Amendment 1 RFP HHS-NIH-NIDA-AG-RFP-11-159 3-15-12.doc

HHS-NIH-NIDA(AG)-RFP-11-159

Amendment No. One (1)

OMB Approval 2700-0042

OF

PAGES

7. ADMINISTERED BY (If other than Item 6)

National Institute on Aging NIMH/NIA R&D Contracts Management Branch

NIDA Neuroscience COAC

National Institutes of Health

6001 Executive Boulevard, Room 8154, MSC 9661 Bethesda, MD 20892-9661

TO PROSPECTIVE OFFERORS

“NIA CLINICAL TRIALS OPERATIONS SUPPORT CENTER”

HHS-NIH-NIDA(AG)-RFP-11-159

2/21/2012

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE

FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FORMCHECKBOX

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

FORMCHECKBOX

is extended, FORMCHECKBOX 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.

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

FORMCHECKBOX

is not, FORMCHECKBOX 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 respond to questions received from potential offerors. The responses are offered for information only and do not modify or become part of this solicitation.

Offerors must acknowledge receipt of the final posting of Amendment #1, on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The due date for submission of proposals is unchanged (4:00 PM, Eastern time on April 6, 2012).

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.

Yvette Brown Contracting Officer, NIDA Neuroscience COAC

16C. DATE SIGNED

(Signature of person authorized to sign)

BY _____________________________________

(Signature of Contracting Officer) 3/15/12

NSN 7540-01-152-8070

30-105

STANDARD FORM 30 (REV. 10-83)

THE FOLLOWING PROVIDES ANSWERS CONCERNING A NUMBER OF INQUIRIES WE HAVE RECEIVED FOR THE ABOVE NUMBERED ACQUISITION:

Question 1 Page 80 of the RFP provides the following requirement:

“Accessibility of staff: The contract will require that personnel be available for up to 10 hours per week to meet with NIA staff in Bethesda, Maryland, with three hours notice, for the purpose of reviewing progress and discussing data analysis and quality assurance issues.”

A similar requirement is embedded in the Availability section appearing on page 3 of the Statement of Work. However, the statement of work requirement does not state that such meetings have to be face-to-face onsite at the NIA. Confirm specifically if participation in these meetings must be onsite at the NIA, versus participation via teleconference or videoconference with the same level of notice.

Response:

Yes, participation in these meeting must be onsite at NIA in Bethesda, Maryland.

Question 2 Is it acceptable for the meetings required “with three hours notice, for the purpose of reviewing progress and discussing data analysis and quality assurance issues” take place via telephone or video conference instead of in person? Will a representative be needed for these impromptu meetings in order to be considered for award?

Response:

As stated above, participation in these meeting must be onsite at NIA in Bethesda, Maryland.

Question 3 Is it the Government’s intention to make a single award of an IDIQ contract with subsequent task orders rather than the award of a completion-type contract?

Response:

Yes

Question 4 Is it the Government’s intention that the maximum amount that can be awarded under the contract is $3,750,000, to cover all task orders over the five-year span of the contract?

Response:

Yes

Question 5 Article L.1.e of the RFP states the expected level of effort of the work is 14,820 labor hours. Is this amount for the first year of the contract or is it expected to cover all five years? Or is this amount for the sample task order provided in Attachment 6?

Response:

The expected level of effort is to cover all five years.

Question 6 The RFP states, “the Government considers the effort to be approximately 14,820 hours for a small business set aside for IDIQ, for no more than $3,750,000. Are these figures correct?

Response:

Yes

Question 7 Concerning section L.2.b, RFP Technical Proposal Instructions, and b.1.a of Task order 1: The RFP states that the proposals shall be based on the requirements of Task Order 1, which has a 12 month period of performance, plus the entire contract period of performance of five years. Do these two periods need to be in separate sections of the proposal, or can offerors present an integrated approach annotating the differences, where applicable?

Response:

The NIA requests a proposal for Task Order 1, which represents the first year of performance, and for the entire five year period of performance. The offeror’s business proposal should provide a breakdown of proposed cost on a yearly basis.

Question 8 Task Order 1 appears to ask for a detailed plan for all work areas for year 1 of the contract period while the entire contract proposal expands the same work areas to the five year period. Do these two responses encompass an IDIQ response? Is the RFP asking for two separate technical as well as business proposals for Task Order 1 and for the 5-year IDIQ contract.

Response:

The offeror’s proposal for Task 1 and the offeror’s proposal for the entire five year period of performance encompass the IDIQ proposal response. Offerors should provide a business proposal and a technical proposal for the entire five year period of performance, by year, noting that Year 1 is represented by(and is identical to) the proposal for Task Order 1.

Question 9 Concerning Work Area 3, “Safety-Related Operations Support”, of the Statement of Work, please provide the following information for uniform proposal assumptions:

a.

Number of SAEs expected for the first year

Response:

The number of AEs/SAEs reported in a clinical trial cannot be predicted. Thus, it is impossible to provide an answer to this question. Offerors shall review their previous experience with the number of AE/SAE reported in their trials, review trials funded by NIA and estimate the number.

b.

Number of quarterly safety report reviews expected for the first year

Response:

NIA estimates about 8.

c.

Number of trials for which quarterly SAE summaries need to be developed in the first year

Response:

NIA estimates about 10.

d.

Number of AEs to code per MedDRA in the first year.

Response:

The number of AEs/SAEs reported in a clinical trial cannot be predicted. Thus, it is impossible to provide an answer to this question. Offerors shall review their previous experience with the number of AE/SAE reported in their trials, review trials funded by NIA and estimate the number.

e.

Number of DSMBs that will require adverse event coding and executive secretarial support

Response:

NIA estimates about 10.

Question 10 Concerning Work Area 4, “Statistical and Methodological Consultation”, how many statistical consultation requests are anticipated?

Response:

The number of statistical consultation requests cannot be predicted. However, NIA estimates not fewer than 5 Question 11 Concerning Work Area 6, “Maintenance of the NIA Database on Human Intervention Studies,” please clarify the following:

a. Where is the current interventional studies database hosted?

Response:

Currently the interventional studies database is hosted at NIA.

i. If at the incumbent contractor, will the server and database be transferred to the successor contractor?

ii. If at the incumbent contractor, does the authentication process use NIH External Active Directory or a custom LDAP to verify user accounts?

b. What is the current RDBMS platform for this database?

Response:

Currently the RDBMS platform is MS ACCESS.

Question 12 What is the purpose of the three (3) Dell Latitude laptop computers which are listed as Government Furnished Property?

Response:

The purpose of the three laptop computers is to provide access to NIA/NIH IT resources.

Question 13 Is there a reading room available for this solicitation containing Standard Operating Procedures and other relevant materials?

Response:

No.

Question 14 Please identify the Key Personnel needed to support this RFP?

Response:

It is the Offeror’s responsibility to identify key personnel required to support the contract. However, typically the Prime Investigator (PI) is a” key personnel”.

Question 15 Is this a re-competition of the current project or an expansion to include future tasks as part of the IDIQ structure?

Response:

Yes this is a re-competition of the NIA Clinical Trials Support Center.

Question 16 Is there a page limitation for the Technical and Business proposals? Do Past Performances and Resumes count towards the page limitation?

Response:

There is no page limitation for the Technical and Business proposals.

Question 17 Is there a required format for the Technical Proposal?

Response:

Offeror’s are required to follow the instructions provided in Section L INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, of the RFP, paying particular attention to L.2.b, Technical Proposal Instructions.

Question 18 May offerors use the NIH Excel template in the business proposals for “Breakdown of Proposed Estimated Costs”?

Response:

Yes. The correct site for this spreadsheet including instructions is http://oamp.od.nih.gov/contracts/rfps/BUSCOST.HTM Question 19 Is the place of performance at the contractor’s site or at the Government site?

Response:

The place of performance will be primarily at the contractor’s site. In accordance with the Statement of Work, meetings will be held at the NIA site and travel will be required to clinical trial sites in the 48 continental states.

Question 20 Who is the incumbent on this RFP?

Response:

The contractor for the current “NIA Clinical Trials Support Center” contract is KAI Research, Inc.