RFP Amendment 2 - Female 6-29-12.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 14

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

2 (Two) See Block 16C N/A N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE N/A

Eunice Kennedy Shriver National Institute of Child Health and Human Development Office of Acquisitions, NICHD Branch 6100 Executive Blvd, Rm. 7A-07, MSC 7510 Bethesda, MD 20892-7510

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) X 9A. AMENDMENT OF SOLICITATION NO.

TO ALL PROSPECTIVE OFFERORS

NIH-NICHD-CRHB-2012-03

9B. DATED (SEE ITEM 11)

May 2, 2012

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

(�) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET

FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

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

PURPOSE: To amend RFP No. NIH-NICHD-CRHB-2012-03 to provide the answers to questions received regarding the RFP. See page 2.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Alice M. Pagán Contracting Officer, OA, NICHD, NIH, DHHS

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY_____________/s/______________

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

Amendment No. 2 to RFP NIH-NICHD-CRHB-2012-03

Request for Proposal No. NIH-NICHD-CRHB-2012-03 is amended as follows:

A. Page 31, Section H.19 - ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010) is hereby deleted from the RFP.

B. Page 43, Section J, Solicitation PART III - Section J-List of Attachments, Business Proposal

Attachments, is amended to incorporate the following Attachments:

Attachment No. 13A - Section K - Representations, Certifications, and Other Statements of Offerors:

http://oamp.od.nih.gov/DGS/FORMS/sectionk.pdf

Attachment 13B - Breakdown of Proposed Estimated Costs w/Excel Spreadsheet:

http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls

C. Page 55, Section L, 2.a. No. 6, is modified to read as follows:

Evaluation of Proposals

The Government will evaluate proposals in accordance with the factors set forth in SECTION M, page

no. 100-103 of this RFP.

D. Page 98, Section M, EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY - SECTION 508 is hereby deleted from the RFP.

E. Page 101, Technical Evaluation Factors, No. 2 Organizational Experience and Facilities, a.

Organizational Experience, shall read as follows:

Organizational Experience (20 Points) Experience of the offeror and proposed subcontractors with respect to similar projects, including project dates and sponsors, specific responsibilities with respect to these projects, the type of personnel allocated to these projects and their respective level of effort, accomplishments with respect to these projects, and evidence of meeting performance objectives and submitting deliverables on schedule. Specific demonstrations of the ability to recruit, enroll, and retain subjects in compliance with project protocols and timeline objectives will be evaluated, including access to special populations and pools of established research eligible subjects. The ability to identify and recruit a target population of reproductive age women who are eligible for the study will be evaluated. In the case of a Phase I study, plans for recruitment and documentation of the ability to recruit 20 subjects per year must be described. A phase II trial should expect a recruitment target of 30 subjects per year. For a Phase III or IV study, documentation of the ability to recruit and plans for the recruitment of 100 subjects per year should be described. Offeror should describe the particular strengths and types of trials their organization is equipped and staffed to complete.

F. Attachment No. 5, page no. 6, Business Proposal Instructions, 2) shall read as follows:

TO 2 - Offerors must provide a budget for a period of 30 months. Anticipated period of performance:

11/15/12 – 5/14/15. Estimate level of effort for this task order is approximately 3,765 per year.

G. Answers to questions received regarding this RFP, please note that individual questions may have been combined or reworded.

Technical Questions

1. Question: A “Staffing Plan” is required as a part of the Technical Proposal per Section L.2.b. on page 59 of the RFP and in Section C.1 on page 2 of Attachment 5. Could the Staffing Plan be addressed as part of the Personnel section in the Technical Proposal or does this need to be its own subparagraph heading as detailed in “Other Considerations” in Section L.2.b.2. on pages 61-62 of the RFP?

Answer: Offerors must include a Staffing Plan as a separate section which shall address the issues of qualifications of clinical staff as well as contribution of effort to each task, back up coverage for key personnel, availability in non-traditional business hours, etc. The detailed description of key staff shall be included for the response to the IDIQ technical proposal, but a separate description of individual staff effort that will be specific to the statement of work of each task order must be included for each task order proposal (TO1 and TO2). Although the Principal Investigator (PI) will be involved in every task at some proposed level of effort, other individuals along with their respective responsibilities and their percent effort will differ for each task order.

2. Question: If our institution has developed standard data and safety monitoring plans for Phase I and II clinical trials and include the IRB-approved monitoring plan as a part of our proposal as detailed on page 74 in Section L.2.b.4.j., does “a complete and specific data and safety monitoring plan” also need to be included in the proposal as mentioned on page 73 of the same section?

Answer: Each clinical trial will have an independent Data Safety Monitoring Board (DSMB) that is set up by NICHD. Each site must have Institutional Review Board (IRB) approval for each protocol and must be able to comply with monitoring requirements by the Statistical and Clinical Coordinating Center (SCCC) for Good Clinical Practice (GCP) clinical trials including random audits such as may be conducted by the Food and Drug Administration (FDA). The SCCC will monitor each site during each clinical trial. The frequency of such monitoring visits will depend upon the demands of the protocol and the number of subject visits. The site does not need to establish its own DSMB, other than what is required by the institution.

3. Question: Page 102, Technical Evaluation Factors: Is it necessary to have access to clinics receiving Title

X funding?

Answer: No, it is not necessary.

4. Question: During the past 7 years of the CCTN, how many Task Orders were issued?

Answer: 15 task orders were issued and from those, 11 are clinical trials:

Female sites: 9 task orders, 7 clinical trials for female studies;

Male sites: 6 task orders, 4 clinical trials in male contraception.

5. Question: During the past 7 years of the CCTN – How many projects did each CCTN site participate in (on average)?

Answer: Female trials: on average, each site participated in 4 clinical trials (range 2-7).

6. Question: During the past 7 years of the CCTN – What was the general distribution of trial types (i.e., how many Phase I vs. phase II, III or IV)

Answer: Female trials: Phase I – 2 trials, Phase II - 2 trials, Phase III – 3 trials.

7. Question: In the next 7 years, are there a minimum number of projects a site is expected or allowed to participate in during the 7 year period?

Answer: Please keep in mind the resultant contracts will be IDIQ type contracts, which are used to acquire supplies and/or services when the exact times and/or exact quantities of future deliveries are not known (other than a minimum or maximum quantity) at the time of contract award. As specified under Article B.2 of the RFP, the minimum guaranteed by the Government for each IDIQ contract is $50,000.

8. Question: Attachment #3: Is there an age range for the patients in TO#2?

Answer: The final protocol will determine the age range, but a likely range is 18-40.

9. Question: Registration/ClinicalTrials.Gov, page 74: Is there a Lead Clinical Site for this study? How is this decided?

Answer: No, there will not be a Lead Clinical Site. Registration requirements are managed by the SCCC.

10. Question: Will the pharmacokinetic (PK) evaluations, which require very frequent blood work, be limited to one clinical site? If so, do all proposals need to include this component?

Answer: PK evaluations will be limited to one or two sites. Sites have the option to propose to conduct a PK study for TO2 but they are not required to propose that aspect of the task. It is not necessary to have the capability of conducting a PK study to be a participating site in TO2. A proposal to conduct a PK study will be evaluated independently based on experience with similar studies and expertise of staff. If an Offeror wish to be considered as a potential PK site, it must include a PK proposal as an appendix to technical proposal for TO2 and include costs in a separate portion of the TO2 business proposal.

11. Question: Will data be collected in an Electronic Data Capture (EDC)?

Answer: In most cases yes, but we are not sure what the new SCCC might require.

12. Question: Does the TO1 (Core functions) technical proposal require a human subjects section?

a. I wrote a sort of general overview about how human subjects is considered in protocol development, but it does not seem to fit (i.e. more applicable for a particular protocol)

Answer: Please address Human Subjects considering the work to be performed for the entire IDIQ contract.

13. Question: Key Personnel, p. 15 and 61 -What is the definition of Key Personnel? Page 15 states only the

Principal Investigator. Are the study coordinator and data/research manager considered key personnel (requiring a CV/resume)? Resumes of all key personnel: do you mean the NIH bio sketch or a full CV?

Answer: In addition to the PI, key personnel are individuals who contribute to the execution of the project in a substantive way; those individuals that are considered critical to the project, i.e., their absence from the project would have a significant impact. The PI is usually considered key personnel. Study coordinators and research managers are considered also key personnel for these projects. The contractor and program officials should use their discretion in identifying key personnel other than the PI. Prior approval requirement for changes in status of personnel applies to those key personnel named in the IDIQ contract or task orders.

CV/Resumes are required for all key personnel. An NIH biosketch, a resume or CV are acceptable documentation. See Page no. 100, Technical Evaluation Factors: IDIQ/TO1, No. 1: “Personnel.” See also Attachment No. 5, page no. 2, “Additional Proposal Instructions” - “Staffing Plan.”

14. Question: Page 100, Technical Evaluation Factors: Should co-investigators who may participate in future trials (but not in TO #2) be listed as co-investigators or key personnel on the IDIQ/TO#1? Page 60, Personnel: For co-investigators/key personnel who will be involved in future clinical trials (not TO#2) what is needed? Is a resume/CV sufficient? Is the letter of commitment only for personnel who will need to be hired?

Answer: If co-investigators/key personnel will play a substantive role at the site for contributions in future task orders, they should be proposed in the key personnel for the site in response to the overall solicitation (IDIQ). However, an individual should not be listed if they are not truly involved in the activities of the site. Each individual and/or collaborating organization must include a letter confirming their role on the proposed project or future project.

15. Question: Can there be a Co-Principal Investigator?

Answer: Yes.

16. Question: Should the Offeror’s Management Plan (which will be evaluated for the ability to carry out both the TO1 and TO2) (pg. 102) be listed in all three technical proposals?

Answer: Yes, it should be listed in all three proposals.

17. Question: For TO2: Will there be a central DSMB, or does each site have its own DSMB?

Answer: There will be a Central DSMB convened by NICHD. See Answer to Question no. 2

18. Question: Please confirm that the study is designed to evaluate contraceptive efficacy and endometrial safety and thus participants will be at risk of pregnancy and seeking contraception.

Answer: This study is designed to evaluate evidence for contraceptive efficacy and endometrial safety. At this point it is not clear if subjects will be at risk of pregnancy or will be asked to use another method (condoms or tubal ligation).

19. Question: Is TO2 a Phase I, I/II or II trial? How many clinics will be involved? What is the anticipated study sample size?

Answer: TO2 is considered Phase 2A. It is anticipated that eight (8) sites will be involved. Likely 30 subjects per site, but each site should indicate how many subjects they would expect to be able to enroll in one year for a trial of this nature. Please try to be realistic and accurate in this projection.

20. Question: Why is there an endometrial biopsy scheduled in proliferative phase of the cycle?

Answer: The final number and timing of endometrial biopsies will be determined in the final protocol. For comparison of the tissue treated with a Progesterone Receptor Modulator (PRM), proliferative phase may be the appropriate comparison due to concern that an antiprogestin could cause an “unopposed estrogen” effect.

21. Question: If a subject during Control Cycle showed un-ovulatory, will she be enrolled to the study?

Answer: Subjects are required to meet eligibility requirements, including history of regular cycles. In the event a subject does have an irregular cycle during screening, depending on the subject's meeting all other criteria, it is reasonable to defer enrollment a month to await a regular cycle or to request a waiver depending on the other eligibility criteria being met, especially if the site has a history with the potential subject.

22. Question: For Task Order 2, will the endometrial biopsies be read at a central lab or should we budget for the endometrial biopsies in our pathology lab?

Answer: Most likely endometrial biopsies will be read in a central lab, but that remains to be determined.

Include the cost of biopsies in the local path lab but with clear itemization so that those costs could be deducted at a later time.

23. Question: As we calculate our budgets for Task Order 2 (referencing STATEMENT OF WORK TASK ORDER NO. 2, Attachment No. 5, starting on page 113 of the solicitation), it seems that there are many unknowns when it comes to how many times and where samples and lab tests must be collected and performed. Will there be any more updates to the protocol before the application deadline so that we can more accurately estimate the lab and procedure costs that will need to be accounted for in our business proposals?

Answer: The participating sites will develop the protocol in consultation with NICHD. The final number of visits, procedures and endpoints will be determined by the protocol. It is likely that there will be a central lab for measurements of hormones that can be pooled and assayed in bulk. The sites should budget for use of local labs for screening and for any measurements that need results for clinical decisions during the conduct of the study. Labs for GC/CT, CBC, chem panel, lipid panel, hepatic function, pap smear, hCG, urinalysis will likely be done locally and should be itemized individually in the budget based on an assumption of 30 subjects.

24. Question: For TO2: Will the database be centralized? Can you explain the proposed procedure for CRFs?

Answer: The SCCC will have a central database. CRFs will be developed based on the needs of the protocol determined by the participating investigators. CRFs will be printed by the SCCC and distributed to the sites. The format for how to report data to the coordinating center may depend on what entity is selected as the SCCC for the network.

25. Question: For TO2: Will the cervical mucus testing be done at each site will that be centralized?

Answer: Cervical mucus will be determined locally at each site.

26. Question: Will serum progesterone collected in the pre-dose cycle be tested at the Central Lab or local lab?

Answer: Serum progesterone measurements that are needed for screening and for specific clinical judgments within the protocol will be done locally. Other P values will be done in a central lab. See Question No. 22.

27. Question: Can subjects 18-20 years of age be included?

Answer: Yes. Although, participants between the ages of 18-20 are considered children, according to the NIH guidelines for inclusion of children in clinical studies, they are considered adults for the purpose of choosing to participate in the trial and for providing informed consent.

28. Question: On page 3 of Attachment 3 (TO2), section IV. C. 1. it states that subject visits will occur during treatment cycles 1, 2, 3, 4, 6. Is it safe to assume that cycle 5 was missed in error, or is there truly not a cycle 5 visit planned?

Answer: As indicated in the RFP, there is no cycle 5 visit.

29. Question: For TO2, is the effort during the Start-up Period (first 6 months) in addition to the effort that is expected under Task Order #1?

Answer: Yes. All effort associated with TO2 is independent of effort that is expected under TO1.

30. Question: For TO2, should this be written as a detailed study protocol, understanding that the final protocol will be developed by the selected Investigators? For examples: Attachment No. 3, page 3, B.1.a:

screen candidates for potential eligibility. Should I specify what my proposed eligibility criteria would be, including proposed lab tests, exclusionary concomitant medical conditions and medications, etc;

Attachment 3, page 4, C.1.c: should I propose the frequency of cervical mucus and ultrasound assessments?

Answer: Offerors should use their best judgment about how to respond and what level of detail is necessary to demonstrate their expertise and understanding of the complexity of the project and what is involved. Please see Page 103, Section M -Technical Evaluation Factors for TO2.

Business Questions

1. Question: It appears there are 3 separate technical proposals, and 2 business proposals.

Answer: Yes. Please see Attachment No. 1 and Attachment No. 5 - page 5, D. INSTRUCTIONS FOR PROPOSING ON IDIQ CONTRACT AND TASK ORDER INCLUDED WITH RFP: Offerors must submit three (3) Technical Proposals and two (2) Business Proposals in order to be considered for award.

2. Question: Please provide clarification regarding proposal submission such as outline and content. Please describe what should be included particularly for the IDIQ proposal (maximum 50 pages), as opposed to Task Order No. 1 (TO1) (maximum 25 pages). Section D.1.a).1) on page 5 of Attachment No. 5 requires Offeror to address the IDIQ contract Statement of Work. Should this be prepared as a separate response from TO1’s Statement of Work considering that IDIQ and TO1 Technical Evaluation Factors are lumped together in Section M on pages 100-102 of the RFP?

Answer: See Attachment No. 5, page 5, D. INSTRUCTIONS FOR PROPOSING ON IDIQ CONTRACT AND TASK ORDER INCLUDED WITH RFP: Offerors must submit three (3) technical proposals in order to be considered for award of the IDIQ contract. The IDIQ proposal should address the IDIQ statement of work (SOW). Information in this proposal will be the primary consideration for inclusion in the Network.

Additional proposals are required to address the specific elements of the SOW in Task Order No. 1 (TO1) and to address the specific elements in the SOW for Task Order No. 2 (TO2). See Attachment No. 3 of the RFP for all SOWs. The proposals will be technically evaluated in accordance with Section M - Technical Evaluation Factors (pages 100-102 IDIQ/TO1, pages 103-TO2).

In addition to Attachment No. 3 - SOW and Section M – Technical Evaluation Factors, see also Section L, page 59 - Technical Proposal Instructions.

Award of the IDIQ contract will be accompanied by award of TO1. Award of TO2 will be determined based on evaluation of the technical proposal for TO2. As mentioned previously, TO2 is a Phase II trial.

Sites that do not score in the top tier for TO2 may have other strengths that would be required for a different phase clinical trial such as a Phase I or Phase III trial. Those strengths should be emphasized in the response to the IDIQ SOW.

3. Question: Does the IDIQ go to a different group of reviewers than Task Orders 1 & 2? It would seem like there could potentially be overlap between the IDIQ and Task Order #1. Is that permissible?

Answer: Unlike grants, all reviewers on the panel will evaluate all proposals required by the solicitation.

It is acceptable for Offerors to reference details that were already addressed; however, we recommend repeating information that is required for each SOW rather than referencing another proposal, as the evaluation can be more difficult for the reviewers if they have to jump back and forth among the documents. If the information is a verbatim repeat of information already provided in the IDIQ proposal, it may be helpful to preface the material by adding a statement specifying that the information duplicates what was previously described and citing the section where it is included in the IDIQ technical proposal.

4. Question: Is the budget for TO1 to include budget items for the IDIQ? If so, what are the allowed/and or/expected line items to be included? Because there is no business proposal requirement for the IDIQ contract, are we to assume that any budget items for IDIQ be listed in the TO1 budget and in the business proposal for the TO1?

Answer: As indicated on Attachment No. 1 and Attachment No. 5: Offerors are required to submit only two (2) Business Proposals, one for TO1 and one for TO2. No business proposal for the IDIQ is requested because no funding will be awarded under the IDIQ contract. The budget for TO1 should include what Offerors understand is necessary to perform the work stipulated under TO1.

5. Question: According to ADDITIONAL PROPOSAL INFORMATION AND INSTRUCTIONS, D.

INSTRUCTIONS FOR PROPOSING ON IDIQ CONTRACT AND TASK ORDER INCLUDED

WITH RFP (Attachment NO.5, pages 126-127 of the solicitation), the estimated level of effort for TO1 is 520 hours per year and for TO2, the estimated level of effort is to be 3,675 hrs per year. Is this the estimated total for study staff only, or are sites to use their discretion in allocating this time to both study staff and investigators?

Answer: The estimated level of effort was provided as guidance and represents an estimate for all the work to be performed under the particular task order; therefore, it is inclusive of study staff and investigator time for each task.

6. Question: What are the margin, font type-size, and spacing requirements?

Answer: There are no specific guidelines related to margin, font type-size or spacing requirements. Use your best judgment, and understand that the file submitted needs to be easily readable. See page no. 54 of this RFP, Instructions to Offerors for additional information.

7. Question: Page 54, Section 2, #2- Authorized Official and Submission Proposal:

Can you confirm how the proposals are to bound (i.e. rubber bands, staples, binder)?

Answer: Please submit your proposals in a bound format that will ensure all pages stay in order and together. Please no rubber banded copies.

8. Question: Attachment No. 1 indicates that 15 copies of each technical proposal and 4 copies of each business proposal are requested. How do they want the paper proposal packaged?

Answer: Each copy of the proposal should be bound separately, but they should be packaged together as a single submission under one cover letter.

9. Questions: Do Attachments 3 and 4: Statements of Work and Reporting Requirements need to be attached to our proposal? Do we also need to incorporate or address the Reporting Requirements in Attachment 4 in our technical proposal?

Answer: Offerors do not need to include Attachment No. 3 or Attachment No. 4 to their proposal.

However, Offerors must address the statements of work on their technical proposals. See Question No. 2.

In addition, Offerors shall demonstrate understanding of the level of detail sufficient to manage the work performed as well as producing the associated deliverables and reports.

10. Question: Where in the proposal should we include the required completed and signed Federal forms (e.g., Form NIH-2043 in Section J; Section K Reps and Certs, etc…)? Is there any particular order these forms should be in?

Answer: These documents must be included with the Business Proposal submission, but there is no particular order required. See Business Proposal Instructions on page 81 of the RFP and Section J – Business Proposal Attachments.

11. Question: Is the first page of the proposal (Section L.1.a.(c).(2) on page 46 of the RFP) and the cover page (Section L.2.a.2 on page 55 of the RFP) two different items? We note that the Business Proposal has detailed instructions for its cover page. Is the cover page instruction in Section L.2.a.2 on page 55 of the RFP intended for the technical proposal cover page?

Answer: Use form NIH 2043 identified in Section J as your Business Proposal cover page. For Technical Proposal cover page, see page 55 that indicates that Offerors must include RFP title and number, name of organization, DUNS number, proposal part, and identify if the proposal is an original or a copy.

12. Question: A copy of the Institution’s Travel Policy will be included in the original Business proposal, but travel costs will be calculated using the Institution’s per diem rates rather than GSA as stated in Section L.2.C.13.a on page 92 of the RFP. How should we address this in the Business Proposal?

Answer: A copy of the travel policy of the Institution is sufficient.

13. Question: We note that NIH only requires one copy of the Travel Policy in the original business proposal.

In line with that, should we only include one copy of the “Proposer’s Annual Financial Report” (in Section L.2.C.12 on page 92 of the RFP) in the original business proposal or all copies as well?

Answer: Either way is considered acceptable; however, if the Offeror decides to include these documents once, please make reference to it in all the other business proposal copies.

14. Question: For Type of Contract Proposed, do you envision Cost-Reimbursement or Fixed Price? Do we select the contract type that is being requested for the sample Task Order proposals or should the type reflect all possibilities for future Task Order proposals as well? We imagine that there might be multiple contract types proposed depending on the task order?

Answer: The resultant contracts will be Hybrid IDIQ contracts to allow for the issuance of both Cost Reimbursement Completion or Term Form and Firm Fixed Price Task Orders that will be determined based on each individual project requirements. See Section I “Contract Clauses”, page 36 of the RFP.

15. Question: If the grant is awarded will there be an opportunity to renegotiate the budget if the study design is modified?

Answer: Please remember this is a competition for a contract award not for a grant. If there is a change in the SOW, the Government may consider renegotiating depending of the type of the change.

16. Question: How can we get access to Section K?

Answer: Offerors can go to the Online Representations and Certifications Application (ORCA) that can be accessed at: https://orca.bpn.gov/.

Or complete the following form and include it as part of your Business Proposal:

http://oamp.od.nih.gov/DGS/FORMS/sectionk.pdf

17. Question: Our organization does not have an active negotiated indirect cost rate agreement (NICRA) rate at this time but would want to obtain one for the purposes of this contract. Should we begin negotiating a rate now or should we wait until we are informed that our application is successful? How should we address our NICRA status in our budget submissions?

Answer: Indirect cost rates are required for cost reimbursement type awards to provide an equitable method for allocating indirect costs to all awards and provide a uniform method to fund and reimburse indirect costs on contracts.

If a commercial organization does not have a negotiated indirect rate agreement, it must contact the NIH Division of Financial Advisory Services (DFAS) Indirect Cost Branch as soon as possible at 301-496-2444 or dfas-idc@nih.gov for advice. If a commercial organization’s provisional indirect cost rate(s) recently expired and DFAS has not received a new rate proposal, DFAS typically would recommend that the expired provisional rate(s) be used for funding purposes. If a long period of time has transpired since the rate(s) expiration date, DFAS may need an updated indirect cost proposal before recommending funding rates.

To obtain an HHS negotiated indirect cost rate for a college/university or non-profit organization, the Offeror must contact the HHS, Division of Cost Allocation: http://rates.psc.gov/.

18. Question: Section L.2.C.9.c on page 90 of the RFP, clarify what Financial Capacity means? Are you asking for a list of facilities and resources (e.g. equipment, office space, clinical expertise sites) or is this section purely a description of what other sources of funding are available for this proposal? Please clarify.

Answer: The contract shall be awarded to responsible prospective contractors only. Financial Capacity means that the contractors must have adequate financial and institutional resources to perform the specific requirements of the contract or have the ability to obtain them. See FAR 9.103 and FAR 9.104-1(a).

19. Questions: What are the quantity limits that have been stated in terms of dollar values? What is the dollar value?

Answer: Attachment No. 5, page no. 1, A. General Information, #4 states:

Minimum and Maximum Quantity Limitations: FAR 16.504 requires the Government to establish minimum and maximum quantity limitations for all IDIQ contracts. Limits may be stated as number of units or dollar values. It should also be noted that per FAR 16.501-2(b)(3), “Indefinite-quantity contracts limit the Government’s obligation to the minimum quantity specified in the contract.” The $50,000 (minimum) or $35,000,000 (maximum) amounts represent what the Government may order during the specified period of time. The minimum is the amount guaranteed by the Government and the maximum is the amount not to exceed for the entire IDIQ contract that includes all task orders.

20. Question: Page 92 indicates that commitment letters are required for proposed subcontractors. If we are proposing a subcontractor site, my question is regarding the details of the subcontractor site. I am assuming these must be placed in the IDIQ technical proposal. I note that the qualifications of the subcontractors must be in Task Order 1. Is that correct? If I want to propose that subcontractors attend investigator meetings to develop protocols, should this be in the budget for TO1?

Answer: Each individual and/or collaborating organization must include a letter confirming their role on the proposed project. Therefore, a letter from the collaborating institution must be included. If a subcontractor is proposed to perform core function related activities that are under TO1, these costs should be included under the TO1 budget and Offerors must justify the contribution of the subcontractor in their budget narrative. See Page No. 92 of the RFP (Business Proposal Instructions – 11 Subcontractors) that provides a detailed list of requirements when subcontractors are proposed.

Please consider that this task order would allow protocol discussion on an “as needed” basis; since subcontract sites will not be asked to participate in all clinical trials, it is not cost efficient to pay them every month as part of core function activities. Some hours of effort can be included for subcontract PI effort in the core task, however, only actual hours that were utilized can be billed in any monthly invoice.

21. Question: Should we get letters from possible subsites in the application, though they will not be used for the current proposal? If we are not going to use a subcontractor on the current proposal, do we need to still submit their budgets or just a letter of commitment?

Answer: A letter of commitment from potential collaborating institution must be included. However, no budget is required until these institutions are to be proposed for work to be performed under a specific task order.

22. Question: Section L.2.C.11 on page 92 of the RFP indicates that subcontractors are not required. If no subcontractors are proposed at the proposal phase, would we be able to collaborate with subcontractors should the need arise when we compete for TO1 and TO2 or future Task Orders if we are selected for an award?

Answer: The evaluation and decision for award will be based only on the information provided by the Offerors in their proposal submissions.

If an Offeror intends to include a subcontractor(s) in response to the IDIQ contract, TO1 or TO2, it is necessary to include the appropriate information within proposals submitted in response to the specific task order request, in order to allow review and approval of the subcontract site. Appropriate reasons to include subcontract sites in response to the IDIQ contract might include capacity, expertise or demographic diversity that would be of value to the contract and to the Network. In the event that a special need arises in a future task that would require an increase in capacity or some other element of performance, a prime contractor may request to collaborate with a subcontractor(s) that has not already been prequalified during the initial solicitation. However, such requests would only be made if the task required capacity or capability that is not already present in the available pool of sites and pre-approved subcontracts.

23. Question: P. 85, Section C.6 Small Business Subcontracting Plan, is a Small Business Subcontracting Plan submitted for each task order greater than $650,000? Or is this submitted just once and at what point? If the sample Task Order proposal exceeds $650,000, must the Small Business Subcontracting Plan be submitted with the proposal or can this be submitted at a later point?

Answer: For Indefinite-Delivery Indefinite-Quantity (IDIQ) type contracts, Offerors must consider the total maximum estimated value of the requirement.

24. Question: If we are not proposing to use subcontractors, do we still need to have a Small Business Subcontracting Plan?

Answer: Yes. Offerors are required to submit a Small Business Subcontracting Plan (SBSP) when the proposed contract exceeds a total estimated cost of $650,000 for the entire period of performance. An acceptable SBSP is required prior to award of the contract. The SBSP is based on the Offeror’s planned subcontracting in support of the specific contract. Offerors should provide the maximum practicable opportunity for Small Businesses, Small Disadvantaged Businesses, Women-Owned Small businesses, HUBZone Small Businesses, Veteran-Owned Small Businesses, and Service Disabled Veteran-Owned Small Businesses to participate in the performance of the contract. Please see FAR 19.702 and Page 85-87 for additional information in regard to this matter.

25. Question: For the Small Business Subcontracting Plan: How do we address travel costs if we use a woman owned disadvantaged small business for travel and they charge a fee for their service, how is it calculated, just on the fee or based on all the costs?

Answer: It depends on who receives the payment. For instance, if the payment is directly to the airline, then the entire amount should be reported as a subcontract to large business (if the airline is a large business). If all of the funds are paid to the travel agency, then the entire amount can be attributed to the travel agency and reported in the appropriate size category.

If the prime contractor uses a travel agency but is required to pay the airline directly, the airfare would be attributable to a large business (if the airline is a large business). However, the travel agency fee can count separately from the cost of the airline ticket and can be reported as a subcontract with the travel agency.

26. Question: Attachment #3: Is the study coordinator included in the budget for Task Order No. 1 or IDIQ?

Answer: An IDIQ business proposal is not required. Proposed personnel related costs must be included under the specific task order where he/she will be providing services.

27. Question: Section M, page 98, “The evaluation will be based on information obtained from references provided by the Offeror”. Should the Offeror supply references, if so how many and what type?

Answer: Offerors must provide at least three references.

28. Question: Page 91 Item 10 Qualifications of Offeror- "b" Organizational Experience Related to the RFP: "Can you please clarify what is wanted here? We have many years of experience with CCTN that we can describe. However item 10 b. states" "Organizational experience is defined as the accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall Offeror corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this RFP".

Answer: Please note that page no. 91, item 10 of the RFP is indicating that the Government will not evaluate an Offeror’s organizational experience on the basis of the personal experience of the Offeror’s key personnel. However, Offerors may also submit information regarding key personnel who have relevant experience.

It appears that there is some confusion in regard to the information requested for the organizational experience and past performance. Please be advised that the reviewers will ONLY evaluate the technical proposals (not the Business Proposals) based on the technical factors in Section M of the RFP (pages 100- 103). Therefore, Offerors should include the necessary information on their technical proposals that demonstrate their organizational experience. On the other hand, past performance information must be provided as part of the business proposal, please see pages 58 and 98 for additional information.

29. Question: Past performance information (RFP pg. 58) asks for contract information from the last 12 months and RFP pg. 91 asks for the last 3 years. Which should we provide?

Answer: To clarify this discrepancy, Offerors are required to provide a list of contracts completed within the last three (3) years. Past performance information must be provided as part of the business proposal, please see pages 58 and 98 for additional information.

Please be advised that the reviewers will ONLY evaluate the technical proposals (not the Business Proposals) based on the technical factors in Section M of the RFP (pages 100-103). Therefore, Offerors should include the necessary information on their technical proposals that demonstrate their organizational experience. Note that there is no time limit for description of relevant past experience and successful completion of similar trials in response to this section in the technical proposals. It is not necessary to describe clinical experience that is not relevant to the types of clinical trials expected to be performed in the current contract. See Answer to Question No. 28.

30. Question: Past performance information (RFP pg. 91) should this information be provided for the department in the organization who is submitting the application and who would be doing the work, or do you want past performance information for any contract/grant awarded to any department in the organization?

Answer: Offerors are required to provide organizational experience related to the RFP of the Offeror. This includes overall Offeror or corporate experience. Please see Answers to Questions 28 and 29.

31. Question: Is there a page limit for appendix items including supporting documentation, letters of support, etc.?

Answer: No, the page limitation indicated for each technical proposal does not include appendix items.

Also, please be aware that the page limitations were provided for guidance purposes only. Therefore, no pages in excess of the limitations will be removed.

32. Question: Will the Information Security (section 508) and Human Subjects Sections be required for all 3 technical proposals? To what degree?

Answer: Section 508 is not applicable for this acquisition. Human Subject requirements should be covered in your IDIQ technical proposal. Please see page 62 of the RFP that provides details for inclusion in your IDIQ technical proposal.

33. Question: For Task Order No. 2, can we include materials and supplies in the budget in addition to the personnel and travel?

Answer: Yes, if the Offeror understands it is necessary to perform the work stipulated under the task order.

Please see page no. 81-83, Business Proposal Instructions for additional information. Please do not include items that would be covered within Overhead or Indirect Costs.

34. Question: Will we receive capitation payments from the SCCC for each study participant? Do these payments include participant reimbursement? Do they include supplies? Anything else included? Do we need to add shipping costs to the budget?

Answer: No, sites will not receive capitation payments from the SCCC. Allowable costs related to the work performed under a task order will be charged to the particular task order (project) and paid by the NIH. Offerors should include in their proposed budgets what they understand is necessary to perform the work stipulated under the individual task order. Please see page no. 81-83, Business Proposal Instructions for additional information. In general, subjects will receive a modest reimbursement for participation in the trial. Amounts for reimbursements should not be considered payment or incentives for participation.

35. Question: Per Attachment #5, 2. Business Proposal, 2) TO2 – the close out period was left out of the performance range of dates – was this intentional? To include the 3-month close out date, the end date of TO2 would be 5/14/2015.

Answer: This is an error. Please use 5/14/2015 as the end date for Task Order No. 2. The anticipated period of performance for TO2 is 11/15/12 – 5/14/15.

36. Question: What process should we follow to propose an Alternate FAR clause?

Answer: Any proposed substitutions and/or modifications to the clauses included in the contract should be proposed and included in your business proposal.

37. Question: Is the travel in Task Order 1 and Task Order 2 the same trips or are they separate trips?

Answer: For budget purposes, TO1: please assume 1 trip per year for a 2 day meeting and 2 study personnel traveling to the Washington D.C. area. TO2: please assume 1 trip per year for a 1 day meeting and 2 study personnel traveling to the Washington D.C. area.

38. Question: For TO2: the 1.8 FTE (3,765 hours) for TO2. Do these hours include a coordinator?

Answer: This information is provided for guidance purposes only. Offerors should propose the amount of individual and total effort from all personnel who will perform the work required under the task order.

39. Question: For IDIQ: Is the Human Subjects section part of the Technical Proposal considered outside the 50 page limit?

Answer: Yes, Human Subjects must be addressed on your IDIQ technical proposal submission. Please be aware that the page limitations were provided for guidance purposes only. Therefore, no page in excess of the limitations will be removed.

40. Question: Could NIH pinpoint us to the Section 508 standards identified in the Statement of Work per Section H.19.b on page 31 of the RFP?

Answer: Section 508 is not applicable for this acquisition.

41. Question: Page 90, does the time-tracking system need to be an electronic system?

Answer: No.

42. Question: Page 98, Section M.6. Evaluation of Electronic and Information Technology Accessibility -

Section 508

a. Having reviewed the HHS Guide to Completing the Section 508 Evaluation Template at http://www.hhs.gov/od/vendors/index.html, it does not appear that we would be developing a product, service or supporting feature that matches any of the criteria of the template. What product is being evaluated?

Answer: Section 508 does not apply for this acquisition.

b. Is the "Section 508 Product Assessment Template" submitted applicable to all proposals or is it only applicable under specific criteria and if so, what are the criteria? Is it preferable to submit this section with the proposal or can/should this section be submitted later?

43. Question: In Section M.6. on page 98 of RFP, would a statement assuring that Offeror will comply with the Electronic and Information Technology (EIT) Accessibility Provisions be sufficient or is the HHS Section 508 Product Assessment Template a required component of the proposal?

44. Question: Do the sections outlined for the technical proposal on pages 75 – 81, Security Requirements for Federal Information Technology Resources, HHSAR 352.239-72 (January 2010) apply to TO1 or TO2?

Answer: This clause applies to the entire IDIQ contract.

45. Question: According to pages 8, 27, and 76 of the RFP, an “IT Security Plan (IT-SP)” is not due until 30-days after contract award. However, the 2nd sentence in Section L.2.b.5.A.c.1 on page 76 of the RFP states that, “The IT-SP shall be consistent with and further detail the approach to, IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract.” Does this mean that Offerors are required to include an IT security plan in the proposal? If so, could this be a brief statement, and where should this section be included in the proposal?

Answer: The IT-SP is due within thirty (30) days after contract award.

46. Question: Please confirm the address that accepts FedEx deliveries for the CCTN contract.

Answer: Please see Attachment No. 1 of the RFP. For hand delivery or delivery services other than US Postal Service, please use the Rockville, MD address.

47. Question: Can you tell me if I should be putting 3% increases on the budget for outlying years?

Answer: For proposal purposes, it is recommended that Offerors use 3%.

Note: Additional questions pertaining to this RFP must be submitted in writing no later than July 20, 2012 to Alice Pagán, Contract Officer at alice.pagan@nih.gov.