Amendment_0001_3.pdf

Questions with Answers

RFP 75N91023R00036

Amendment 1

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