Amendment_0002_0002.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

3. EFFECTIVE DATE

07/28/2023

2. AMENDMENT/MODIFICATION NO.

6. ISSUED BY CODE NCI-EXEC

National Institutes of Health National Cancer Institute

Bethesda, MD 20892-7511

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

1. CONTRACT ID CODE

4. REQUISITION/PURCHASE REQ. NO.

7. ADMINISTERED BY (If other than Item 6)

9A. AMENDMENT OF SOLICITATION NO.

75N91023R00036

X

9B. DATED (SEE ITEM 11)

07/28/2023

I

PAGE OF PAGES

1 I 3

5. PROJECT NO. (If applicable)

CODE I

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

I&] The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers � is extended. Dis 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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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 letter or electronic communication, provided each letter or electronic communication 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 ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. b�gE c:���� ii�Efo� ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

E. IMPORTANT:

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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)

Contractor Dis not Dis required to sign this document and return _______ _ copies to the issuing office.

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

The purpose of this amendment is to: 1) change the due date for responses to October 06, 2023 at 2:00 PM Eastern Time and 2) provide responses to questions received.

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 1 0A, 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)

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED

(Signature of person authorized to sign)

Previous edition unusable

KARINA A. PETERSON

16B. UNITED STATES OF AMERICA

(Signature of Contracting Oflicer)

16C. DATE SIGNED

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Questions with Answers

RFP 75N91023R00036

Amendment 2

Question 1: NAICS Code 541715 -- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) is listed in the RFP, but the work outlined in the Base IDIQ SOW as well as the TO 1A and TO 1B Task Order SOWs is administrative management and oversight. Would the government consider changing to a NAICS Code that more closely aligns with the PWS Task requirements, such as 541611 - Administrative Management and General Management Consulting Services?

Government Response 1: The NAICS code will not be changed for this requirement.

NAICS code 541715 was selected because this requirement is in support of R&D services and therefore best describes the principal purpose of this requirement. Per NIH policy, the term R&D includes research, development, demonstration and R&D support.

Question 2: Given the scope of the Base IDIQ SOW Tasks (administrative management), can the government remove the requirement for Federal-wide Assurance (FWA) in order to be considered for award?

Government Response 2: The FWA is a requirement for this award and must be provided no later than receipt of a Final Proposal Revision. All other Human Subjects protections must be addressed with proposal submission.

All institutions engaged in human subjects research that is not exempt from the regulations, and is conducted or supported by any HHS agency must be covered by FWA. An institution may extend its FWA to cover a collaborating individual investigator under certain conditions using the sample Individual Investigator Agreement or a comparable agreement developed by the institution.

Per the OHRP site, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/index.html if the non-assured institution is the primary awardee for an HHS-supported award providing support for non-exempt human subjects research, the institution must obtain its own OHRP-approved FWA.

1. Obtain an FWA

a. FWAs can be obtained through the online platform. Institutions should read through the form and instructions first, so that they have all of the needed information handy.

i. FWA form: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-form-2017/index.html

ii. FWA instructions: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-instructions/index.html

iii. FWA terms: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html

iv. Portal to file an FWA application: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/file-a-new-fwa/index.html https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/index.html https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/index.html https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Fforms%2Ffwa-form-2017%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=No2cREwn0W5DK%2Byps4XJprb8CQV%2Bn2uc8MflQ9zTdg8%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Fforms%2Ffwa-form-2017%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=No2cREwn0W5DK%2Byps4XJprb8CQV%2Bn2uc8MflQ9zTdg8%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Fforms%2Ffwa-instructions%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=OHnSPqOP73qrhqfh3GQSw1%2FTP5Mfn6yo6JsgFQIAQmQ%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Fforms%2Ffwa-instructions%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=OHnSPqOP73qrhqfh3GQSw1%2FTP5Mfn6yo6JsgFQIAQmQ%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Ffwa-protection-of-human-subjecct%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=j5ieptPnKhhbQsFIr6uuFv5JlC3HXy2pFGUCG%2BcgwVE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Ffwa-protection-of-human-subjecct%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=j5ieptPnKhhbQsFIr6uuFv5JlC3HXy2pFGUCG%2BcgwVE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Ffile-a-new-fwa%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NHlZOgFS%2B9dJdlHtwI%2FAB3j1WPRIIAYVV4pSeHn63%2FY%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Ffile-a-new-fwa%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NHlZOgFS%2B9dJdlHtwI%2FAB3j1WPRIIAYVV4pSeHn63%2FY%3D&reserved=0

b. The FWA application requires designation of one or more institutional review boards (IRBs). If the institution operates its own IRB that will review the HHS-supported research, then that is the IRB that should be listed. If the institution will rely on an external IRB to oversee the HHS-supported research, then the external IRB that reviews the largest percentage of that research should be listed. There is nothing to prohibit the FWA from listing multiple IRBs. Each IRB needs to be registered with the OHRP office before it will obtain an 8-digit number that gets added to the FWA application.

i. check that the IRBs that review this research are up-to-date with OHRP office. You can see this here:

https://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc

ii. To update or renew an IRB registration, follow instructions here:

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/update-renew-registration/index.html

c. Videos on how to use OHRP software platform to obtain an FWA can be found here: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/resources-on-how-to-file-an-fwa-and-related-resources/index.html

d. General FWA-related FAQs can be found here:

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/assurance-process-faq/index.html

2. If an institution does not operate its own IRB, they must ensure an IRB reviews any nonexempt research under the award on behalf of the engaged institution. Awardees are generally considered “engaged” in all nonexempt research supported by their award. Sometimes this might mean there is more than one protocol, with different IRBs reviewing.

a. The activities of the engaged awardee can be described in the IRB-approved protocol(s). For ongoing protocols that don’t currently do this, it might mean amending the protocol and having the IRB approve the changes.

b. When the IRB is operated by an external institution, then per the requirements of 45 CFR 46.103(e), the engaged institution and the organization operating the reviewing IRB need to document the reliance, and the roles and responsibilities each institution will take to follow the regulatory requirements.

c. This “IRB reliance” can be documented in a variety of ways – the regulations offer flexibility. For example, the research protocol can describe the reliance and the roles and responsibilities of the institution(s) and the IRB – which those. Also, a written agreement can be used. OHRP has created a template agreement that can be used as one way to fulfill this requirement:

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/irb-authorization-agreement/index.html https://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Firb-registration%2Fupdate-renew-registration%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ZbtjkFcZEPZuP7ZjJ4fizkgSOJcQT7JSja61eafCyzE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Firb-registration%2Fupdate-renew-registration%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ZbtjkFcZEPZuP7ZjJ4fizkgSOJcQT7JSja61eafCyzE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Fresources-on-how-to-file-an-fwa-and-related-resources%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=01HdscAOxJN9sfgBh8qf1MxXM6VXglsXjz2tNxEwabg%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Fresources-on-how-to-file-an-fwa-and-related-resources%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=01HdscAOxJN9sfgBh8qf1MxXM6VXglsXjz2tNxEwabg%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Fassurance-process-faq%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=43mrGHMVNqGuawn20nkUAgQf8zJA81lPBzKMrNovGSc%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Ffwas%2Fassurance-process-faq%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=43mrGHMVNqGuawn20nkUAgQf8zJA81lPBzKMrNovGSc%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Fforms%2Firb-authorization-agreement%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ys8xTTmxEaKXkjadAB5QTxnD%2BALFwTq4vdaHYq0FI1I%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Fregister-irbs-and-obtain-fwas%2Fforms%2Firb-authorization-agreement%2Findex.html&data=05%7C01%7Ckristi-jo.noel%40nih.gov%7Caa691a2c07af4a9b47cd08dbae24b81e%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638295244971196989%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ys8xTTmxEaKXkjadAB5QTxnD%2BALFwTq4vdaHYq0FI1I%3D&reserved=0