9-month start-up period

• Proposed workflow diagram of the entire platform

What if my state is already screening for MPS II?

• You are NOT eligible to apply for the Newborn Screening Pilot Studies for MPS II task order

• You MAY still be eligible to apply for the IDIQ/TOA Technical Proposal to be part of the newborn screening pilot studies pool of contractors to be considered for future task orders.

Do contractors follow the same protocol for screening, or does each contractor do their screening process differently?

• There is no requirement that a specific protocol needs to be followed by each contractor

• Each offeror should choose the method that makes the most sense for their state and newborn screening system, as long as a rationale is provided

Is Attachment 12 required for TOB only? Or should it be submitted with the IDIQ/TOA proposal as well? For proposals with subcontracting sites, which site(s) should prepare/submit Attachment 12?

• Attachment 12 is the Protection of Human Subject Assurance

Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310)

• Please submit Attachment 12 with the IDIQ/TOA portion of the proposal, in addition to the optional TOB proposal (if applicable).

• For proposals with multiple sites, the site serving as the single IRB of record should prepare Attachment 12.

Additional Questions?

Thank You for your Attendance!

Webinar slides and answers to questions received during this webinar will be posted in an amendment on the

SAM.gov website following this event.