AMENDMENT 00001 - CISA.docx

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT

00001

3. EFFECTIVE DATE

06/12/2012

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

Centers for Disease Control & Prevention (CDC)()

Procurement and Grants Office (PGO) Acquisition and Assistance, Branch II, Team I 2920 Brandywine Road Atlanta, GA 30341-5539

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

TO WHOM IT MAY CONCERN

X

9A. AMENDMENT OF SOLICITATION NO.

2012-N-14296 9B. DATED (See Item 11) 5/24/2012

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 6 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 RESULTIN 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.

ITEM 10A.

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.)

This document lists the changes to Solicitation 2012-N-14296. The changes are highlighted in yellow with the bold italics fonts. See pages 2-5.

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

16A. NAME OF CONTRACTING OFFICER

Jeffrey A. Miller

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

06/12/2012

NSN 7540-01-152-8070

STANDARD FORM 30 (REV. 10-83)

SOLICITATION 2012-N-14296 AMENDMENT 00001 – PAGE 2 OF 5

1. Solicitation Document Section C.4: Technical Requirements Subsection: C.4.1, Requirement 1: Clinical case reviews and evaluation of vaccine safety issues, and coordination activities to support this function. Paragraph 4, add the 2 sentences below:

The Contractor may provide clinical expertise in various disciplines. In this capacity, the Contractor may need input from experts who can participate in the clinical review, synthesis and evaluation activities. In addition to knowledge of vaccine safety, examples of the areas of expertise include pediatrics, internal medicine, allergy, neurology, and obstetrics and gynecology. The Contractor may also provide selected subject matter expertise to CDC for other ongoing activities regarding vaccine safety. The Contractor should be knowledgeable about standards of care for US medical practice and US medical policies (e.g., Advisory Committee on Immunization Practices (ACIP) recommendations, published by CDC). The Contractor must have experience providing medical advice or consultations to US healthcare providers.

2. Solicitation Document Section C.4 Technical Requirements Subsection C.4.2 Requirement 2: Research studies to advance knowledge of vaccine safety and inform clinical and public health practice. Paragraph 2, add the phrase below

Under this contract requirement, Contractors may conduct all activities that would support the management and development of this research requirement within CISA as required in the applicable Task Orders. Activities include those directly related to conduct of the study such as enrolling patients residing in the United States, collecting patient data (including biological specimens), and analyzing data. In addition, the Contractor may obtain Institutional Review Board (IRB) documentation, organize phone conferences and meetings, prepare minutes, and provide cost reports to CDC. The Contractor may also provide the appropriate facilities, data management, and other equipment necessary for conducting this requirement. This includes the appropriate office facilities, record keeping, disaster recovery plans, computer hardware and software, communication, and conferencing equipment.

3. Solicitation Document Section C.5 Place of Performance

Note: the information in section C.5 is replaced with the following sentence:

Place of performance will be specified on the individual Task Orders.

4. Solicitation Document Section L.11 Technical Proposal Instructions Subsection 1. Technical Approach and Methodology, add the phrases below to a. and d.

In preparing the technical response portion to the clinical vaccine safety evaluation and research components of the CISA project, the Offeror shall provide a narrative and other information that is considered relevant to the work required to provide the services identified that best demonstrates the Offeror’s technical capabilities and innovative approaches in those areas.

SOLICITATION 2012-N-14296 AMENDMENT 00001 – PAGE 3 OF 5

The Offeror shall specifically address aspects such as technical understanding, methodology and approach, for the items below.

a. The Offeror shall describe their ability and general approach to conducting clinical case reviews and evaluations for individual vaccine safety cases referred from healthcare providers in the United States, across the life stages, which have been assigned by CDC.

d. The Offeror shall describe the approach they would take to recruit an adequate number of pregnant women residing in the United States to conduct vaccine safety clinical studies, including collection of biological specimens. The Offeror should specifically describe how they would explore the potential effect of immune responses after vaccination during the first trimester and shortly before conception on pregnancy outcomes.

5. Solicitation Document Section L.11 Technical Proposal Instructions Subsection 2. Management, Staffing and Experience, add the phrase below to c.

c. Provide a description of the Offeror’s organization, include, the name, the type of facility, and the organization’s experience and capability in developing projects as specified in this PWS. Describe how your organization will be well suited to implement the clinical and research components of this PWS, including access to patients residing in the United States, an Institutional Review Board, and clinical experts.

6. Solicitation Document Section L.11 Technical Proposal Instructions Subsection 2. Management, Staffing and Experience, add the sentence below to b.

b. The Offeror shall describe the approach they would take to provide clinical experts in various disciplines that would be readily available to participate in the Working Groups for clinical case evaluations. This narrative should specifically describe how expertise in the following disciplines will be routinely covered: pediatrics, internal medicine, infectious diseases, neurology, allergy, and obstetrics and gynecology. In addition, the Offeror should explain how they would identify experts in other disciplines to address a wide variety of clinical cases, such as experts in inborn errors of metabolism, sleep disorders, ophthalmology, or immunology. The Offeror shall demonstrate knowledge and experience of standards of care for US medical practice

SOLICITATION 2012-N-14296 AMENDMENT 00001 – PAGE 4 OF 5

7. CISA SAMPLE TASK ORDER #3, Attachment J.3: Title of Project: Adverse Events Following Immunization in Persons with Autoimmune Diseases Section 8. Technical Requirements, add the phrases below Page 3 to 4

With technical guidance from CDC, the Contractor shall accomplish the following two activities: 1) Develop a draft protocol for a prospective clinical study of vaccine safety in persons with autoimmune diseases residing in the United States and 2) complete an IRB approved pilot study within 12 months of the Contract award. The Contractor shall be the primary site and lead the pilot study, under technical guidance from CDC. The Contractor could conduct the study as a single or multi-site study. The study shall recruit persons residing in the United States. All Contractors or sub-Contractors involved in the study must adhere to federal and institutional policies for human subjects protection. In addition, CDC policies for scientific review and clearance of protocols, abstracts, and manuscripts would apply (see the Special Considerations Section C.9.2 and C.9.3 of the Basic PWS). Additional specifications are described below.

8. FAR clause 52.232-18 Availability of Funds (APR 1984) is added to the contract in Section I-1 – Clauses Incorporated by Reference, and is also applicable to each Sample Task Order.

9. All Offerors are required to e-mail complete copies of their technical and business proposal to afx2@cdc.gov and submit six (6) hard copies of their technical and business proposal to the below address:

Centers for Disease Control and Prevention (CDC) Procurement and Grants Office (PGO) Acquisition and Assistance, Branch II, Team I ATTN: Jeff Miller, K-14 2920 Brandywine Road Atlanta, GA 30341-5539

10. Solicitation Document The following statement is added to Section L of the solicitation: CDC reserves the right to award all, some or none of the Sample Task Orders.

SOLICITATION 2012-N-14296 AMENDMENT 00001 – PAGE 5 OF 5

11. Solicitation Document Section: L.11 Technical Proposal Instructions Figure 1: CISA Project Organization for Sample Tasks; replaced figure 1 with the figure below

Figure 1: CISA Project Organization for Sample Tasks

This diagram is for illustrative and informational purposes only.

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