Solicitation Amendment 00002.doc

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

2. AMENDMENT/MODIFICATION NO.

00002

3. EFFECTIVE DATE

04/20/2010

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

FORMTEXT

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, Rm 3000

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (PGO)

Procurement and Grants Office

2920 Brandywine Rd, Rm 3000

Atlanta, GA 30341-5539

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

X

9A. AMENDMENT OF SOLICITATION NO.

2010-N-11535 9B. DATED (See Item 11) 03/31/2010

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers _ is extended, X_ 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 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 ACKNOWLEGMENT

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.

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

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

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

Amendment 00002 is hereby issued to address the following regarding solicitation 2010-N-11535:

1. Respond to questions specific to Task Order 3 receievd by April 12, 2010;

2. The proposal due date has not been extended.

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 OF CONTRACTING OFFICER

Leonard M. Mutter III

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

NSN 7540-01-152-8070

STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE

30-105 Prescribed by GSA

FAR (48 CFR) 53.243

Amendment 00002 is hereby issued to respond to questions specific to task order 3 submitted to solicitation 2010-N-11535:

131. For Sample Task Request 3, after the completion of the Pre-Study Visit/Initiation Site Visits, if we determined there are significant issues with a site that would prevent them from adequately following the study protocol and completing the study, are we required to assist them with resolving these issues? For example, if the site has no locking filing cabinet to store sensitive documents, are we to assist the site in obtaining such equipment?

Answer: contractor is to provide technical assistance to the partner for them to make the improvements. This may include providing a report or list of corrective or necessary actions that must be taken but not necessarily the acquisition of equipment.

132. Will the clinical sites be provided human subject research and study implementation training prior to the pre-study/initiation site visit? If not, is the contractor expected to provide this training?

Answer: Comprehensive training programs are not part of this TO. The contractor is to assess site and staff readiness/ability to conduct and implement the protocol as part of Task #1. The contractor is to provide remedial and ongoing TA/guidance as necessary.

133. Is the study involved in this project a clinical trial for which it must adhere to FDA regulations? If yes, is this study being conducted to change labeling on an approved project or for approval of a new product?

Answer: The study is not subject to FDA regulations.

134. How many study subjects will there be at each site?

Answer: Approximately 10,000 or 240 per clinical site.

135. Will the contractor be responsible for monitoring and assuring site adherence to Kenya national human subject research regulations?

Answer: The contractor will be responsible for monitoring and ensuring investigators adhere to the IRB approved protocol and meet the reporting requirements (i.e., AEs, renewal) of other approving agencies (e.g., MOH, local ethics committee). The protocol may be approved by more than one regulatory agency (e.g., CDC IRB, local IRB, other national agency). The contractor should confirm all regulatory and reporting requirements with the investigators and ethics committees of record. [

136. Is this study a HIV/AIDS vaccine study?

Answer: No.

137. Will the study include children or pregnant women?

Answer: The study does not specifically target vulnerable populations but may include pregnant women.

138. What kind of organization is serving as a site (e.g., local clinics, hospitals, medical schools, etc.)

Answer: The study intends to include rural and urban clinical sites. These may or may not include the examples given.

138. The task period of performance is stated as “Eighteen months from date of award of the task order”, but the due date deliverable for Task #3 is defined as “Within eighteen months after the notification of study closure”. This places the due date for Task #3 deliverable outside of the task order period of performance, please clarify the dates.

Answer: The period of performance for the study is 24 months.

140. On page 2 of Sample Task Order #3, the PWS states that the purpose of the contract is to “monitor the sponsored clinical trial”, does this mean that the trial is sponsored by CDC or by a private pharmaceutical company?

Answer: CDC

141. What is the length of the enrollment period at each site?

Answer: approx. 6-9 months

142. What is the duration of participation for each study subject?

Answer: approx. 6 months

143. Is the patient clinical visit for participating in this study part of a regular care visit or a special visit to the clinic?

Answer: Both

144. In Task #3, the PWS requires that the contractor “confirms that pertinent IRBs have been informed that the study has closed. OHRP regulations states that a study site cannot close if the site continues to have possession of identifiable data”. At the point of the close-out site visit, will CDC have possession of the site study files/medical records?

Answer: The study may or may not capture or retain identifiable information or specimens. CDC will not necessarily receive all study files at the time of close-out. Agreements with the country or countries regarding data retention may apply.

145. How will research documents be maintained at study sites - in paper or electronic files or a mix of both?

Answer: Varies by country and site capacity.

146. Will the monitoring be expected to adhere to ICH Standards for Monitoring?

Answer: Yes. In some cases, sponsored agencies/institutions may have chosen additional standards as part of their Federalwide Assurance.

147. Will the contractor be responsible for monitoring for adherence to Kenya national human subject research and clinical trial regulations?

Answer: See 135 above.

148. Related to task #3

a. How many protocols are being researched? Is the number of protocols consistent at each site?

Answer: In the scenario given, the same protocol is being implemented by 4 agencies/institutions in 42 total clinical sites. Each agency/institution may have slightly different requirements or logistics for implementation. [my reference to 4 “agencies” is synonymous to “countries”. See item c below.]

b. Will a protocol synopsis and/or schedule of the research be provided?

Answer: The specific protocol is unknown at this time.

c. What is the expected number of participants at each of the 4 research sites?

Answer: There are approximately 10,000 participants roughly evenly distributed across 42 clinical sites.

End of Questions

ITEM 10A.