275201200001I_JOFOC.pdf

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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 & Human Services, National Institutes of Health (NIH)

b. Sponsoring organization:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Division of Epidemiology, Biostatistics and Prevention Research (DESPR), Prevention Research Branch (PRB)

c. Project Officer Information:

• Name: Ronald J. Iannotti, PhD.

Staff Scientist

NICHD, DESPR, PRB

• Mailing Address: 6100 Executive Blvd Suite 7B05, MSC 7510 Bethesda, Maryland 20892-7510

• E-mail address: iannottr@mail.nih.gov

• Telephone: (301) 435-6951

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

a. Acquisition purpose and objectives:

The Prevention Research Branch (PRB), an intramural research group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), conducts research on child and adolescent health behavior. One of the PRB areas of emphasis is assessment of the prevalence and determinants of health indicators and health behaviors among adolescents. Toward this end, the PRB, through a contract with the CDM Group, is currently conducting a four-year longitudinal assessment of a nationally-representative cohort of U.S. school children starting at grade 10. The goal of this study is to use information to improve long-term health consequences resulting from adolescent behavior and the quality of health programs and services for youth. CDM has recruited and consented the cohort, has completed two years of data collection, and is in the process of completing the third and fourth years of assessment. CDM provides NICHD with de-identified data but has ‘ownership’ of the cohort. Although the period of performance of the new contract partially overlaps with the current contract, there is no overlap in the tasks involved in the two contracts.

The purpose of this new contract, Contract No. HHSN275201200006C, will allow CDM to continue collecting data in this longitudinal cohort and to add needed assessments including assessments of peers of participants to better define the participants’ social network and identify peer influences on the health behaviors of adolescents as they transition from high school to late adolescence and early adulthood. CDM will also continue to collect biological data and measures of cardiovascular risk factors including diet, physical activity, sedentary behavior and sleep for the subsample of normal weight and overweight adolescents.

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b. Project background:

(i) Name of Current Contractor: CDM Group, Inc.

(ii) Period of Performance: June 1, 2008 – September 29, 2014

(with options)

(iii) Contract Number: HHSN267200800009C

(iv) Total amount obligated: $9,538,251 (including JOFOC*)

(v) Initial Award: Competitive

* JOFOC was approved November 2009 for $2,272,923

On June 1, 2008 a contract (HHSN267200800009C) was awarded to the CDM Group on a competitive basis for the purpose of conducting the 2009/2010 U.S. HBSC survey. In addition, two (2) options were incorporated: Option 1, a 4-year longitudinal survey of representative sample of 11-year-old students and Option 2, a 4-year longitudinal survey of representative sample of 15-year-old. Subsequently, on September 30, 2008, only Option 2 was exercised and Option 1 was removed entirely from the contract. The focus of the longitudinal (cohort) study is on four major areas of adolescent risk: obesity, substance use, dating violence, and motor vehicle accidents.

Later, in an effort to increase understanding of young people's health and after consultation with experts on obesity, cardiovascular disease, and adolescent risk behaviors within NIH and outside of NIH; NICHD in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA) and the Maternal and Child Health Branch of the Health Resources and Services Administration (HRSA/MCHB) agreed on the necessity of filling significant gaps in current research on adolescence in the U.S. These experts strongly recommended that obtaining additional measures of obesity, risk factors for obesity, and other adolescent risk factors was absolutely essential to the longitudinal study. At that moment, there were no current national longitudinal surveys of health behaviors, mental health, and their determinants during this critical developmental period.

In order to accomplish the longitudinal study, a November 2009 JOFOC allowed CDM to start gathering anthropometric, genetic, and geographical data from all participants in this study. In addition, the JOFOC allowed CDM to collect biological data and measures of diet, physical activity, sedentary behavior, and sleep for a subsample of normal weight and overweight adolescents. These measures include: objective assessment of physical activity, sedentary behavior, and sleep; biological markers for obesity, cardiovascular disease, and metabolic syndrome - fasting blood glucose, HbA1c, total cholesterol, triglycerides, LDL-C, HDL, C-reactive protein, uric acid, cotinine, height, weight, waist circumference, and blood pressure and assessment of nutrient intake. This 2009 JOFOC resulted in a contract modification for the expansion of work under Contract No. HHSN267200800009C.

This would fill significant gaps in current research on adolescence in the U.S. and:

1. Identifies the trajectories of adolescent health behaviors, including healthful diet and physical activity, substance use, dating violence, driving and health status, including obesity, metabolic syndrome, and injuries due to motor vehicle crashes or dating violence, from adolescence through the post-high-school year.

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2. Identifies individual, family, school, social, and environmental factors (e.g., access to recreational resources, walker/biker friendly neighborhoods) that promote or sustain positive health, positive health behaviors and mental health.

3. Identifies transition points in health risk behaviors and risk indicators.

4. Identifies changes in individual, family, school, and social/environmental precursors to developmental changes in diet, physical activity, substance use, dating violence, risky driving, and other health risk factors.

5. Examines the role of social networks in obesity and substance use, including identifying the direction of causal pathways for peer selection and peer influence.

6. Explores gene-behavior interactions which might serve as the basis for interventions for those identified as at risk for obesity or substance use.

The ongoing Contract, Contract No. HHSN267200800009C, includes annual surveys in 2010, 2011, 2012 and 2013 (original contract), annual measures of height, weight, and waist circumference in 2010, 2011, and 2012, and collection of genetic material (one occasion) in the entire cohort. A subset of the cohort receives additional measures of cardiovascular and driving risk factors. These measures include better (more objective) measures of diet, physical activity, sedentary behavior, and sleep in 2010, 2011, 2012, and 2013, measures of fasting blood glucose, HbA1c, total cholesterol, triglycerides, LDL-C, HDL, C-reactive protein, uric acid, cotinine, height, weight, waist circumference, and blood pressure in 2010 and 2013, and a more objective measure of driving in 2013 (November, 2009 JOFOC).

This proposed acquisition for the NEXT Generation Health Study would support additional assessments of the cohort of adolescents who have completed the above assessments on the ongoing Contract, Contract No. HHSN267200800009C. The proposed acquisition under a new separate procurement (HHSN275201200006C) includes a base contract to provide objective measures of driving in 2012 and geocoding of home addresses in 2014 and 2016. Options for this contract include: measure driving performance in 2014, 2015 and 2016; measure academic performance in 2012, 2014, and 2016; conduct a survey in 2014, 2015, and 2016;

survey peers in 2013 and 2015; assess diet, physical activity, sedentary behavior in 2014, 2015, and 2016; measure fasting blood glucose, HbA1c, total cholesterol, triglycerides, LDL-C, HDL, C-reactive protein, uric acid, cotinine, height, weight, waist circumference, and blood pressure in 2016; and additional surveys in 2012, 2014, and 2016. There is no duplication of work between the proposed acquisition and the current contract.

3. Description of the supplies or services required to meet the agency’s needs

a. Project title:

“NEXT Generation Health Study”

b. Project description: (See Attachment 1 – SOW)

• 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

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Design-build Other (specify): ____________________

• Type of action:

New requirement Follow-on

⌧ Other (specify) Options in the proposed contract extend the annual assessments of the longitudinal cohort but also include gathering of new data not specified in the current contract.

• 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: __________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number:

Contract No. HHSN275201200006C

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

Fiscal Year

Contract Amount Plus Options

FY12 $834,957

FY13 $404,356

FY14 $3,513,526

FY15 $3,392,625

FY16 $3,459,462

Total $11,604,925

(See Attachment 2 - IGCE)

d. Period of Performance: March 20, 2012 through March 19, 2017

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) (A) & (B).

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:

Contractor: CDM Group, Inc.

7500 Old Georgetown Road, 9th Floor

Bethesda, MD 20814

b. Nature of the acquisition and proposed unique qualifications of the contractor:

The CDM Group Inc., under the existing contract, Contract No. HHSN267200800009C has recruited and consented a nationally-representative cohort and completed two years of assessments. The CDM Group and their subcontractor Abt Associates is conducting home visits with their cohort and have a working relationship with the schools and families that they recruited. Moreover, as part of the existing requirements under the ongoing contract, the CDM Group will be conducting annual assessments of this cohort in 2012 and 2013, maintaining contact with participants over time, and optimizing retention of their sample. The proposed new contract, Contract No. HHSN275201200006C, will include additional measures in 2012 and 2013 integrated into the ongoing study. Therefore, awarding a contract to another contractor would require them to duplicate work already completed; that is, independently obtain IRB and OMB approval, recruit, consent and establish a relationship with an entirely new cohort including school districts, schools and participants, conduct surveys, anthropometric, biologic, and environmental assessments, and incorporate and complete all of the new assessments referenced previously. This would result in unacceptable delays, substantial duplication of effort, and increased costs to the Government. CDM is in the process of completing a third year of assessments and has a contract to continue the assessments in the fourth year. A new contractor would have to recruit and consent a new

6 | P a g e cohort and repeat four years of assessments already completed, placing substantial burden on the study, the investigators, and a new cohort of participants.

To summarize, confidentiality of all identified personal information that is currently being gathered is strictly maintained and rigorously safeguarded by the CDM Group and cannot be released to any other party. The current contractor has an existing cohort with the required assessments, a well-defined knowledge of the functions and responsibilities required for this new proposed contract, Contract No. HHSN275201200006C, and the requisite qualified staff to continue performance without any impact or delay. Therefore, with the exception of the CDM Group, there is no other organization that has access to this already recruited cohort.

Two years of data have already been gathered with this cohort and a third year of collection is already underway. This contract will be to continue these data gathering efforts in the fifth through seventh year and to provide some additional assessments in 2012 and 2013 consistent with the initial goals of the project. As stated above, it is expected that the use of any other source for this requirement would result in substantial duplication of costs as well as additional time to develop the sample, assessments, and capability within another contractor’s workforce that is not expected to be recovered through competition.

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 Synopsis for Small Businesses was issued on April 7, 2011. Interested small business organizations were requested to submit capability statements no later than April 28, 2011. One response was received from Computer Aided Logistics Engineering, CAL Engineering, but on June 24, 2011, an amendment to extend the synopsis was issued through July 11, 2011 to provide adequate time for small businesses to respond. One response from the Grant Group was received. Both responses were reviewed and were found that neither of the small business was capable to perform this study.

Consequently, a presolicitation notice was published in the Federal Business Opportunities on August 2, 2011 with the 15 day notification being completed by August 17, 2011. No inquiries from the public concerning this project were received by the due date.

(See number 10 below). (See Attachment 3 - FedBizOpps Announcement)

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) has been developed based upon estimates from previous projects conducted by the CDM Group for NICHD. The Project Officer and Contracting Officer will evaluate all proposed costs and complete and sign the Project Officer Technical Questionnaire.

A cost analysis of the CDM Group business proposal will be conducted by the Contracting Officer in accordance with FAR 15.404-1(c). Furthermore, a cost realism analysis will be performed by the Contracting Officer in accordance with FAR 15.404-1(d). In addition, Certified Cost and Pricing Data will be obtained from the Contractor and pursuant to (FAR 15.406-2), CDM will be required to sign the Certificate of Current Cost or Pricing Data.

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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 Project Officer has determined through his own market research that the CDM Group is the only organization uniquely capable of performing this study. From January 15 to April 18, 2011, the Project Officer and research assistants conducted extensive reviews of the literature as well as online searches of known studies and surveys of adolescent health. This research determined that there were no ongoing longitudinal studies of this nature and that no other contractor currently demonstrated the ability to provide a nationally-representative sample of 10th grade students that has completed the necessary assessments as required in this contract. Furthermore, there was no evidence that such a survey was planned in the near future. CDM was the only contractor or source that had the necessary sample and data and could complete the additional measures indicated for this study.

Additionally, as stated above, a sources sought announcement was published April 7, 2011 and the 2 capability statements were received and reviewed by the panel of three experts.

The Panel concluded that the statements did not meet the criteria set out in the source sought. Then a pre-solicitation notice was published in FedBizOpps on August 2 for a fifteen

(15) day period. Copies of the sources sought and pre-solicitation notices are included in Attachment 3.

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

Awarding a contract to another contractor would require them to duplicate work already completed; that is, independently obtain IRB and OMB approval, recruit, consent and establish a relationship with an entirely new cohort including school districts, schools and participants, conduct surveys, anthropometric, biologic, and environmental assessments, and incorporate and complete all of the new assessments referenced previously. This would result in unacceptable delays, substantial duplication of effort, and increased costs to the Government. CDM is in the process of completing a third year of assessments and has a contract to continue the assessments in the fourth year. A new contractor would have to recruit and consent a new cohort and repeat four years of assessments already completed, placing substantial burden on the study, the investigators, and a new cohort of participants. It is expected that the use of any other source for this requirement would result in substantial duplication of costs as well as additional time to develop the sample, assessments, and capability within another contractor’s workforce that is not expected to be recovered through competition. The Project Officer estimates that it would take an additional 38 months and $4.9 million to award a contract to another contractor. Because this is a longitudinal study of a particular cohort of teenagers who have been followed since age 15 it is not feasible to award to another contractor.

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

Computer Aided Logistics Engineering, Inc. and the Grant Group were the only organizations that expressed interest in this acquisition. Dr. Ronald Iannotti, the Project Officer for the effort reviewed their capability statements and determined that neither demonstrated that they had experience conducting these or similar tasks nor did they document that they have the staffing or resources to conduct the effort. Furthermore, they did not provide evidence that they met the criteria specified in the Sources Sought under Expertise, Past Performance, and Staffing, Facilities and Equipment (See Attachment 4 – Capabilities Statement and Evaluation)

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

There are currently no plans to acquire the same type of services in the future.

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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

Contracting Officer’s Technical Representative

Ronald J. Iannotti, Ph.D.

COTR Immediate Supervisor

Bruce Simons-Morton, Ed.D.

Head of the Sponsoring Program Office

Germaine Buck Louis, Ph.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

Contract Specialist Ryan Hash

Team Lead/Contracting Officer

Elizabeth Osinski

Branch Chief/CMB Erin Goldstein

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

Official Name & Title Signature Date

Chief of the Contracting Office

Olga Acosta-Polston

Head of the Contracting Activity

Diane Frasier

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate Walter Schaffer, Ph.D