Request for Quote _RFQ_ 2009-Q-11285.pdf

RFQ No. 2009-Q-11285 PAGE 1

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ IS X IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

1 8

1. REQUEST NO.

2009-Q-11285

2. DATE ISSUED

04/27/2009

3. REQUISITION/PURCHASE REQUEST NO.

00HCVGEB-2009-69143

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

Centers for Disease Control and Prevention (PGO)

Acquisition and Assistance Branch 2

2920 Brandywine Road, MS K-14

Atlanta GA 303415539

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

TELEPHONE NUMBER NAME

AREA CODE NUMBER

Russell Oxford (770) 488-2082

8. TO: 9. DESTINATION

a. NAME b. COMPANY a. NAME OF CONSIGNEE

c. STREET ADDRESS b. STREET ADDRESS

c. CITY

d. CITY e. STATE f. ZIP CODE d. STATE e. ZIP CODE

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

05/04/2009

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

PROJECT TITLE:

Effectiveness of Rotavirus Vaccine

SEE ATTACHED STATEMENT OF WORK

“See Continuation Page”

Quotes must be received via email or fax no later than 5:00PM EST on Monday, May 4, 2009. Please reference the Solicitation

Number 2009-Q-11285 in the email subject line, or annotate on fax cover sheet.

Please email quotes to roxford@cdc.gov or fax to 770-488-2044.

d. CALENDAR DAYS

NUMBER PERCENTAGE

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

d. CITY e. STATE f. ZIP CODE c. TITLE (Type or print) NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 18 (REV. 6-95)

Previous edition not usable Prescribed by GSA FAR (48 CFR) 53.215-1(a)

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule)

RFQ No. 2009-Q-11285 PAGE 2

Line Items

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Rotavirus Vaccine Project

**Effectiveness of Rotavirus Vaccine in

Preventing Rotavirus Gastroenteritis**

1. Assess the duration of pentavalent rotavirus vaccine protection among children 1 - <3 years of age

2. Determine the vaccine effectiveness of mixed receipt of monovalent and pentavalent rotavirus vaccine among children 15 days - <12 months of age

3. Evaluate vaccine effectiveness against the most commonly detected strain during the 2009 season

1 Job

STATEMENT OF WORK

SOLICITATION NUMBER : 2009-Q-11285

Title of Project: Effectiveness of Rotavirus Vaccine in Preventing Rotavirus Gastroenteritis

C.1 Background and Need

Rotavirus gastroenteritis is the most common cause of severe diarrhea in US children <5 years of age, accounting for more than 30% of all severe childhood gastroenteritis episodes requiring medical attention.

In 2006, a pentavalent rotavirus vaccine was licensed and recommended for use in the United States and in 2008, a monovalent rotavirus vaccine was licensed and recommended. In an evaluation of the rotavirus vaccine program during the 2008 season, the pentavalent rotavirus vaccine was found to be 85%-89% effective against rotavirus acute gastroenteritis requiring an emergency department visit or inpatient admission during the first rotavirus season post-vaccination. With the introduction of the monovalent vaccine, it is important to determine the effectiveness of monovalent and pentavalent rotavirus vaccines when used simultaneously in the community and in combination for individual patients. Additionally, as vaccinated children become older, it is necessary to document the duration of protection conferred by vaccination during subsequent seasons. Furthermore, given the wide variety of heterotypic rotavirus genotypes not included in present day vaccines and the constant evolution of new strains, it is important to monitor protection against all rotavirus strains and determine if changes occur in circulating strains as a result of vaccine selection pressure in the post-vaccination era.

C.2 Project Objective

1. Assess the duration of pentavalent rotavirus vaccine protection among children 1 – <3 years of age.

2. Determine the vaccine effectiveness of mixed receipt of monovalent and pentavalent rotavirus vaccine among children 15 days – <12 months of age.

3. Evaluate vaccine effectiveness against the most commonly detected strain during the 2009 season.

RFQ No. 2009-Q-11285 PAGE 3

C.3 Scope of Work

The contractor shall provide all labor, equipment, supplies, and facilities necessary to 1) conduct active surveillance in the emergency department and inpatient wards to identify children age <3 years of age presenting with acute gastroenteritis, 2) collect immunization information from all enrolled children, and

3) enroll control patients <3 years of age presenting with acute respiratory illness.

The Period of performance will not exceed 12 consecutive months following the award of a U.S.

Government Purchase Order / Contract.

C.4 Technical Requirements

The Contractor shall conduct the following tasks:

1) Conduct active surveillance for acute gastroenteritis: Children ages 15 days – <3 years with diarrhea

(≥3 loose stools in a 24 hour period) who present for treatment shall be enrolled in the active surveillance program. Information about the history of the illness and a stool specimen should be collected from each enrolled patient. Serum or plasma shall be collected from patients who have blood drawn as part of their clinical care.

2) Test collected stool specimens: Stool specimens shall be tested for rotavirus using an enzyme immunoassay (EIA).

3) Enroll control patients with acute respiratory infections: Children ages 15 days – <3 years with acute respiratory infection (ARI) symptoms who present for treatment shall be enrolled as control-patients.

4) Collect rotavirus immunization history on all enrolled cases and controls: Immunization records shall be obtained from the parent/guardian of participants, if available at the time of enrollment. ImmTrac, the statewide immunization registry, shall also be searched for immunization records and the patient’s most recent immunization providers shall be contacted for immunization records

C.5 Reporting Schedule

All work shall begin within 7 calendar days after date of award of the order and shall be completed within

1 year after date of award.

The vendor shall provide a monthly progress report along with his invoice showing the number of cases and controls enrolled during the month, the number of stool and serum specimens collected, and the number of stool and serum specimens collected that tested positive for rotavirus.

C.6 Special Considerations

Confidentiality of Data: Data will be kept on password-protected computers behind security firewalls.

All printed data and electronic data will be kept in locked offices. Only the PI and the PI's staff will have access to the data. The potential risk of a loss of confidentiality will be minimized by the use of study identification numbers, which can only be linked to the patient by the study investigators.

Human Subjects Review: The vendor shall obtain approval to conduct the study from their Institutional

Review Board prior to beginning data collection.

RFQ No. 2009-Q-11285 PAGE 4

Identification and Disposition of Data: Databases containing clinical histories of diarrhea patients, rotavirus test results, and immunization records from all cases and controls along with a brief report with information deemed to be relevant for data analysis and interpretation shall been delivered to the project officer at CDC. Data shall be submitted in Access, Excel, or other similar flat file format. Additionally, aliquots of serum, plasma, and stool specimens shall be sent to the viral gastroenteritis laboratory at CDC.

The key linking study identification numbers with individual patients shall be maintained by the vendor and shall be destroyed when instructed to do so by CDC.

Review of Data: Data generated as part of this contract will be reviewed by staff epidemiologists in the

Division of Viral Diseases prior to publication or dissemination to the general public.

C.7 Government Furnished Property

The vendor shall provide all equipment required to perform the services.

C.8 References - NONE

C.9 Deliverables

All data collected including clinical histories of diarrhea patients, rotavirus test results, and immunization records from all cases and controls along with a brief report with information deemed to be relevant for data analysis and interpretation shall be delivered to the project officer at CDC by contract end date.

Additionally, aliquots of serum, plasma, and stool specimens shall be sent to the viral gastroenteritis laboratory at CDC. Data shall be submitted in Access, Excel, or other similar flat file format. All laboratory specimens shall be sent to:

Rotavirus Laboratory, Attention: Jon Gentsch

C/o Tara Kerin

Division of Viral Diseases

Centers for Disease Control and Prevention

1600 Clifton Rd., NE

DASH Unit 75

Mailstop G-04

Atlanta, Georgia 30333

Item

Description

Quantity

Delivery Date

1 Progress report showing active surveillance, control enrollment, and collection of immunization records

1 to Project Officer Monthly following the end of the month

2 Synthesis of surveillance data, test results, and immunization records into database 1 to Project Officer By contract end date

3 Aliquots of serum, plasma, and stool specimens

1 Aliquot from all available specimens to

CDC Viral

Gastroenteritis

Laboratory

By contract end date

RFQ No. 2009-Q-11285 PAGE 5

C.10 Project Officer

Jacqueline Tate, PhD

Epidemiologist

Epidemiology Branch/Division of Viral Diseases

National Center for Immunizations and Respiratory Diseases

1600 Clifton Road, NE, MS-A47

Atlanta, Georgia 30333

Tel: 404.639.4559

Fax: 404.639.8665

E: jqt8@cdc.gov

C.11 Payment Terms

Payment will be made for each month the work is completed within 30 days after receipt and acceptance of the work by the Project Officer, provided that the contractor prepares and submits an acceptable invoice.

Invoicing Instructions This is a Firm Fixed Price Purchase Order / Contract. The Contractor is authorized partial payments (monthly invoicing); however, the total sum of all invoices submitted to the CDC Financial Management Office will not exceed the contract amount as annotated on Page 1, block 17(i) of the Purchase Order (Optional Form

347).

The Contractor shall mail the ORIGINAL copy of the invoice/voucher to the BILL TO address shown below; or fax / email a *signed copy of the invoice to:

fax number : (404)-638-5324 email address: fmoapinv@source.cdc.gov

*Signed copy of the invoice shall include the legal signature - and typed signature block - of an authorized representative of the business/ organization submitting the invoice/ voucher for payment.

BILL TO ADDRESS:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

In addition, the contractor shall email or fax an additional copy (1 copy) of the invoice/voucher to the

CDC Project as listed below:

Jacqueline Tate, PhD

CDC / National Center for Immunizations and Respiratory Diseases

Epidemiology Branch/Division of Viral Diseases

1600 Clifton Road, NE, MS-A47

Atlanta, Georgia 30333

Tel: 404.639.4559

Fax: 404.639.8665

E: jqt8@cdc.gov

RFQ No. 2009-Q-11285 PAGE 6

The Contractor agrees to include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information above.

(13) DUNS + 4 Numbers

In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

Once a correct and complete copy of the invoice(s) have been forwarded to the appropriate CDC Office and/or Individual, PLEASE CALL THE CDC Financial Management Office (FMO) HELP DESK 770-

498-4050 (1-800-335-2455) TO INQUIRE ABOUT PAYMENT STATUS.

*FAILURE TO FOLLOW THESE INSTRUCTIONS WILL RESULT IN DELAYED or DENIED PAYMENT.*

C.12 Minimum Vendor Qualifications

The vendor must have a large patient population (at least 750 cases of acute gastroenteritis among children <2 years of age seen in the emergency department per year for the past 2 years) that will ensure collection of adequate numbers of specimens (at least 70 rotavirus positive stool specimens) to calculate vaccine effectiveness during a dampened rotavirus season. In a rotavirus vaccine effectiveness evaluation performed, 90 rotavirus positive cases were indentified which enabled vaccine effectiveness to be estimated.

The vendor must have knowledge of vaccine coverage rates to assess vaccine impact and access to an immunization registry to obtain immunization status of enrolled participants as well as established relationships and protocols with area physicians to collect immunization data on patients not included in the registry.

The vendor must have established protocols for data collection that will enable rapid and efficient collection of data during an abbreviated rotavirus season.

C.13 Evaluation of Quotes / Proposals

A competative negotiation source selection process is employed where non-price factors of a vendor’s qualifications are evaluated to determine which quotes / proposals are technically acceptable and award is made to the offeror of a technically acceptable proposal with the lowest price.

RFQ No. 2009-Q-11285 PAGE 7

Federal Acquisition Regulation (FAR)

Provisions / Clauses

FAR SOURCE TITLE AND DATE

52.203-6 Restrictions on Subcontractor Sales to the Government (Sep 2006)

52.204-7 Central Contractor Registration (Apr 2008)

52.204-9 Personal Identity Verification of Contractor Personnel (Sep 2007)

52.207-4 Economic Purchase Quantity - Supplies (Aug 1987)

52.211-16 Variation in Quantity (Apr 1984)

52.213-1 Fast Payment Procedure (May 2006)

52.213-2 Invoices (Apr 1984)

52.219-8 Utilization of Small Business Concerns (May 2004)

52.219-9 Small Business Subcontracting Plan (Apr 2008)

52.219-14 Limitations on Subcontracting (Dec 1996)

52.222-3 Convict Labor (Jun 2003)

52.222-19 Child Labor - Cooperation with Authorities and Remedies (Feb 2008)

52.222-21 Prohibition of Segregated Facilities (Feb 1999)

52.222-26 Equal Opportunity (Mar 2007)

52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and

Other Eligible Veterans (Sep 2006)

52.222-36 Affirmative Action for Workers With Disabilities (Jun 1998)

52.222-37 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and

Other Eligible Veterans (Sep 2006)

52.222-41 Service Contract Act of 1965 (Nov 2007)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 1989)

52.222-43 Fair Labor Standards Act and Service Contract Act - Price Adjustment (Multiple Year and Option Contracts) (Nov 2006)

52.222-44 Fair Labor Standards Act and Service Contract Act - Price Adjustment (Feb 2002)

52.222-47 Service Contract Act (SCA) Minimum Wages and Fringe Benefits (May 1989)

52.222-50 Combating Trafficking in Persons (Aug 2007)

52.223-6 Drug-Free Workplace (May 2001)

52.223-9 Estimate of Percentage of Recovered Material Content for EPA-Designated Items

(May 2008)

52.223-9 Alternate I Estimate of Percentage of Recovered Material Content for EPA-Designated Items -

Alternate I (May 2008)

52.225-1 Buy American Act - Supplies (Jun 2003)

52.225-3 Buy American Act-Free Trade Agreements-Israeli Trade Act (Aug 2007)

52.225-3 Alternate I Buy American Act - Free Trade Agreements - Israeli Trade Act - Alternate I (Jan

2004)

52.225-3 Alternate II Buy American Act - Free Trade Agreements - Israeli Trade Act - Alternate II (Jan

2004)

52.225-5 Trade Agreements (Nov 2007)

52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008)

52.225-15 Sanctioned European Union Country End Products (Feb 2000)

52.225-16 Sanctioned European Union Country Services (Feb 2000)

52.226-4 Notice of Disaster or Emergency Area set-Aside (Aug 2006)

52.226-5 Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007)

52.232-25 Prompt Payment (Oct 2008)

52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration (Oct 2003)

52.232-34 Payment by Electronic Funds Transfer - Other than Central Contractor Registration

(Jul 2004)

52.232-36 Payment by Third Party (May 1999)

RFQ No. 2009-Q-11285 PAGE 8

52.233-3 Protest after Award (Aug 1996)

52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

52.239-1 Privacy or Security Safeguards (Aug 1996)

52.243-1 Changes - Fixed Price (Aug 1987)

52.243-1 Alternate I Changes - Fixed Price - Alternate I (Apr 1984)

52.243-1 Alternate II Changes - Fixed Price - Alternate II (Apr 1984)

52.243-1 Alternate III Changes - Fixed Price - Alternate III (Apr 1984)

52.243-1 Alternate IV Changes - Fixed Price - Alternate IV (Apr 1984)

52.243-1 Alternate V Changes - Fixed Price - Alternate V (Apr 1984)

52.247-68 Report of Shipment (REPSHIP) (Feb 2006)