JA_1100793_R.pdf

Req #1100793

Justification and Approval (J&A) FAR 6.302-1:

1. Agency: Food and Drug Administration (FDA), Department of Health and Human Services

a) OVRR/Mail Code:HFM-434

b) 9000 Rockville Pike, Bethesda, MD 20852

c) Contracting Activity: OAGS, 5630 Fishers Lane, Rockville, MD 20857

2. Nature of Action Being Proposed for Approval: The FDA intends to issue a sole source contract to the Oklahoma University Health Sciences Center (OUHSC). The purpose and objective is the Characterization and Use of a Baboon Model of Pertussis Disease and Transmission.

3. Title and Description of Supplies or Services and Estimated Value:

a) Characterization and Use of a Baboon Model of Pertussis Disease and Transmission

b) Contract/Order Number: TBD

c) Description of supplies or services: See #5

d) Estimated Dollar Value for a T&M contract:

1. Base: $565,000.00

2. Option Year 1: $445,000.00

3. Option Year 2: $445,000.00

4. Option Year 3: $445,000.00

4. Statutory Authority:

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(C)(1) as set forth in the Federal Acquisition Regulations 6.302-1. There is only one responsible source and no other supplies or services will satisfy the agency requirement.

5. Contractor's Unique Qualifications to Provide the Services or Supplies and/or Why The Nature of the Acquisition Requires Use of the Authority Cited.

The Oklahoma University Health Sciences Center (OUHSC) Baboon Research Resource maintains a highly specialized, closed breeding colony of Olive Baboons (Papio anubis). The OUHSC Laboratory Animal Program has maintained accreditation with the Association for Assessment and Accreditation for Laboratory Animal Care International (AAALAC) continuously since 1973. OUHSC Public Health Service (PHS) Office of Laboratory Animal Welfare (OLAW) assurance number is A3165-01.

These studies require animals to be at their most susceptible age for infection that, similar to humans, is in the infant stage of development. The OUHSC is the only P. anubis breeding facility in the United States that can supply weanling animals in the numbers necessary for this research project. Additionally, maternal vaccination studies require the provision of females with accurately timed pregnancies. Past and ongoing studies have been successfully performed using animals from this colony. Therefore, in order to compare past results with work performed under this contract, it is necessary to continue to use animals of the same genetic background. Additionally, based on the terms of this contract, after initiation of acute Bordetella pertussis infection in our animal facility, the animals are returned to the OUHSC for follow-on long-term, immunity studies. Animals to be entered into these long-term studies will be compared to animals already returned from CBER, therefore, only the Oklahoma University Health Sciences Center (OUHSC) Baboon Research Resource can conduct these studies.

Finally, long-term vaccination and infection studies using neonatal and maternal vaccination strategies were initiated in FY2011 at the Oklahoma facility that will be continued in FY2012 utilizing funding under this agreement. Only the Oklahoma University Health Sciences Center (OUHSC) Baboon Research Resource can conduct these studies.

Originally a competed procurement under contract #HHSF223201110652P, only the State of Oklahoma submitted a proposal to the FDA. The contractor provided FDA access to their Baboon Resource Center for the study of Pertussis Disease Transmission. Unknown to the contract specialist at that time, this was not a finite project but the first phase of the study. Successful results of the first phase were contingent on proceeding with a second phase of the project. Therefore, the procurement strategy should have had options and not have been made a one year firm fixed price contract.

In order to compare past results with the second phase (Requisition #1100793), it is necessary to continue to use animals of the same genetic background which are only available from the current breeding colony.

Additionally, the FDA will be re-using the same animals from contract #HHSF223201110652P as a control group while adding animals as a variable group from the same Baboon species for re-exposure to the Pertussis disease. Future phases of the study on the same species will consist of pathology and imaging of the Pertussis effects in this long-term immunity study.

6. Description of Efforts Made to Ensure Offers Are Solicited from As Many Potential Sources As Practicable.

The lead scientist identified three sources for the original requirement, a Request for Information was conducted by the contract specialist and the requirement was solicited as full and open competition. Only the State of Oklahoma submitted a proposal to the FDA and their proposal resulted in contract award

#HHSF223201110652P.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable.

The Contracting Officer determined that there is sufficient data from contract #HHSF223201110652P to evaluate the cost reasonableness of this follow-on work. The anticipated costs to the Government are in line with what the Contractor has previously charged. This takes into consideration additional animal purchases as a result of the on-going study and related animal housing charges noted in the IGCE. The IGCE was prepared using data from the current contract. Based on the above, it is anticipated that negotiations will be determined fair and reasonable.

8. Description of the Market Survey Conducted and the Results, or Statement of the Reasons a Market Survey was not conducted.

A market survey was originally conducted for this requirement under contract #HHSF223201110652P.

The scientific review committee found the State of Oklahoma capable to conduct the study. Since the continuation of the study’s second phase requires the use of animals from the same genetic pool (only available from the current breeding colony), an additional market survey would prove unnecessary in order to maintain the continuity of genetic data.

9. Other Relevant Facts Supporting the Proposed Noncompetitive Acquisition.

Currently, the FDA relies heavily on the study’s genetic data. Another contractor could not “continue” the study without data contamination. The Agency would need to discard all current research data and start from the beginning. This would be an unrealistic expense that the Agency would incur if this would happen.

In addition, the FDA has government furnished property (GFP) installed at the Baboon Resource Center so that the on-site scientists can conduct the experiments. Movement of the equipment and re-establishment at another facility would incur additional expenses to the Agency. There is also a possibility that the FDA would have to purchase new instruments to accommodate space restrictions at other laboratories, increasing expenses to the Agency.

Lastly, the lead FDA researcher (COR) made several trips to Oklahoma to provide specific training in methods required to perform Pertussis infections of primates. Likewise, the lead researcher would have to re-train those methods if another Contractor is selected thereby incurring additional expenses to the Agency.

10. Sources that have Expressed Interest in the Acquisition in Writing.

N/A

11. Statement of Actions, if any, to Remove or Overcome Barrier to Competition Before any Subsequent Acquisition for the Supplies or Services.

The lead scientist noted that the study would conclude after the base and four option years. This justification takes into consideration the previously awarded contract HHSF223201110652P, which has a one year period of performance. Therefore, the overall effort shall not exceed an aggregate of five (5) years.

12. Provide a statement that indicates that the use of the Justification for procuring this supply or service is not a result of a lack of planning or the expiration of funds.

The procurement of animals and services under this contract is not the result of a lack of planning or the expiration of funds.

Certification and Signatures:

Program Office Certification:

This is to certify that the data supporting this justification is the responsibility of the undersigned program office personnel, including verifying the Government's minimum needs or schedule requirements or other rationale for limited sources (pursuant to 8.405-6(e)(2)(x)) or for other then full and open competition justification (pursuant to 6.303-2(b)) which form a basis for this justification, and that such data and rationale are accurate and complete.

Signed 5/7/2012 Tod Merkel Date Contracting Officer’s Representative

Signed 5/17/2012

Jay E. Slater Date Director, DBPAP, OVRR

Contracting Officer Certification:

I certify that this submission is accurate and contains complete data necessary to support the recommendations for approval. The contracting officer further certifies that an award of this contract action from this requirement will be made only if the price or cost to the Government is determined to be fair and reasonable.

Signed 5/15/2012

David Kordel Date Contracting Officer

Reviewed and Concur:

Signed 5/16/2012 Doreen Williams Date Contracting Officer, Team Leader

Reviewed and Concur:

Signed 5/21/2012 Ronald Rouse Date Contracting Officer, Division Director, OAGS

Approved:

Signed 5/22/2012

Glenda Barfell Date Director, Head of Contracting Activity, OAGS

Approved:

Signed 5/29/2012

Walter Harris Date Competition Advocate