Amendment__3.pdf

Amendment #3 to BAA-NIAID-DAIT-NIH-AI201800007 Large-Scale T Cell Immune Epitope Discovery

Amendment to Solicitation No.: BAA-NIAID-DAIT-NIH-AI201800007

Amendment No.: 3

Issue Date: July 25, 2018

Effective Date:

Proposal Due Date:

July 25, 2018

October 9, 2018 3:00 pm (Unchanged)

Issued By: Tom Bahrami, MBA Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane Room 3C20 MSC 9821 Rockville, MD 20852

Point of Contact: Brandon White, Contract Specialist whitebra@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 remains unchanged. Offerors must acknowledge receipt of this amendment. Failure to receive your acknowledgement of this amendment may result in the rejection of your offer.

NOTE: As part of this Amendment, we request that all questions pertaining to the BAA be submitted to the Government no later than September 17, 2018, 3:00pm EST.

SECTION J-LIST OF ATTACHMENTS in the solicitation document. SECTION J-LIST OF ATTACHMENTS, INFORMATION ATTACHMENTS, is hereby updated to include:

Attachment No. Title Location Attachment 28: PHS HUMAN SUBJECTS AND CLINICAL

TRIALS INFORMATION FORM

25T Uhttps://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-filesU25T

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.

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

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.

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, 2. INSTRUCTIONS TO OFFERORS, b. Technical Proposal Instructions, 4. Human Subjects, is hereby amended to include the following:

NEW HUMAN SUBJECT AND CLINICAL TRIAL INFORMATION FORM

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:25T https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files 25T.

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:25T PHS Human Subjects and Clinical Trials Information 25Tform).

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).

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

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.