Amend. No. 3 - RFP Female.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 6

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

3 (Three) 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 and 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. 3 to RFP NIH-NICHD-CRHB-2012-03 Page 2 of 6

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

A. Page 103, Technical Evaluation Factors, Task Order No. 2, is hereby amended to include the Technical Evaluation Factors to be used to evaluate the Pharmacokinetic Optional Proposal under Task Order No. 2.

See Attachment No. 1 of this Amendment.

B. Attachment No. 5, page 2, B. Additional Proposal Instructions, 5. Task Order No. 2 (TO2), is modified to include the following:

i. Optional Proposal for PK - Offerors have the option to propose to conduct a pharmacokinetic (PK) study for Task Order No. 2 (TO2) but they are not required to propose. A proposal to conduct a PK study will be evaluated independently based on experience with similar studies and expertise of staff.

If an Offeror wishes to be considered as a potential PK site, it must include a PK proposal as an appendix to technical proposal for TO2 and include a separate PK budget under the TO2 business proposal.

C. Attachment No. 5, page 5, D.1. Technical Proposal, a) 3) TO2 Proposal, is modified to include the following:

i. PK Proposal – (Optional) Offerors have the option to propose to conduct a pharmacokinetic (PK) study for Task Order No. 2 (TO2) but they are not required to propose. A proposal to conduct the PK study will be evaluated independently based on experience with similar studies and expertise of staff.

In order to be considered as the PK site, Offerors must include a PK proposal as an appendix to technical proposal for TO2.

D. Attachment No. 5, page 6, D.12. Business Proposal, a) 2) TO2 Proposal, is modified to include the following:

i. PK Proposal – (Optional) Offerors have the option to propose to conduct a pharmacokinetic (PK) study for Task Order No. 2 (TO2) but they are not required to propose. A proposal to conduct the PK study will be evaluated independently based on experience with similar studies and expertise of staff.

In order to be considered as the PK site, Offerors must include a separate PK budget to the business proposal for TO2.

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

Questions

1. 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: Respondent should provide details necessary to establish their expertise in this type of study

– eligibility criteria would be appropriate, as well as criteria used for determining frequency of assessments.

2. Question: As a subcontractor, our budget is less than $650,000 threshold for small business subcontracting plan. Do we have to submit a small business subcontracting plan?

Answer: With the exception of subcontracts with small business concerns, the prime contractor shall insert clause 52.219.9 in all subcontracts that are $650,000 or more. Contractors are required to assure subcontractors comply with this requirement. See FAR part 19.704(a)(9). Nevertheless, the CO is only responsible to review the prime contractor’s plan. The contractor with the individual subcontracting plan requirement is responsible for obtaining, approving, and monitoring the Individual Subcontracting Plans of its subcontractors (when required). Under the flow-down provision, subcontractors with subcontracting plans must submit their subcontracting achievements via the electronic subcontracting reporting system as the prime contractors do. The prime contractor will review either the Individual Subcontract Report (ISR) of its first-tier subcontractors and the first-tier subcontractors will likewise review the reports of the second-tier subcontractors, and so forth.

The subcontractor must also complete a Summary Subcontract Report (SSR) that will be reviewed by the government (OSDBU HQ). This enables the government to collect subcontracting statistics from all of the subcontracting tiers.

3. Question: RFP says that if the estimated total cost exceeds $650,000, offerors are required to submit a Small Business Subcontracting Plan (SBSP). Is this applicable for TO1 or TO2 or both? Do you have a template for the ‘SBSP’ so that we will get to know what information we need to include in the SBSP.

Appreciate your help and support.

Answer: For Indefinite-Delivery Indefinite-Quantity (IDIQ) type contracts, Offerors must consider the total maximum estimated value of the requirement which is $35,000,000.

4. Question: How do we find small businesses?

Answer: There are a variety of methods to find small businesses. Here are a few resources:

• Review SBA Dynamic Small Business Search Site

• Review Vetbiz (SDVOSB search engine)

• Contact minority and small business trade associations

• Contact business development organizations and local chambers of commerce

• Attend SB, SDB, WOSB, HUBZone, VOSB and SDVOSB procurement conferences and trade fairs

• Review sources from the Central Contractor Registration (http://www.ccr.gov/)

• Consider using other sources such as the National Institutes of Health (NIH) e-Portals in

Commerce, (e-PIC), (http://epic.od.nih.gov/) or FedBizOpps

• Utilize SBA SUB-net or newspaper and magazine ads to find sources

In addition, the Small Business Administration has Commercial Market Representatives (SBA CMR) assigned to its regions to counsel contractors. A CMR may assist in identifying small business concerns by means of the CCR, SBA DSBS, Business Matchmaking events, and other resources and tools. Link to the SBA’s CMRs: http://www.sba.gov/content/government-contracting-field-staff-directory/. The HHS OSDBU Small Business Specialists supporting the NIH can also be contacted at 301-496-9639 for assistance.

5. Questions: Do we need to include specific names of disadvantaged vendors/subcontractors that we will work with at the time our proposal is submitted. Or, can we make general reference to working with these groups and having these arrangements in place upon award?

Answer: For the subcontracting plan purposes, specific arrangements can be put in place after award, however, market research to locate vendors in order to develop a plan is encouraged. Per the 13 Code of Federal Regulations (CFR) 121.404 (e) and 13 CFR 121.411(a), you must have a supporting written size self-certification for every small business you are counting in the small business and socioeconomic section of the report at the time they submit their proposal except as authorized in special legislation for ANC and Indian tribes. If you do not have a written size self-certification at that time, the subcontracts must be counted in the large business field when reporting.

For the Small Disadvantaged Business Participation Program, the extent to which SDB concerns are specifically identified will be considered, the SDB concerns that are specifically identified will be listed in the contract, and the contractor shall be required to notify the contracting officer of any substitutions of firms that are not SDB concerns.

6. Question: I do not see reference to a salary cap. Is the salary cap not applicable to this RFP?

Answer: The salary rate limitation applies to all NIH contracts. For 2012, the amount was reduced to Executive Level II of the Federal Executive Pay scale which is $179,700. See page 40, HHSAR Clause 352.231-70, Salary Rate Limitation (March 2012), page 84 of the RFP and page 6 of Attachment no. 5.

7. Question: Page 11, question 27 of the written response states that the Offerors must provide at least three references.

Answer:

• Is there a particular NICHD form that you would like the individuals who are serving as references to complete? No, there is no form required.

• If there is not a form, is there a particular format that should be followed or is a letter format acceptable? No, there is not a particular format required.

• Should the three references be included in the business proposal or should they be mailed independently to NICHD by the individual serving as a reference? Offerors must include their reference in their business proposals with their past performance information. See page 58-59 of the RFP.

8. Question: Attachment 6 (Targeted Planned Enrollment Table) only seems appropriate for TO 2

(Ulipristal Acetate) where we are actually proposing a study and participant enrollment. Should it be left out of the IDIQ technical and TO 1 technical proposals?

Answer: Yes, Attachment No. 6 - Targeted/Planned Enrollment Table only applies for Task Order No.

2.

9. Question: Attachment 7 - Technical Proposal Cost Summary only seems appropriate for TO1 and TO2 where costs are proposed. Should it be left out of the IDIQ technical?

Answer: Yes, Attachment No. 7 - Technical Proposal Cost Summary only applies for Task Order No.

1 and Task Order No. 2. It is not applicable for the IDIQ because there are not costs associated to it.

10. Question: Attachment 7 – Technical Proposal Cost Summary, are we to indicate costs for both TO1 and TO2? If so, do we combine them or submit two separate versions?

Answer: Offerors are required to submit separate technical proposals for each task orders, therefore, Attachment no. 7 have has to be included under each one. See also answer to question no. 9.

11. Question: Attachment 9 - Protection of Human Subject Assurance only seems appropriate for TO 2 where we are proposing to enroll subjects. Should it be left out of the IDIQ and TO 1 technical proposals?

Answer: Attachment No. 9 – Protection of Human Subject Assurance is applicable to the overall project, therefore to the IDIQ contract.

12. Question: We are naming subcontractors who will solely serve as trial recruitment sites (they will not be conducting visits). Do they meet the definition of “subcontractors proposed for the conduct of clinical trials” as referenced in Attachment 5? Do we need to furnish staffing, management, and recruitment plans for these sites?

Answer: You still have to submit a staffing plan to demonstrate the subcontractor’s experience, qualifications, availability and explain the work they will perform. See Attachment No. 5, page 2-3, C.1.a-h.

13. Question: Attachment 5 makes a distinction between “management” and “staffing” plans. However, the technical evaluation factors for IDIQ/TO1 include elements of the staffing plan under “management plan” (p.102). Can you confirm if these are indeed two separate sections and, if so, if IDIQ/TO1 will be evaluated for staffing plan as well.

Answer: Yes, these are separate sections: “management” is regarding the overall oversight, “staffing” is regarding the personnel needed to conduct the work.

14. Question: For all personnel we are to “state the estimated time, proposed duties and the areas or phases for which he/she will be responsible” (technical proposal instructions, p.61). I am assuming we list this information in each portion of the technical proposal (IDIQ, TO1, TO2). For the IDIQ, do we describe these details for work performed on both task orders combined or TO1 only?

Answer: Only for Task Order 1 and Task Order 2 that have associated costs.

15. Question: Is the Certificate of Current Cost or Pricing Data (FAR 15.406-2) required? This form attachment was not included in Section J Business Proposal attachments.

Answer: Certified Cost and Pricing Data is not required for this acquisition.

16. Question: Should we include, as part of our Cost/Pricing data, Business Proposal, a budget justification/narrative?

Answer: Yes, Offerors are required to submit a budget narrative. See page 82 of the RFP: “The offeror shall support any data provided with explanations or supporting rationale, as needed, to permit the Contracting Officer and authorized representative to evaluate the documentation”.

17. Question: Our site is submitting a proposal to be a PK Site – will it be necessary to travel to NIH offices to discuss this protocol prior to implementation? And, are funds allowed for travel to a national scientific meeting to present PK study results in addition to the travel funds already allowed for TO2?

Answer: No, travel will not be necessary; protocol will be done electronically or by teleconference. We will have an investigators meeting prior to initiating the protocol. Since the PK will be done as a sub-study within the main protocol, it is not necessary to have a separate meeting.

18. Question: We currently have a -80 degree Celsius freezer. However, it is likely that it will not be functional for the full duration of this contract. Is it acceptable to include the cost of a new freezer at year 4 of the TO1?

Answer: Due to budget limitations, fund will not be provided new equipment.

19. Question: At the bottom of NIH-2043, the box right above the "Signature of Business Representative" says, "THIS OFFER EXPIRES ____ DAYS FROM THE DATE OF THIS OFFER (120 days if not specified)."

I don't see any mention of the offer expiring in the RFP. Could you advise me on what the intention is with the above statement? Is there a preferred number of days I should put in there? It would be great if I could provide me with some kind of instruction or clarification so that I could make a better assessment of what to put in the blank space. Is there a preferred date? How's 1-year from the date of submission? What are our advantages and disadvantages with this date?

Answer: The period of time that an offer is valid is strictly up to the individual offeror and we can’t advise you in this matter. Please keep in mind that the anticipated award date is November 15, 2012. In addition, if you do not list the number of days on the form the proposal will be valid for 120 days.

20. Question: What systems would be involved in the project?

Answer: Web-based systems are likely to be provided by the SCCC, so sites need only have web-access and existing computer hardware.

21. Question: We would like to find out if we have to put all the CVs in all the Technical Proposals or just in the IDIQ Contract?

Answer: Offerors must include CVs or resumes of the proposed staff as part of the specific project they are proposed to work on.