Amendment 2 to RFP NIHAO2010049.pdf

AMENDMENT OF SOLICITATION / MODIFICATION OF

CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

1 1

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

June 10, 2010

4. REQUISITION/PURCHASE REQ. NO

5. PROJECT NO.

(If applicable)

6. ISSUED BY

National Institutes of Health, NIAID, AMOB

CODE

7. ADMINISTERED BY

10401 Fernwood Road, MSC 4813 Bethesda, MD 20817

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP code)

All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

NIHAO2010049

9B. DATED (SEE ITEM 11)

May 27, 2010

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

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.

Offerors 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 1 copies 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 ACKNOWLEDGEMENT 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 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 date 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 data, etc.) SET

FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY

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)

The purpose of this amendment is to answer questions received from potential offerors. Please see pages 2-5 for the complete list of questions and answers.

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)

Terrie Nestor, Contracting Officer, AMOB, NIAID

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

(Signature of person authorized to sign)

16C. DATE SIGNED

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

30-105

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

RFP General Questions:

1. Are the required documents of section 1 of the Technical Proposal excluded from the page limit?

Yes.

2. Are we allowed to print duplex and will that be counted against the page count?

Yes, printing in duplex is allowed and encouraged, but each side of a page will be counted as one page.

3. Section 1 of the Technical Proposal includes the Proposal Summary and Data Record (NIH- 2043), and it is also requested in the Business Proposal. Which proposal should it be include in?

Please include this form as part of the Business Proposal.

4. Can resumes be in the Appendix and not counted against the page count?

Resumes are not counted against the page limit. In addition, the IT Security Plan requirements are not included in the 35 page limit.

ALL other technical documents will be counted against the page limit.

RFP Technical Questions:

1. Should we assume only Phase I protocols will need safety labs?

No, at a minimum there will be ALT, Hgb and/or HCT labs needed at screening and after each study injection in Phase II.

2. Please confirm NIH wants Offeror to bid on biostatistical analysis as well as Clinical Study

Report.

Yes, Offeror’s bids should include support for biostatistical analysis and clinical study report.

3. Please confirm NIH does not want to include medical monitoring or SAE processing in this bid.

If these services are required, please identify the specifications and scope for the medical services as we did not see this information in the RFP.

NIAID/VRC will provide medical monitoring. SAE’s should be processed as per protocol requirements.

4. Task Order 001 (Task Area 1) – Will the contractor be responsible for payment to the sites?

5. Task Order 001 (Task Area 1) # 4 Paragraph 2 (Testing and Study Specimen Management) –

Does “responsible” mean specimen logistics at the clinic at time of collection or merely provisions and oversight of SOPs for this step?

The offeror is responsible for all aspects of the task order requirements. Although, the clinical site will be where the specimen logistics and sample collection takes place, the offeror is ultimately responsible for successful completion of all contract requirements.

6. Task Order 001 (Task Area 2) (Electronic Data Management Services) - What type of data reporting capabilities are being looked for in the EDC system?

Data that is validated, integrated and exportable in real time.

7. Task Order 001 (Task Area 2) (Electronic Data Management Services) - Are there any estimated

CRF counts for each type of study to be conducted under this RFP?

Refer to Question#12.

8. Task Order 001 (Task Area 2) (Electronic Data Management Services) - How frequently will interim analyses be performed on each type of study?

There will be no more than one interim analysis per protocol.

9. Task Order 001 (Task Area 3) - Does Task Area 3 include development of the CSR?

Yes

10. Task Order 001 (Task Area 3) - Who is responsible for any amendments to the INDs?

NIAID IND and Protocol Team.

11. Task Order 001 (Task Area 3) #3 (Study Data) - Does “responsible” mean initial data entry at the clinic or merely provisions and oversight of SOPs for this step?

The offeror is responsible for all aspects of the task order requirements. Although, the clinical site will be where the data entry takes place, the offeror is ultimately responsible for successful completion of all contract requirements.

12. For the purposes of preparing the proposal could you please provide the following information:

a. An estimated number of patient visits for each of the protocol types (phase 1, Phase 1B, phase 2, national history and sample collection).

For purposes of the proposal a maximum of 10 visits per participant per protocol is anticipated.

b. An estimated number of monitoring visits per protocol.

For purposes of the proposal use an estimate of 3 site monitoring visits per year per site.

c. An estimated number of sites per protocol.

The number of sites will vary depending upon the protocol type and size, but in general, there may be as few as 1 and would not be expected to be more than 10 site for any study.

d. Number of estimated unique pages of CRF pages for each study type.

The CRF’s are expected to be electronic and not pages per se. The number of CRF’s will depend upon the study, but for purposes of the proposal assume that a study with 6 visits and 90 participants will involve about 4500 electronic CRF screens to be completed.

e. Number of estimated users for the EDC system per study type (site and NIAID personnel).

For the purposes of the proposal; estimate that there may be 20 NIAID “read-only” users and up to 10 personnel per site that may need to access the EDC.

f. Are SAS datasets required to be in SDTM format?

SAS SDTM format capability is desirable; discuss your SAS capabilities in your proposal.

g. How many data transfers per study are expected to NIAID?

In general, the electronic data transfers of complete datasets to NIAID are expected to occur at the end of the study. However, NIAID expects to have access to assembled reports posted in electronic formats as part of the EDC about the data throughout the study, as needed routinely, for regulatory and safety monitoring.

h. Do you have an estimated number of samples to be collected for the natural history and sample collection study?

For the purposes of this proposal, a maximum of 10 samples per subject participant should be assumed.

13. Is overnight confinement required for any of the studies described in Attachment 7, or would all be done on an outpatient basis?

No, overnight confinement will not be required.

14. Attachment 7 refers to a 30 day start-up for the chosen Phase II site from award. Is there an IND already in place for that drug? If not, it will be impossible to create and submit an IND in that time frame, as FDA requires a 30-day waiting period before studies can start with a new IND.

All IND submissions will be performed by the NIAID IND and Protocol Team. Refer to Attachment 7 - Deliverables for description of “Phase II Infrastructure Development Plan and Activation Timeline” requirement that is due 30 days after contract award.

15. For the INDs, is the contractor to write both the pre-clinical reports and the summaries? Will the VRC prepare any pieces of the reports or is the contractor responsible for the complete document?

The NIAID/VRC will furnish a written document(s) that will be given to the Offeror. The Offeror will provide technical support via personnel with medical/scientific writing skills related to clinical trials. The Offeror will review, edit, assist with content development and format provided document(s) for clarity.

16. Are IND submissions to be electronic or paper? What format is required?

NIAID will be responsible for all IND submissions.

17. For the 4 INDs specified in Attachment 7, are these to be staggered or concurrent submissions?

Can a projected time frame for the submissions be provided?

Refer to Question#16.

18. Attachment 3 describes preparation and review of pre-IND briefing documents, as well as preparation of summaries. Is the contractor to be present at the meeting?

Please refer to the response in Question #15. The contractor will not be present at IND meetings.

19. Per Attachment 7 the contractor will generate 4 Investigator Brochures. Will the VRC provide any portion of the text? Attachment 3 mentions review of protocol and informed consents. Is the contractor to be involved in protocol generation?

NIAID/VRC will provide DRAFT Investigator Brochures and Protocols. Refer to response to Question #15 for the role of the contractor.

20. For the studies in Attachment 7, can a projected timeline for these studies be provided?

Preparation, implementation and activation will commence at the time of contract award.

21. The Natural History and Sample Collection requires PBMC cryopreservation and serum storage within 6 hours of blood specimen collection. This time frame requires the processing capability to be on-site or at a nearby facility. This biological processing capability is not normal at Phase I facilities. More normal requirement would be blood processing within 36 hours of collection.

Could this requirement be changed?

No, the Offeror is required to locate sites with this capacity.

22. Is the contractor expected to provide full statistical support including formatted, secure, and compatible data reports and analysis?

23. For the Safety Data Review, is the contractor expected to provide any safety tables, figures, and listings (such as AE, SAE, protocol deviations and other endpoints)? Is there any Data Monitoring Committee (DMC) support needed for interim safety review?

Yes, via EDC and as per protocol requirements.

24. Who will be responsible for medical monitoring and how will the Contractor interact with the medical monitor?

The Offeror is not asked to provide medical monitoring. The medical monitor will be provided by NIAID/VRC. The medical monitor will be available as needed to address protocol related safety issues.

25. The SOW states the contractor will "Assist trial sites with SAE/AE reporting and updates...";

will this contract be required to perform any SAE analyses or processing activities?

The Offeror should ensure that sites understand and follow the SAE’s reporting instructions provided via the protocol(s).

AMENDMENT OF SOLICITATION / MODIFICATION OF CONTRACT