jofoc_for_award_notice.pdf

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. National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA)

b. Sponsoring organization. National Human Genome Research Institute (NHGRI), Computational and Statistical Genomics Branch

c. Project Officer information.

Project Officer name.

Mailing address.

E-mail address.

Telephone number.

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

a. Acquisition purpose and objectives. The purpose of this contract is to collect clinical, environmental and phenotypic data and biological specimens from lung cancer patients, their families, and frequency matched normal control individuals for use in studies of the genetic epidemiology of lung cancer. The objectives are: 1) To ascertain lung cancer patients from the State of Louisiana in a rapid ascertainment network; 2) To collect phenotypic and environmental exposure data and biologic specimens from selected lung cancer patients (selected because they have a family history of lung cancer) and their families to be delivered to the Government so that the following analyses can be performed: genotyping, genetic linkage analyses, familial-case-control genome-wide and targeted association analyses, genome sequencing analyses, and genotype-phenotype correlation analyses; 3) To collect phenotypic and environmental exposure data and biologic specimens on matched control (unaffected) individuals (frequency matched on age, smoking status, area of residence, race/ethnicity) who are biologically unrelated to the lung cancer patients for use in the analyses described above; and 4) To continue follow-up of previously enrolled lung cancer patients and their families to allow updating of new cancer diagnoses within the families.

b. Project background. Lung cancer is one of the most common cancers in the United States, and despite advances in therapy, one of the most rapidly fatal. Many epidemiologic studies have shown that there are many strong environmental risk factors for lung cancer and there is little doubt that the majority of lung cancer cases are attributable to cigarette smoking and other behavioral and environmental risk factors. However, mounting evidence, both epidemiologic and experimental, suggests that genes are involved in lung cancer causation, that lung cancer shows familial aggregation over and above that expected due to common smoking behaviors and that differential susceptibility to lung cancer may be inherited in a Mendelian fashion. Localization of susceptibility genes in lung cancer is particularly important since the majority of studies that suggest the existence of such loci also suggest that these genes act in conjunction with smoking, so if susceptibility allele carriers can be identified they can be targeted for intense intervention aimed at modifying their environmental exposures. In addition, these high-risk individuals could also be targeted for screening studies that may lead to earlier diagnosis and/or to therapies that may reduce their risk of lung cancer.

Given that the majority of lung cancer cases at present occur among non-smokers or ex-smokers, these latter two approaches are quite important in addition to targeted smoking cessation. Furthermore, identification of such susceptibility alleles for other cancers, such as the p53, BRCA1 and BRCA2 loci, has helped us to better understand the mechanisms of carcinogenesis in general – and can be expected to do the same for lung cancer.

The Genetic Epidemiology of Lung Cancer Consortium (GELCC) is a group of scientists who have combined their lung cancer studies into a joint effort to unravel the genetic risk factors for this disease. The data collected under this contract is used along with data from the other GELCC data collection sites for more powerful analyses. The GELCC has published (et al., in press, 2004) the first evidence of a major susceptibility locus with alleles that increase risk of lung cancer (in conjunction with cigarette smoking) and has identified a potential candidate gene. Follow-up of clinical status in existing families of all enrolled lung cancer patients, enrollment of additional lung cancer patients and their families (when appropriate), and frequency-matched controls are needed for linkage confirmation, fine-mapping and association studies so that this susceptibility locus can be definitively identified and characterized. Since this 6q locus did not appear to account for all highly aggregated lung cancer families, these additional data collection efforts are also critical to enable us to identify additional lung cancer susceptibility loci. In addition to rare, high penetrance risk alleles, recent population-based genome-wide association studies have given evidence for several loci that may harbor common alleles with small effects on lung cancer risk. A small Genome-Wide Association Study (GWAS) using our familial cases and matched smoking controls confirmed one of these loci and showed that use of cases with a family history and appropriately age and smoking matched controls is a powerful strategy and a larger sample familial GWAS is needed and planned by the GELCC, including samples to be collected by this contract. Beyond this GELCC GWAS, at present additional large consortia are required to allow the performance of powerful GWAS analyses that stratify based on age at onset, histology and family history. The proposed ongoing collection of lung cancer patients with a family history for our larger GELCC familial GWAS will be an important component of one of the planned very large consortium analyses (headed by a GELCC collaborator and funded by NCI) since our cases will greatly increase the sample size in the family history subsets.

NHGRI and the GELCC currently plan to continue the study of familial lung cancer patients and their families using multiple genetic tools and strategies: 1) linkage studies to help localize genes with rare, high-penetrance susceptibility alleles; 2) a genome-wide association study of cases with a family history compared to controls matched on age, smoking history, ethnicity and region of residence to localize genes with common, lower-penetrance risk alleles; 3) targeted and whole exome/whole genome sequencing of DNA from familial lung cancer patients to identify these risk loci; and 4) characterization of candidate genes such as RGS17 (in the laboratories of GELCC collaborators). To accomplish these goals, the existing enrolled families must be followed for new cancer diagnoses, and additional highly-aggregated families must be collected, along with lung cancer patients with a family history of the disease and matched controls. The contribution of Louisiana patients, families and controls funded by this study will make an important contribution to this effort.

This project will continue work that has been ongoing since the early 1990’s this study began at Louisiana State University Medical Center.

The project continued under Contract N01-HG-65404 which was awarded to Louisiana State University. A total of $3,044,120 was obligated in support of the project for the period of September 30, 1996 – September 29, 2011. The project is currently conducted under Contract HHSN268201200007C. Following are details regarding the current contract: (i) Contractor: Louisiana State University Health Sciences Center (LSUHSC). (ii) Period of performance: October 3, 2011 - November 30, 2016. (iii) Amount obligated to Contract HHSN268201200007C to date: $1,21,934. (iv) Sole-source history and basis for approval of previous JOFOC: 1) The two previous contracts were awarded on a sole-source basis; 2) LSUHSC had already established the only rapid ascertainment network for lung cancer in the state of Louisiana and the only successful genetic epidemiology family study of lung cancer patients, which involved years of work to achieve;

3) No other researchers or entities in Louisiana had such a network or the required experience in studying and enrolling lung cancer families into genetic studies; 4) If we attempted to transfer this project to another institution unacceptable delays would be engendered while any other entity sets up a rapid ascertainment system, designs and implements the necessary protocols, designs and tests questionnaires, obtains Institutional Review Board (IRB) approval for their new questionnaires and procedures, and becomes experienced in the data collection process.

This eventual possibility assumes that the 30 hospitals in southern

Louisiana that are already collaborating with the LSUHSC investigators would be willing to sever an existing successful research collaborative agreement and enter into another such agreement with another entity which has no experience in this field (a very unlikely possibility); and

5) No other entity currently has access to this population or has the necessary expertise, interest and proximity to the population to allow them to successfully carry out this study in a timely manner in southern Louisiana. It is important that a lung cancer linkage study be performed in this southern Louisiana population because it is the only population in which a segregation analysis has been performed. This segregation analysis gave evidence that an inherited susceptibility to lung cancer may exist in some families and the results of this analysis will be necessary for use in the linkage analysis. While these results could possibly apply to other populations, there is no guarantee that they do so. Therefore, NIH investigators have the best chance of successfully locating a lung cancer susceptibility locus if they study this same southern Louisiana population.

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

a. Project title. Determination of Genetic Susceptibility to Lung Cancer in Families from Southern Louisiana

b. Project description. Please see Attachment 1, Statement of Work.

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 (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

Other (specify): ___________

Completion Form Term form

Acquisition identification number. Solicitation Number

NIH-NHLBI-CSB-HG-2017-09-KC

c. Total estimated dollar value and performance/delivery period. The Government’s total estimated amount of this acquisition is $ for the three-year period of December 1, 2016 – November 30, 2019.

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(b)(1).

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). Louisiana State University Health Sciences Center, 433 Bolivar Street, New Orleans, LA 70112-1393

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). Lung cancer is a rapidly fatal disease. Even though many families exist where multiple family members have been affected with lung cancer, it is rare to find such a family with more than one living affected person at any one time. Thus, collection of families that are informative for linkage studies or family-based association studies, is a very difficult task. Only a very small number of groups in the world have ever been successful at doing this – the existing study at LSUHSC is one of the few such successful studies. It is also quite difficult to collect large numbers of lung cancer patients with a family history for a familial case-control study since this accounts for 10% of all cases. To accrue adequate numbers of such patients, a large catchment area must be included in the study, making a rapid ascertainment network absolutely crucial to the success of the study. Without such a rapid ascertainment network, many lung cancer patients will be too ill to participate or will already be deceased by the time they are contacted to enroll in a study.

The proposed contractor is uniquely qualified to provide these services because they have over 20 years of experience with their existing rapid ascertainment network in Louisiana, have a track record of success in collecting large, highly informative families and familial cases and matched controls, have a highly skilled statistical geneticist leading their team (the only person in the State of Louisiana with these critical skills), have the cooperation of 30 hospitals, plus private and university system oncology and hematology services, have data collection devices (family history and environmental risk factor questionnaires) that are already developed and well-tested, have Institutional Review Board approval in place for their protocol and informed consent documents, have existing database management systems that have been well-tested and that meet data security requirements, have experience in preparing the electronic format data files required by the Project Officer for analysis of the data collected under the contract, and have years of experience in successfully conducting this data collection study taking into account the unique geographic and cultural aspects of Louisiana. While it may be possible in time for another entity to do the work of accruing new patients and their families, unacceptable delays in the research project would be engendered while another entity sets up a rapid ascertainment system, designs and implements the necessary protocols, designs and tests questionnaires, obtains IRB approval for their new questionnaires and procedures, and becomes experienced in the data collection process.

This eventual possibility assumes that the hospitals in southern Louisiana that are already collaborating with the LSU investigators would be willing to sever an existing successful research collaborative agreement and enter into another such agreement with another entity that has no experience in this field (an unlikely possibility). However, because of Human Subjects Ethics rules (in place for all studies of humans and overseen by an Institutional Review Board), it is standard practice that the personal identifiers (i.e. name and contact information) for study participants should not be shared outside the clinical investigation group that enrolls the participants into the study. The Informed Consent forms signed by all study participants to date follow this practice, assuring the participants that their privacy will be protected and that their personal identifying information will never be shared with any other investigators, including the Government. Thus, no new contractor source would be able to recontact and follow the existing study participants for clinical follow-up. If the existing families cannot be re-contacted, it will severely limit the utility (i.e. statistical power) of the existing families. In addition, if the existing families cannot be contacted, the Government would not be able to learn about newly affected individuals. Learning of newly affected individuals in existing families increases the statistical power of those families to detect the location of genetic loci that increase the risk of lung cancer. Follow-up of existing study participants is essential to the scientific integrity of this study. It is essential to use the same contractor to maximize the Government’s existing investment in this rare resource of families.

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 Presolicitation Notice which publicized NHLBI’s intent to award a contract to LSUHSC on a noncompetitive basis was posted in FedBizOpps on April 6, 2016. No responses were received to this notice.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. An Independent Government Cost Estimate (IGCE) was developed based on the history with this contractor.

The information shown in invoices submitted under the current contract and the current Federal Government Rate Agreement were also used to develop the IGCE. The Contracting Officer will perform a thorough cost analysis. The contractor will be asked to provide a Certificate of Current Cost or Pricing Data with their final proposal revision. Based on the above, it is anticipated that the Contracting Officer will negotiate fair and reasonable costs, therefore an audit will not be performed.

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.

Upon reviewing the literature on familial lung cancer studies the only groups performing such studies are the investigators who are members of the Genetic Epidemiology of Lung Cancer Consortium. There are 5 data collection sites for this consortium, one of which is the LSUHSC contract site. The others are at University of Cincinnati, Mayo Clinic in Minnesota, Karmanos Cancer Center in Detroit, Michigan, and University of Toledo, Ohio. None of these other groups are prepared to take on data collection in another state (Louisiana), nor would they be allowed to recontact LSUHSC-enrolled study participants due to ethics rules, nor could they increase the number of families and familial cases that they collect by expanding their staff in their own states, since they are currently studying all available patients in their catchment areas. It is only by ascertaining patients from another large catchment area that we can increase our sample size. Since there is no other group of cancer geneticists in the country (or the world based on the scientific literature) that are successful at collecting these types of lung cancer families and familial lung cancer cases, there do not appear to be any other viable alternative contractors.

A Small Business Sources Sought (SBSS) notice was posted in FedBizOpps on March 17, 2016 to assess the availability of small business to perform this requirement. At the same time, a Research and Development Sources Sought (RDSS) notice was also posted in FedBizOpps to assess the availability of all qualified sources to perform this requirement. It was noted within the RDSS notice that a SBSS notice was being issued simultaneously and if two or more small businesses were found to be capable of performing the requirement, it would be set-aside. Upon the due date of April 1, 2016, no capability statements were received for this requirement.

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

A noncompetitive award is also in the best interest of the Government due to unacceptable delays in performance. Data collection would be delayed for approximately one year while a new contractor tried to duplicate the existing infrastructure, including the rapid ascertainment network that includes all of the hospitals and oncology practices in southern Louisiana. These organizations have negotiated agreements with the current contractor, NOT with NIH, to allow the current contractor to rapidly contact newly diagnosed lung cancer patients.

Given the rapid fatality of lung cancer, this is a critical aspect of the study and is not easily done. Using tumor registry reports is not an adequate way to ascertain newly diagnosed lung cancer patients. Years of work setting up this functional rapid ascertainment system will be lost and would have to be duplicated by the new contractor, which would cause delays in the project. A new contractor would have to get agreements in place with 30 hospitals, which would require preparing the protocol documents for the Institutional Review Boards (IRBs) at each hospital (usually 1 per hospital, using multiple formats and following different rules for the protocols set by each hospital), obtaining approval from the IRB or IRBs at each hospital, and also obtaining a legal review by the hospitals. In addition, a new contractor would have to contact and get the approval from all of the individual oncology services with which the current contractor also works.

This assumes that all of the institutions will agree, which is not guaranteed. Any chance of losing hospitals and/or oncology services from the rapid ascertainment network would be unacceptable, as this would reduce the number of familial patients and their families that can be enrolled into the study. This would result in decreasing the statistical power of the study to detect the location of genetic loci that increase the risk of lung cancer. Finally, a new contractor would be unable to perform a critical task, recontact and follow-up of existing study participants due to ethics rules and human subjects protections rules.

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.

At this time, the NIH knows of no action that it can take to encourage competition because of the uniqueness of these resources. At the end of the requested renewal, the Government will reevaluate the need for this study and survey the market to determine if other sources are capable of performing this requirement.

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

Project Officer’s

Immediate Supervisor

Head of the Sponsoring

Program Office

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

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

N/A

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive

Attached: Previous approved Justification for Other than Full and Open Competition