Amendment_3_BAA-NIAID-NIHAI201700104.pdf

Amendment No. 3 to BAA-NIAID-NIHAI201700104 “Immune Mechanisms of Protection against Mycobacterium tuberculosis Center (IMPAc-TB)”

Amendment to Solicitation No.: BAA-NIAID-NIHAI2001700104

Amendment No.: 3

Issue Date: July 25, 2018

Effective Date:

Proposal Due Date:

July 25, 2018

August 15, 2018 at 3:00 p.m. (ET)

Issued By: Liem T. Nguyen Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane, MSC 9821 Rockville, MD 20892-9821

Point of Contact: Albert Nguyen, Contract Specialist nguyenal@niaid.nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals remain unchanged. Offerors must acknowledge receipt of this amendment. Failure to provide your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – AMENDMENT TO THE SOLICITATION

SECTION J – LIST OF ATTACHMENTS, INFORMATION ATTACHMENTS is hereby amended to include the following:

Attachment 27: PHS HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, 2. INSTRUCTIONS TO OFFERORS, b. Technical Proposal Instructions, 4. Human Subjects, b. Instructions to Offerors Regarding Protection of Human Subjects is hereby amended to read as follows:

Offerors must address the following human subjects protections issues if this contract will be for research involving human subjects (note: under each of the following points below, the offeror should indicate whether the information provided relates to the primary research site, or to a collaborating performance site(s), or to all sites:

a. Risks to the subjects o Human Subjects Involvement, Characteristics, and Design :

Briefly describe the overall study design in response to the solicitation.

mailto:nguyenal@niaid.nih.gov

Describe the subject population(s) to be included in the study; the procedures for assignment to a study group, if relevant; and the anticipated numbers of subjects for each study group.

List any collaborating sites where human subjects research will be performed, and describe the role of those sites and collaborating investigators in performing the proposed research.

o Study Procedures, Materials, and Potential Risks Describe all planned research procedures (interventions and interactions) involving study subjects; how research material, including biospecimens, data, and/or records, will be obtained; and whether any private identifiable information will be collected in the proposed research project.

For studies that will include the use of previously collected biospecimens, data or records, describe the source of these materials, whether these can be linked with living individuals, and who will be able to link the materials.

Describe all the potential risks to subjects associated with each study intervention, procedure or interaction, including physical, psychological, social, cultural, financial, and legal risks;

risks to privacy and/or confidentiality; or other risks. Discuss the risk level and the likely impact to subjects.

Where appropriate, describe alternative treatments and procedures, including their risks and potential benefits. When alternative treatments or procedures are possible, make the rationale for the proposed approach clear.

b. Adequacy of Protection Against Risks o Recruitment and Informed Consent:

Describe plans for the recruitment of subjects and the procedures for obtaining informed consent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. When appropriate, describe how potential adult subjects' capacity to consent will be determined and the plans for obtaining consent from a legally authorized representative for adult subjects not able to consent. The informed consent document for the Contractor and any collaborating sites should be submitted only if requested elsewhere in the solicitation. Be aware that an IRB-approved informed consent document for the Contractor and any participating collaborative sites must be provided to the Government prior to patient accrual or participant enrollment.

• For research involving children: If the proposed studies will include children, describe the process for meeting HHS regulatory requirements for parental permission and child assent (45 CFR 46.408). See the HHS page on Research with Children FAQs and the NIH page on Requirements for Child Assent and Parent/Guardian Permission.

• If a waiver of some or all of the elements of informed consent will be sought, provide justification for the waiver.

o Protection Against Risk:

Describe the procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness.

Discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects where appropriate.

In studies that involve interventions, describe the provisions for data and safety monitoring of the research to ensure the safety of subjects.

o Vulnerable Subjects, if relevant to your study - Explain the rationale for the involvement of special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

'Prisoners' includes all subjects involuntarily incarcerated (for example, in detention centers).

Pregnant Women, Fetuses, and Neonates or Children - If the study involves vulnerable subjects subject to additional protections under Subparts B and D (pregnant women, fetuses, and neonates or children), provide a clear description of the risk level and additional protections necessary to meet the HHS regulatory requirements.

• HHS' Subpart B - Additional Protections for Pregnant Women, Fetuses, and Neonates

• HHS' Subpart D - Additional Protections for Children

• OHRP Guidance on Subpart D Special Protections for Children as Research Subjects and the HHS 407 Review Process

c. Potential Benefits of the Proposed Research to the Subjects and Others o Discuss the potential benefits of the research to the subjects and others.

o Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.

o Describe treatments and procedures that are alternatives to those provided to the participants by the proposed research, where appropriate.

Note: Financial compensation of subjects should not be presented as a benefit of participation in research.

d. Importance of the Knowledge to be Gained o Discuss the importance of the knowledge gained or to be gained as a result of the proposed research.

o Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that may reasonably be expected to result.

Note : If a test article (investigational new drug, device, or biologic) is involved, name the test article and state whether the 30-day interval between submission of offeror's certification to the Food and Drug Administration (FDA) and its response has elapsed or has been waived and/or whether the FDA has withheld or restricted use of the test article.

Collaborating Site(s)

When research involving human subjects will take place at collaborating site(s) or other performance site(s), the offeror must provide in this section of its proposal a list of the collaborating sites and their assurance numbers. Further, if you are awarded a contract, you must obtain in writing, and keep on file, an assurance from each site that the previous points have been adequately addressed at a level of attention that is at least as high as that documented at your organization. Site(s) added after an award is made must also adhere to the above requirements.

OFFERORS, b. Technical Proposal Instructions, 4. Human Subjects, NEW HUMAN SUBJECT AND CLINICAL TRIAL INFORMATION FORM is hereby amended as follows:

a. Offerors shall submit the "New Human Subjects and Clinical Trials Information Form" for each technical proposal including work involving human subjects.

FORM SUBMISSION INSTRUCTIONS

1. The PHS Human Subjects and Clinical Trials Information Form must be submitted as a separate document via the electronic Contract Proposal Submission (eCPS) website for each technical proposal.

2. Offerors must use the form and follow the associated instructions posted on the website at:

https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files .

OFFERORS, b. Technical Proposal Instructions, 4. Human Subjects is hereby amended to include the following:

PLAN FOR SINGLE INSTITUTIONAL REVIEW BOARD (sIRB)

a. Offerors are required to submit a plan for the Single Institutional Review Board (sIRB) information in the technical proposal for each protocol involving more than one domestic site. At a minimum, the plan shall:

1. Participating sites will adhere to the sIRB Policy;

2. Sites and the sIRB will adhere to the communication plan described in the authorization/reliance agreement; and

3. If, in the case of restricted-award, a sIRB has not yet been identified, include a statement that the offeror will follow the sIRB Policy and communicate plans to select a registered IRB of record. This information must be provided to the Contracting Officer prior to initiating recruitment for a multi-site study.

The Offeror may request direct cost funding for the additional costs associated with the establishment and review of the multi-site study by the sIRB, with appropriate justification;

all such costs must be reasonable and consistent with cost principles, in accordance with the Federal Acquisition Regulation (FAR) 31.202, Direct Costs and FAR 31.203, Indirect Costs.

EXCEPTIONS TO THE SINGLE INSTITUTIONAL REVIEW BOARD (sIRB) POLICY

a. In the technical proposal, Offerors may request an exception to the sIRB policy for one or more studies.

1. For sites for which Federal, state, or tribal laws, regulations or policies require local IRB review

(policy-based exceptions):

a. The Offeror shall identify any site that meets the requirements for the Single IRB policy but is required to have local IRB review because of a federal, state, or tribal law, regulation or policy; and

b. The Offeror shall provide specific citation for policy-based exceptions.

2. Time Limited Exception: ancillary studies to ongoing research without a sIRB- new multi-site non-exempt human subjects' ancillary studies, that would otherwise be expected to comply with the sIRB policy, but are associated with the ongoing multi-site parent studies, will not be required to use the sIRB of record until the parent study is expected to comply with the sIRB policy. The Offeror shall provide the parent contract number to request an exception.

3. Other exceptions when Offeror believes that one or more research sites should be exempt from use of the single IRB of record to conduct local IRB review based on compelling justification:

a. Offerors should request an exception in the sIRB plan attachment within the contract proposal (section 3.2 in the Study Record: PHS Human Subjects and Clinical Trials Information form).

b. Offerors must include the name of the site(s) for which an IRB other than the sIRB of record is proposed to review the study for the sites(s).

c. Offerors must substantiate their exception request with sufficient information that demonstrates a compelling justification for other exceptions to the sIRB policy. The rationale should include why the sIRB of record cannot serve as the reviewing IRB for the site(s), and why the local IRB is uniquely qualified to be the reviewing IRB for the specific site(s).

- For instance, the justification may consider ethical or human subjects protections issues, population needs, or other compelling reasons that IRB review for the site(s) cannot be provided by the single IRB of record.

d. Note that the proposed budget in the proposal must reflect all necessary sIRB costs without an approved other exception. The Offerors should not assume that an other exception will be granted when considering what sIRB costs to include in the budget.

Post-Award Exception Requests

For any post-award changes that necessitate an exception request, such as the addition of a new domestic site that may be unable to use the sIRB Contractor shall contact their Contracting Officer (CO). For policy-based exceptions, the Contractor shall provide the appropriate citation to verify the requirement for local IRB review for the newly added site(s) to the CO. For other exceptions, the Contractor shall provide compelling justification to the CO to be reviewed by the NIH Exceptions Review Committee (ERC) (see Steps to Request an Other Exception to the sIRB Policy above). For time limited exceptions, Contractor shall provide the parent contract number to the CO.

Notice of Approval or Disapproval of Other Exception Requests

The sIRB exception requests will be considered after peer review for proposals in the competitive range. All requests for other exceptions must be reviewed by the NIH ERC. The decision of NIH ERC is final. Offerors will be notified of the final decision by their CO prior to award. Approved exceptions will be incorporated as a term and condition in the contract award. Also, any exception requests submitted after award must be submitted to the CO and reviewed by the NIH ERC. No further revisions of the exception request will be accepted.

The award budget may need to be adjusted if an exception is granted.

SECTION 2 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to the solicitation and its amendments for additional Questions & Answers.

Question 1: We understand that subcontractors with budgets over $700,000 need to complete a Small Business Subcontracting Plan (per page 74 of the RFP). Can you please confirm whether this applies to subcontractors located outside the United States as well?

Response 1: If the contractor is located outside of the U.S. and its outlying areas, and the services provided by the subcontractor performed outside of the U.S. and its outlying areas, the SBSP is not required. See FAR 19.702 Statutory Requirements, paragraph (b)(3).

(b) Subcontracting plans (see subparagraphs (a)(1) and (2) of this section) are not required --

(3) For contracts or contract modifications that will be performed entirely outside of the United States and its outlying areas; or

Question 2: Is it possible to submit the Annual Financial Report (as required on page 83) as a URL rather than submit a complete copy in the PDF?

Response 2: Yes, offerors can provide a URL where the government can access and review the Annual Financial Report as required on pg. 83 of the solicitation as a part of your business proposal.

Question 3: Regarding “General Experience, Organizational Experience Related to this RFP, Performance History and Pertinent Contracts” (pages 82-83): Should the information submitted under this section be related to the experience of the prime contractor only, or may we also include information in these sections for other institutions proposed as subcontractors with whom we would be collaborating?

Response 3: The information submitted under the General Experience, Organizational Experience Related to this RFP, should be related to that of the Prime Contractor and major Subcontractors.

Question 4: Per the BAA, we understand that NIH will establish a Scientific Advisory Panel for the IMPAcTB program and per the instructions we will not name any potential members in our proposal. But we would also like to form an internal Scientific Advisory Board, to advise our project. Are we allowed to do this, and if so can/should we include the names of suggested members in our proposal?

Response 4: You are not prohibited from doing so. As this is a competitive acquisition NIAID is not permitted to provide feedback on the content of your proposal.

Question 5: We would like to know if it is allowed to have sub-awards of sub-awards in the mechanism of this solicitation. In other words, can we give a sub award to a US institution which in turn gives a sub award to a foreign site as part of the service they provide to us, or do we have to give separate sub awards, directly for our institution, to each. We seem to get discordant opinions.

Response 5: There is no limitation on subcontractors entering into sub-agreements with a foreign site, however a foreign clearance must be obtained by NIH before moving forward. A subcontracting Plan is required if the estimated cost of the contract may exceed $700,000 ($1,500,000 for construction). Small businesses and foreign entities are excluded from this requirement.

Question 6: We are aware that there is an entry for the excel budget upload; however, should we upload one excel budget spreadsheet or multiple excel files if we have several subsites? If only one excel file is to be uploaded, should we include the subsite’s budget as tabs?

Response 6: An excel file for each of the subcontracts is recommended.

Question 7: For the annual meeting and site visit at the offeror site, are refreshments considered an allowable budget expense? Article B3 and H.35 contradict.

Response 7: Article B.3. provides a list of items that are prohibited or restricted unless otherwise approved by the Contracting Officer. Article B.3. and Article H.35 provide the same information related to the use of contract funds for conferences, meetings and food, and other items as listed in B.3. A written approval from the Contracting Officer is required.

Question 8: Are resumes included in the Technical Proposal 150 Page Limit?

Response 8: Yes, Resumes are included in the Technical Proposal’s 150-page limit. In addition, each resume has a page limit of 3.

Question 9: Following the normal NIH bio-sketch information, will the reviewers still seek to have the personal statement on the resume or would that not be necessary?

Response 9: A personal statement on the resume is not required for this BAA.

Question 10: Are there any indirect cost limits that apply to foreign subcontractors, or will NIH pay foreign subcontractors their full indirect cost rates if adequately justified?

Response 10: It’s the Prime contractor’s responsibility to review and negotiate the Indirect Cost (IDC) rates with their foreign subcontractors. The foreign subcontractor’s IDC rates included in the Prime’s proposal will be reviewed by the government for reasonableness.

Question 11: If the proposal involves non-exempt human subjects research, are we required to submit a single IRB plan for multi-site research?

Response 11: All grant and contract applications submitted after January 25, 2018 are required to follow NIH’s policy requiring a single IRB for multi-site research. Details are available in the Notice “Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research”: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-004.html. Please note that foreign and tribal sites may be exempt from the single IRB policy, as stated in the above Notice and the Notice “Guidance on Exceptions to the Single-IRB Policy”: https://grants.nih.gov/grants/guide/notice-files/NOT- OD-18-003.html

Question 12: I found information in the BAA instructions for the IMPAcTB regarding the Business Proposal – Direct labor that says, “furnish bases for estimates”. We plan to have a subcontract in a foreign site, how we can provide this data since all documentation will be in another language (for example pay stubs). This also affects the quotes required for the materials and services, which would be all in a foreign currency. Would you please advise on how to proceed regarding language and currency differences?

Response 12: Per the BAA page 41 section INSTRUCTIONS TO OFFERORS-- Broad Agency Announcement d.5.v., “Offerors shall submit proposals in response to this solicitation in English, unless otherwise permitted by the solicitation, and in U.S. dollars…”

Documentation must be submitted in English and in U.S. currency.

Question 13: BAA pg. 54 describes how we should include a separate section of the proposal entitled Human Subjects where we’ll need to document “Protection of Human Subjects”, “Inclusion of Women, Minorities, and Children”, etc. Pg. 65 then describes that we must use the new “Human Subjects and Clinical Trials Information Form”. This form asks for documents uploads of “Protection of Human Subjects” and “Inclusion of Women, Minorities, and Children”. Do we need to include this information twice- in the text of the technical proposal and as an attachment in the PDF HS form? Or just include in the HS form?

Response 13: Please include the information in the HS form as an attachment and refer the attachment in the technical proposal.

Question 14: Does optional 310 form need to be completed by all subcontractors involved in human subject research?

Response 14: Answer: Any subcontractors involved in Human Subject research will each have to complete the Optional 310 form.

Question 15: What is the policy for including publications in the budget for this proposal?

Response 15: Answer: Article B.3. prohibits or restricts the use of contract funds (for printing/publication etc.), unless otherwise approved by the Contracting Officer. Publication of research findings directly related to and supported by the contract may be approved by NIAID.

Question 16: Although the BAA notates font size as 10 to 12; it does not reference any specific or preferred font type. We plan to use 10 Times New Roman but have received some advice that NIH prefers font size 11 and Arial type. We hope to avoid any document reformatting once proposal is accepted and in review.

Response 16: The BAA Attachment 1 “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website” does not specify a particular font type. Offerors may select which font type or size, between 10 to 12 points, they would like to use.

Question 17: Please advise as to the process for obtaining NIH clearance for the foreign sub-agreement.

Response 17: NIH foreign clearance will be obtained by NIAID after Final Proposal Revisions have been received and prior to contract award. The offeror must ensure that foreign subcontractors must not be from countries that are sanctioned by the U.S. Department of State.

Question 18: What are the instructions for the following statement? I cannot find the “formats for submission of line item summaries” You must show the relationship between contract line item prices and the total contract price. You must attach cost element breakdowns for each proposed line item, using the appropriate format prescribed in the "Formats for Submission of Line Item Summaries'' section of this table. You must furnish supporting breakdowns for each cost element, consistent with your cost accounting system. We cannot locate the “Formats for Submission of Line Item Summaries'' within the contract spreadsheet and where to place the percentages.

Response 18: NIAID noted that you are referring to the section C.2. Certified Cost or Pricing Data, line item 1.D. of General Instructions. This refers to the excel spreadsheet, Summary of Proposed Costs, where you provide the summary of total costs including each line item then in each of the subsequent tabs provide a breakdown for each of the proposed line item listed/included in the Summary of Costs. There are more instructions in the spreadsheet for you to follow and prepare your proposed budget. The link to the Excel spreadsheet is included in Section J, page 37 of the Solicitation.

Question 19: In addition to the prime offeror’s sections, are the following sections required for each of our proposed subcontractors:

• Total Compensation Plan

• Section K - Representations and Certifications of Offerors

Response 19: Prime or Subcontractors should be registered in SAM.gov, therefore their Representations & Certifications should be available in SAM. A Compensation Plan must be described/included in the Subcontract agreement.

Question 20: Is it necessary to include all of the list of requirements, within the Subcontractor LOI.

Response 20: Items 11.a. through 11.f are required for any subcontractors proposed in the proposal.

Question 21: We have human and macaque models. The RFA says small animals are encouraged. If we have the human and macaque, do we still need small animal? Would a proposal without small animals be considered non-responsive?

Response 21: A proposal with only NHP and human studies would not be responsive to this BAA. Iterative studies using small animals, NHP and humans are a requirement of this solicitation.

Question 22: Are representations and certifications attachment 11 and lobbying form required by foreign entities?

Response 22: Foreign entities (both Prime and subcontractors) must have an active registration in SAM to do business with the Federal Government. To register in SAM, at a minimum, you will need the following information:

International Registrants:

1. Your NATO Commercial and Government Entity (NCAGE) Code.

• If you don't already have one, you can request an NCAGE Code online for FREE.

2. Your DUNS Number, Legal Business Name, and Physical Address from your D&B record. Make sure your DUNS information and NCAGE information match.

• If you don't already have one, you can request a DUNS Number for FREE from D&B.

Once you registered in SAM, your Reps and Certs will be available in SAM. You can reference the Reps & Certs in attachment 11.

Business entities who do contracts with the U.S. Federal Government and receive federal funds must fill out the Stand Form LLL (Disclosure of Lobbying Activities).

Questions 23: We are trying to figure out the best way to organize information in the PHS Human Subjects Form.

Is it’s best to submit only one form with information about all studies, or submit multiple forms for each project study, or study site?

Response 23: Please follow NIH's current Human Subjects guidance, which indicates that offerors should submit one form for each proposed study, not per site.

Question 24: Based on the language below from the small business subcontracting plan template, we wanted to confirm whether we would need to enter the subcontractors’ reports in eSRS along with ours, or if they would have the ability to submit reports in the eSRS system on their own.

6. Reporting and Cooperation: (FAR 52.219-9(d)(10)); (FAR 19.704(a)(10))

“The contractor gives assurance of 1) cooperation in any studies or surveys that may be required; 2) submission of periodic reports which illustrate compliance with the subcontracting plan; 3) submission of its Individual Subcontracting Report (ISR) and Summary Subcontract Report (SSR); and 4) subcontractors submission of ISRs and SSRs. ISRs and SSRs shall be submitted via the Electronic Subcontracting Reporting System (eSRS) website https://esrs.symplicity.com/index?_tab=signin&cck=1

Please refer to FAR Part 19.7 or contact the Contracting Officer for regulatory reporting requirements and other obligations you are accepting as part of your signing of this document and acceptance of any subsequent contract award that may be granted.”

Response 24: The Prime is required to submit the ISRs and SSRs, including those of the subcontractor(s) within its report(s).

https://esrs.symplicity.com/index?_tab=signin&cck=1