N62645-15-R-1004_Amendment_0002.doc

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been modified:

BIDDER QUESTIONS AND RESPONSES

Bidder Questions and Responses: Solicitation N62645-15-R-1004

Q1. May the offeror or a Commercial Accounting Firm complete the SF 1408 or should this only be completed by DCAA?

Response: No. For the Department of Defense, DCAA has overall responsibility for determining the acceptability of a contractor’s accounting system. If no information is available to DCAA to make this determination, a Pre-award Survey of Prospective Contractor -- Accounting System (SF 1408) may be requested from DCAA. DCAA has developed a pre-award accounting system adequacy checklist for contractors new to cost reimbursement contracts with the Government. The checklist can be located at:

http://www.dcaa.mil/preaward_accounting_system_adequacy_checklist.html.

Q2. If an organization’s government customers have not to date elected to conduct accounting system review, how should the offeror provide evidence of an adequate accounting system and be compliant with this requirement?

Response: In this case, the offeror should state this information in its proposal. If the offeror is selected for award, the Government reserves the right to review the offeror’s accounting system for adequacy prior to award. Please refer to FAR 16.301-3(a)(3) and DFARS 252.242-7006 Accounting System Administration.

Q3. If an offeror is proposing as a small business and does not have subcontractor government sales exceeding $25 million, and the offeror ’s government customers has not to date elected to review its purchasing system how should the offeror provide evidence of an approved purchasing system and be compliant with this requirement?

Response: If the offeror’s sales to the Government (excluding competitively awarded firm-fixed-price and competitively awarded fixed-price with economic price adjustment contracts and sales of commercial items pursuant to FAR Part 12) are not expected to exceed $25 million during the next 12 months, then a Contractor Purchasing System Review (CPSR) would not be required. Sales include those represented by prime contracts, subcontracts under Government prime contracts, and modifications. If the CPSR is not required per the requirements of FAR 44.302, then the offeror should state this information in its proposal. Please refer to FAR Subpart 44.3 and DFARS 252.244-7001 Contractor Purchasing System Administration.

Q4. If an offeror does not have subcontractor government sales exceeding $25 million, and the offeror ’s government customers has not to date elected to review its purchasing system how should the offeror provide evidence of an approved purchasing system and be compliant with this requirement?

Response: See response to question Q3.

Q5. If an offeror does have subcontractor government sales exceeding $25 million, and the offeror’s government customers has not to date elected to review its purchasing system how should the offeror provide evidence of an approved purchasing system and be compliant with this requirement?

Response: In this case, the offeror should state this information in their proposal. If the offeror is selected for award, the Government reserves the right to conduct a Contractor Purchasing System Review (CPSR) in accordance with FAR Subpart 44.3 and DFARS 252.244-7001.

Q6. If the offeror does not have a current rate agreement or forward pricing agreement may the offer provide a prospective estimate of indirect rates as a basis for the Rate Agreement and be compliant with this requirement?

Response: Yes, NMLC would accept this information and consider it compliant.

Q7. If the offeror does not have a current rate agreement or forward pricing agreement may the offer provide fixed indirect rates as a basis for the Rate Agreement and be compliant with this requirement?

Response: No, NMLC does not desire to hold the successful offeror to fixed indirect rates.

Q8. If the offeror does not have a current rate agreement or forward pricing agreement may the offer provide provisional rates submitted to Defense Contract Management Agency (DCMA), Department of Health and Human Services (DHHS), or other Federal Government contracting offices and be compliant with this requirement?

Response: Yes, NMLC would accept this information and consider it compliant.

Q9. If an organization’s government customers have not to date elected to conduct an audit, how should the offeror provide a copy of any DCAA audit the supports the proposed contract rates or costs and be compliant with this requirement?

Response: NMLC recognizes that an offeror may not have a recent DCAA audit. In this case, the offeror should state this information in its proposal.

Q10. If the offeror does not have a have a DCAA audit or any other DCAA type audit from other Federal Government Contracting offices may the offer provide provisional rates submitted to DCAA or other Federal Government Contracting offices to be compliant with this requirement?

Response: Yes, NMLC would accept this information and consider it compliant.

Q11 Background. Page 6: Section 4.0, Estimated Staffing, defines Key Personnel as those performing at the Senior Management Consultant and Management Consultant IV levels. It goes on to state that resumes shall be provided for all key personnel positions.

Question 11: Would the government allow the offeror flexibility in defining its key personnel based on its understanding of the work and the proposed solution? For example, all Senior Management Consultants may not necessarily be key personnel due to the limited number of hours worked or the role they serve on the effort. Conversely, there may be a lower level position considered "key" due to that individual’s niche expertise or skill set employed in performance of the mission.

Response: Please review Page 5 Section 4.0 paragraph 2.

“This is the Government’s estimation of the staffing needed to accomplish this effort. The offeror may have an alternative approach to staffing during the proposal phase. However, any deviation from the staffing estimated could be perceived as noncompliance if not sufficiently supported by the offeror and acknowledged by the evaluator/client. Therefore, if an alternative is being proposed, it is required that the offeror first address the base requirement as a minimum and then augment such with an alternative if the offeror is proposing an alternative.

Resumes shall be provided for all key personnel positions. Key personnel shall demonstrate sufficiently enough to the evaluator or client that the person proposed has the knowledge and experience relevant to accomplish the aforementioned tasks.”

Q12 Background. Page 7: In Section 5.0 (Travel and Other Direct Costs) and Section 6.0 (Consultants)

Question: Are the NTE amounts provided considered plug numbers for use by all offerors? ODC and Consultant NTEs specify “per year before contractor burdens.” Please confirm the NTE for travel of $125K per year is also “before contractor burdens.”

Response: The NTE amounts are recommended to be used by all offerors. Confirmed, the NTE for travel of $125K per year is also “before contractor burdens.”

Q13 Background. Page 93 Section L.7.2.1; Volume 1 Subpart 2 instructions: The instructions state for the Management section, offerors are allowed “20 pages excluding letters of commitment and key personnel resumes.” On page 95 paragraph 2, the instructions state “The Offeror must present resumes for proposed candidates, consisting of one (1) resume per labor category, in order to evaluate the Offeror’s recruiting capability.”

Questions:

a. Are offerors to submit resumes for all key personnel plus one resume for each remaining labor category?

b. If the answer to Question 3a is “yes,” are all resumes excluded from the Management section page count?

Response:

a. Offerors are to submit resumes for all key personnel and at least one additional resume from each the remaining labor categories.

b. Yes, all resumes are excluded from the page count.

Q14. Page 6 of 104, Paragraph 3.21 of the PWS states that the performer must have current/active Data Use Agreement (DUA) in place with OSD at the time of award. Since Data Use Agreements are very specific to contract and PoP, not even the incumbent contractor can meet this requirement. The PWS states that this requirement is a minimum requirement for the contract.

Response: Please refer to the language below that has been incorporated in Section C. 3.21. and Section L.8.1.6 of this RFP.

The awarded contractor must have an active Data Sharing Agreement (DSA) in place before commencement of services with OSD (Defense Health Agency- DHA) granting access to medical and personnel records resident in the Military Health System (MHS) including the TMDS, the MDR, Defense Occupational and Environmental Health Readiness System (DOEHRS) Hearing Conservation (HC) and pre/post deployment health assessments/reassessments. A DSA must also include full access to protected health information. Obtaining an active DSA is a minimum requirement for the awarded contractor as failure to have a current DSA with OSD (TMA) before commencement of services would result in a work stoppage in NHRC department 161 and a failure for the client to meet funding sponsor requirements for product delivery.

Q15. Page 8 of 104 Paragraph 7.4 of the PWS states that there is human research involved as a part of this contract. Can you define the scope of human research activities that will be required under this contract?

Response: Collecting, characterizing, analyzing, and reporting of Personally Identifiable Information (PII) / Protected Health Information (PHI) data from multiple sources, including both in-house sources such as the Expeditionary Medical Encounter database (EMED) and external sources such as the Military Health System (MHS), the VA, civilian/homeland defense data, tactical data, operational data, and personnel data.

Q16. Page 8 of 104 Paragraph 7.5 of the PWS states that there will be a mix of on-site and off-site contractor staff, but the PWS does not state the mix. Can you please specify the required mix of on-site and off-site contractor staff or provide the current mix as a basis for estimating future on-site vs off-site support requirements?

Response: Possibly up to 5 of the 34 contractor personnel positions will be located off-site.

Q17. Page 6 of 104 In paragraph 4 on estimated staffing, it states that the Senior Management Consultant and the four Management Consultant IV positions are key. Can you confirm that all four Management Consultant IV positions are key?

Response: Confirmed, all four Management Consultant IV positions are key.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

PERFORMANCE WORK STATEMENT

OPERATIONAL MEDICINE RESEARCH MODELING SUPPORT SERVICES

FOR THE NAVAL HEALTH RESEARCH CENTER

1.0 BACKGROUND

The Naval Health Research Center (NHRC) performs medical modeling and simulation research for Department of Defense (DoD), homeland defense, humanitarian assistance, peace-keeping and disaster relief activities including casualty projection, medical planning factor development, identification of weapons effects both ground and shipboard-based, projection of resource requirements, database development and maintenance, and quality of life outcome studies.

2.0 SCOPE OF WORK

This acquisition will provide contractor support services for research modeling such as casualty projection in support of operational medicine. It is heavily data driven and depends upon the collection, characterization, analysis, and reporting of data from multiple sources, including both in-house sources such as the Expeditionary Medical Encounter database (EMED) and external sources such as the Military Health System (MHS), the VA, civilian/homeland defense data, tactical data, operational data, and personnel data.

3.0 SPECIFIC REQUIREMENTS

The Modeling and Simulation (M&S) department (Department 161) at NHRC conducts analysis and develops models to provide medical decision support to operational commanders, medical logisticians, and field medical personnel as they see to determine the resources required to support combat and peacetime deployments. M&S works with medical planners providers and logisticians to develop projects that assist in field medical services planning, systems analysis, operational risk assessment, wargaming, and to determine the best course of action for treating a particular patient stream using the available resources.

Activities to accomplish the aforementioned requirement include:

3.1 Manage both in-house and external medical modeling and simulation data sets, monitor for data integrity, and perform statistical analysis of these data sets. The contractor shall draft NHRC technical reports, informational/marketing material, and articles for peer-reviewed journals based on the results of the analyses of these data sets. The performer must demonstrate experience and knowledge developing operationally-relevant research ideas, operationally-relevant research designs, and be capable of interpreting research results in terms of operationally-relevant concepts, products and recommendations.

3.2 Support for studies, analyses and reporting. Assemble, examine, and abstract relevant clinical data from service member medical records, theater medical data, event data, and large DoD/VA databases from both in-house and remote locations such as DoD/VA Medical Treatment Facilities (MTFs) and enter data into the EMED or other DoD, homeland defense, humanitarian assistance, disaster relief and Dept 161 databases. This task requires clinical experience and knowledge in military, humanitarian/disaster response, and homeland defense clinical environments.

3.3 Develop database structures, monitor data integrity, perform data quality assurance, maintain databases, and write data queries to extract data from both in-house and large, external DoD, homeland defense, humanitarian assistance, and disaster relief databases. Experience working with large military, VA, humanitarian/disaster response, and homeland defense data sets is desired.

3.4 Develop injury/ICD-9/ICD-10 (International Classification of Diseases 9th/10th edition/revision) profiles for various operational scenarios and model weapons effects and medical resource requirements.

3.5 Develop clinical ICD-9/ICD-10 based treatment profiles for operational scenarios and model weapons effects and medical resource requirements.

3.6 Assign medical supplies to ICD-9/ICD-10 treatment profiles for various operational scenarios and model weapons effects and medical resource requirements. Knowledge of and experience using Navy, Marine Corps, Army or Air Force supply assemblages is required.

3.7 Develop data sets and methodologies to project casualty rate estimations using both current methodologies as well as demonstrating knowledge and experience developing new methodologies. Identify medical planning factors and model their effect on DoD operational scenarios, humanitarian assistance, homeland defense and disaster relief missions.

3.8 Code data abstracted from member medical records using the following taxonomies: International Classifications of Diseases, Abbreviated Injury Scale, Injury Severity Score, and DSM-IV (Diagnostics and Statistical Manual of Mental Disorders 4th edition) Axis Codes. Specific knowledge and experience using the Military Abbreviated Injury Scale-2008 required.

3.9 Develop, manage, and execute longitudinal, large cohort studies of casualty experiences, clinical, rehabilitative, long term, and quality of life outcomes. This includes senior epidemiological scientist, study manager/analyst/writer, interviewers, development and maintenance of subject identification and tracking methodologies, website design, advanced scientific analysis techniques, drafting of scientific papers and publishing of scientific papers in peer review publications.

3.10 Examine, interpret, and prepare reports on various aspects of casualty clinical records, including subject areas of general surgery, orthopedic surgery, neurology, pathology, and radiology. The contractor shall examine and interpret casualty clinical records; code injury data into diagnostic and severity categories; analyze both in-house and external DoD data; and write reports describing findings in scientific peer review publications.

3.11 Possess detailed knowledge and experience using large DoD/VA clinical, operational and personnel data bases for performing epidemiological research. Demonstrated experience using SAS and SPSS to perform advanced statistical analyses on large DoD/VA data sets. These data sets include the Theater Medical Data Store (TMDS), Military Health System Data Repository (MDR), Clinical Data Repository (CDR), Armed Forces Health Longitudinal Technology Application (AHLTA), and Armed Forces Health Longitudinal Technology Application-Theater (AHLTA-T), Veteran Affairs (VA), Expeditionary Medical Knowledge Warehouse (EMedKW), and the Expeditionary Medical Encounter Database (EMED).

3.12 Provide information technology to support: in-house and external database infrastructure development, maintenance, and querying of the EMED.

3.13 Provide technical support to other commands to install, instruct, and oversee NHRC developed software and applications to facilitate expansion of functional capabilities into the training and exercise support domains, including federating NHRC medical models into larger DoD war-gaming simulations. Provide liaison capability between NHRC and operational commands. Provide on-site support of Department 161 activities at commands outside NHRC.

3.14 Provide programming support for integrating NHRC modeling and simulation tools into both service-specific and DoD simulation tools and suites.

3.15 Oversee, manage and develop plans to modernize NHRC developed software and applications, including casualty forecasting and injury projection. Knowledge and experience using EMedKW, Enterprise Estimating Supplies Program (ESP), ReSupply Validation Program (RSVP), Joint Medical Planning Tool (JMPT) and Medical Planners Toolkit (MPTk) clinical modeling tools is required.

3.16 Assist in the design and development of new tools and applications in support of DoD,VA, homeland defense, humanitarian assistance, and disaster relief modeling and simulation.

3.17 Conduct epidemiology support to ongoing and future projects by developing testable research hypotheses, reporting data trends and data management of longitudinal data sets using TMDS, MDR, CDR, AHLTA, Pharmacy Data Transaction Service (PDTS), AHLTA-T, EMED, MPTk, and JMPT.

3.18 Provide editorial and clerical support for the aforementioned projects to include editing, word processing, and project maintenance requirements and budgeting elements.

3.19 Monitor theater medical data collection activities and provide theater data collection support and training.

3.20 Develop procedures, identify data sets, and perform studies and analyses using clinical and tactical event data in both classified and unclassified environments.

3.21 The awarded contractor must have an active Data Sharing Agreement (DSA) in place before commencement of services with OSD (Defense Health Agency- DHA) granting access to medical and personnel records resident in the Military Health System (MHS) including the TMDS, the MDR, Defense Occupational and Environmental Health Readiness System (DOEHRS) Hearing Conservation (HC) and pre/post deployment health assessments/reassessments. A DSA must also include full access to protected health information. Obtaining an active DSA is a minimum requirement for the awarded contractor as failure to have a current DSA with OSD (TMA) before commencement of services would result in a work stoppage in NHRC department 161 and a failure for the client to meet funding sponsor requirements for product delivery.

3.22 Demonstrated experience working within a US military-oriented environment required for all positions.

4.0 ESTIMATED STAFFING

The period of performance shall be for one base period of 12 months, followed by four, 12 month option years, for a potential total of approximately 60 months. The expectation is that this is approximately a 66,000 hour (or less) effort for the base period of performance. An estimate of the type of direct labor required to accomplish the aforementioned research include:

*Considered key personnel in performance of the contract

This is the Government’s estimation of the staffing needed to accomplish this effort. The offeror may have an alternative approach to staffing during the proposal phase. However, any deviation from the staffing estimated could be perceived as noncompliance if not sufficiently supported by the offeror and acknowledged by the evaluator/client. Therefore, if an alternative is being proposed, it is required that the offeror first address the base requirement as a minimum and then augment such with an alternative if the offeror is proposing an alternative.

Resumes shall be provided for all key personnel positions. Key personnel shall demonstrate sufficiently enough to the evaluator or client that the person proposed has the knowledge and experience relevant to accomplish the aforementioned tasks.

5.0 TRAVEL AND OTHER DIRECT COSTS

Travel: There may be travel (CONUS and OCONUS) required to perform this PWS. Travel approval must be processed in accordance with client-command procedures (e.g., TAD request), in accordance with Joint Travel Regulations, documented and submitted with the Monthly Status Report, and correlated with a corresponding line item in the invoice for payment. The number of Contractor personnel required will be determined at the discretion of the technical point of contact. There may be circumstances requiring contract personnel to drive or ride in a Government vehicle in the performance of conducting various research study requirements, including (but not limited to) travel to off-site commands for meetings, relocation of research equipment or transportation of research subjects, but not including any personal services. Should such a situation arise, the contractor must first be in compliance with local base/command regulations. For all trips, the point of departure is San Diego, CA, unless otherwise directed by the technical point of contact. Travel claims for all on-site Contractor personnel shall be in accordance with the Joint Travel Regulations (JTR). All travel will need to be approved by the technical point of contact and COR in writing via e-mail. Travel into any of the OCONUS or FOREIGN areas must be processed in accordance with standing DoD Directives and Command area of responsibility procedures. Travel destinations may include but are not limited to:

Total (NTE): $125K per year

Other Direct Costs (ODCs): There may be ODCs (includes items incidental in performance such as costs associated with executing research studies.) required to perform this PWS (NTE $200,000 per year before contractor burdens), and will be defined on an as needed basis in writing (e.g., e-mail) by the technical point of contact for this contract.

6.0 CONSULTANTS

There may be consultants (NTE $670,000 per year before contractor burdens) required to perform this PWS. The Government estimates this would equate to 6700 hours (or less) per each period of performance (base and options). In order to further research goals, consultants would provide the following capabilities:

a. Project management

b. Advisement

c. Data Analysis

d. Manuscript writing

e. IT/database support

7.0 ASSUMPTIONS AND CONSTRAINTS

7.1 The expectation is that this will be an incrementally-funded Cost-Plus Fixed-Fee contract because the service is directed toward objectives for which the work cannot be precisely described in advance. This requirement addresses an indeterminate amount of data to be processed and analyzed. The Offeror shall already be approved for performance on a Cost-Plus-Fixed-Fee contract and a security clearance level of SECRET (requiring a DD254).

7.2 This effort is considered non-severable because it represents a single undertaking which, if severed mid-performance, would be deleterious to the desired outcome of the program. Specifically, there are models being developed / maintained in support of operational requirements that cannot be terminated before completion / exercised.

7.3 Health Insurance Portability and Accountability Act (HIPAA) of 1996 related guidance and requirements in accordance with BUMEDINST 7050.1B – Agreements with non-DoD entities: NHRC is a DoD activity and as such is a Covered Entity as defined by the aforementioned BUMED instruction. However, in performance of its mission, NHRC does contract out to non-DoD entities such that these non-DoD entities may have access to information covered under the HIPAA of 1996. In this circumstance, NHRC must execute documentation in accordance with this instruction as it pertains to non-DoD entities by executing with the non-DoD entity a Business Associate Agreement (BAA). The Offeror will be required to sign a BAA and is contained in Attachment 1.

7.4 There is human research involved with this effort requiring human-subject research assurance certification by the contractor performer. Specifically, a Federalwide Assurance (FWA) and MPA DoD-Addendum to the FWA.

7.5 This effort represents a mix of on-site and off-site contractor personnel. Those personnel performing on-site shall be processed in accordance with on-site base/command procedures (e.g. CAC cards, personnel physicals, etc.). Contractor personnel shall be required to wear a contractor identification badge while on Government property. On-site contractor personnel are expected to conform to client-agency, normal business hours, which is an Alternative Work Schedule with nine-hour days and alternate Fridays off, with the exception of Federal holidays. On-site work will be performed at NHRC in San Diego, CA.

7.6 This effort is not considered a new requirement (legacy contract: N62645-12-C-4076) and therefore the employer-employee right of first refusal concerning incumbent employees with the successful offer is relevant to this contract.

7.7 Resumes shall be provided for the aforementioned positions if proposed, as they are considered key personnel. However, after award, resumes shall be provided for all positions prior to hire. The Contracting Officer’s Representative (COR) reserves the right to review the qualifications of all personnel performing or to be performing on this contract (see Section 4.0).

7.8 The period of performance shall be for a base period of 12 months, followed by four, 12 month option periods, for a total of approximately 60 months. The expectation is that this is approximately a 66,000-hour (or less) direct labor effort for each 12 month period of performance. In addition, there is an anticipated 6,700 hours (or less) of consultant efforts (NTE $670,000) for each 12 month period of performance. Other Direct Costs are estimated at $200,000 and travel at $125,000 per year (before contractor burdens) with a 3% escalation applied annually to direct labor before indirect costs are applied.

8.0 PERFORMANCE STANDARD

Tasks will be evaluated for completeness, timeliness, utility, and accuracy. Positive and negative performance will be documented in the Contractor Performance Assessment Report System (CPARS).

8.1 Performance: The Contracting Officer’s Representative (COR) will measure the contractor’s performance by assessing the quality of the services delivered by the contractor as evaluated by the NHRC staff. Examples of services to be provided include research, studies, and reports provided in accordance with the tasks in the performance work statement. The quality standards are defined as follows:

· Successful services are defined as those that conform to the task description provided in the Performance Work Statement (PWS) with little or no rework required of the contractor by the Government.

· Unsuccessful services are defined as those that do not conform to the task description provided in the PWS, thereby requiring significant rework by the contractor at the direction of the Government.

8.2 Schedule: The Contracting Officer’s Representative (COR) will determine whether the contractor has met the schedule using the due dates for receipt of deliverables. The quality standards are defined as follows:

· Successful delivery is defined as delivery of data and accomplishment of the metrics at least 95% of the time.

· Unsuccessful delivery is defined as delivery of data and accomplishment of the metrics less than 95% of the time.

8.3 Cost: The COR will review monthly cost vouchers to monitor the contractor’s expenditures in comparison to the contractor’s proposed budget (submitted under the Monthly Progress Reports) throughout the contract performance. The quality standards are defined as follows:

· Successful cost control is defined as performance of the tasks within the amount of funds allotted. If the contractor’s actual expenditures on a monthly basis exceed the budgeted amount for expenditures, the contractor must provide an explanation as to why this occurred and what changes have been made to ensure completion of the work within the ceiling in order to still receive a successful assessment of performance.

· Unsuccessful cost control is defined as exceeding the funding allotted for the tasks or exceeding the original ceiling of the contract for reasons not attributable to the Government. Furthermore, if the Government is not notified of why budgetary overruns have occurred on a monthly basis and what steps the contractor is taking to ensure completion of the work within the ceiling, the contractor will receive an unsuccessful assessment of performance.

9.0 METHODS OF QUALITY ASSURANCE SURVEILLANCE

The Quality Assurance Surveillance Plan for this requirement is contained in Attachment 2.

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

INSTRUCTIONS TO OFFERORS

L.1.1 SOLICITATION QUESTIONS

Questions concerning the proposal are due no later than 2:00 PM local time, 30 April 2015. Questions shall be submitted to ronald.s.sanford2.civ@mail.mil by the required time, and no questions shall be addressed after this cutoff date. Offerors shall submit one set of questions only; multiple emails shall not be accepted. An amendment to the solicitation will be issued providing responses to the questions.

L.1.2 PERIOD FOR ACCEPTANCE OF OFFERS

The period for acceptance of offers is one hundred eighty (180) days after the closing date of the solicitation.

L.2 PRE-CONTRACT COSTS

The Contractor will not be reimbursed for any costs incurred prior to the effective date of the contract.

L.3 CONTRACT Award

L.3.1 TYPE OF SOLICITATION

This Solicitation is being issued as a full and open competition under which all contractors eligible for Federal contracts are encouraged to participate.

L.3.2 ONE PROPOSAL

The Government will evaluate only one proposal from each prime offeror.

L.3.3 TYPE OF CONTRACT

See FAR 52.216-1 included in the solicitation.

L.4 AWARD ON INITIAL OFFER

The Department of Defense preference is to engage offerors in discussion after the receipt of proposals. However, the Government may decide in certain cases to award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror’s initial proposal should contain the best terms from a cost and technical standpoint as there may not be an opportunity to revise the proposal through the discussion process. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary (FAR 52.215-1(f)(4)).

L.5 PROPOSAL SUBMISSION

a. Offerors are invited to submit a proposal in accordance with Paragraph L.7, Proposal Preparation Instructions, to arrive electronically through the AMRDEC SAFE website no later than the proposal due date for this solicitation. The Government does not authorize submission of telegraphic, facsimile, paper or CDROM offers via hand carry or mail carrier for this solicitation.

b. The proposal due date is 2:00 PM local time on 20 May 2015. Timeliness will be determined by receipt of the AMRDEC SAFE generated email.

c. All proposals submitted in response to this solicitation will be submitted electronically via the AMRDEC SAFE website. No paper copies or electronic copies submitted outside of the SAFE website (i.e., emailed directly to the NMLC POC or other NMLC email inbox) will be accepted.

d. Submitting your proposal:

The AMRDEC SAFE application is used to send large files to individuals which would normally be too large to send via email. There are no user accounts for SAFE - authentication is handled via email and Common Access Card (CAC). The application is available for use by offerors.

The AMRDEC SAFE application can be accessed via https://safe.amrdec.army.mil/safe.

Offerors shall proceed as “Non- CAC Users” under all circumstances.

After selecting the “Non- CAC Users” option above, the page will be redirected to the package upload form. Fill in all the required input fields (field names are in italics):

Personal Information:

Your Name - Your name, Your Company Name.

Your Email address - Your email address.

Confirm Your Email Address - Re-enter your email address.

File Information:

Description of File(s) - Enter a description for the package;

File(s) - Click the "Browse" button to select your file(s). You may add up to 25 files per package, so long as the total file size does not exceed 2GB. The total file size is the combined file size of all submitted files.

Deletion Date – Leave this date at the default setting of two weeks (14 days) from the submission date.

Recipient Information:

Manually Enter Email Address: Input usn.detrick.navmedlogcomftdmd.mbx.research@mail.mil and hit the add button. (To remove a recipient, highlight their name and click the "Remove" button.)

Email Settings:

Check all four of the boxes:

- Encrypt email message when possible.

- Notify me when file(s) downloads are STARTED.

- Notify me when file(s) downloads are COMPLETED.

- Require CAC for Pick-up (all recipients will need to log in with a CAC to download file(s).

To the right of “Email Settings” is a nondescript box with two options (None or FOUO). Select the FOUO option and select “sensitive” from the dropdown menu below.

Review all fields for accuracy and hit the ‘submit” button. Clicking the "Submit" button will upload the files and submit the package. Guest users will need to check their email to verify their email address before the recipients will be notified. After the package has been uploaded, the Government will receive a link to the package download page as well as a password. These passwords are unique for each recipient (not the package), and will be disabled once SAFE detects that the user successfully downloaded each file within the package.

Once the offeror has submitted their proposal, they shall send a confirmation emai to usn.detrick.navmedlogcomftdmd.mbx.research@mail.mil and provide their company name and contact information as well stating that they have submitted a complete proposal to SAFE in response to solicitation N62645-15-R-1004. Submission of proposals is a onetime affair (unless in unusual circumstances multiple SAFE submissions are required because an offeror exceeded the 25 file limit per SAFE submission.). Additional documents will not be accepted after receipt of the confirmation email from the offeror to the usn.detrick.navmedlogcomftdmd.mbx.research@mail.mil inbox that confirms successful submission of the proposal.

e. Any data previously submitted in response to another solicitation, whether submitted to the Naval Medical Logistics Command or another agency, should be assumed to be unavailable during this proposal evaluation and source selection process. Proposal data shall not be incorporated into the proposal by referring to another proposal or other source.

f. Elaborate brochures or other presentations beyond that sufficient to present a complete and effective proposal are neither necessary nor desired.

g. The Government reserves the right to request additional information after receipt of offeror’s response to the RFP. The proposal shall be valid for not less than 180 calendar days from the proposal due date. The offeror shall make a clear statement that the proposal is valid until such date in Volume I.

h. A company with multiple Divisions (and each division registered separately in SAM) is permitted to submit a separate proposal by Division for award consideration. However, offerors are cautioned that if one company submits separate proposals from multiple Divisions, each Division’s proposal should address the full RFP requirements uniquely based on their particular Division’s capabilities. For example, management approach, small business participation plans, and/or past performance submissions of a different Division may not be used in support of the Division submitting the proposal. The proposal must be specific to the Division submitting the proposal.

L.6 SEQUENCE OF EVENTS

The Government will employ source selection techniques to evaluate proposals, conduct negotiations and determine the successful offeror in this acquisition. "Offer," for the purposes of this solicitation, shall be defined as a response to the solicitation that, if accepted, would bind the offeror to perform the resultant contract. If the Government deems discussions necessary, a competitive range determination will be made.

The following describes the sequence of events that offerors can expect during proposal evaluation and negotiation:

a. The offeror's proposal shall be submitted in accordance with Paragraph L.7, Proposal Preparation Instructions.

b. Upon receipt, the proposals will be reviewed for completeness and compliance with RFP requirements. If a proposal is incomplete or received late (in part or in full) the proposal may not be evaluated.

c. In accordance with FAR 15.306, the Government may conduct exchanges with offerors after receipt of proposals leading to the establishment of the competitive range and any subsequent competitive range determination that may be made.

d. The Government may conduct exchanges with offerors prior to establishment of the competitive range that may be made in order to enhance the Government’s understanding of proposals; allow reasonable interpretation of the proposal; or facilitate the Government's evaluation process. Such communications shall not be used to cure proposal deficiencies or material omissions, materially alter the technical or cost elements of the proposal, and/or otherwise revise the proposal. Such communications may be considered in rating proposals for the purpose of establishing the competitive range. Furthermore, such communications do not and will not permit offerors to modify, revise, or otherwise change any element of their proposal.

e. The Government reserves the right to make award without entering into discussions. Offerors shall be prepared to enter into discussions and/or negotiations and, if authorized by the Contracting Officer, may be allowed to revise or modify their proposals. For those Offerors in the initial competitive range, the Government will submit Discussion Items, which will require a response per instructions that will be provided at that time.

f. The Government will incorporate into the resultant contract any and/or all commitments made in the offeror’s proposal.

L.7. PROPOSAL PREPARATION INSTRUCTIONS

L.7.1 INTRODUCTION AND PURPOSE

This section specifies the format and content that offerors shall use in this Request for Proposal (RFP). The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified in Sections L.7. and L.8. Any proposal which does not provide, as a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration.

L.7.2 PROPOSAL SUBMISSION

Proposals shall be submitted in two Volumes:

Volume I – Technical (Administrative, Management Approach/Risk, and Past Performance)

Volume II – Cost

Volume I and Volume II will be reviewed and evaluated. Each volume shall be a stand-alone document and shall clearly and completely provide the information being requested. The two volumes will be evaluated as part of the source selection evaluation process (see Section M). In addition to the volumes addressed above, each proposal shall include the following:

L.7.2.1 WRITTEN PROPOSAL

The overall proposal shall consist of the following separate, individually titled volumes. Each copy of each volume shall be separated, with appropriate identification.

MS Word is an acceptable file format for Volume I of the proposal. MS Word with MS Excel are acceptable file formats for Volume II of the proposal. Adobe Acrobat is an acceptable format for those items requiring fill ins.

Volumes and number of copies each are identified below. The Government cannot consider pages submitted in excess of the stated page limitations. Page limitations include all text, graphs, pictures, appendices, references and exhibits unless otherwise noted. Cross reference matrices, tabs, index sheets, tables of contents, dividers and other such aids that are solely used to assist the evaluator in locating information and are advisory in nature, imparting no other information other than the identification of content, will not be counted against any page limits stated within this RFP. Type shall be no smaller than a font size of eleven (11) and shall have 1.0 line spacing with a minimum of 1” margins. Type for graphics, tables and reproductions shall be no smaller than a font size of 10 with a minimum of 1” margins. Page size shall not exceed 8 ½” x 11”. Foldout illustrations are not allowed. The page limits described below do not include Title Page, Table of Contents, and Glossary. Double column pages are not allowed.

Section III- Section K (Reps and Certs)

Section IV- Small Business Participation Plan and (if applicable) Subcontracting Plan Sec III- No page limit

Sec IV- 30 page limit (Subcontractor consents may be an appendix to Subpart IV and not included in the page count).

Section V- Verification of Security Clearance Level

Section VI - Use of Human Subjects in Research Sec V- No page limit

Sec VI- No page limit

No Page Limit

L8. EVALUATION APPROACH

L.8.1 VOLUME I, SUBPART I: ADMINISTRATIVE

The offeror shall submit an Executive summary, required solicitation documents, the required Representations and Certifications through the System for Award Management (SAM), a Small Business Participation Plan (for all offerors) and Subcontracting Plan (for other than small business concerns, educational institutions, and non-profits), and verification of security clearance level. All subparts shall be submitted with the proposal or the proposal may be considered incomplete.

L.8.1.1 SECTION II: SOLICITATION DOCUMENTS

Offeror(s) shall complete the OFFER part of the Standard Form (SF) 33 format (cover page). An official having the authority to bind the firm contractually must sign the cover page. If this individual is not an officer of the company, the proposal shall be accompanied by some form of written evidence of the individual's authority to bind the company, under contract, to a particular course of action. This might include such evidence as a written delegation of said authority, signed by an officer of the company.

Offeror(s) shall acknowledge all amendments that may be issued under this RFP by official signature of an individual possessing the authority to bind the firm contractually. All amendments must be acknowledged, signed and included in Section II.

L.8.1.2 SECTION III: SECTION K (REPS AND CERTS)

The offeror shall complete the annual representations and certifications electronically through SAM at http://www.sam.gov. The offeror shall verify their SAM registration is current, accurate, complete, and applicable to this solicitation as of the date of this offer and is incorporated in this offer by reference. The applicable NAICS code for this solicitation is 541712. The small business size standard is 500 employees. In addition to submission to SAM, the offeror shall complete the SAM Certification Sheet and the fill-ins required by the full text clauses in Section K, and submit a electronic copy of each in Section III of Volume I. (Refer to SAM Certification Sheet and the full-text clauses in Section K.)

The offeror shall be registered and current in SAM in accordance with FAR 52.204-13.

L.8.1.3 SECTION IV: SMALL BUSINESS PARTICIPATION PLAN AND SUBCONTRACTING PLAN

All offerors are required to submit a small business participation plan. If applicable (for other than small business concern offerors under the assigned NAICS code herein), the offeror shall submit a subcontracting plan in accordance with FAR Clause 52.219-9 and DFARS Clause 252.219-7003 (for reference see FAR 19.704 and DFARS 219-704). The subcontracting plan requirement is not applicable to small business concerns qualified as such under the NAICS code assigned to this solicitation. Master subcontracting plans can be included as an appendix to the subcontracting plan and will not count towards the page count.

L.8.1.4 SECTION V: VERIFICATION OF SECURITY CLEARANCE LEVEL

The offeror shall submit documentation verifying a SECRET facility clearance by submitting a completed DD Form 254 for a contract held within the past three years. One for this requirement will be provided at time of contract award.

L.8.1.5 SECTION VI: USE OF HUMAN SUBJECTS IN RESEARCH

The successful Offeror may be required to support research involving human subjects under this contract. Compliance with the applicable provisions concerning living organisms in paragraph ((a) For human subjects) listed below is required. Research involving human subjects will not be awarded or begin and no funds expended until all approvals have been obtained. To address research involving human subjects, the Offeror must submit as part of its proposal: (1) copy of the Offeror’s DHHS-issued Federalwide Assurance (FWA) and (2) the Offeror’s approved DoD-Navy Addendum to the DHHS-issued FWA. Information about assurance applications and forms can be obtained by contacting ONR_343_contact@navy.mil. DON HRPP guidance for human subject research is located at http://www.med.navy.mil/bumed/humanresearch/. Failure to provide the required documentation may render the proposal unacceptable and it will not be considered for award.

For human subjects:

(1) Common Federal Policy for the Protection of Human Subjects codified by the Department of Health and Human Services (DHHS) at 45 CFR 46 Part A, and implemented by the Department of Defense at 32 CFR 219. This includes both a Federal-wide Assurance (FWA) administered by DHHS and a DoD-Navy Addendum. Information about assurance applications and forms can be obtained by contacting ONR_343_contact@navy.mil.

(2) DoD Instruction 3216.02 and applicable DON Component policies.

(3) 10 U.S.C. 980, Limitation on use of humans as experimental subjects.

(4) Food and Drug Administration policies and regulations, when applicable.

L.8.1.6 SECTION VII: USE OF DATA SHARING AGREEMENT

The awarded contractor must have an active Data Sharing Agreement (DSA) in place before commencement of services with OSD (Defense Health Agency- DHA) granting access to medical and personnel records resident in the Military Health System (MHS) including the TMDS, the MDR, Defense Occupational and Environmental Health Readiness System (DOEHRS) Hearing Conservation (HC) and pre/post deployment health assessments/reassessments. A DSA must also include full access to protected health information. Obtaining an active DSA is a minimum requirement for the awarded contractor as failure to have a current DSA with OSD (TMA) before commencement of services would result in a work stoppage in NHRC department 161 and a failure for the client to meet funding sponsor requirements for product delivery.

L.8.2 VOLUME I, SUBPART II: MANAGEMENT APPROACH/RISK

The Offeror must present its approach in the following areas: any subcontract management, ability to monitor contract activities, ability to submit deliverables in a timely manner, and identification and resolution of problem areas.