SOW_for_Child_Strength_Study_FINAL.docx

Performance Work Statement (PWS) Child Strength Study

Description of Services The contractor shall design and conduct studies to measure the strength capabilities of children.

Background Consumer Product Safety Commission (CPSC) use data on human strength and capabilities to develop product safety standards and inform other CPSC staff activities. Strength capabilities of children are essential information to incorporate into the design of products that are intended for children to reduce or eliminate the risk such products might pose to a child (e.g., breaking, collapsing, or liberating a small part). In addition, products not intended for children but that can be hazardous to children can be made safer by incorporating performance requirements that consider children’s’ ability to interact with product components. Strength data for preschoolers are limited and similar data for toddlers and infants are almost non-existent. The existing data that staff commonly rely upon are listed in Appendix A.

Collecting strength data for young children, especially children under three years old, is challenging. Traditional methods to collect maximum muscle strength on demand are not appropriate for young children who often fail to follow directions and might be difficult to motivate. For this reason, new measurement methods in a play or nursery environment, where a child is likely to exert maximum strength naturally, will need to be developed.

Staff is interested in collecting data on static strength with a focus on real-world scenarios including measures in which movement is constrained (e.g. child is strapped in a chair) and measures in which the child is free to choose their position and method of exertion.

Objective The purpose of this contract is to expand and update the available strength data for children five years old and younger.

Contract Type This is an Indefinite-Delivery, Indefinite-Quantity (“IDIQ”) contract that shall include a one-year base period and four option years. The minimum guaranteed amount is one task order for the base year only. Individual task order performance dates shall be governed by the individual task order.

Issuance of Task Orders:

Task orders will be issued against this IDIQ contract. The Government will send a written request for quotation for a proposed task. The Contractor shall submit a written proposal describing the technical approach to complete the work, a firm fixed price and price breakdown, substantiating hours and any other supporting information required by the request for quotation. Upon completion of negotiations for a task, the Government will issue a firm fixed priced task order. The Contractor is not authorized to commence work on a task until after a task order has been awarded. The issuance of all task orders will be contingent upon the agency decision to fund the service.

Period of Performance The contract performance period shall begin on the effective date of this contract and continue for one year, with four optional periods of performance of one year each. Individual task order performance dates shall be governed by the individual task order.

Description of Work Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, materials, services, facilities, and resources to perform the work set forth below:

The Contractor shall design a study to collect child strength data.

The Contractor shall either adapt an existing test fixture and methodology or shall develop a new test fixture and methodology to collect data from children.

The Contractor, with the assistance of CPSC, shall prepare all necessary documents and implement any changes to the study plan needed for Office of Management and Budget (OMB) Paperwork Reduction Act (PRA) approval. The contractor shall adjust the materials based on CPSC's 6b clearance process, any comments received through the PRA requirement fulfillments, and OMB approval process.

The Contractor shall implement all activities needed to secure and obtain the Institutional Review Board (“IRB”) approval for research studies involving interventions with human subjects that involve more than minimal risk.

The Contractor shall secure a location or locations (mobile and/or permanent) for the study that is appropriate for the user research method. CPSC representatives shall be allowed to visit the site at any time during the study.

The Contractor shall obtain appropriate data collection tools, including hardware and software, needed for the study.

The Contractor shall prepare all test or study materials.

No data collection shall begin until the Contractor has received approval for the research study from both the IRB and OMB, if required.

The Contractor shall demonstrate that it has an Information Technology (IT) system used to store any personally Identifiable (PII) collected during the performance of this project and shall comply with an Authorization to Operate (ATO) from a US Government Agency. If the Contractor does not have an ATO from a US Government Agency, the Contractor shall demonstrate IT compliance in protecting PII.

The Contractor shall recruit participants.

The Contractor shall collect and analyze data as specified in the task order.

Reporting Requirement/Deliverables The Contractor shall submit all deliverables and reports to the Contracting Officer’s Representative (“COR”). Specific reporting requirements and deliverables will be outlined in each individual task order. Results may be incorporated into one or more publically released CPSC staff report(s).

Contractor Qualifications The Contractor shall have at least 5 years of experience in human factors, ergonomics, kinesiology, or biomechanics-related research. The Contractor shall demonstrate the ability to develop instrumentation (e.g. fabrication facilities, electrical engineering and mechanical engineering expertise). The Contractor shall demonstrate the ability to collect, analyze, and report the data requested. The Contractor shall have experience recruiting and conducting studies with children under 6 years old and/or with collecting strength data. The Contractor shall demonstrate experience following the Common Rule for human subjects research.

The Contractor shall list the Institutional Review Board (IRB) that they will use to get approval for human subjects research. This IRB shall have Federalwise Assurance (FWA). The Contractor shall provide the FWA and IRB registration numbers.

At least one of the key personnel should have experience conducting studies with children under 6 years old or evaluating children under 6 years old in clinical settings. At least one key personnel should have a background in child development, child psychology, or early childhood education.

A clear distinction is made between Government and Contractor personnel. No employer-employee relationship will occur between government employees and contractor employees. Contractor employees shall report directly to their employer (the Contractor) and shall not report to Government personnel.

Place of Performance The work to be performed under this contract shall be performed at the contractor’s facility (mobile and/or permanent).

Government-Furnished Materials The Government shall furnish to the Contractor for use in connection with this contract copies of examples of previous CPSC analyses and reports as needed. Additional Government-furnished materials may be provided, as specified in a task order.

Other Contract Requirements

Travel Any travel expected shall be inclusive of travel costs necessary to perform the work required under this contract. Travel shall be conducted in accordance with the Federal Travel Regulations. Travel costs shall be quoted as part of the Contractor’s firm fixed price quote.

Quality Control The Contractor shall develop and maintain a quality control program to ensure qualified and professional personnel are being provided and that their performance is in accordance with the criteria stated within this statement of work and commonly accepted commercial practices. At a minimum, the Contractor shall develop quality control procedures that address the areas identified in the statement of work.

Quality Assurance The Contracting Officer Representative (COR) will review, for completeness, preliminary or draft documentation that the Contractor submits and may return it to the Contractor for correction. Absence of any comments by the COR will not relieve the Contractor of the responsibility of complying with the requirements of this contract.

Performance Assessment Plan Specific performance measures may be incorporated into individual task orders. However, at a minimum, successful performance will be measured by:

Place of Delivery U.S. Consumer Product Safety Commission Directorate for Health Sciences 5 Research Place Rockville, MD 20850

The CPSC Contracting Officer Representative (COR) and e-mail address will be indicated on each individual task order award.

Inspection and Acceptance The final report will be reviewed within 14 calendar days of receipt of the report for any additional questions and/or comments. If returned to the Contractor as a result of the review, the Contractor shall address and/or revise their report accordingly and return the final version to the COR within 14 calendar days of receipt.

Task Order 0001 Strength Data Update: Strength Measures for Children 2 through 5 Years Old

1. Description of Services The Contractor shall design and conduct a study to measure strength data for children 2 through 5 years old.

Objective The purpose of this task order is to update the available strength data for children 2 through 5 years old related to upper body, lower body, and full body strength measures.

Contract Type This is a firm-fixed price task order.

Period of Performance The contract performance period shall begin on the effective date of this order and continue for a 3 year period.

Description of Work Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, materials, services, and facilities to perform the work set forth below. The Contractor shall furnish all necessary resources to perform the work set forth below:

1. The Contractor shall collect data for twenty strength measures from the following categories for children 24 months through 71 months old:

· Grip/squeeze

· Pinch or pinch-pull

· Pull with hand(s)

· Pull with foot/feet

· Push with hand(s)

· Push with finger(s)

· Push with foot/feet

· Push with shoulder/body

· Twist with hand/wrist

The strength measures shall reflect real-world hazard scenarios with regards to body parts used (e.g. one finger, both feet), direction of movement, constraints on movement, fixture type (e.g. knob, bar, pedal), and fixture position. The Contractor shall collect at least one strength measure from each category, any deviations shall be submitted to the COR for CPSC staff review and approval. Prior to collecting data, the Contractor shall provide a proposed list of strength measures to the COR for CPSC staff review, comment, and approval. An example list is provided in Appendix B.

The Contractor shall recruit and test participants from the age groups shown in Table 1. For each strength measure, the Contractor shall test at least 50 participants per age group with balanced gender distribution[footnoteRef:1] and collect strength data from at least 40 participants per age group.[footnoteRef:2] Participants shall reside in the U.S. and shall not have any known developmental delays. [1: Gender balance shall be 50-50 with a 20% allowance. ] [2: This provision is intended to account for some children’s refusal to complete testing for each strength measure. Contractor shall collect relevant demographic data and relevant anthropometric dimensions for all participants. Contractor shall attempt to collect strength data for each strength measure for the first 50 participants, and continue with recruitment and testing until at least 40 participants per age group complete testing for each strength measure.]

Table 1. Age Groups

The Contractor shall collect relevant demographic data, including precise age, gender, and race for all participants.

The Contractor shall measure relevant anthropometric dimensions and landmarks including stature, weight, shoulder height (standing and seated), shoulder breadth, hip breadth, elbow height (standing and seated), arm length to fingertips, arm length to grip, upper arm length, lower arm length, hand length, hand breadth (at palm and thumb), upper leg length (buttock to knee, seated), knee height, ankle height, foot length, and foot breadth for all participants.[footnoteRef:3] [3: The Contractor shall use definitions provided in Childata (1995) or other CPSC staff-specified source for the anthropometric measurements.]

The Contractor shall either use existing validated methods[footnoteRef:4] or develop and validate[footnoteRef:5] methods to collect data from children in the specified age groups. [4: See existing studies provided in Appendix A] [5: A method can be validated by measuring an older child’s or adult’s strength with the existing method and the new method and comparing the values. If this is not feasible, correlation between the measurement and the age, height, and weight could be pursued.]

Reporting Requirements and Deliverables The Contractor shall submit all reports, documents, and files to the Contracting Officer’s Representative (COR).

The Contractor shall hold a kick-off meeting with CPSC staff.

The Contractor shall provide written status reports.

1) Format: The reports shall be provided in either Microsoft Word or Adobe Acrobat format and shall be provided to the COR by e-mail.

2) Content: Each report shall contain the following:

Status of project and new developments Problems and proposed solutions Changes in schedule

The Contractor shall provide a proposed list of strength measures.

1) Format: The report shall be provided in either Microsoft Word or Microsoft Excel format and shall be provided to the COR by e-mail.

2) Content: The list shall include body parts used (e.g. one finger, both feet), direction of movement, constraints on movement, fixture type (e.g. knob, bar, pedal), and fixture position.

The Contractor shall provide a final list of strength measures.

1) Format: The list shall be provided in either Microsoft Word or Microsoft Excel and shall be provided to the COR by e-mail.

2) Content: See required content under proposed list of strength measures. The final list shall address all of the comments received from the CPSC staff.

The Contractor shall provide a draft methodology, recruitment strategy, and test plan

1) Format: The draft methodology and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: The draft shall contain a detailed description of the proposed instrumentation and methodology for collecting data for each strength measure. Details shall include method of motivating participants and instructions provided to participants. The draft shall also contain a detailed description of the recruitment strategy and description of test location or locations.

The Contractor shall provide a final methodology, recruitment strategy, and test plan.

1) Format: The final methodology and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: See required content under draft methodology, recruitment strategy, and test plan. The final methodology, recruitment strategy, and test plan shall address all of the comments received from the CPSC staff.

The Contractor shall provide all necessary documents needed for OMB Paperwork Reduction Act (PRA) approval.

The Contractor shall provide a draft final report

1) Format: The draft final report shall be provided as a Microsoft Word electronic document and shall be provided to the COR by e-mail.

2) Content: The report shall detail all results gathered for this task order. At a minimum, the report shall include:

1. Table of Contents

1. Contractor Information The contract pursuant to which the report is prepared.

The name of the Contractor preparing the report pursuant to such contract.

Executive Summary Background Methods

1. Description of instrumentation and methodology for each strength measure, including a drawing or picture Description of validation of instrumentation and method Detailed discussion of the methods used to conduct the study, including participant selection and recruitment Participants

1. Demographic characteristics, including age, gender, and race, and relevant anthropometric data, including weight and height Total sample size for each age group and strength measure If any participants dropped out of the study or did not complete testing for all strength measures, a description of reason(s) for drop out or failure to complete testing.

Results

1. Summary of data analysis by age group, including sample sizes, 5th, 50th, and 95th percentile values, standard deviation, mean, minimum, and maximum values for males, females, and combined.

Data shall include both anthropometric and strength measurements.

Discussion

1. Key findings from the study.

1. Lessons learned during study.

1. Implications and shortcomings.

The Contractor shall provide a final written report.

1) Format: The final written report shall be provided in a Microsoft Word format. The contractor shall provide one electronic copy to the COR by e-mail and two hard copies.

2) Content: See required content under draft final report. The final written report shall address all of the comments received from the CPSC staff.

The Contractor shall provide a data analysis file.

1) Format: The data analysis file shall be provided as a Microsoft Excel electronic document and shall be provided to the COR by e-mail.

2) Content: The file shall include sample sizes, 5th, 50th, and 95th percentile values, standard deviation, mean, minimum, and maximum values for males, females, and combined for each age group. Data shall include both anthropometric and strength measurements as well as demographic data.

The Contractor shall provide raw data set.

1) Format: The raw data set shall be provided in Microsoft Excel electronic document and shall be provided to the COR by e-mail.

2) Content: The raw data set shall include all collected data for each participant, separated by strength measure.

Delivery Schedule The following items must be performed or delivered in accordance with the following schedule:

Task Order 0002 Strength Data Expansion: Strength Measures for Children 6 Months through 23 Months Old

The Contractor shall design and conduct a study to measure strength data for children 6 months through 23 months old.

Objective The purpose of this task order is to expand the available strength data by collecting data for children 6 months through 23 months old related to upper body, lower body, and full body strength measures.

Contract Type This is a firm-fixed price task order.

Period of Performance The contract performance period shall begin on the effective date of this order and continue for a 3 year period.

Description of Work Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, materials, services, and facilities to perform the work set forth below. The Contractor shall furnish all necessary resources to perform the work set forth below:

1. The contractor shall attempt to collect data for twenty strength measures from the following categories for children 6 months to through 23 months old:

· Grip/squeeze

· Pinch or pinch-pull

· Pull with hand(s)

· Pull with foot/feet

· Push with hand(s)

· Push with finger(s)

· Push with foot/feet (kicking with feet for children under one-year-old.)

· Push with shoulder/body

· Twist with hand/wrist

These strength measures shall reflect real-world hazard scenarios with regards to body parts used (e.g. one finger, both feet), constraints on movement, fixture type (e.g. knob, bar, pedal), and fixture position. The Contractor shall collect at least one strength measure from each category, any deviations shall be submitted to the COR for CPSC staff review and approval. Prior to collecting data, the Contractor shall provide a proposed list of strength measures for each age group to the COR for CPSC staff review, comment, and approval. An example list is provided in Appendix B.

For each strength measure, the Contractor shall either adapt a test fixture and/or methodology used to collect data from older children for use with younger children or shall develop a new test fixture and methodology. The test fixture and methodology shall take into account issues specific to the age groups being tested, including ability to follow instructions and motivation. The Contractor shall submit a draft test plan and methodology to the COR for CPSC staff review, comment, and approval. The Contractor shall conduct a pilot study with at least 5 children per age group in order to assess feasibility of testing. The Contractor shall submit the results of the pilot study to the COR along with a recommendation on the feasibility of full-scale testing.

If testing for a given age group is deemed feasible by CPSC staff, the contractor shall complete testing for that age group. If testing for a given age group is deemed not feasible by the Contractor, the Contractor shall report their attempts and specific reasons explaining why the data cannot be collected for CPSC staff’s review. CPSC staff shall review the information submitted by the Contractor to determine if the testing for that age group can be performed. CPSC staff, at their discretion, may request that the contractor attempt to complete testing for a given age group, but modify or remove certain requirements such as minimum number of participants and gender distribution. If CPSC staff determines that the testing for that age group cannot be performed, the contractor shall report lessons learned, and suggestions for future work.

The Contractor shall recruit and test participants from the age groups shown in Table 2. For each strength measure for which testing is deemed feasible, the Contractor shall test at least 50 participants (not including those tests done in the pilot) per age group with balanced gender distribution[footnoteRef:6] and collect strength data from at least 30 participants per age group.[footnoteRef:7] Participants shall reside in the U.S. and shall not have any known developmental delays. [6: Gender balance shall be 50-50 with a 20% allowance.] [7: This provision is intended to account for some children’s refusal to complete testing for each strength measure. Contractor shall collect relevant demographic data and relevant anthropometric dimensions for all participants. Contractor shall attempt to collect strength data for each strength measure for the first 50 participants, and continue recruiting and testing until at least 30 participants per age group complete testing for each strength measure.]

Table 2. Age Groups

The Contractor shall collect relevant demographic data, including precise age, gender, and race for all participants.

The Contractor shall measure relevant anthropometric dimensions and landmarks including stature or body length, weight, shoulder height (standing and seated), shoulder breadth, hip breadth, elbow height (standing and seated), arm length to fingertips, arm length to grip, upper arm length, lower arm length, hand length, hand breadth (at palm and thumb), upper leg length (buttock to knee, seated), knee height, ankle height, foot length, and foot breadth for all participants.[footnoteRef:8] [8: The Contractor shall use definitions provided in Childata (1995) or other CPSC staff-specified source for the anthropometric measurements. Contractor shall collect data for every measure indicated by age. For children that are too young for sitting and standing measures, contractor shall collect comparable infant measures.]

The Contractor shall either use existing validated methods[footnoteRef:9] or develop and validate[footnoteRef:10] methods to collect data from children in the specified age groups. [9: See existing studies provided in Appendix A] [10: A method can be validated by measuring an older child’s or adult’s strength with the existing method and the new method and comparing the values. If this is not feasible, correlation between the measurement and the age, height, and weight could be pursued.]

The Contractor shall submit all reports, documents, and files to the Contracting Officer’s Representative (COR).

0. The Contractor shall hold a kick-off meeting with CPSC staff.

The Contractor shall provide written status reports

1) Format: The report shall be provided in either Microsoft Word or Adobe Acrobat format and shall be provided to the COR by e-mail.

2) Content: Each report shall contain the following:

1. Status of project and new developments

1. Problems and proposed solutions

1. Changes in schedule

The Contractor shall provide a proposed list of strength measures

1) Format: The report shall be provided in either Microsoft Word or Microsoft Excel format and shall be provided to the COR by e-mail.

2) Content: The list shall include body parts used (e.g. one finger, both feet), direction of movement, constraints on movement, fixture type (e.g. knob, bar, pedal), and fixture position.

The Contractor shall provide a final list of strength measures

1) Format: The list shall be provided in either Microsoft Word or Microsoft Excel format and shall be provided to the COR by e-mail.

2) Content: See required content under proposed list of strength measures. The final list shall address all of the comments received from the CPSC staff.

The Contractor shall provide a draft methodology, recruitment strategy, and test plan

1) Format: The draft methodology and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: The draft shall contain a detailed description of the proposed instrumentation and methodology for collecting data for each strength measure. Details shall include method of motivating participants and instructions provided to participants. The draft shall also contain a detailed description of the recruitment strategy and description of test location or locations.

The Contractor shall provide a final methodology, recruitment strategy, and test plan

1) Format: The final methodology and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: See required content under draft methodology, recruitment strategy, and test plan. The final list shall address all of the comments received from the CPSC staff.

The Contractor shall provide all necessary documents needed for OMB Paperwork Reduction Act (PRA) approval.

The Contractor shall provide a report on the results of pilot testing.

1) Format: The report shall be provided as a Microsoft Word electronic document and shall be provided to the COR by e-mail.

2) Content: The report shall detail all results of pilot testing. At a minimum, the report shall include:

1. Table of Contents

1. Contractor Information

1. The contract pursuant to which the report is prepared.

The name of the Contractor preparing the report pursuant to such contract.

Executive Summary Background Methods

1. Description of instrumentation and methodology for each strength measure, including a drawing or picture Detailed discussion of the methods used to conduct the study, including participant selection and recruitment Participants

1. Demographic characteristics, including age, gender, and race, and relevant anthropometric data, including weight and height Total sample size for each age group and strength measure Results

1. Summary of data collected If applicable, detailed description of observations and reasons why data could not be collected for a given age group or participant Determination on whether full testing is feasible or infeasible. If testing is infeasible, detailed rationale on why testing is infeasible and description of a path forward for collecting data in the future.

Discussion

1. Key findings from the study Lessons learned during study If applicable, suggestions for future work to develop instrumentation and methodology for measuring data for the desired age groups Implications and shortcomings The Contractor shall provide a draft final report

1) Format: The draft final report shall be provided as a Microsoft Word electronic document and shall be provided to the COR by e-mail.

2) Content: The report shall detail all results gathered for this task order. At a minimum, the report shall include:

1. Table of Contents

1. Contractor Information

1. The contract pursuant to which the report is prepared.

The name of the Contractor preparing the report pursuant to such contract.

Executive Summary Background Methods

1. Description of instrumentation and methodology for each strength measure, including a drawing or picture Description of validation of instrumentation and method Detailed discussion of the methods used to conduct the study, including participant selection and recruitment Participants

1. Demographic characteristics, including age, gender, and race, and relevant anthropometric data, including weight and height Total sample size for each age group and strength measure If any participants dropped out of the study or did not complete testing for all strength measures, a description of reason(s) for drop out or failure to complete testing.

Results

1. Summary of data analysis by age group, including sample sizes, 5th, 50th, and 95th percentile values, standard deviation, mean, minimum, and maximum values for males, females, and combined.

Data shall include both anthropometric and strength measurements.

Discussion

1. Key findings from the study.

Lessons learned during study.

Implications and shortcomings.

The Contractor shall provide a final written report

1) Format: The final written report shall be provided in a Microsoft Word format. The contractor shall provide one electronic copy to the COR by e-mail and two hard copies.

2) Content: See required content under draft final report. The final written report shall address all of the comments received from the CPSC staff.

The Contractor shall provide a data analysis file

1) Format: The data analysis file shall be provided as a Microsoft Excel electronic document and shall be provided to the COR by e-mail.

2) Content: The file shall include sample sizes, 5th, 50th, and 95th percentile values, standard deviation, mean, minimum, and maximum values for males, females, and combined for each age group. Data shall include both anthropometric and strength measurements.

The Contractor shall provide raw data set

1) Format: The raw data set shall be provided in Microsoft Excel electronic document and shall be provided to the COR by e-mail.

2) Content: The raw data set shall include all collected data for each participant, separated by strength measure.

Delivery Schedule The following items must be performed or delivered in accordance with the following schedule:

Task Order 0003 Strength Data Update: Bite Strength Measures for Children 3 through 5 Years Old

The Contractor shall design and conduct a study to measure bite strength data for children 3 years through 5 years old.

Objective The purpose of this task order is to update the available strength data for children 3 through 5 years old related to maximum and sustained incisal and buccal bite strength.

Contract Type This is a firm-fixed price task order.

Period of Performance The contract performance period shall begin on the effective date of this order and continue for a 3 year period.

Description of Work Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, materials, services, and facilities to perform the work set forth below. The Contractor shall furnish all necessary resources to perform the work set forth below:

1. The contractor shall collect data for bite strength for children 36 months through 71 months old. The contractor shall develop a test fixture and methodology for measuring maximum and sustained incisal and buccal bite strength. The test fixture and methodology shall take into account issues specific to the age groups being tested, including ability to follow instructions and motivation. Prior to collecting data, the Contractor shall provide a draft test plan and methodology to the COR for CPSC staff review, comment, and approval.

The Contractor shall recruit and test participants from the age groups shown in Table 3. For each strength measure, the Contractor shall test at least 50 participants per age group with balanced gender distribution[footnoteRef:11] and collect strength data from at least 40 participants per age group.[footnoteRef:12] Participants shall reside in the U.S. and shall not have any known developmental delays. [11: Gender balance shall be 50-50 with a 20% allowance.] [12: This provision is intended to account for some children’s refusal to complete testing for each strength measure. Contractor shall collect relevant demographic data and relevant anthropometric dimensions for all participants. Contractor shall attempt to collect strength data for each strength measure for the first 50 participants, and continue with recruitment and testing until at least 40 participants per age group complete all testing.]

Table 3. Age Groups

The Contractor shall collect relevant demographic data, including precise age, gender, and race for all participants.

The Contractor shall measure relevant anthropometric dimensions and landmarks including stature, weight, mouth breadth, and maximum vertical mandibular opening for all participants.[footnoteRef:13] The Contractor shall also record number, status, and location of teeth. [13: The Contractor shall use definitions provided in Childata (1995) or other CPSC staff-specified source for the anthropometric measurements.]

The Contractor shall either use existing validated methods[footnoteRef:14] or develop methods to collect data from children in the specified age groups. [14: See existing studies provided in Appendix A]

The Contractor shall submit all reports, documents, and files to the Contracting Officer’s Representative (COR).

0. The Contractor shall schedule a kick-off meeting.

The Contractor shall provide a written status report every other week during the performance period:

1) Format: The report shall be provided in either Microsoft Word or Adobe Acrobat format and shall be provided to the COR by e-mail.

2) Content: Each report shall contain the following:

1. Status of project and new developments

1. Problems and proposed solutions

1. Changes in schedule

The Contractor shall provide a draft methodology, recruitment strategy, and test plan

1) Format: The draft methodology and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: The draft shall contain a detailed description of the proposed instrumentation and methodology for collecting data for each strength measure. Details shall include method of motivating participants and instructions provided to participants. The draft shall also contain a detailed description of the recruitment strategy and description of test location or locations.

The Contractor shall provide a final methodology, recruitment strategy, and test plan

1) Format: The final methodology and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: See required content under draft methodology, recruitment strategy, and test plan. The final list shall address all of the comments received from the CPSC staff.

The Contractor shall provide all necessary documents needed for OMB Paperwork Reduction Act (PRA) approval.

The Contractor shall provide a draft final report

1) Format: The draft final report shall be provided as a Microsoft Word electronic document and shall be provided to the COR by e-mail.

2) Content: The report shall detail all results gathered for this task order. At a minimum, the report shall include:

1. Table of Contents Contractor Information

1. The contract pursuant to which the report is prepared.

The name of the Contractor preparing the report pursuant to such contract.

Executive Summary Background Methods

1. Description of instrumentation and methodology for each strength measure, including a drawing or picture Description of validation of instrumentation and method Detailed discussion of the methods used to conduct the study, including participant selection and recruitment Participants

1. Demographic characteristics, including age, gender, and race, and relevant anthropometric data, including weight and height Total sample size for each age group and strength measure If any participants dropped out of the study or did not complete testing for all strength measures, a description of reason(s) for drop out or failure to complete testing.

Results

1. Summary of data analysis by age group, including sample sizes, 5th, 50th, and 95th percentile values, standard deviation, mean, minimum, and maximum values for males, females, and combined.

Data shall include both anthropometric and strength measurements.

Discussion

1. Key findings from the study.

Lessons learned during study.

Implications and shortcomings.

The Contractor shall provide a final written report

1) Format: The final written report shall be provided in a Microsoft Word format. The contractor shall provide one electronic copy to the COR by e-mail and two hard copies.

2) Content: See required content under draft final report. The final written report shall address all of the comments received from the CPSC staff.

The Contractor shall provide a data analysis file

1) Format: The data analysis file shall be provided as a Microsoft Excel electronic document and shall be provided to the COR by e-mail.

2) Content: The file shall include sample sizes, 5th, 50th, and 95th percentile values, standard deviation, mean, minimum, and maximum values for males, females, and combined for each age group. Data shall include both anthropometric and strength measurements.

The Contractor shall provide raw data set

1) Format: The raw data set shall be provided in Microsoft Excel electronic document and shall be provided to the COR by e-mail.

2) Content: The raw data set shall include all collected data for each participant, separated by strength measure.

Delivery Schedule The following items must be performed or delivered in accordance with the following schedule:

Task Order 0004 Strength Data Expansion: Bite Strength Measures for Children 3 Months through 35 Months Old

The Contractor shall design and conduct a study to measure strength data for children 3 months through 35 months old.

Objective The purpose of this task order is to expand the available strength data by collecting data for children 3 months through 35 months old related to maximum and sustained incisal and buccal bite strength.

Contract Type This is a firm-fixed price task order.

Period of Performance The contract performance period shall begin on the effective date of the order and continue for a 3 year period.

Description of Work Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, materials, services, and facilities to perform the work set forth below. The Contractor shall furnish all necessary resources to perform the work set forth below:

1. The Contractor shall attempt to collect data for bite strength for children 3 months to 36 months old. The Contractor shall either adapt a test fixture and/or methodology used to collect data from older children for use with younger children or shall develop a new test fixture and methodology. The test fixture and methodology shall take into account issues specific to the age groups being tested, including ability to follow instructions and motivation. Prior to collecting data, the Contractor shall provide a draft test plan and methodology to the COR for CPSC staff review, comment, and approval.

The Contractor shall conduct a pilot study with at least 5 children per age group in order to assess feasibility of testing, and provide the results to the COR with a recommendation on feasibility of full-scale testing.

If testing for a given age group is deemed feasible by CPSC staff, the contractor shall complete testing for that age group. If testing for a given age group is deemed not feasible by the Contractor, the Contractor shall report their attempts and specific reasons explaining why the data cannot be collected. CPSC staff shall review the information submitted by the Contractor to determine if the testing for that age group can be performed. CPSC staff, at their discretion, may request that the Contractor attempt to complete testing for a given age group, but modify or remove certain requirements such as minimum number of participants and gender distribution. If CPSC staff determine that the testing for that age group cannot be performed, the Contractor shall report lessons learned, and suggestions for future work.

The Contractor shall recruit and test participants from the age groups shown in Table 4. For each strength measure for which testing is deemed feasible, the Contractor shall test at least 50 participants per age group with balanced gender distribution and collect strength data from at least 30 participants per age group.[footnoteRef:15] Participants shall reside in the U.S. and shall not have any known developmental delays. [15: This provision is intended to account for some children’s refusal to complete testing for each strength measure. Contractor shall collect relevant demographic data and relevant anthropometric dimensions for all participants. Contractor shall attempt to collect strength data for each strength measure for the first 50 participants, and continue recruitment and testing until at least 30 participants per age group complete all testing.]

Table 4. Age Groups

The Contractor shall collect relevant demographic data, including precise age, gender, and race for all participants.

The Contractor shall measure relevant anthropometric dimensions and landmarks including stature or body length, weight, mouth breadth, and maximum vertical mandibular opening for all participants.[footnoteRef:16] The Contractor shall also record number, status, and location of teeth. [16: The Contractor shall use definitions provided in Childata (1995) or other CPSC staff-specified source for the anthropometric measurements.]

The Contractor shall either use existing validated methods[footnoteRef:17] or develop methods to collect data from children in the specified age groups. [17: See existing studies provided in Appendix A]

The Contractor shall submit all reports, documents, and files to the Contracting Officer’s Representative (COR).

0. The Contractor shall hold a kick-off meeting.

The Contractor shall provide written status reports every other week during the performance period.

1) Format: The report shall be provided in either Microsoft Word or Adobe Acrobat format and shall be provided to the COR by e-mail.

2) Content: Each report shall contain the following:

1. Status of project and new developments

1. Problems and proposed solutions

1. Changes in schedule The Contractor shall provide a proposed list of strength measures

1) Format: The report shall be provided in either Microsoft Word or Microsoft Excel format and shall be provided to the COR by e-mail.

2) Content: The list shall include body parts used (e.g. one finger, both feet), direction of movement, constraints on movement, fixture type (e.g. knob, bar, pedal), and fixture position.

The Contractor shall provide a final list of strength measures

1) Format: The list shall be provided in either Microsoft Word or Microsoft Excel format and shall be provided to the COR by e-mail.

2) Content: See required content under proposed list of strength measures. The final list shall address all of the comments received from the CPSC staff.

The Contractor shall provide a draft methodology, recruitment strategy, and test plan

1) Format: The draft methodology and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: The draft shall contain a detailed description of the proposed instrumentation and methodology for collecting data for each strength measure. Details shall include method of motivating participants and instructions provided to participants.

The Contractor shall provide a final methodology, recruitment strategy, and test plan

1) Format: The final methodology, recruitment strategy, and test plan shall be provided in Microsoft Word format and shall be provided to the COR by e-mail.

2) Content: See required content under draft methodology and…