AMENDMENT_1__-_NICHD_SOLICITATION_NIH-NICHD-CDBB-2019-15.pdf

OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 4

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

001 (One) June 14, 2019

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 Office of Acquisitions 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-CDBB-2019-15

x 9B. DATED (SEE ITEM 11)

06/14/2019

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)

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: (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 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 RFP NIH-NICHD-CDBB-2019-15, entitled NIH Infant and Toddler Toolbox to provide responses to questions received.

DUE DATE: Until July 01, 2019, 2:00 PM Local Time (Eastern Standard Time (EST) (Unchanged)

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

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 Contract Management Branch, 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

RFP No: NIH-NICHD-CDBB-2019-15

AMENDMENT NO.: 001 CONTINUATION PAGE

This Amendment provides answers to questions received regarding this RFP. The responses are provided for information only as guidance to potential offerors and do not supersede any terms of the RFP. The responses to inquiries are as follows:

Questions and Answers regarding RFP No. NIH-NICHD-CDBB-2019-15; NIH Infant and Toddler Toolbox

QUESTION 1: We would like to better understand the NIH’s Single IRB Mandate and the provisions in the revised Common Rule, for the IDIQ contract type. Does the requirement to use a single IRB apply to all task orders conducted under the contract, or to the task orders individually, such that the offeror’s IRB could serve as the single IRB for some, but not all, of the task orders?

ANSWER 1: The Single IRB policy applies to studies that are conducting the exact same study protocol at multiple sites. It requires that all sites agree to adhere to a single IRB review of the in-common study protocol. That is, it applies per study protocol (regardless of/not per Task Order (TO)). In the case of the NBT contract, IRB review would most certainly be needed, at minimum, for pilot testing NBT (TO2) and norming the NBT (TO3, even though norming activity might cross two contract budget years). Thus, a single IRB would be needed for IRB review for NBT piloting (TO2) & a separate IRB review needed for NBT norming (TO3) as they are separate study protocols, even if the exact same sites were named in both piloting and norming the IRB reviews.

If there are two or more study protocols, the IRB reviews for each protocol do not need to be the same IRB review group (that is, there is no requirement for one IRB to review all the relevant study protocols, although they may be reviewed by the same IRB).

As the NBT tasks, as written, are clinical research and not clinical trials (i.e., there is no NIH-defined biomedical or behavioral health-related intervention outcome, akin to NIH Clinical Trial Case Study 18a), an IRB review is necessary/required for the protection of the clinical research participants.

Note however that the Revised Common Rule does not allow EXEMPT CATEGORY 2 to be applied to children in a clinical research study such as planned by the NBT IDIQ contract:

“Research involving children is eligible for this exemption only when it related to educational tests or observations in which the investigators don’t participate in the activities being observed.

Additionally, children are not eligible for this exemption if the project requires limited IRB review.”

See also:

Common Rule single IRB requirement for cooperative research: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PA RT&ty=HTML#se45.1.46_1114 NIH Single IRB for Multi-Site Research Policy FAQs:

https://grants.nih.gov/grants/policy/faq_single_IRB_policy_research.htm NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule):

https://nexus.od.nih.gov/all/2019/01/07/nih-implementation-of-the-final-rule-on-the-federal-policy-for-the-protection-of-human-subjects-common-rule/ https://grants.nih.gov/policy/clinical-trials/case-studies.htm#case1 https://grants.nih.gov/policy/clinical-trials/case-studies.htm#case1 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1114 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1114 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1114 https://grants.nih.gov/grants/policy/faq_single_IRB_policy_research.htm https://nexus.od.nih.gov/all/2019/01/07/nih-implementation-of-the-final-rule-on-the-federal-policy-for-the-protection-of-human-subjects-common-rule/ https://nexus.od.nih.gov/all/2019/01/07/nih-implementation-of-the-final-rule-on-the-federal-policy-for-the-protection-of-human-subjects-common-rule/

AMENDMENT NO.: 001 CONTINUATION PAGE

Question 2: Sixty months overall should be enough time to complete this project. However, the time allotted to Task Order 1 may force the selection of measures which are simpler than the RFP contemplates if complicated measures are selected which require extended time to adapt for the selected tablet format. Furthermore, Task Order 1 contains the activities which are the most likely to experience delays beyond an Offeror’s control (e.g. copyright clearance, OMB waiver for formative usability, if an OMB waiver for pre-norming activities is not granted, if the OMB places a moratorium on data collection during the census (as there was in 2010), if authors of selected measures delay the production of specifications prior to adaptation for the selected tablet, etc.). Can we suggest, justify and budget for a longer timetable within our proposal or would you prefer a single budget, minimizing time and cost, but with assumptions clearly stated?

ANSWER 2: An OMB Waiver is no longer required for these activities because of the 21st Century Cures Act that went into effect in 2017. This project has been determined to bed research as defined by the Cures Act below. The 2020 census will not then affect this project either. Due to the 21st Century Cures Act, a bipartisan effort “to accelerate the discovery, development, and delivery of 21st Century Cures”, NIH research activities are exempt from PRA approval.

“SEC. 2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements. States Code, shall not apply to the voluntary collection of information during the conduct of research.’’

OER has applied the definition of research to make PRA exempt determinations. Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (46 CFR 46.102 and the Common Rule .102(l))

For this RFP, budgets for a longer or alternate timetable for Task 1 are not acceptable. Offerors should propose a one-year budget for Task 1. Task 2 also should have a one-year budget proposal as requested in the RFP. These are two separate budgets. If there are delays on this project in Task 1, Task 1 could then be extended by a bilateral contract modification, if these delays occur. There are two separate budgets required in this RFP. The Task 1 budget is separate from the Task 2 budget. Only Task 1 will be funded at contract inception.

Question 3: The RFP calls for the production of resumes. Can NIH bio-sketches be substituted when available?

ANSWER 3: Yes, either bio-sketches or resumes are acceptable.

AMENDMENT NO.: 001 CONTINUATION PAGE Page 4 of 4

Question 4: Can we consider Task Order 2 a delayed-onset study because it cannot be defined until after TO1 is complete? It is our understanding that the NIH requires pre-approval to submit a delayed-onset study, but we do not believe that the announcement makes any reference to this. It would save significant upfront effort if we could mark TO2 as delayed onset (which we believe it is) rather than guessing at all the human subject details in advance?

ANSWER 4: Answer: No, Task Order 2 cannot be categorized as a delayed-onset study because we have identified the major activities for Task Order 2 in the Task Order 2 Statement of Work. An Offeror’s proposal needs to define what it proposes technically for Task Order 2. The study “N” for piloting may need to be flexible by virtue of the fact that it will be formative piloting, but Task Order 2 does expect an offeror to identify a minimum and maximum number of participants for piloting the NBT. The technical proposals for both Tasks 1 and Task 2, along with the overall IDIQ technical proposal, will be evaluated by the Peer Review Technical Evaluation Committee.

END OF AMENDMENT #001 TO RFP (NIH-NICHD-CDBB-2019-15)