December 11, 2015

Frequently Asked Questions for Cooperative Agreements

Application Related

  1. Can I apply to both the OT award and grant solicitations?
    You may apply to both OT award (OT-PM-16-001; OT-PM-16-002) and grant solicitations (RFA-PM-16-001; RFA-PM-16-002; RFA-PM-16-003; RFA-PM-16-004).
  2. Can a Principal Investigator submit multiple RFA applications?
    The Requests for Applications (RFAs) state that “Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:
    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

    For additional policy guidance on this question, please see: http://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.3_application_information_and_processes.htm?Highlight=duplicate

  3. Are application due dates firm or is there a possibility that these dates may be extended?
    The application due dates are non-negotiable.  Late applications will not be considered.
  4. Are there any page limits to the research strategy portion of the application?
    Yes. The research strategy section of the application is limited to 12 pages. See also: Table of Page Limits.
  5. Will there be a DSMB/OSMB?
    The PMI Cohort Program is currently evaluating the needs and responsibilities of an Observational Study Monitoring Board (OSMB).  Applications will be evaluated for involvement of human subjects and the proposed protections from research risk relating to their participation, as detailed in the Guidelines for the Review of Human Subjects. As there is no intention of a multi-site clinical trials being developed, there is no requirement for a DSMB.
  6. Can the NIH provide context for the overlapping tasks in each of the RFAs?
    As stated in the background sections of all solicitations, “In its full implementation phase, the PMI Cohort Program will consist of a consortium of several highly integrated components. The major components are being solicited through this FOA and three other companion FOAs: (1) a central PMI Cohort Program Coordinating Center (CC); (2) healthcare provider organizations (HPOs), (3) a participant technologies center, and (4) a central Biobank.

    In addition, in early 2016, NIH plans pilot activities including a direct volunteer pilot program focused on learning what prospective and enrolled participants like, need, and want; developing successful communications methods and content; understanding how to create and implement specialized data technologies, including website, apps, sensors, and clinical data; and building and testing research infrastructure for acquiring and managing biosamples. The output of the pilot phase will be knowledge needed to conduct successful long-term engagement with PMI Cohort Program volunteers, and scientific datasets of relatively limited scope and size. Prototype participant interaction and data acquisition technologies will also be tested in the pilot phase. If successful, these technologies may be transitioned to the full implementation phase Coordinating Center. The pilot phase is expected to start in early 2016 and extend through approximately January 2017, followed by transition to the full implementation phase.

    In addition, “The PMI Cohort Program will function as a Consortium, with all awardees considered to be members of the Consortium with specific roles in its governance structure (see Terms and Conditions, Section VI.2). For example, the PMI Cohort Program Steering Committee will consist of the Program Directors/Principal Investigators (PDs/PIs) from each of the awards, the NIH Project Scientist(s), representatives of the research participants, and academic and private researchers representing scientists who will use the PMI Cohort Program platform. The Steering Committee will meet shortly after funding to review and further develop a draft protocol and to plan for its rapid implementation.

    The Steering Committee will meet, at least monthly, to share information on planning, recruitment progress, data and biospecimen collection, preliminary results, and analyses in progress.

    The PMI Cohort Program Consortium will include participant representatives in all aspects of its governance structure. Additional working groups will be established by the PMI Cohort Program Consortium Steering Committee to oversee the development and implementation of Consortium policies and goals.

    The PMI Cohort Program will have a single Institutional Review Board (IRB), to the extent permitted by law, constituted to ensure prompt and thoughtful consideration of the evolving protocols in the PMI Cohort Program and the central importance of participants as research partners. The PMI Cohort Program IRB will include significant representation by members of the public and representatives of the participant community.”

  7. Is it necessary to have Letters of support for the Letter of Intent?
    No, letters of support are not required for the LOI.  As noted in the RFA: prospective applicants are asked to submit a letter of intent that includes the following information:
    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity 
  8. Can the “planned enrollment report table” and “inclusion of women and children” sections of the grant application for the PMI Cohort Program Biobank and PMI Cohort Program Personal Technologies Center be marked as “not applicable”?
    Yes, this approach is acceptable. The HPO and Coordinating Center need to include these sections for the participants they plan to enroll.
  9. Are large businesses eligible to participate in RFA-PM-16-004?
    Yes, as stated in the RFA “For-Profit Organizations (Other than Small Businesses) “are eligible.
  10. Are foreign sub-contractors permitted?
    As stated in the RFAs, foreign components are not allowed.  To determine whether or not the contractor activity qualifies as a foreign component, please see the Foreign component definition in the NIH Grants Policy Statement.

Administrative and Budget Related

When established, the PMI Cohort Program Steering Committee and Governance Structure will develop and approve the final protocol for exams and biospecimen collection, including content and distribution of the kits. Final determinations on implementation will be addressed at that time.

For all four RFAs, direct costs should not exceed the yearly amounts specified.  However, as indicated in the Award Information table for each of the four RFAs, “Requests exceeding this guidance should be strongly justified.”

  1. Is profit allowed in the budget?
    Under the Request for Applications (RFA) announcements, please refer to the NIH Grant Policy Statement (GPS) Section 7.9.1 Selected Items of Cost. Profit and fees are not considered to be "costs" and are not allowable under this program.
  2. How are applicants to describe and budget for aspects that will be determined by the PMI Cohort Program?
    Applicants should provide a budget that is commensurate with the proposed research strategy that is achievable, and may include possible budget scenarios for aspects that will be determined by the PMI Cohort Program governance structure related to biospecimen collection and standard exams.
  3. Will full indirect cost rates be applied to the awards?
    Applicants should propose their current negotiated F&A rate, as applicable.
  4. Does the Indirect cost (Overhead) of the subcontracts need to be included in the Direct Cost Cap?
    Applications that include a limitation on direct costs are to exclude from that limit the facilities and administrative (F&A) costs requested by consortium participants.

    See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html

  5. Is it possible for the Contact PI role to rotate among the Multiple PIs?
    Applicants/Recipients may always ask for change of PI for MPIs at the same institution both pre and post award, but it is up to the NIH Awarding Official to approve or reject the request. If information is incongruent in the application and the leadership plan that is peer reviewed then the application may not score well. The Contact PI should not rotate among institutions.
  6. Will the presentation and Q&A information from the technical assistance webinar for the Precision Medicine Initiative® (PMI) Cohort Program Requests for Applications (RFA) be made public?
    Yes. The materials are available at https://www.nih.gov/precision-medicine-initiative-cohort-program/events.
  7. Will these awards be subject to the standard NIH administrative reductions?
    Administrative cuts are not anticipated for these awards.  Applicants are expected to propose a budget that they consider is necessary, and include justification for their budget.
  8. Who pays for biospecimen collection and the physical exams?
    RFA-PM-16-001 specifies that the Coordinating Center should “Schedule, track, and fund” both biospecimen acquisition and clinical exams (also referred to as physical exams) for direct volunteers:
    • The protocol and method for obtaining clinical exams and biospecimen collections for direct volunteers will be developed by the PMI Cohort Program Steering Committee and Governance Structure, and will be overseen by the Coordinating Center.  Applicants should include a proposal for how they might do the physical exam, including a cost per person estimate, within the “Research Strategy” section for the Administrative Core.
    • The kits and shipping costs for direct volunteers will be provided by the Biobank as specified in RFA-PM-16-004.

      RFA-PM-16-002 specifies that the healthcare provider organizations (HPOs) should address multiple issues including “Conducting the standard examination” and “Collecting, processing and shipping biospecimens to the designated biobank using standardized PMI Cohort Program protocols and consumables”:

    • The HPOs should provide a budget for clinical exams and biospecimen collections for participants they enroll.
    • When established, the PMI Cohort Program Steering Committee and Governance Structure will develop and approve the final protocol for exams and biospecimen collection, including content and distribution of the kits. Final determinations on implementation will be addressed at that time.  
  9. Can investigators submit applications above the yearly budget totals in the RFAs?
    The HPOs should provide a budget for clinical exams and biospecimen collections for participants they enroll.

    When established, the PMI Cohort Program Steering Committee and Governance Structure will develop and approve the final protocol for exams and biospecimen collection, including content and distribution of the kits. Final determinations on implementation will be addressed at that time.

    For all four RFAs, direct costs should not exceed the yearly amounts specified. However, as indicated in the Award Information table for each of the four RFAs, “Requests exceeding this guidance should be strongly justified.”

  10. If we have subcontractors working within our research team, is this considered a consortium?
    Yes, subcontractors are considered consortiums in the SF424 budget expression.
  11. If a subcontractor has a commercial price for routine goods and services, is a breakout of cost (i.e. indirect rates) required?
    No, subcontracts for commercially available supplies or services should show total cost in the budget and state that select items of cost are commercial rates in the budget justification.
  12. Can travel have indirect loaders added to the cost (i.e. G&A)?
    This answer depends on whether or not the travel will be managed by the Applicant or outsourced to a third party provider. For example:
    • When travel is managed by the applicant organization then the F&A costs should be commensurate with the applicant’s normal treatment of the cost.
    • When travel is outsourced to a third party and is commercially available then total cost is appropriate and must be identified in the budget justification.

Specific to: Cohort Program Coordinating Center (U2C) RFA-PM-16-001

  1. Is there a need to employ systems that can easily transfer electronic medical records?
    Although EHR platforms and interconnectivity of EHRs are desired components of the Precision Medicine Initiative® Cohort Program Coordinating Center (U2C), there are many more components which must be addressed in the RFA. We suggest that your organization work with your professional networks to identify potential partners and determine if, as a team, you can support an application that addresses all areas of the RFA.
  2. For the PMI Cohort Program Coordinating Center, will the NIH allow a commercial entity to perform as a subcontractor under FAR Part 12?
    A commercial entity as a subcontractor is allowable.
  3. How many volunteers should we plan for the coordinating center being directly responsible for recruiting and managing?
    The CC should provide an enrollment plan with a timeline and milestones for direct volunteers. It is anticipated that the CC will enroll 30-40% of the total enrollments, whereas the HPOs will enroll 60-70% of the total Cohort, with an aggressive timeline of one million or more volunteers enrolled by 2019.  Applicants may want to review the recent presentation about the PMI Cohort Program given to the Advisory Council to the Director.
  4. Are volunteers going to be required to obtain certain devices (e. g., smartphones)?
    Mobile technologies, including smartphones, will be the responsibility of RFA-PM-16-003 and their use within the PMI Cohort Program will be determined by the Steering Committee.  Under the purpose and objectives section of the RFA (bullets 2 and 4):
    • Provide alternative methods of gathering core participant data for those without smartphone access (e.g., feature phones, website)
    • Identify, evaluate, obtain, and/or implement various technologies on behalf of the PMI Cohort Program to increase smartphone accessibility of participants, obtain passive sensor technologies for participants, and extract data from technologies that participants currently use.
  5. Who will pay for procedures the volunteer subjects need to undergo, such as interviews by physicians, biosample drawings, etc.?

    RFA-PM-16-001 specifies that the Coordinating Center should “Schedule, track, and fund” both biospecimen acquisition and clinical exams (also referred to as physical exams) for direct volunteers.

    The protocol and method for obtaining clinical exams and biospecimen collections for direct volunteers will be developed by the Steering Committee, and will be overseen by the Coordinating Center. Applicants should include a proposal for how they might do the physical exam, including a cost per person estimate, within the “Research Strategy” section for the Administrative Core.

  6. What will be the process of proposal review?
    Each proposal will be reviewed by a single committee.  As detailed in the review criteria section of the FOA, reviewers will provide an overall impact score and will also provide a separate score for the stated review criteria in the overall section, and for each core.  See Section V. “Application Review Information” within RFA-PM-16-001.
  7. Is it the government’s intent to issue a future funding announcement for a National Direct Volunteer physical Evaluation and Biospecimen Collection Opportunity (NOT-PM-16-002), or is this part of the scope of the PMI Cohort Program Coordinating Center RFA-PM-16-001?

    RFA-PM-16-001specifies that the Coordinating Center should “Schedule, track, and fund” both biospecimen acquisition and clinical exams (also referred to as physical exams) for direct volunteers.

    The protocol and method for obtaining clinical exams and biospecimen collections for direct volunteers will be developed by the Steering Committee, and will be overseen by the Coordinating Center, applicants should include a proposal for how they might do the physical exam, including a cost per person estimate, within the “Research Strategy” section for the Administrative Core.

    The need for additional funding announcement(s) will be evaluated as the program develops over the coming years.

  8. Is the Coordinating Center expected to pay for DNA sequencing on all 1M patients?
    No, the Coordinating Center is not expected to pay for DNA sequencing under the current Request for Application (RFA). The current RFAs are focused on developing the PMI Cohort Program resource and do not cover collection of sequencing or other genomic data. We anticipate future funding announcements for the collection of additional detailed measures on participants, including genomic data and other biologic measures.
  9. Is it permissible to use commercial entity in the amount over $150K for fixed priced activity for the Precision Medicine Initiative Cohort Program Coordinating Center?
    This cost may be allowable if the supply or service is commercially available and the cost is consistently charged to all of its customers. The Applicant/Recipient must demonstrate that the appropriate procurement procedures were used in analyzing the appropriateness of cost proposed and its allocability to the research activity.  Please also consult with your Authorized Business Official for internal guidance on the treatment of this type of cost.

Specific to: Cohort Program Healthcare Provider Organization Enrollment Centers HPO (UG3/UH3) RFA-PM-16-002

  1. Is direct volunteer enrollment appropriate for the NIH PMI Cohort Program Healthcare Provider Organization (HPO) Enrollment Centers (UG3/UG4)?
    Applicants for RFA-PM-16-002 should not propose direct volunteer enrollment. It is anticipated that the enrollment processes and protocol for direct volunteer enrollment will differ in important respects from HPO enrollment. Two other funding opportunities, OT-PM-16-001 and RFA-PM-16-001, specifically focus on direct volunteer enrollment.
  2. Would leveraging pre-existing cohort infrastructure to enroll and follow underserved populations be appropriate for the UG3 mechanism?
    An organization that focuses on a specific disease/population will not be responsive to the FOA. However, applicants may build upon and expand an infrastructure developed for a specific disease/population as long as it is clear in the application that this will not inhibit its generalizability and applicability to the PMI Cohort Program.
  3. We are considering partnering with at least one other site. Can we have co-PIs from different institutions, and if allowed, should we submit a Leadership Plan?
    Multiple PI/PDs are allowed, and a leadership plan must be submitted. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
  4. Are all surveys, brief exams and biospecimens to be collected at the point of recruitment?
    The core data (survey, standard exam, health records, and biospecimens) for a given participant may be collected at deferred times and scheduled at the convenience of the participant. However, per The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine, p. 24 – “Each of these requirements must be met for each participant in order for them to be considered enrolled in the PMI cohort …”
  5. How extensive is the standard exam and what elements are required?
    Once the awards are made, the final decision as to the content of the standard exam for the entire Cohort Program will be agreed upon through the steering committee within the governance structure.
  6. Who is responsible for budgeting for kits, shipping, and processing for biospecimens collected by HPOs?

    RFA-PM-16-002 states applicants should describe “Collecting, processing and shipping biospecimens to the designated biobank using standardized PMI Cohort Program protocols and consumables” and “Collection of biospecimens to be determined by the PMI Cohort Program (e.g., blood, saliva, and urine samples) from study participants who consent to it near the time of enrollment, process the biospecimens to create aliquots of plasma, serum, and other biosamples and send them to the PMI Cohort Program designated biobank ….”

    The HPOs may propose to provide their own materials for specimen collection (e.g., blood, saliva, and urine samples) and periodically send bulk shipments to the Biobank. HPO applicants should budget for these expenses. When established, the Steering Committee will develop and approve the final protocol for biospecimen collection, including content and distribution of the kits.

  7. Is the urine specimen required, as biomarkers in urine samples do not keep long or freeze well. Is the urine specimen to be collected as in standard medical practice (sterile prep, mid-stream)?
    As noted, urine may be an important biospecimen for certain aspects of the cohort program. Once the awards are made, the final decision as to the content and protocol for the biospecimen core collections for the entire Cohort Program will be agreed upon through the steering committee within the governance structure.
  8. Is there any planning and development phase built in to the initiative?
    This award is funded through a UG3 /UH3 Exploratory/Developmental Phased Award Cooperative Agreement (you may access the hyperlinks over UG3/UH3 to read about the purpose of these awards). As stated in the Funding Opportunity Purpose in Part 1 of RFA-PM-16-002, “Awards made through this FOA will initially support a 1-year, milestone-driven development phase (UG3), with possible rapid transition to a full implementation phase (UH3). UH3s will be awarded after administrative review of eligible UG3s that have met the scientific milestone and feasibility requirements. The UG3/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA.”

    Per the RFA, the HPO should “Describe how the HPO will plan to enroll at least 10,000 participants in year 1 from diverse populations (enrollment number proposed in the application should be well justified), obtain informed consent, obtain baseline data, arrange for an initial screening exam and acquisition of biospecimens as agreed upon by the Steering Committee.”

  9. Are there any restrictions on the number of site PI’s for the PMI Cohort Program Healthcare Provider Organization Enrollment Centers?
    There are no restrictions on the number of sites. Multiple PI/PDs are permitted.
  10. Will there be a blanket Certificate of Confidentiality or will each HPO have to apply for this?
    It is expected that a Certificate of Confidentiality (CoC) will be applied to the PMI Cohort Program overall. Although, we do not anticipate each HPO to apply for a CoC, it may be a re-visited once the steering committee is established.
  11. Can the NIH provide further information about the required elements for the standard health exam that HPO’s will need to complete for PMI cohort participants?
    For budgetary purposes, applicants should provide a standard health exam that they feel is reasonable. Final considerations and protocols will be developed and finalized through the PMI Cohort Program Steering Committee Governance structure.
  12. Will the samples be processed for exomes?
    The sample processing for future analyses has not yet been determined.
  13. Will blood samples be required on every patient?
    Biospecimens are required. As stated in the objectives of the PMI Cohort Program, “In order to be part of the PMI Cohort Program, all volunteers will be asked at entry for consent to join the Cohort Program and to be contacted for future studies. They will be asked to complete a brief survey and to undertake a standard exam, to share their healthcare records, and to be willing to submit biospecimens, including blood, urine, and saliva.”
  14. Will blood volumes be adjusted for pediatric populations?
    Applicants should propose the best plan for obtaining biospecimens in accordance with the standards for the subject population(s).
  15. Will DNA sequence data be made available back to the submitting institutions and to the patients?
    The PMI Cohort Program is committed to providing participants with access to their information according to their preferences. The form, content, and reasonable timing of providing access to those results will be determined by the Governance Structure of the NIH PMI Cohort Program.
  16. Will a pediatric population (0-17 years, or any age range within) be recruited as part of the PMI?
    As described in the research strategy, applicants may “Describe how overall enrollment data will be gathered, including for specific populations including families, children, difficult to reach and underserved populations.” For more information, please reference the PMI Working Group Report, and the RFA-PM-16-002 purpose and objectives section, where it states: “Individuals enrolled through HPOs should typically be invited to participate regardless of disease status and should represent all life stages."
  17. During enrollment will a new biospecimen be required?
    New biospecimens are a requirement for full enrollment into the PMI Cohort Program. Per The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine, p. 33 “Recommendations for eligible HPOs.”
  18. Will any incentive be allowed in order to increase enrollment?
    Incentives may be proposed, and will need to be part of the protocol that will require IRB approval.
  19. Do you anticipate that the kits for tumor access will be provided outside of the awardees budget?
    Tumor access is not a requirement of the FOA.
  20. Will we need to factor venipuncture etc into our budgets?
    Yes, the applicant will need to budget for venipuncture.
  21. Will NIH provide the mobile technologies?
    Mobile technologies will be the responsibility of RFA-PM-16-003 and their use within the PMI Cohort Program will be determined by the Steering Committee.
  22. Will NIH indemnify the organization that bring clinical data into a repository so as to eliminate or reduce the costs of cyber-security in case of a breach?
    No. NIH will not indemnify the awardee. Data are to be submitted and stored under the auspices of the coordinating center (CC, RFA-PM-16-001).  Cyber security is the responsibility of the CC. As described in the PI/PD responsibilities section (VI.2) of the RFA, it is the responsibility of the HPO to adhere to “physical, technical, and policy safeguards for data that will ensure state-of-the-art security for all PMI Cohort Program data and systems.”
  23. Will NIH allow the organization collecting the data to commercialize it?
    As stated in the RFA, “A fundamental objective of this cooperative agreement is to ensure that this valuable resource remains available without interruption to the research public for many years to come, even in the event that awardees withdraw or are terminated or otherwise can no longer manage the resource, or when the associated scientific grants, discussed elsewhere in this FOA, are expired. NIH will own the biospecimens and related data and may take exclusive custody and control of them at its reasonable discretion upon termination or expiration of this cooperative agreement.”

    In addition, the RFA also states “Rights to Subject Inventions: Under the Bayh-Dole Act, awardees generally retain the right to elect title to inventions made by its employees as a result of the work performed under the award. The Bayh-Dole Act also allows for a different disposition of such “subject inventions,” when the agency determines that exceptional circumstances exist such that restriction or elimination of the right to retain title to any subject invention will better promote the policy and objectives of the Act. NIH intends, to make such a “Determination of Exceptional Circumstances” (“DEC”) for this award, to assure that patents directed to inventions made under this award cannot be used to block access by the research public to this important resource and associated technology.

  24. Can participants consent for both internal research studies at our institution and the Precision Medicine Initiative?
    Yes. The participants are eligible to consent to both. The PMI Cohort Program will require new, PMI-specific biospecimen collections.
  25. Is the HPO Enrollment Center comprised of a single healthcare provider or can the structure be that of a consortium of healthcare provider organizations?
    A consortium of HPOs may be proposed, and there are no limits to the number of HPOs within the proposed consortium.
  26. Do we need to allocate for biospecimens to be collected multiple times during the 5 year follow up for each enrolled patient , or have just a one-time collection?
    Per the RFA, organizations will periodically obtain additional biospecimens as specified by the PMI Cohort Program. For budgetary purposes, applicants should provide a level of additional collection that they feel is reasonable.  Final considerations and protocols will be developed and finalized through the PMI Cohort Program Steering Committee Governance structure.
  27. Are the awardees expected to store the medical data from their patients in a central data warehouse environment?
    Per the RFA, in the UG3 phase the HPOs should work collaboratively “with the CC, other HPOs, the participant technologies coordinating center, and the PMI Cohort Program Biobank to develop and pilot procedures, including recruitment and enrollment of study participants.” Mobile technologies will be the responsibility of RFA-PM-16-003 and their use within the PMI Cohort Program will be determined by the Steering Committee.

    The HPOs should curate data locally. They should also “provide a set of structured clinical data from study participants to the coordinating center at least quarterly.” In the UH3 phase they should streamline “the pipeline that sends data to the Coordinating Center data management system to enable data from the supported HPOs to be jointly used for data analysis.”

  28. Will study protocols and informed consent documents be submitted to a centralized/national IRB?
    For further information on the NIH’s approach to the IRB, please review Section 1 of the Funding Opportunity Description of RFA-PM-16-001, which states “the PMI Cohort Program will have a single Institutional Review Board (IRB), to the extent permitted by law, constituted to ensure prompt and thoughtful consideration of the evolving protocols in the PMI Cohort Program and the central importance of participants as research partners. The PMI Cohort Program IRB will include significant representation by members of the public and representatives of the participant community.”  This IRB will be established at the NIH and is expected to be able to carry out thorough and timely reviews.
  29. Will the PMI provide the IC & protocol that consents the patient to participate in the PMI?
    It is anticipated that the brief enrollment protocol will be finalized by the Steering Committee, and should happen relatively quickly. The protocol will need to be agreed upon prior to participant accrual.
  30. Does the proscribed Informed consent require a digital signature or a face to face informed consent process?
    Under the “Resource Sharing Plan” in the Research Strategy section, it states: “A standardized and centralized electronic consent protocol should be used with all PMI Cohort Program participants to ensure consistency, minimize organizational burden, and maximize participant recruitment.”
  31. Will there be a proscribed message for web portals? Or will everyone make their own?
    Applicants are expected to work with awardees of the Communication Support for the Precision Medicine Initiative® Research Programs at NIH (OTA)* as well as with other members of the PMI Cohort program to coordinate messaging for the program.
  32. Are the HPOs required to build a consent portal and process?
    As stated in the Coordinating Center RFA, the Data Core will “Develop and implement methods to acquire and store participant consent and preferences for specific PMI Cohort Program activities such as self-report measures, clinical data, biospecimens, and return of results.  In addition, under RFA-PM-16-003, it states: “PMI Cohort Program Mobile Application. The PMI Cohort Program smartphone app is envisioned as a core component of the PMI Cohort Program, serving four critical functions: 1) facilitate online enrollment and consent, especially of direct volunteers, but also for HPOs needing additional technology support to enroll and consent; 2) collect data, both from active engagement (e.g., baseline and longitudinal surveys, prompted self-report) and from passive sensor technologies in the phone (e.g., location, movement); 3) provide “Sync for Science” (S4S) enhancements to Blue Button Download-View-Transmit functionality that enables participants to acquire, view, and annotate their clinical data from multiple providers, and transmit it to the PMI Cohort Program CC; and 4) serve as the communication conduit between the PMI Cohort Program and participants, providing regular updates, prompts, and feedback to sustain engagement and ensure complete data collection.”
  33. Could the exam be performed by a Walgreens or other telemed program?
    For the direct volunteers there is currently an RFI on the street to identify appropriate ways to conduct exams.  It is expected that the HPO will perform the exams through their own infrastructure.
  34. Can the exam have already been performed by a physician in the past (up to 12 months previous to blood draw)?
    The applicant may propose to include an exam that was conducted within the last few months (and should provide specific parameters), but final decisions on protocol, content, and timing will be decided at the Steering Committee level within the PMI Cohort Program Governance Structure.
  35.  Can the NIH provide further clarification of the enrollment centers scope of work in year 5?
    The enrollment centers should continue to enroll participants, and carry out other activities as described in the RFA in year 5. The bullet in Section IV.2.3.B “Plans to continue enrolling and consenting at least 35,000 study participants from diverse populations in each of years 2-4 (enrollment numbers proposed in the application should be well justified) and fostering study participant retention, data collection, and continued engagement in the PMI Cohort Program (see bullets under section “3).A. UG3 Phase” above)” should refer to years 2-5.
  36. Will the hotline for patients to enter into the study be provided by the Coordinating Center and then they will delegate participates to an Enrollment Center or does each Enrollment Center need to provide a local hotline/call-in center?
    The Coordinating Center is responsible for managing Direct Volunteer recruitment, including providing a toll-free help desk number for Direct Volunteer customer support. The Coordinating center will not delegate participants to an HPO Enrollment Center. The HPO Enrollment Centers are responsible for the infrastructure needed to recruit and enroll participants within their healthcare provider organization.
  37. Do Enrollment Centers need to include local advertising funds for mass mailings, Radio/TV advertisement or local/institutional advertising?
    The HPO Enrollment Centers are responsible for the infrastructure needed to recruit and enroll participants within their healthcare provider organization, and are expected to coordinate these efforts with the steering committee within the governance structure of the PMI Cohort Program. If local advertising is needed to meet recruitment target implementation, then the HPO Enrollment Center should budget for it.
  38. Does each enrollment site will have access to their own local dataset for additional ancillary studies?
    As outlined on page 34-35 of The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine, “A key factor to the success of building the PMI cohort will be effective partnership with HPOs.”  One of the recommendations from the ACD Working Group report is that: “The PMI –Cohort Program should share PMI cohort-generated research data with participating healthcare provider organizations that are providing ongoing data and biospecimens to the PMI cohort, according to participant preferences.”  Details of this framework will need to be evaluated and vetted through the PMI Cohort Program Steering Committee and Governance Structure.
  39. If an Enrollment Center includes multiple institutions, will it be the responsibility of each Enrollment Center to manage their site locations (i.e. IRB management, enrollment reports, monitoring of baseline assessments, training, and/or study initiations)?
    The PD/PI assumes responsibility for the entire project, even if it spans multiple institutions.  Multiple PI/PDs are allowed, and a leadership plan must be submitted.  For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
  40. Do the enrolling sites have the ability to be part of the central IRB?
    While recommendations for IRB membership may be solicited from the broad research community including organizations or institutions that are conducting PMI research, the NIH Institutional Official will appoint IRB members.
  41. Should the application include a 5-year detailed budget for both the UG3 Year 1 development phase and a detailed budget for the UH3 full implementation phase (Years 2-5)?
    To be considered responsive, an application submitted to RFA-PM-16-002 requires a scientific and budget plan for both UG3 and UH3 phase activities. At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 Demonstration Project implementation phase. UH3 transition requests will undergo an administrative review to determine whether the milestones have been met. Scientifically justified changes to the budget, reflected in revised budget justification documents as applicable, may be submitted for administrative review consideration at that time.
  42. Will appendices be accepted for data related to our population?
    Appendices are allowed for these applications. Do not use the appendix to circumvent the page limits of the research Strategy or any other section of the application for which a page limit applies. Please refer to instructions on appendix in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/funding/424/sf424_rr_guide_general_verc.pdf.

    For additional information regarding Appendix material and page limits, please refer to the NIH Guide Notice NOT-OD-11-080, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-080.html.

  43. Will the NIH make arrangements to add CMS electronic health records data without requiring any of the individual HPO applicants to arrange to obtain the data from CMS?
    As outlined in the research strategy section for the Data Core of the PMI Cohort Program Coordinating Center (RFA-PM-16-001), the Coordinating Center is responsible for  how data will be curated, including “Approaches to retrieval of medical claims data from CMS, insurers and other sources, to use along with participant EHR data, and other PMI Cohort Program core data elements.” The HPOs are not required to do this activity.
  44. For multi-site applications, are individual sites required to combine curated EHR data for transfer or do each site directly interact with the PMI Data Core?
    As noted in the RFA, applicants should develop a pipeline to provide a set of structured clinical data from study participants to the Coordinating Center, and should include plans to curate EHR data locally- translate and reformat heterogeneous clinical data to a high quality research resource- before delivery to the Coordinating Center. The applicant should propose an approach and budget for the approach that they consider most viable for meeting these goals for data transfer from multiple sites.
  45. Besides monitoring participant enrollment and retention, should there be any other analytics performed in the Enrollment Centers? 
    Participants should perform any analytics needed to reach the goals of the HPO, including curating their EHR data locally before delivery to the Coordinating Center, and working jointly with the Coordinating Center and HPOs to build additional capacity to enhance research generated through the PMI Cohort Program.  The Research Support Core will serve as an initial point of contact for users of all levels of sophistication, including citizen scientists, study participants and academic researchers, to design and implement studies using the PMI Cohort Program datasets.
  46. Since there is a component of return results, is there a requirement for upfront genetic counseling for potential findings at enrollment/biospecimens collection?
    A committee that includes substantial representation from the participant community will be established to advise the NIH Office of the PMI Cohort Program about the development and implementation of policies related to the return of aggregate and individual results to participants. The applicant should propose an approach and budget for the approach that they consider most viable for addressing return of results in their HPO setting. The PMI Cohort Program is committed to providing participants with access to their information according to their preferences. The form, content, and reasonable timing of providing access to those results will be determined by the Governance Structure of the NIH PMI Cohort Program.
  47. Is it the expectation of the NIH that enrollment centers will enroll both healthy participants as well as participants with previous diagnoses for those diseases?
    As per the RFA-PM-16-002 purpose and objectives section: “Individuals enrolled through HPOs should typically be invited to participate regardless of disease status and should represent all life stages."
  48. Does the NIH expect that enrollment centers will play a role in participant engagement and return of results beyond recruitment and enrollment or will these activities be centrally determined?
    As noted in the “Participant Engagement Plan” section of the RFA, “Applicants must detail specific plans for partnering with PMI Cohort Program participants and their advocates in the governance, design, conduct, oversight, dissemination, and evaluation activities”.
  49. Into what types of tubes will the blood be drawn? How many tubes?
    As noted in the application:  While the precise configuration of the kits will be determined after award, at this time it is anticipated that kits will include the following 13x100 blood collection tubes: 2 EDTA, one plasma separator, one serum separator, and one ACD, as well as one 13x75 EDTA blood collection tube. Applicants should propose the tubes they think are most appropriate for the required tasks. Applicants are expected to propose an aliquoting scheme.
  50. Will the Coordinating Center require daily shipments of blood samples (presumably on ice packs), or batched shipping according to a pre-defined schedule?
    Final decisions about shipment schedules will be agreed upon through the steering committee within the governance structure. The applicant should propose an approach and budget they consider most viable for the coordination of data shipments in collaboration with the Biobank and CC.
  51. Can you please address what happens between two separate institutions in terms of grant funding "credit"?
    Both PI's receive credit for the award but one PI needs to be selected as the contact PI and they are the Recipient shown in the system. Multi-PI applicants should develop research plan and budget that is appropriate for the respective PI responsibilities. Both recipient institutions and PI's are responsible for performance and compliance after awards are made. We recommend your consult with the business offices of your respective institutions.
  52. Will one kit be for one participant, or is this just the amount of supplies that come per kit (i.e. 2 EDTA, one plasma separator, one serum separator, and one ACD, as well as one 13x75 EDTA blood collection tube)?
    When established, the Steering Committee will develop and approve the final protocol for biospecimen collection, including content and distribution of the kits. As guidance for what might be needed per subject, refer to the Biobank FOA on information on supplies included in a kit for one participant: “While the precise configuration of the kits will be determined after award, at this time it is anticipated that kits will include the following 13x100 blood collection tubes: 2 EDTA, one plasma separator, one serum separator, and one ACD, as well as one 13x75 EDTA blood collection tube. In addition, the kit will include collection materials for up to 10mls of urine, along with packing and shipping materials."
  53. Should enrollment sites budget for database development or will this be provided by the Coordinating Center (i.e. will funding will be supplied by PMI or are sites are expected to cover this themselves)?
    Sites should budget for database development as needed to achieve the activities proposed in their research strategy and to interface with the activities of the Coordinating Center.
  54. Will the PMI Cohort Program Biobank be able to accept blood samples from the PMI Cohort Program Enrollment Centers between July 2016 to January 2017 (end of pilot phase)?
    It is anticipated that the biobank will be able to accept bulk shipments of blood samples collected from the PMI Cohort Program Enrollment Centers starting as early as August 2016.
  55. Will the costs of DNA processing be borne by the central Biobank or by the PMI Cohort Program Enrollment Centers?
    The HPO will be responsible for costs of processing the biospecimens to create aliquots of plasma, serum, and other biosamples and sending them to the PMI Cohort Program designated Biobank. The Biobank will be responsible for any additional sample processing, including any DNA extraction, after the biospecimens are received at the Biobank.
  56. Will there be study recruitment outside of the Health Provider Organizations (HPOs)?
    In addition to the HPOs, we will also be recruiting Direct Volunteers through Precision Medicine Initiative®Cohort Program Direct Volunteers Pilot Studies (OTA)*  and later through the Precision Medicine Initiative® Cohort Program Coordinating Center (U2C). For more information on our plans for recruiting participants, you may want to review the recent presentation about the PMI Cohort Program given to the Advisory Council to the Director.
  57. Are there specific locations you would like to enroll/avoid enrollment of patients (i.e. primary care, specialty, ED, rehab,etc.)? Should our target enrollment focus on the population that is seen in our specific healthcare system?
    As described in the research strategy, applicants may “Describe how overall enrollment data will be gathered, including for specific populations including families, children, difficult to reach and underserved populations.” For more information, please reference PMI Working Group Report, and the RFA-PM-16-002 purpose and objectives section, where it states: “Individuals enrolled through HPOs should typically be invited to participate regardless of disease status and should represent all life stages."
  58. Is the NIH envisioning a system in which the Coordinating Center or Steering Committee will define enrollment targets based on demographics and clinical characteristics?
    We envision a program that welcomes anyone in the U.S. to volunteer and to be part of a cohort reflecting America’s rich diversity. Both direct volunteer and HPO enrollment will be closely monitored and the PMI Cohort Program Steering Committee and Governance Structure may, if needed, implement additional strategies to ensure the diversity of representation.
  59. Will DNA samples be returned by the PMI Cohort Program Biobank after processing to the contributing PMI Cohort Program HPO?
    DNA samples will not be returned to the PMI Cohort Program HPOs.
  60. Should HPOs plan on saliva biospecimen collections in phase 1 and blood and urine collections in phase 2?
    Phase 1 and Phase 2 refer to stages for the Biobank, see FAQ in the Biobank section about collection in those phases. HPOs have a UG3 and UH3 phases. As stated in the RFA “Collection of biospecimens to be determined by the PMI Cohort Program (e.g., blood, saliva, and urine samples)”. To clarify, this means final decisions on protocols for biospecimen collection, including the timing and specific specimens to collect will be determined by the PMI Cohort Program Steering Committee and Governance Structure.  For their applications, HPOs may propose a protocol for biospecimen collection and processing that they feel is reasonable for the UG3 and UH3 phases.
  61. In budgeting for the HPO Enrollment Centers application, are sites allowed to include costs for Administrative Support, given the administrative magnitude and managerial expertise needed for this proposal?
    Applicants should review the section on direct charging salaries of administrative and clerical staff (section 8.1.1.6) of the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/index.htm

    The salaries of administrative and clerical staff should normally be treated as indirect (F&A) costs. Direct charging of these costs may be appropriate only if all of the following conditions are met:

    1. Administrative or clerical services are integral to a project or activity;
    2. Individuals involved can be specifically identified with the project or activity;
    3. Such costs are explicitly included in the budget; and
    4. The costs are not also recovered as indirect costs.

    Such charges must also meet the criteria for allowable costs described in 45 CFR 75.403.

  62. Will the PMI Cohort Program have technologies for the HPOs to input data into in the first year of enrollment?
    When established, the PMI Cohort Program Steering Committee and Governance Structure will develop and approve the final protocol for data collection. The Participant Technologies Center and Coordinating Center will be informed by work during the Direct Volunteers Pilot Studies OT-PM-16-001, and are expected to have technologies to input data in the first year of enrollment. The HPOs may also be able to leverage the Direct Volunteers Pilot Studies tools for registration/consent/baseline survey data etc., prior to full Participant Technologies Center functionality.

Specific to: Cohort Program Participant Technologies Center (U24) RFA-PM-16-003

  1. Are applications focused on technology that allows for data capture and organization to aid in patients decision making, responsive to the Precision Medicine Initiative Cohort Program Participant Technologies Center?
    There are four main goals of the PTC:
    • “Develop, test, maintain, and upgrade PMI Cohort Program mobile applications and associated server systems that will provide enrollment, consent, data collection, and communication and feedback functions in a secure environment.
    • Provide parallel platforms to deliver these functions to those without a smartphone (e.g., feature phones, website), closely coordinating these efforts with data acquisition systems of the Coordinating Center (CC) and the participating healthcare provider organizations (HPOs).
    • Assist the CC in data acquisition and management of the data generated from a wide array of potential participant technologies.
    • Work with various technology entities on behalf of the PMI Cohort Program to increase smartphone accessibility of participants, obtain passive sensor technologies for selected participants, and extract meaningful and interoperable data from technologies that participants currently use.”

    It is recommended that you review the other FOAs for the PMI Cohort Program to gain the bigger picture of the full implementation phase of the Cohort Program and how the various components are expected to interact.

  2. Will the Coordinating Center be responsible for providing data access to the Technology Center or is the TC required to budget for data access?
    Applicants to RFA-PM-16-003 are encouraged to propose systems architecture, data models and system interactions required to support the functional requirements outlined within the RFA.  The specifics will not be clear until the awards are in place and the steering committee is established.  We expect that these types of decisions will be vetted and finalized through the governance structure. For the purposes of the cooperative agreement application, applicants may propose scenarios such that the PTC will store the data it collects long enough to provide feedback to the participants, but that if trend data are included/warranted, the CC might be the permanent place for long-term storage and retrieval. Alternatively, the CC may receive data directly with data systems designed to support dynamic interaction with PTC systems. The applicant should propose an approach and budget for the approach that they consider most viable for the coordination of data in collaboration with the CC.
  3. Can we propose development, release, and funding of pilot opportunities to extend capabilities and address gaps?
    Applicants may propose pilot opportunities if they feel that will help achieve the goals of the RFA. As with other activities, such opportunities should be justified and budgeted for within the application.
  4. Would creating a Participant Technologies Center research/advisory panel be duplicative with the PMI Steering Committee or Working Groups?
    There will be an overarching advisory panel for the PMI Cohort Program. However, applicants may propose additional panels they think are necessary to achieve the goals of the RFA, and the larger PMI Cohort program. In order to minimize potential conflicts during the review process, applicants should outline the type of expertise they would put on such a panel, they should not name or ask specific people to serve on these panels prior to award. Once the awards are made, final decisions about needed advisors and stakeholder representation for the various components will be agreed upon through the steering committee within the governance structure.
  5. If a Participant Technologies Center research/advisory panel is proposed, should names of community representatives be included?
    In order to minimize potential conflicts during the review process, applicants should outline the type of expertise they would put on such a panel, they should not name or ask specific people to serve on these panels prior to award.
  6. Will wearable devices be provided to the participants via the technology core?
    PMI Cohort Program Mobile Application. The PMI Cohort Program smartphone app is envisioned as a core component of the PMI Cohort Program, serving four critical functions: 1) facilitate online enrollment and consent, especially of direct volunteers, but also for HPOs needing additional technology support to enroll and consent; 2) collect data, both from active engagement (e.g., baseline and longitudinal surveys, prompted self-report) and from passive sensor technologies in the phone (e.g., location, movement); 3) provide “Sync for Science” (S4S) enhancements to Blue Button Download-View-Transmit functionality that enables participants to acquire, view, and annotate their clinical data from multiple providers, and transmit it to the PMI Cohort Program CC; and 4) serve as the communication conduit between the PMI Cohort Program and participants, providing regular updates, prompts, and feedback to sustain engagement and ensure complete data collection.

    Alternate Technology Modality. Smartphones are envisioned as the core participant technology for the PMI Cohort Program, but it is assumed that unless and until smartphones are made available to all participants, there will be a need to provide as many of the core functions as possible via feature phones and other communication technologies. Therefore, the PTC is expected to develop and maintain a responsive PMI Cohort Program website as an alternative means for cohort enrollment, survey administration, email prompts, and PMI Cohort Program communications to participants. The PTC also is expected to develop as many of smartphone app functions as possible that can be delivered via feature phone (e.g., text messaging for surveys, prompts).

  7. Should HPO awardees refer their patients to the PMI web site/portal for information, surveys, and consent?
    The website will be the focus of an initial pilot phase, with a goal of “An informational website and potentially other materials which, through extensive experimentation and testing, will be used to help identify the best communications and approaches to encourage volunteers to become participants.”  During the full implementation phase,, the website will be the responsibility of the Coordinating Center and the Participant Technologies Center. All awardees under the PMI Cohort Program Consortium are expected to coordinate all activities through the Steering Committee and the Governance Structure.  Please also review the PI/PD primary responsibilities outlined in Section VI.2 “Cooperative Agreement Terms and Conditions of Award.”

Specific to: Cohort Program Biobank (U24) RFA-PM-16-004

  1. Can the NIH advise on what kind of biosample technology platforms and assays would be helpful to the PMI Cohort Program?
    The specific products used in biospecimen analyses are not yet determined, and we do not anticipate making decisions about specific analytic methods to be used until later in the development of the program.
  2. Would an application where a subcontracted organization performs most of the work and the prime organization receives a minority percentage of funding be acceptable?
    There is no restriction on the structure of the award.  You may want to also consider the multiple PI/PD structure, see section III.1: “For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.”

    Please also note that the NIH Grants Policy Statement, http://grants.nih.gov/grants/policy/nihgps/HTML5/section_15/15.1_general.htm?Highlight=conduit states that “the prime recipient must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. This includes being able to provide appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.”

  3. Are applicants expected to propose a project that achieves all 3—i.e., Phase 1, Phase 2a, and Phase 2b—within the first 5-year period?
    Yes. Applicants are expected to achieve all phases within the 5 year period.
  4.  How or by whom would blood be drawn?
    This aspect of the biospecimen collections is being considered through an RFI, as the program considers the best approaches for these activities.
  5. Should applicants propose their own solutions for how, when, where, and by whom the blood samples will be obtained from PMI-CP participants?
    No, the Biobank applicant is requested to propose a solution to the tasks outlined.  The how, when, and by whom the blood samples will be obtained is the focus of other efforts (see also RFA-PM-16-001).
  6. For sites that have biobanking protocols already, will a combined consent be considered?
    The PMI Cohort Program consent and process will be established in the Steering Committee within the overarching Governance Structure.
  7. Is the NIH planning for the full biospecimen collection phase to last for 16 years?
    It is expected that the PMI Cohort Program will reach 1 Million volunteers in year 4; however, biospecimen collections may lag after enrollment.
  8. Will cryopreserved lymphocytes be collected or just non-cryopreserved buffy coats (lymphocytes)?
    Applicants may propose options available as well as limitations for long-term storage of lymphocytes for future use.
  9. Could you please help clarify how the details of NOT-PM-002  affects the requirements outlined in RFA-PM-16-004?
    Applicants submitting a proposal to the PMI Biobank RFA should provide a response to the requirements outlined in the RFA as stated in the “Purpose and Objectives of the PMI Cohort Program Biobank” section.  The purpose of the NOT-PM-16-002, “is to solicit input on identifying or establishing a system(s) for conducting a physical evaluation and collecting biospecimens from Direct Volunteers for the Precision Medicine Initiative® (PMI) Cohort Program.”

    Some of the activities described in NOT-PM-16-002, such as providing kits and processing samples, are requirements for the PMI Biobank, and the applicant should include a plan for those activities in the proposal.  However, other activities, such as physical evaluation and sample collection, are outside the requirements of the RFA and should not be included a proposal in response to the RFA.  All individuals and organizations are welcome to provide responses to NOT-PM-16-002.

  10. Does study "enrollment" include: a) agreeing to join, b) completing the baseline exam, c) providing a biospecimen, or d) some combination of those?
    In order to be part of the PMI Cohort Program, all volunteers must consent to join the Cohort Program and to be contacted for future studies. They must provide a biospecimen, complete a baseline exam and complete an enrollment survey. If they have EHR data they must agree to share it; however, EHR data is not required to be a PMI Direct Volunteer.  HPOs must share core data elements from the EHR to the PMI cohort for each enrolled participant. Per The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine, p. 33 – “Each of these requirements must be met for each participant in order for them to be considered enrolled in the PMI cohort …
  11. Who will be responsible for the cost of shipping the phase 1 kits (saliva) back to the biobank?
    The PMI Biobank will pay for shipping for the phase 1 kits (saliva.)  
  12. Will the phase 2 blood/urine collections begin in January 2017 or June 2017?
    As outlined in the Structure of the PMI Cohort Program, transition to the full implementation phase is expected in approximately January 2017, and transition for the Biobank to phase 2(a) is expected at that time. The HPO RFA sites are each expected to recruit at least 10,000 participants in year 1 (UG3) phase, combined with the Direct Volunteers there will be a substantive number of participants enrolled in the program at the time of this transition.
  13. Will purchase of equipment required to perform the work outlined for the Biobank (robotic liquid handlers, DNA extractors, robotic sorters) be allowed on the budget?

    Capital expenditures for special purpose equipment are allowable as direct costs, provided that items with a unit cost of $5,000 or more have the prior written approval of the HHS NIH awarding agency or pass-through entity. http://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.9_allowability_of_costs_activities.htm#Equipment

  14. For the Oragene Saliva kit, there are two options – FDA approved kit or Research kit. Will there be a requirement for the FDA approved kit?
    Final decisions about any requirements will be agreed upon through the steering committee within the governance structure. Applicants should propose the kits they think are most appropriate for the required tasks.
  15. Will CAP certification of the laboratory be sufficient to be compliant with CLIA procedures for the Biobank?
    Applicants must “meet the applicable requirements of the Clinical Laboratory Improvement Amendments (CLIA), using processes consistent with CLIA for all steps of biospecimen handling and laboratory tests.”   CLIA certification is a CMS function.  For information on CAP and CLIA, as well as other accreditations, please access the following CMS resource: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/howobtaincliacertificate.pdf. Further questions should be addressed to CMS, and a contact for questions about CLIA made be found in the PDF linked to here.
  16. The National Direct Volunteer Physical Evaluation and Biospecimen Collection Request for Information (NOT-PM-16-002) states “the blood specimens will require prompt separation into plasma and serum.” Can the NIH please define prompt and also provide a list of the types of tests to be performed on these collections?
    The expectation is that collected vacutainers will be centrifuged at the collection site, or shortly after collection, and that plasma or serum will be drawn off and stored within 36 hours.

    At this time, the types of tests have not been determined. However, we anticipate that fresh blood samples will be assayed for hemoglobin and blood counts and that the stored blood and urine samples will eventually be tested for analytes similar to those being assayed by UK Biobank (see http://www.ukbiobank.ac.uk/wp-content/uploads/2013/11/BCM023_ukb_biomarker_panel_website_v1.0-Aug-2015.pdf).

  17. Is it correct that in addition to the 10,000 participants enrolled in the pilot phase 1 (June 2016-January 2017), each collection site (x7) will enroll 10,000 participants January-June 2017 (year 1), each collection site (x7) will enroll 35,000 participants each year in years 2-4, and 60,000 volunteers will be enrolled each year in years 2-4?

    Your interpretation is a fair first approximation, however there are a number of factors that will impact the numbers. You’ve correctly specified the minimum enrollment for years 1-4 for individual HPOs funded under (http://grants.nih.gov/grants/guide/rfa-files/RFA-PM-16-002.html) , however enrollment centers should continue to enroll participants, and carry out other activities as described in the RFA in year 5. As stated in the RFA, NIH will fund up to 7 awards, but may fund fewer. Further some awardees may not successfully transition from the UG3 to the UH3 phase. We do anticipate that volunteers will be enrolled in year 1.  CC applicants should provide an enrollment plan with a timeline and milestones for direct volunteers, which will determine the exact number of volunteers enrolled in year 1 (for phase 2 of the Biobank). Recruitment by additional sources, such as Federally Qualified Health Centers (FQHCs), is also being considered.  Applicants may want to review the recent presentation about the PMI Cohort Program given to the Advisory Council to the Director.

  18. Are there any restrictions on the central biobank being able to perform laboratory assays for the PMI cohort in the future?
    There are no restrictions for biobank awardees to submit applications for future calls for laboratory testing.
  19. The timeframe for phases 2(a) and 2(b) of the implementation phase is unclear. Will the implementation of the lab automation be left up to the discretion of the biobank or are there definite timelines for the lab automation implementation?
    Applicants should propose timelines and milestones for the transition from phase 2(a) to 2(b) that they think are most appropriate to meet the goals of the biobank RFA and the overall PMI Cohort Program. Final decisions on the timing of the transition will be established in the Steering Committee within the overarching Governance Structure.
  20. Since the tube diameter 13X100 can be either a 6 ml tube or a 7 ml tube, we were wondering what the exact volume of the blood tubes need to be?
    Applicants should propose and justify the tubes and volume amounts they feel are most appropriate for the task and for the goals of the PMI Cohort Program.
  21. What type of anticoagulant should the "plasma separator tube" be? (EDTA, sodium citrate, sodium heparin, etc...)?
    Applicants should propose and justify the type of anticoagulant they think is most appropriate for the task and for the goals of the PMI Cohort Program.
  22. Is there only a maximum of up to 35 vials that can be used in the storage scheme or can we propose alternate aliquoting schemes as long as we do not exceed the budget caps?
    Applicants should propose and justify the volume amount they think is most appropriate for the task and for the goals of the PMI Cohort Program.
  23. Will the biobank be responsible for tracking and storing consents, or is this the function of the coordinating center?
    The Coordinating Center will be responsible for tracking, storing and updating consents. As stated in the RFA, it states: “working closely with the Coordinating Center to use Research Unique Identifiers (RUIDs) for linking the biospecimens with the metadata associated with the samples located at the CC.”
  24. Does the Biobank need to cover these holidays as well or is it okay to account for shipping over the weekends and other non-Federal holidays?
    As noted in the RFA: “It is expected that samples will be received within 24 hours of collection, 6 days a week. Therefore, the Biobank must describe a plan to coordinate shipping and to receive samples to accommodate this requirement, including on weekends and holidays, if necessary.” Applicants should propose and justify a plan that addresses how they will best handle this requirement.
  25. Is the initial centrifugation of the serum and plasma separator tubes is going to be done in the field?
    Final considerations and protocols will be developed and finalized through the PMI Cohort Program Steering Committee Governance structure. The plasma and serum separator tubes are intended to be spun at the collection site and then shipped to a laboratory that will be designated for processing. For budgetary purposes, applicants should provide additional plans for centrifugation they feel is reasonable.
  26. What is the total number of kits the biobank should expect to provide and receive?

    As stated in RFA-PM-16-004, "During the full implementation phase, the Biobank will receive a full set of biospecimens from up to one million individuals and, in some cases, providing kits for sample collection and receipt."  The RFA later states that "it is anticipated that up to 60,000 kits will need to be provided each year of the full implementation phase." 

    The Biobank should budget to receive a full set of biospecimens from up to one million individuals, and budget to provide up to 60,000 kits per year. When established, the PMI Cohort Program Steering Committee and Governance Structure will develop and approve the final protocol for biospecimen collection, including content and distribution of the kits.

  27. Are the 60,000 kits per year bulk shipments of kits to clinical sites to collect 1,000,000 participant biospecimens?
    The 60,000 kits per year are to collect 60,000 participants’ biospecimens. Additional samples will come from bulk shipments, as well as from any other recruitment and enrollment processes developed during the PMI Cohort Program. Applicants should note that final decisions of biospecimen collection, aliquoting and shipping will be developed by the PMI Cohort Program Steering Committee and Governance Structure.
  28. Will there be a phase 1 sample collection of saliva only that will be followed by a phase 2 sample collection of blood (and urine)?
    The final protocol for biospecimen collection will be determined by the PMI Cohort Program Steering Committee and Governance Structure. As specified in the Biobank RFA: “The pilot phase is expected to start in early 2016 and extend through approximately January 2017, followed by transition to the full implementation phase.” During the pilot phase, the PMI Cohort Program Biobank will collect and receive saliva samples from at least 10,000 participants. During the full implementation phase, the Biobank will receive a full set of biospecimens from up to one million individuals.
  29. For the purpose of budget development how many individual aliquots should the applicant assume will need to be performed?
    As noted in the RFA: “The aliquoting scheme will be finalized after award, but is anticipated to yield a total of approximately 35, 1 to 2ml cryovials per participant, including aliquots of plasma, serum, urine, red blood cells, DNA, and buffy coats. Applicants are expected to propose an aliquoting scheme.” For the purpose of budget development, applicants should budget for aliquoting of the 60,000 kits per year.  Applicants should budget for storage and retrieval from up to 1 million participants. Applicants should note that final decisions of biospecimen collection, aliquoting and shipping will be developed by the PMI Cohort Program Steering Committee and Governance Structure.
  30. Are letters of support required for the PMI Cohort Program Biobank proposal?
    Letters of support are allowed for the PMI Cohort Program Biobank proposal. See instructions in http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf (page I-140, Filed Name 12. Letters of Support (e.g. Consultants).  Letters should be limited to those named in the application (e.g., collaborators, senior/key personnel and other significant contributors), or otherwise documenting a substantive contribution to the scientific development or execution of the project. Letters from people who are not making substantive contribution to the project creates conflicts and makes the review of applications significantly more difficult.

This page last reviewed on March 24, 2016