ATBC_JOFOC_Redacted.pdf

J & A Award ATBC Follow On_06-12-2015

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. Department of Health and Human Services (DHHS) / National Institutes of Health (NIH)

b. Sponsoring organization.

DHHS/NIH/National Cancer Institute (NCI)/ Division of Cancer Epidemiology and Genetics (DCEG)

c. Project Officer information.

Project Officer name: Demetrius Albanes, M.D.

Mailing address:

9609 Medical Center Drive, Room 6E342, Rockville, MD 20850

E-mail address: DAA@NIH.GOV

Telephone number: 240-276-7212

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The primary purpose of this acquisition is to provide for the continued health outcome surveillance of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort in Finland.

The objectives of this acquisition are to provide ongoing project support in the form of: 1) population-based data linkages (cancer registry, causes of death, medications, and hospital diagnoses) of this unique, well-characterized cohort that has extensive risk factor data in conjunction with prospectively collected biologic samples; 2) abstracting and review of selected cancer case medical records; 3) replacement serum and whole blood samples from the Finnish Helsinki repository and continued access to toenail samples; and, 4) tumor tissue collection based on NCI requirements. Preservation of the ongoing passive follow-up and related support activities will maintain the value of the original investments in the ATBC Study of Finnish smokers and will continue to facilitate a wide range of cancer etiology, early detection, and prevention studies in NCI.

Post-trial follow-up has continued to monitor for late effects of the trial vitamins. The data obtained by this acquisition will allow NCI to conduct cancer etiologic, survival, early detection research, prevention research based on the high-quality biological specimens, dietary and other cancer risk factor data collected at the start of the original study.

b. Project background.

The mission of the Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) includes the planning and conduct of cancer epidemiological research in human populations.

The division is specifically charged with conducting state-of-the-science cancer research aimed at discovering cancer causes and potential preventive and early detection strategies.

In support of this mission, DCEG conducted the ATBC Study, which consisted of a cancer prevention trial of 29,000 male smokers that tested the effects of beta-carotene and vitamin E supplementation on cancer incidence and mortality from 1985-1993. The study was a scientific collaboration between NCI and the (then) National Public Health Institute of Finland (now National Institute for Health and Welfare), which was and currently is responsible for carrying out the national registry linkages based on the social security numbers of the study participants.

The study participants have been an integral population cohort and scientific resource for the NCI for cancer-related biomedical research.

This acquisition will maintain the necessary health registry surveillance of the study population to continue to be implemented by the Finnish National Institute for Health and Welfare (NIHW) which solely retains personal identifiers for the study participants (i.e., Finnish social security numbers) used for all data linkages for nearly three decades.

Social Security numbers are not available outside this source.

Historically, these registry linkages and other support functions, including providing cancer case reviews and biospecimens to NCI, have been provided to NCI under a total of four successive, non-competitive awards to the Finnish National Institute of Health and Welfare.

On March 31, 1984, the first of three non-competitive contracts were awarded to the Finnish National Public Health Institute (NPHI):

Contract Nos. N01-CN-45165, N01-RC-45035, and N01-RC-37004.

During the period of performance from 1985 through 2009, approximately $30.4M was obligated under those contracts, the majority of which was required for the ten-year active trial period (and close out) in the field.

As a result of the Finnish government agency reorganization, NPHI was absorbed by the National Institute for Health and Welfare (NIHW).

On December 1, 2009, a non-competitive contract, Contract No.

HHSN261201000006C, was awarded to the National Institute for Health and Welfare under the basis of FAR 6.302-1 “Only one Responsible Source”. The purpose of this follow-on contract was to maintain the cancer and other outcome passive surveillance of the ATBC Study Cohort through the Finnish Cancer and other national registries. NIHW was additionally tasked with retrieving medical records, pathology specimens, and tumor tissue samples from hospitals and other organizations and delivering these materials to the NCI. The period of performance of this contract is from December 1, 2009 through June 30, 2015. The total amount obligated to date is $1,411,285.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study Cohort

b. Project description.

The proposed acquisition is for a 5-year follow-on contract of the National Cancer Institute (NCI) Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort follow-up based in Finland.

The study population includes all participants (n=29,133 male smokers) from the ATBC Study that was conducted in southwestern Finland between 1985 and 1993, originally as a cancer prevention trial testing supplementation with the micronutrients beta-carotene and vitamin E. The ATBC Study has been an integral cohort and scientific resource for NCI for over two decades. The originally conducted controlled primary cancer prevention trial of vitamin supplementation collected medical, serial chest x-ray, anthropometric, dietary, smoking, and occupational data, along with highly valuable biospecimens including fasting serum, whole blood, red blood cell, and toenail samples. Half of the biospecimens are stored by Finland in Helsinki.

Post-trial cancer and mortality surveillance of the cohort with essentially complete ascertainment has been maintained through contracts with Finnish government institutions: first the National Public Health Institute, and most recently, the National Institute of Health and Welfare. The latter institution solely retains personal identifiers, including the Finnish social security numbers used for all of the cohort’s data linkages and medical record access. The ATBC Study cohort is a valuable biomedical resource for NCI because of its relatively large size; up to 30 years of follow-up; complete national registry endpoint and other linkages (having ascertained ~11,000 cancers to date); stored fasting serum and DNA; and, high-quality information for other health behavior characteristics such as diet, body weight, smoking, physical activity, and other illnesses such as cardiovascular disease and diabetes. The cohort resources continue to be used by DCEG/NCI and other investigators, and the project has been the basis of hundreds of high-quality research studies relating to cancer etiology, survival, prevention, and early detection. The cohort project has also been used to research other health outcomes including cardiovascular disease, COPD, diabetes, Alzheimer’s disease, Parkinson’s disease, and ALS. No one else has a longitudinal study of this size. There is no other access to the Social Security numbers and personally identifiable information. There are thirty years of history under this study and if the work were to be recreated, it would duplicate costs and lose time.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement: Cost No-Fee Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. N02CO57011-13

c. Total estimated dollar value and performance/delivery period.

$596,000

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States

Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(ii).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

National Institute for Health and Welfare Mannerheimintie 166 Helsinki FI-00271

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The Finnish National Institute for Health and Welfare (NIHW) is the only source that holds the personal identifiers for the ATBC Study participants (i.e., Finnish social security numbers) that are required for all the registry data linkages that NCI requires. In addition, NIHW is uniquely qualified to perform the services this acquisition requires as, only the NIHW: 1) can access the required cancer case medical records from Finnish hospitals and clinics, as well as Finnish death certificates; and 2) currently stores ATBC Study biospecimens that NCI requires for its research programs. As a result, only NIHW has the capability to conduct the registry linkages of the study cohort.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A Sources Sought Notice was posted to the Government Point of Entry (GPE) on the Federal Business Opportunities (FedBizOpps) website on October 21, 2014, with a response date of October 31, 2014. The notice enabled potential sources to learn of the project and additionally provided them an opportunity to submit information in order for the Government to evaluate their capabilities. However, there were no responses to this notice. In accordance with FAR 5.204 Presolicitation notices, a Presolicitation notice was posted to the Government Point of Entry (GPE) on the Federal Business Opportunities (FedBizOpps) website on January 23, 2015, with a response date of February 9, 2015. To date, no inquiry has been submitted by additional potential sources.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

A cost analysis of the proposal will be conducted by the Contracting Officer using FAR Subpart 15.404 and the principles established in OMB Circular A-122 "Cost Principles for Non-Profit Organizations".

The Project Officer and Contracting Officer will evaluate all proposed costs, then complete and sign the Project Officer Technical Questionnaire form;

Certified cost and pricing data will be obtained from the offeror since this is a noncompetitive acquisition.

An evaluation of the separate cost elements of the proposal will be compared against the Independent Government Cost Estimate.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

A Sources Sought Notice was posted to the Government Point of Entry (GPE) on the Federal Business Opportunities (FedBizOpps) website on October 21, 2014, with a response date of October 31, 2014. The notice enabled potential sources to learn of the project and additionally provided them an opportunity to submit information in order for the Government to evaluate their capabilities. However, there were no responses to this notice. This will serve as the market survey to ascertain that there are no other known qualified sources capable of satisfying the Government’s requirement.

9. Any other facts supporting the use of other than full and open competition.

There would be unacceptable delays in fulfilling the agency’s requirements as there is no other organization that has both the ATBC Study participant identification numbers and Finnish social security numbers required for the cancer and other registry data linkages. Additionally, no other organization has access to the FNIHW ATBC Study biospecimen collection in Helsinki.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is possible that following this three-year contract for cancer monitoring, medical records, and biospecimen provision to NCI, that another award will be required for NCI programmatic elements. In this event, and for the reasons outlined above, the Government has no means to avoid another noncompetitive acquisition based on 1) the need to access Finnish national registries and medical records with Finnish social security numbers, and, 2) only the proposed Contractor has ownership of the ATBC Study biospecimens in Finland. Therefore, there is no reasonable alternative to contracting directly with FNIHW.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Demetrius Albanes, M.D.

Project Officer’s Immediate Supervisor

Christian C. Abnet, Ph.D., MPH

Head of the Sponsoring Program Office

Stephen J. Chanock, M.D.

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Jill M. Johnson, Team Lead, ETSB, NCI, OA

Branch Chief Wanda M. Neal, Chief, ETSB, NCI, OA