JOFOC_4213981_Final.docx

J&A

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS.NIH

b. Sponsoring organization. NCI/DCEG/MEB

c. Project Officer information.

Christian Abnet 9609 Medical Center Dr., Rm 6E344 Bethesda, MD 20892 abnetc@mail.nih.gov 240-276-7213

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

a. Acquisition purpose and objectives.

The purpose of this requirement is to collect exposure information as well as covariate data from paper and electronic clinic records from 16 IVF clinics in Israel that will be linked with the national birth registry and cancer registry. The final linked dataset will be used to evaluate long-term cancer risk in women receiving IVF treatment.

b. Project background.

The use of assisted reproduction technology (ART) is expanding worldwide, with the number of children born after ART now exceeding 5 million. Since the introduction of in vitro fertilization (IVF) in 1978, the number and proportion of children born after ART has increased annually, with an estimated 240,000 ART conceived children born each year worldwide. Well-recognized perinatal complications in this population include prematurity, low birth weight, and congenital malformations. Despite the widespread use of ART, the impact on subsequent maternal and child health, particularly rare health outcomes like cancer, is not well understood. Specifically, cancer risk in women receiving multiple IVF treatment cycles has not been adequately evaluated. The Metabolic Epidemiology Branch (MEB) plans to conduct a medical record linkage study in Israel to evaluate cancer risk in women following fertility treatment. To adequately address this research question MEB will focus on collecting medically-documented and detailed exposure information, including cause of infertility, hormonal treatment, and information about procedures performed (e.g. IVF, intracytoplasmic injection (ICSI)), and appropriate confounders (e.g., ethnicity, parity, age at first birth, body mass index, cigarette smoking).

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

a. Project title.

Cancer risk following in vitro fertilization (IVF) in Israel.

b. Project description.

Collect exposure and covariate data for women undergoing IVF treatment at 16 IVF units in Israel. Link data to National Cancer Register to gather information on cancer diagnoses. Link data to National Birth Register to gather additional information related to pregnancy history.

· 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. N/A

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

Total estimated cost: $301,625 Period of Performance shall consist of one (1) year base period ($150,000) with the option for the same coverage for two (2) optional subsequent years.

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.

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).

Women and Children’s Health Research Unit The Gertner Institute for Epidemiology and Health Policy Research Chaim Sheba Medical Center Tal Hashomer 52621, Israel POC: Prof. Liat Lerner-Geva, MD, PhD Tel: 972-3-5303505 Fax: 972-3-5354057 Email: LiatL@gertner.health.gov.il

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

Israel is recognized as the world capital for IVF treatments, with 24 IVF units in the country that perform more than 45,000 ART cycles annually, the highest rate of ART in the world. ART treatments are fully covered by national health insurance through the Ministry of Health for the first two infants with no restriction on the number of ART cycles, type of treatment, or age of the woman, thus reducing potential selection issues related to access to care that exist in other study populations. Israel also utilizes a unique national identification number that facilitates linkage to birth and cancer registries, thus enabling studies of long-term follow-up using retrospective data. The Gertner Institute for Epidemiology and Health Policy Research (TGIEHPR) previously enumerated a retrospective cohort of ART cycles conducted during the same calendar years at 8 IVF units in Israel that will be combined with the current data collection. Further, TGIEHPR and staff have a long history of research on ART in Israel as well as interactions with the directors of the 24 IVF units on a regular basis.

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.

The proposed contract action will be publicized in the Federal Business Opportunities (FedBizOpps) as required by Subpart 5.2.

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

Contracting Officer will consider previous purchase order prices as a determining factor for reasonableness. Based on the aforementioned, there is no reason to believe that the price will not be fair and reasonable to the Government. A final determination will be conducted prior to the award of this Contract.

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.

The MEB has ascertained the uniqueness of the Contractor’s capabilities by reviewing literature published by qualified organizations (See attached reference list).

The MEB has queried the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies available at www.contractdirectory.gov and there is not an existing contract available to meet NCI requirements.

Finally, a pre-solicitation notice was posted on 9/2/16 and no responses were received.

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

All facts have been previously detailed.

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.

NCI anticipates the needs to be met successfully with this fulfillment of this requirement. In the event that additional service is required, the NCI program office and the contracting officer will conduct market research to determine if the current state of technology has advanced and to determine if there are others sources available that can provide the supplies required.

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.

13. Contracting Officer/Deputy Director 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.

References