Amendment No. 4 RFP NIH-NICHD-IDD-2021-7 05.26.21.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)

04 05/26/2021 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 deadline for questions and provide clarifications based on inquiries received regarding RFP NIH-NICHD-NIH-IDD-2021-7 entitled, “Newborn Screening Pilot Studies.” In addition, registration details for the Pre-Proposal Conference scheduled for June 2, 2021 is provided with this Amendment.

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. 04 RFP NIH‐NICHD‐IDD‐2021‐7 Page 2 of 4

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 1, 2021.

2. Pre‐Proposal Conference:

The pre‐proposal conference is scheduled for June 2, 2021 from 2:00pm ‐ 3:00pm ET via Zoom.

Please register in advance by sending your contact information including full name, name of the institution, phone number and email address to Angela Wish at angela.wish@nih.gov and Alice

Pagán at alice.pagan@nih.gov two hours prior to the start of the conference. The link to the Zoom

Meeting will be posted on SAM.GOV no later than June 1, 2021.

Please submit your questions in writing via email to Ms. Wish and Ms. Pagán at the email addresses included above on or before June 1, 2021. The subject line should be marked, "Pre‐proposal conference, RFP No. NIH‐NICHD‐2021‐7" and your question should reference the specific area of the

RFP.

NICHD strongly encourages and recommends that all interested offerors participate; however, participation is not a prerequisite for proposal submission and will not be considered a factor in proposal evaluation. The Program and Contract staff will be available to provide guidance and answer questions related to the solicitation.

All questions and answers discussed during the pre‐proposal conference will be published on the SAM.GOV website as an amendment to the RFP.

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. There are two conflicting requests of what is supposed to appear on the cover page (first page of the proposal). Can NICHD clarify which set of instructions offerors are to follow: Page 70 – Section

L. Instructions, Conditions, and Notices to Offerors, 1 General Information C.2 or Page 78 – Section

L. 2. Instructions to Offerors, 1.a. General Instructions, 2. Authorized Official and Submission of

Proposal.

Answer: Offerors must follow the specific instructions in Section L, page 70. In addition, please add to the cover page the additional information required in L.2. Instructions to Offerors, page 78, which is the RFP Title and the DUNS Number. (See specific references above)

2. Can the HHS 508 Product Assessment Template be submitted as part of the business volume?

Answer: Offerors must submit this form as part of the Technical Proposal. Please be aware that this form does not count for purposes of the page limitation.

Amendment No. 04 RFP NIH‐NICHD‐IDD‐2021‐7 Page 3 of 4

3. Is one letter of commitment at the organization‐level from a subcontractor sufficient to meet the following instructions under “Additional Personnel” on page 96: “For all proposed personnel who are not currently members of the offeror’s staff, a letter of commitment or other evidence of availability is required.” Or does NICHD expect letters of commitment from each individual staff member proposed on behalf of a subcontractor?

Answer: One letter of commitment at the organization‐level from a subcontractor would be sufficient to meet the instructions on page 96. However, Offerors must provide letters of commitment for any subcontractors personnel considered essential for the project. Please see also Item 11, Subcontractors on page 123 of the RFP for additional requirements.

4. On page 96, there is a note to offerors indicating that information on Human Subjects is to be included in a SEPARATE FILE of the Technical Proposal. Is this referencing the Study Record PDF embedded within “PHS Human Subjects and Clinical Trials Information” Form that covers the following:

Inclusion of Individuals Across the Lifespan an expansion of what was previously “Inclusion of Children in Research”

Inclusion of Women and Minorities

Inclusion Enrollment Report (planned and cumulative)

Protection of Human Subjects sIRB plan

Answer: Offerors must address in a separate “Human Subjects” section within the Technical

Proposal the information included on pages 96‐107 of the RFP under Technical Proposal

Instructions, Section 4 “Human Subjects.” The “PHS Human Subjects and Clinical Trials Information” form must be completed and submitted with the Task Order B‐MPSII to show human subjects planned enrollment (inclusion enrollment and study population characteristics) (See NOTE 1 on page

102 of the RFP).

5. Should the PHS Human Subjects and Clinical Trials Information form be consolidated with the rest of the technical proposal as a single PDF? (Note that instructions on pages 129‐130 Packaging and

Delivery of Proposal for Use with the NIH electronic Contract Proposal Submission (eCPS) Website do not reference a separate file for PHS Human Subjects and Clinical Trials Information.

Answer: Yes, Offerors must include the PHS Human Subjects and Clinical Trials Information Form within the Technical Proposal pdf file.

6. If the “PHS Human Subjects and Clinical Trials Information” form is a requirement – is it only for

Task Order B?

Amendment No. 04 RFP NIH‐NICHD‐IDD‐2021‐7 Page 4 of 4

Answer: Correct. Offerors proposing for Task Order B (MPS II) must complete the “PHS Human

Subjects and Clinical Trials Information Form/Planned Enrollment Report”. However, all Offerors must include in their IDIQ Technical Proposals a description in general terms on how they will comply with each bulleted item listed on page 102 for each task order (see NOTE 2 on page 102 of the RFP).

7. Can URLs appear in the bibliography/references, publications referenced in staff resumes, and letters of commitment?

Answer: Yes.

8. Is the past performance information that is to go in the business proposal supposed to map back to IDIQ/TOA, TOB or both? If both, does that mean the contractor is supposed to send 8 references versus 4?

Answer: Offerors are only required to submit a list of four (4) contracts during the past five (5) years that are similar in nature to the work required under this solicitation as specified on pages 82‐83 (IDIQ/TOA and TOB‐MPSII).

9. On page 83, under 16. HHS SECURITY AND PRIVACY LANGUGAGE FOR INFORMATION AND IT PROCUREMENTS, if a contractor is working with state‐level data only, will a moderate background investigation still be required or is this only required for federal level access?

Answer: Currently, the position sensitivity level designation applicable to this RFP is Level 1: Non‐ sensitive which only requires the contractor and subcontracts employees assigned to undergo a Suitability Determination and National Check and Inquiry Investigation (NACI). (See page 83 of the RFP). Background investigations are determined based on the roles, access, and data types to which an individual has access.