BAA-N01DA-15-4422__Amendment_2.pdf

“NIH Pain Consortium Centers of Excellence in Pain Education”

AMENDMENT OF SOLICITATION NO.: BAA-N01DA-15-4422

AMENDMENT NO.: 02

EFFECTIVE DATE: May 14, 2014

DUE DATE: June 16, 2014 3:00 PM EDT (Unchanged)

ISSUED BY:

National Institute on Drug Abuse, NIH

Office of Acquisitions

NIDA R&D Contracts Management Branch

6001 Executive Boulevard Suite 4211 MSC 9559

Bethesda, Maryland 20892-9559

Point of Contact: Brian H. O’Laughlin, Contracting Officer (Email:olaughlinb@nida.nih.gov)

Kara Anderson, Contract Specialist (Email: kara.anderson@nih.gov)

Ryan C. Cleary, Contract Specialist (Email: clearyrc@mail.nih.gov)

NAME AND ADDRESS OF CONTRACTOR: To All Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of Offers is NOT extended. Offerors must acknowledge receipt of this amendment on each copy of the offer submitted. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO

THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

All other terms and conditions of the BAA remain unchanged.

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

PURPOSE: To amend the BAA to extend the question period, amend Attachment 18 and to clarify the BAA requirements by responding to questions submitted under the BAA. Unless specifically noted, all specifications remain unchanged.

PART I. The BAA is amended as follows:

The period for offerors to ask questions has been extended to May 23, 2014; questions must be received by 3:00 P.M. EDT by the NIDA R&D Contracts Management Branch.

Broad Agency Announcement Amendment 2

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Attachment 18 - BAA Instructions and NIDA Research Interests, Section D - NIDA Research

Interest, Subsection 5 - Key Requirements is amended below.

The Content Package must be about 50-100 pages of materials (for proposals purposes each case should be 50 to 70 pages in length) and include enough content to serve in the development of at least 1 hour of course work (the “seat time” for the modules will be 45 minutes to 1 hour). Each Scenario will represent a particular clinical pain situation and its treatment and resolution. All Scenarios must include 10-20 minutes of video instruction/demonstration. Video didactic lessons do not fulfill the requirement, but may be included. The Content Package must be in PowerPoint, or another similar format.

PART II. The following responds to questions received under this solicitation.

QUESTION 1: Is the CoEPE funding going to be done through a grant or a contract?

ANSWER 1: Contract. The funding will be provided through a severable service, level of effort contract. The term of the contract will be a base period of one year and four one year options. There also will be the potential for additional option quantities.

QUESTION 2: Is there a form that should be used for our proposal, providing formatting and suggested page numbers?

ANSWER 2: There is no form that should be used for the proposal, details concerning how the proposals are should be structured are in Section L of the BAA (PDF Pages 46-82).

Additionally, there is no page limit on the proposals submitted under the BAA. The length of the proposals is determined by the business judgment of the offerors.

QUESTION 3: My institution is a current CoEPE. May work partially funded/completed be proposed within the Statement of Work for completion/improvement?

ANSWER 3: Offerors are free to propose how best to respond to the BAA. No duplicate effort can be doubled funded, and offerors can’t charge for completed/pending work.

QUESTION 4: Is this solicitation open to contractors outside the NIH Pain Consortium Centers of Excellence or restricted to the Centers?

ANSWER 4: The BAA is open to all offerors. Offerors do not currently have to be a

CoEPE.

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QUESTION 5: Are contractors required to have an existing relationship with one of the Centers?

ANSWER 5: No.

QUESTION 6: In Part III, Section J – List of Attachments, there are several attachments that say, "SEE ATTACHED" under the location column. However, it's not clear where these are actually attached.

ANSWER 6: The attachments are at the end of the BAA (PDF Pages 87-146). Links to the attachments are found in Section J (PDF Pages 43-44).

QUESTION 7: The links to the attachments do not work for me. How can I access the documents?

ANSWER 7: If you are having trouble accessing the links in Section J, a quick internet search adding “NIH” to the name of the document you are trying to obtain should lead you to a site where the document can be accessed. We attached the links in hard copy to assist with the link issues.

QUESTION 8: What guarantee do we have that funding for the 4 "option" years will be available? What are the criteria to maintain funding? Will we be writing another contract proposal each year?

ANSWER 8: Option years are not guaranteed. Exercise of the option year is the exclusive right of the government and NIDA will factor in current NIDA funding, and continuing need for the services in deciding whether or not to exercise the option year. The costs and work outlined in the option years should be included in the proposal responding to the

BAA. If an offeror is awarded a contract under the BAA, they will not have to submit additional proposals for the option years.

QUESTION 9: I didn’t submit a Proposal Intent. Does this disqualify us from submitting a proposal?

ANSWER 9: An offeror is not disqualified from submitting a proposal if the offeror has not submitted a Proposal Intent.

QUESTION 10: I didn’t submit a Proposal Intent on time. May I still submit a Proposal Intent?

ANSWER 10: Yes, an offeror may submit a Proposal Intent after the due date for Proposal

Intents.

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QUESTION 11: Do we need to build into our budget the travel costs for meetings regarding this project?

ANSWER 11: There are no requirement for meetings under the BAA. If the offeror plans to travel to meet with NIDA staff than those costs must be included in the proposed budget.

QUESTION 12: May there be more than one named Director / PI, or is the use of a Multiple

PI/PD structure allowed?

ANSWER 12: It is up to the business judgment of the offerors on how best to respond to the BAA.

QUESTION 13: Article H.22 says that as a recipient of federal funding, we are required to hold an annual education program about the US Constitution on September 17, is that correct?

ANSWER 13: Yes. Article H.22 states “Each educational institution that receives Federal funds for a fiscal year shall hold an educational program on the United States Constitution on September 17 of such year for the students serviced by the educational institution in accordance with Public Law 108-447.” Only offerors who are education institutions need to comply with this requirement. Many education institutions already hold constitution education programs on September 17 th

. If you are not sure if your institution holds an even, check with the institutions administration.

QUESTION 14: In regards to submission of our Annual [financial] Report with the Business

Proposal – Currently our institution has yearly state audits. Would access/ links to the audit suffice?

ANSWER 14: Offerors should include any relevant audited financial report in their business proposal.

QUESTION 15: Can funds be used to pay an individual to coordinate the development of monthly reporting activities? Would such an individual need to be named in the proposal?

ANSWER 15: Yes, funds can be used to pay an individual to coordinate the development of monthly reporting activities. Offerors must include all individuals in the proposal who will be directly paid from the contract.

QUESTION 16: How does the budget need to be divided? E.g., would a CoEPE receive

$50,000 for one case module for one year, up to $100,000 if the CoEPE contracts to do two modules?

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ANSWER 16: The BAA anticipates a level of effort contract, not a completion contract.

The offeror is expected to expend 760 direct labor per year and will be paid according to the hours expended during the year. During the year the offeror is expected to complete at least one case module.

QUESTION 17: The first page of the announcement states that the estimated amount for the base year and for the option years to be $77,870. Is this amount inclusive of indirect costs or is this direct costs?

ANSWER 17: The $77,870 per year for the base and option years includes direct and indirect costs plus fee (if applicable). Additionally the $52,500 for the quantity options includes direct and indirect costs plus fee (if applicable).

QUESTION 18: The BAA states the base for Year 1 is $77,870, but also mentions $52,500 for each quantity option 1. What does this mean? Is there a maximum number of "quantity options" for each year? Could Year 1 actually be $77,870 + $52,500 (or even $77,870 + $105,000 if there are 2 quantity options)? What specifically is a quantity option?

ANSWER 18: There is one quantity option to add additional direct labor hours to the contract. For example, the additional hours could be used to create an additional case module for each exercise of Quantity Option 1. The government has the unilateral right to exercise Quantity Option 1 up to two times per year. Quantity options are not guaranteed.

Quantity Option 1 increases the level of effort under the contract by 481 direct labor hours each time it is exercised. For example if in the contract base year the government exercises the quantity option once the level of effort hours will increase from the base year of 760 by

481 to 1241 direct labor hours. If in the contract base year the government exercises the quantity option twice the level of effort hours will increase from the base year of 760 by 962

(481 x 2) to 1722 direct labor hours.

The exercise of Quantity Option 1 will also increase the contract amount by $52,500 each time it is exercised. For example if in the contract base year the government exercises the quantity option once the contract amount will increase from the base year of $77,870 by

$52,500 to $130,370. If in the contract base year the government exercises the quantity option twice the contract amount will increase from the base year of $77,870 by $105,000

($52,500 x 2) to $182,870.

Offerors should propose the costs of the quantity options separate from the base contract.

So offerors business proposals should include the a breakdown of total costs plus fee (if applicable) for the base period plus option years and a separate breakdown of Quantity

Option 1 for each potential contract year.

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QUESTION 19: Is there a maximum amount of fringe/benefits/indirect costs that can be charged by an institution?

ANSWER 19: Indirect costs will only be limited by the Indirect Rate agreements the offeror has negotiated with the Department of Health and Human Services Division of

Financial Accounting Services.

QUESTION 20: Regarding our F&A rate agreement, would this particular solicitation qualify for the instructional rate rather than the organizational rate?

ANSWER 20: NIDA reviews what offerors proposed to determine reasonableness of indirect rates. Determination of what indirect rates to propose are the business decisions of the offeror.

QUESTION 21: For Attachment 8: “Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet”: The budget template indicates “Direct Labor Cost” – should this be specified in dollars or person hours?

ANSWER 21: Offerors should include both the person hours and the corresponding direct labor cost specified in dollars.

QUESTION 22: In the solicitation it mentions (attachment 18) that we will be able to request salary using our standard request format of percentage of effort, but on page 48 it mentions that there is anticipated for the project 3800 direct labor hours (if both options and each contract year are awarded). Should we also convert the effort into hours for this purpose for the proposal stage, or is this something that can be done in the reporting after award?

ANSWER 22: Offerors can propose either in direct labor hours or percent of effort. If offerors use a percent of effort format than offerors should convert the anticipated direct labor hours to the equivalent percent of effort.

QUESTION 23: Is my university required to submit a "certified cost and pricing data" type of proposal, or are we exempt from this FAR requirement? If not exempt, how do we certify to be in compliance?

ANSWER 23: As there is expected adequate competition for this solicitation, offerors are exempt from providing certified cost and pricing data. Instead other than certified cost and pricing data will be used.

QUESTION 24: Our understanding is that the key personnel of each CoEPE are responsible for developing educational content for the modules only:

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a. Will the technological component be executed by a vendor (one designated by

NIH or one chosen by our team)?

b. Would the IT training requirement apply for the faculty who are contributing the content for the modules?

c. Are we required to conduct the Vulnerability Scanning?

d. Do the accessibility HHSAR terms outlined on Page 30 apply?

ANSWER 24: a. For a description of the responsibilities of the coordinating center see https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01DA-14-4423/listing.html.

b. Who will be required to take IT training will be determined in accordance with the approved IT Security Plan.

c. Yes, offerors will be required to conduct vulnerability scans.

d. Yes, the accessibility HSSAR terms apply.

QUESTION 25: Page 55 of the solicitation directs us to the following link regarding

“Information regarding background checks/badges”:

http://idbadge.nih.gov/background/index.asp This page describes how "The new HHS ID Badge, or Personal Identity Verification (PIV) card, will serve as the common government identification for all HHS agencies." Does this mean that contractors (if awarded) would be required to specifically have an NIH PIV card, or are we able to use our own institutions' identity card system, as long as it meets the requirements (i.e., (a) is issued based on sound criteria for verifying an individual employee's identity; (b) is strongly resistant to identity fraud, tampering, counterfeiting, and terrorist exploitation; (c) can be rapidly authenticated electronically; and (d) is issued only by providers whose reliability has been established by an official accreditation process.)? Are we to assume that if we will not be physically accessing an HHS-controlled facility then this item does not apply?

ANSWER 25: Correct, Contractors will not be physically accessing an HHS-Controlled facility so this will not apply.

QUESTION 26: Given that we are developing educational content only, can we assume that our contract will be considered Level 1: Non-Sensitive?

ANSWER 26: Yes. Article H.11 subarticle A.c. is marked Level 1: Non-Sensitive. (See also

Section L Subsection 2.a.15)

QUESTION 27: We’re not purchasing any software or property under our contract. Does the https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01DA-14-4423/listing.html http://idbadge.nih.gov/background/index.asp

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“HHS Section 508 Product Assessment Template” form still need to be completed, or would I just say “not applicable”?

ANSWER 27: The form still needs to be completed. If areas based on your approach are not applicable offerors should label as such.

QUESTION 28: In Attachment 6 (HHS Guide to Completing the Section 508 Evaluation

Template) of the BAA, are these “Supporting Features” and “Remarks/Explanations” to be delivered with the content? Or is this section to be completed after the finished, technologically formatted product is delivered?

ANSWER 28: Both the CoEPEs and the Coordinating Center should consider 508 compliance throughout the development process of the learning modules. The

Coordinating Center is responsible for making case scenarios and accompanying videos

508 compliant. It is the responsibility of the CoEPEs to make all other deliverables 508 compliant. Both the CoEPEs and the Coordinating Center will have to document their progress towards/achievement of 508 compliance in their annual 508 compliance reports.

QUESTION 29: Since the potential award amount will be less than $100,000 per year with duration of over 1 year, does the Section 508 template document need to be included?

ANWSER 29: Yes, you are required to submit the Section 508 template. There are no dollar threshold exemptions.

QUESTION 30: We have concerns regarding the numerous requirements and certifications required that deal with information technology (Security Plan, Risk Assessment Plan, Vulnerability Screenings, FISMA, etc.). We are particularly concerned with FISMA compliance and whether we will meet the criteria. Do we have a conversation with our IT department on campus, and will they be able to help with meeting compliance for the IT requirements or certify that our university is within compliance?

ANSWER 30: NIDA’s Information System Security Officer (ISSO) determined that this

FISMA does apply. We will review the proposed security plan to determine the plans acceptability. It is the business judgment of the offeror to determine how to respond.

QUESTION 31: In Attachment 13: This appears to be a reference sheet describing the System

Notices in place. How should this information be used or referenced in our proposal development?

ANSWER 31: Attachment 13 is intended to provide more information on the system of records that is applicable under the Privacy Act.

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QUESTION 32: Will some entity be involved in oversight of the work produced under this contract?

ANSWER 32: Yes. NIDA plans to fund a coordinating center for the CoEPEs under a separate contract (RFP N01DA-14-4423). The coordinating center will serve as a focal point coordinating activities between the CoEPEs.

QUESTION 33: We have found a discrepancy between the RFP for the Coordination Center

(N01DA-14-4423; see https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01DA-14-

4423/listing.html) and the individual CoEPEs (BAA N01DA-15-4422). In the Coordination

Centers RFP, Amendment 2, Question 12 posted online, the Government clarifies that the “the development, filming and editing of videos will not be done by the Coordination Center. The

Coordination Center is only responsible for captioning, formatting for Section 508 compliance, and incorporating...” In BAA-N01DA-15-4422, Section 5, subsection d, we are interpreting this to mean that the Centers of Excellence in Pain Education (CoEPEs) are responsible for ensuring

Section 508 compliance of the case scenarios and accompanying videos we create.

ANSWER 33: The Coordinating Center is responsible for making case scenarios and accompanying videos 508 compliant. It is the responsibility of the CoEPEs to make all other deliverables 508 compliant.

QUESTION 34: The 2012 solicitation had requested specific topics, such as pain from x disease.

Is there such a list of interested topics for the current solicitation?

ANSWER 34: No, there is not a list of interested topics for the current solicitation.

Attachment 18 of the Broad Agency Announcement (BAA) BAA-N01DA-15-4422, which is

PDF pages 138-146 of the BAA, shows the Statement of Work (SOW) for the BAA. Page 2 of the SOW describes NIH’s Research Interest for this BAA. The underlined sentence on page 4 of the SOW encourages all health professions to submit a proposal to become a

CoEPE. Section M of the BAA “Evaluation Factors for Award” informs offerors how NIH will be evaluating the proposals.

QUESTION 35: I am aware that current CoEPEs have completed some materials. Is there a list of content topics already covered available to those interested in answering this solicitation, or should topic no longer be the focus of the of the proposed work - is the focus now on the

CoEPE's process of developing curricular resources and content in a more generalized sense?

ANSWER 35: The materials previous submitted will have no bearing on the review. In

Negotiations, if held, there may be some negotiations about the content to be presented in the cases as to avoid complete duplication of educational messages.

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QUESTION 36: Regarding the work in Task 1 case development:

a. Are there targeted topics NIH would like to see developed, or can we propose whatever we like? Is there a list of modules currently in process so we don’t duplicate work being done by another group?

b. Is developing one case/module a year acceptable or is two preferred?

c. Can CoEPEs both develop the case and complete the technological formatting so it is ready to go? Or are the CoEPEs required to develop the content only and then contract with a specific vendor who will then perform the technological formatting?

d. If the CoEPEs are required to use a specific vendor, is this a budget item that needs to be included in the proposal to pay for this expense?

e. As far as developing the content, how much of the materials are each of the

CoEPEs responsible for developing from scratch? The budget requests will depend heavily on what is expected. For example, developing slides and a script to produce a narrated Powerpoint presentation would cost considerably less than developing slides and also producing original videos to be embedded in these slides.

ANSWER 36: a. You may propose any topics you like. Overall, we would like to reduce redundancies, but there are a great number of pain conditions, patient populations, treatment approaches, issues to be overcome in treatment, etc.

Potentially, there will be some negotiations when proposed topics are overly redundant. However, with all the possible topics, situations of redundant case module topics are expected to be rare.

b. Page 6 of Attachment 18 BAA Instructions and NIDA Research Interests

(PDF page 143 of the solicitation) states that “The Contractor must deliver to

NIDA at least one Content Package per contract year.” If your entity can produce more than one Content Package within the $77,870 budget of one contract year, then you are welcome to do so. If your entity cannot produce more than one Content Package within the $77,870 budget of one contract year, and if your entity wants to propose more than one content package per year, then your entity is may include the costs of the second Content Package through the “Option 2 – Level-of-Effort” hours described on page 7 of 9 of

Attachment 18.

c. NIDA is planning on programming being done by the Coordination

Center. However, if it does not increase costs, facilitates the production of the cases, and adds value to the final product, we would consider help with the programming from the CoEPEs.

d. No specific vendors are required.

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e. If one currently has content which could be used in the development of the case materials, it certainly can be included. But note that videos must be included in all case packages.

QUESTION 37: Regarding the work in Task 3: Are there specific evaluation tools/approaches that each CoEPE is required to use or can we propose our own?

ANSWER 37: Any defensible tools and approaches may be used.

QUESTION 38: Is the intent in this call for proposals JUST the case development? This reads as if NIH is seeking to develop an hour of training that incorporates video demonstration. If this is the case, would it be suitable to submit a 2-year proposal for X number of sessions lasting Y hours/minutes each?

ANSWER 38: This call is for case development, and use of cases in courses in the applying institution. Testing educational materials and dissemination of results is also required.

However, the form testing and evaluation is not set, nor is how materials are to be included in the curriculum.

QUESTION 39: Is the submission of 1-hour of educational content per year satisfactory?

ANSWER 39: Yes, to fulfil that portion of the contract. However, use of cases in courses in the applying institution is also required. Further, testing educational materials and dissemination of results is also required. However, the form testing and evaluation is not set, nor is how materials are to be included in the curriculum.

QUESTION 40: Do we need to propose / conceptualize the content packages for all five contract years?

ANSWER 40: Offerors must propose the content packages for the base year and all option years. The content packages must contain enough information to create a cost estimate for each year and to be evaluated using the Technical Criteria found in Section M.

QUESTION 41: Will a comprehensive [deleted] for an intervention program to treat [deleted] pain be an acceptable product?

ANSWER 41: Because this is a contract solicitation, we are unable to provide specific feedback on your proposal idea. Please review Attachment 18 of BAA-N01DA-15-4422, which is PDF page 138-146 of the BAA and Section M of the BAA “Evaluation Factors for

Award” to see how NIH will be evaluating the proposals.

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QUESTION 42: Regarding the requirement that the materials be integrated into the curriculum:

We are envisioning integrating the materials into a [deleted] that draws students from [deleted] at our university. Would this be permissible?

ANSWER 42: Because this is a contract solicitation, we are unable to provide specific feedback on your proposal idea. Please review Attachment 18 of BAA-N01DA-15-4422, which is PDF page 138-146 of the BAA and Section M of the BAA “Evaluation Factors for

Award” to see how NIH will be evaluating the proposals.

QUESTION 43: Are the requirements and tasks listed in the pre-solicitation still applicable? Specifically, do the following still apply, and should these be addressed in our application? Contractors must:

• Possess the expertise needed to complete the three tasks listed below;

• Have access to the curricula of medical, dental, nursing, mental health, physical therapy, pharmacy, and/or other health care professions (through the Contractor's internal resources or through a subcontract with an educational institution); and

• Have systems in place to integrate these educational resources into the curricula.

Additionally, Contractors must complete the following three tasks:

Task 1: The Contractor must incorporate pain education into the learning institutions defined as the CoEPEs. This requirement can be met through either using the Contractor's own institution or a subcontract with qualified learning institution. The extent to which pain education can be incorporated into the curriculum of a given CoEPE will vary. A Contractor must incorporate pain education into the curriculum of the teaching institutions of its particular CoEPE, as the

Contractor describes in its proposal.

Task 2: The Contractor must develop content that will be used in the development of interactive case-based pain education scenarios.

Task 3: The Contractor must evaluate the effectiveness of Tasks 1 and 2 on the students' understanding of pain and the treatment of pain; the Contractor must disseminate these results.

ANSWER 43: Yes.

QUESTION 44: Is the format for the case based scenarios for this BAA similar to the ones developed by the first group of CoEPEs?

ANSWER 44: It will be similar, however depending on the capability of the Coordination

Center, our new cases may be programmed differently, have somewhat different functionality and have a somewhat different look. Ideally, when our cases are made public, we want them to look and work in a similar way, to make it easier for the users.

QUESTION 45: The deliverable is content in a PowerPoint file (or something similar). If the contractor proposes a reasonable case and offers to have it designed as a serious game by a

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[deleted], then is it possible to request additional funding for the services of the [deleted]?

ANSWER 45: Applications should be for the proposed work in the BAA. However, our goal is to make really good teaching tools, and after funding contracts, we might consider contract quantity options for additional labor hours which will allow NIDA to take advantage of special resources or skills of a contractor to enhance and enrich the training modules.

QUESTION 46: Does the "content package of 50-100 pages of materials" refers to the number of slides that will eventually comprise the case scenario. We understand we would prepare an instructor manual (no page limits given), as well as other items addressed in the Key

Requirements.

ANSWER 46: The final modules will typically have fewer pages then submitted. The modules themselves should typically take an hour or less to complete. Pages supplied by the contractor may be merged and sometimes pages will only “pop-up” if a particular response is given by the learner, for example there may be pop-ups for wrong answers or

“to learn more about… click here” sort of options.

QUESTION 47: Are we able to ask questions about the solicitation in the future?

ANSWER 47: Yes. See Part I of this Amendment. Questions submitted after 3:00pm EDT

May 23, 2014 are unlikely to be answered.

All other terms and conditions of the Broad Agency Announcement (BAA) remain unchanged.