ATTACHMENT J2- Request for Task Order Proposal under IDIQ.doc

DOC document 179 KB Posted

Attached to
DNA Plating and Storage Services IDIQ Federal contract opportunity
Solicitation number
RFP75D301-21-R-71848
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

View the file

Other files for this federal contract opportunity

Other files attached to DNA Plating and Storage Services IDIQ, newest first.
File Type Posted
Request for Proposal 75D301-21-R-71848- Amendment 0001.doc DOC document
SF30 75D301-21-R-71848 Amendment 0001 DNA Plating and Storage.doc DOC document
Questions and Answers RFP 75D301-21-R-71848.pdf PDF
ATTACHMENT J1.docx DOCX document
Request for Proposal 75D301-21-R-71848.doc DOC document

On GovTribe

Work with this file on GovTribe

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

Request for Task Order Proposal Title of Project: DNA Plating and Storage Services Section B - Supplies Or Services and Prices/Costs Base Year Items:

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
0001
Base Period: Arrange receipt of up to 70,000 DNA samples, perform inventory

MIN = 0 MAX = 750

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

9/1/2021 – 8/31/2022 750 Box

0002
Base Period: Store samples (includes freezer maintenance)

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

12 Months

0003
Base Period: Normalize DNA sample sets

(1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

0004
Base Period: Create QC samples (5% of master set) (1 plate of 92 samples)

MIN = 0 MAX = 25

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

25 Each

0005
Base Period: Prepare 96-well aliquot plates - normalized set with QC (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

0006
Base Period: Prepare 96-well aliquot plates - normalized custom set with QC (1 plate of 92 samples)

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Each

0007
Base Period: Ship DNA to researcher

MIN = 0 MAX = 400

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

400 Box

0008
Base Period: Receive unused DNA from researcher

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Box

0009
Base Period: Maintain inventory

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

0010
Base Period: Provide End of Year Report

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

0011
Base Period: Disposal of DNA Samples as needed

MIN = 0 MAX = 10

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

10 Box

Base Year Total Price: $_________________

Option 1, Year 2 Items:

1001
Option Period 1: Store samples in freezes (includes maintenance)

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

9/1/2022 – 8/31/2023 12 Months

1002
Option Period 1: Normalize DNA sample sets (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

1003
Option Period 1: Create QC samples (5% of master set)

MIN = 0 MAX = 25

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

25 Each

1004
Option Period 1: Prepare 96-well aliquot plates - normalized set with QC (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

1005
Option Period 1: Prepare 96-well aliquot plates - normalized custom set with QC (1 plate of 92 samples)

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Each

1006
Option Period 1: Ship DNA

MIN = 0 MAX = 400

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

400 Box

1007
Option Period 1: Receive unused DNA

MIN = 0 MAX = 100

This is a Severable Line Item This is a Fixed Price Line Item

Period of Performance:

100 Box

1008
Option Period 1: Maintain inventory

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

1009
Option Period 1: Provide End of Year Report

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

1010
Option Period 1: Dispose of DNA samples as needed

MIN = 0 MAX = 10

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

10 Box

Option 1 Total Price: $_____________________

Option 2, Year 3 Items:

2001
Option Period 2: Store samples (includes freezer maintenance)

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

9/1/2023 – 8/31/2024 12 Months

2002
Option Period 2: Normalize DNA sample sets (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

2003
Option Period 2: Create QC samples (5% of master set) (1 plate of 92 samples)

MIN = 0 MAX = 25

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

25 Each

2004
Option Period 2: Prepare 96-well aliquot plates - normalized set with QC (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

2005
Option Period 2: Prepare 96-well aliquot plates - normalized custom set with QC (1 plate of 92 samples)

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Each

2006
Option Period 2: Ship DNA to researcher

MIN = 0 MAX = 400

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

400 Box

2007
Option Period 2: Receive unused DNA samples from researcher

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Box

2008
Option Period 2: Maintain inventory

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

2009
Option Period 2: Provide End of Year Report

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

2010
Option Period 2: Disposal of DNA samples as needed

MIN = 0 MAX = 10

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

10 Box

Option 2 Total Price: $____________________

Option 3, Year 4 Items:

3001
Option Period 3: Store samples (includes freezer maintenance)

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

9/1/2024 – 8/31/2025 12 Months

3002
Option Period 3: Normalize DNA sample sets (1 plate of 92 samples)

MIN - 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

3003
Option Period 3: Create QC samples (5% of master set) (1 plate of 92 samples

MIN = 0 MAX = 25

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

25 Each

3004
Option Period 3: Prepare 96-well aliquot plates - normalized set with QC (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

3005
Option Period 3: Prepare 96-well aliquot plates - normalized custom set with QC (1 plate of 92 samples)

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Each

3006
Option Period 3: Ship DNA samples

MIN = 0 MAX = 400

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

400 Box

3007
Option Period 3: Receive unused DNA samples from researcher

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Box

3008
Option Period 3: Maintain inventory

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

3009
Option Period 3: Provide End of Year Report

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

3010
Option Period 3: Disposal of DNA samples as needed

MIN = 0 MAX = 10

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

10 Box

Option 3 Total Price: $___________________

Option 4, Year 5 Items:

4001
Option Period 4: Store samples (includes freezer maintenance)

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

9/1/2025 – 8/31/2026 12 Months

4002
Option Period 4: Normalize DNA sample sets (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

4003
Option Period 4: Create QC samples (5% of master set) (1 plate of 92 samples)

MIN = 0 MAX = 25

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

25 Each

4004
Option Period 4: Prepare 96-well aliquot plates - normalized set with QC (1 plate of 92 samples)

MIN = 0 MAX = 500

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

500 Each

4005
Option Period 4: Prepare 96-well aliquot plates - normalized custom set with QC (1 plate of 92 samples)

MIN = 0 MAX = 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Each

4006
Option Period 4: Ship DNA samples to researcher

MIN = 0 MAX = 400

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

400 Box

4007
Option Period 4: Receive unused DNA samples from researcher

MIN = 0 MAX – 100

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

100 Box

4008
Option Period 4: Maintain inventory

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

4009
Option Period 4: Provide End of Year Report

This is a Nonseverable Line Item

This is a Fixed Price Line Item

Period of Performance:

1 Job

4010
Option Period 4: Disposal of DNA samples as needed

MIN = 0 MAX = 10

This is a Severable Line Item

This is a Fixed Price Line Item

Period of Performance:

10 Box

Total Price (Inclusive of Options): $_________________________ B.2 Option Periods-

a. Unless the Government exercises its option pursuant to the option clause referenced in the Clauses section, this task order consists only of CLIN 0001- 0011..

b. Pursuant to FAR Clause 52.217-9 set forth in the Clauses section of this RFQ, the Government may, by unilateral contract modification, require the Contactor to perform the option period specified in the PWS of this task order. If the Government exercises the option, notice must be given by written notice to the Contractor within 60 days; provided, that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. Specific information regarding the time frame for this notice is set forth in the above referenced clause in the Clauses section of this RFQ.

c. Upon the delivery and acceptance of the Option Item/Services described in the PWS of the task order and identified in the schedule of charges above, the Government shall pay the Contractor the cost as set forth above.

B.3 Type of task order

This is a Fixed Price Task Order

Section C - Description/Specification/Work Statement Title of Project: DNA Plating and Storage Services IDIQ

I. BACKGROUND

The National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations. NHANES is a major program of the National Center for Health Statistics (NCHS). NCHS is part of the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (DHHS) and has the responsibility for producing vital and health statistics for the nation. NHANES is overseen by the Division of Health and Nutrition Examination Surveys (DHANES). In 1991, a DNA biorepository was developed to maintain DNA samples for future research studies that would allow genetic and/or biologic information to be combined with other NHANES data.

As part of the NHANES physical exam, blood is collected from participating sample persons. Beginning with the NHANES III Phase II survey (1991-1994) and in certain subsequent NHANES survey cycles (1999-2002, 2007-2012), a blood sample was collected from participants for extracting DNA. The DNA from the NHANES III participants was extracted from immortalized cells (transformed with EBV) created from a blood sample not from whole blood as in subsequent survey cycles. For subsequent survey cycles two tubes of blood were collected from participants and DNA isolated from each primary and secondary tube. DNA sets were established as follows: 1999-2002 (combines NHANES survey cycles 1999-2000 and 2001-2002), 2007-2008, 2009-2010, 2011-2012.

To ensure continued quality, NHANES III samples had DNA concentration measured and DNA degradation and contamination was assessed. Previously, 1% of samples from the NHANES 1999-2002, 2007-2008, 2009-2010 and 2011-2012 were run on agarose gels to assess DNA degradation. All samples had high molecular DNA present, and none showed any significant signs of degradation. These samples were normalized based on their measured concentrations prior to electrophoresis and the DNA band intensities were similar indicating accurate concentrations. In addition, an assay that detects short tandem repeat (STR) from 8 regions of the genome was run on the same 1% of NHANES 1999-2012 samples to test for contamination. None of the samples showed any evidence of contamination with a 5% limit of detection.

NHANES requires a DNA repository to prepare and distribute DNA samples to researchers. This capability is required for research to be conducted on existing NHANES DNA samples. This Statement of Work (SOW) is part of an acquisition plan for the government to acquire these services.

II. PURPOSE

The purpose of this performance-based work statement (PBWS) is to receive and store DNA samples from approximately 28,650 NHANES participants, and to prepare and ship DNA plates to researchers, as needed. Additionally, inventory management and reporting, receiving returned DNA sample, and destruction of returned or unneeded or unusable sample as requested are required.

III. JUSTIFICATION

NHANES DNA samples are the only nationally representative U.S. collection of stored DNA samples. DHANES has a program to make these samples available to approved researchers for future research studies that would allow genetic and/or biologic information to be combined with other NHANES data. Currently about 70,000 of these NHANES DNA samples from certain NHANES survey cycles (beginning with the NHANES III cycle) are stored under another contract, which is ending on May 11, 2021. A new five-year contract is required so the storage and plating services can continue without interruption, and researchers will be able to receive and analyze the samples for future studies.

IV. SCOPE OF WORK

The contractor shall perform all work necessary to receive, store, process, plate, inventory, record, ship, and/or dispose of NHANES DNA samples in a manner that preserves their research value and allows the DNA to be used for research purposes. The contractor shall implement procedures to ensure high quality laboratory practices.

V. WORK BREAKDOWN STRUCTURE

There are nine tasks in the base year:

Task 0001:

Arrange for receipt of up to 70,000 DNA samples. Inventory samples (scan tube barcodes to match inventory manifest) on a freeze table or comparable method to avoid thawing and provide DHANES with inventory report. The storage facility will be required to ship samples in accordance with all applicable regulations. Notifications of receipt and inventory must be sent to the Contracting Officer Representative (COR) as soon as shipped sample arrives.

Contracting lab will receive:

· Complete assembled master set of crudely extracted DNA of unknown concentrations from survey participants in NHANES III (1991-1994).

· Complete assembled master set plus incomplete secondary set of highly purified DNA from NHANES 1999-2002, 2007-2008, 2009-2010, and 2011-2012

· Normalized DNA (at 50 ng/ul) from NHANES 1999-2002, 2007-2008, 2009-2010, and 2011-2012

Task 0002:

Store DNA samples in -70 or -80 degree Celsius freezer or in liquid nitrogen (for samples in cryovials capable of liquid nitrogen storage).

Task 0003:

Normalize DNA sample sets to a concentration and volume specified by NCHS as needed and store appropriately for long term storage.

Task 000301:

Assemble a set of quality control (QC) samples for NHANES sets. The QC set will consist of 5% of duplicate samples from the master or secondary set which will be blinded to the researchers receiving DNA samples. The identity of these samples will be provided to the contractor by NCHS. Normalize the QC samples to a concentration and volume specified by NCHS as needed and store appropriately for long term storage.

Task 0004:

Prepare 96-well aliquot plates of the normalized DNA samples set and QC sets to ship to researcher(s) as needed on request (with an option to create more than one set at a time).

Task 000401:

Prepare 96-well aliquot plates of a normalized partial DNA samples set (custom set) and QC sets to ship to researcher(s) as needed on request.

Task 0005:

Ship DNA sample sets and complete shipping manifest to researcher using standard secure shipping methods in accordance with all applicable regulations for biological materials. The contractor shall provide receipt and inventory of DNA samples electronically. Notification of inventory and shipping must be sent to the COR as soon as the plated DNA ships. See Appendix A for shipping procedures.

Task 0006:

Arrange for receipt of remaining unused DNA samples from researcher at the completion of their study. . This will involve working with the researcher to ensure proper shipping and inventory recording. Notifications of receipt and inventory must be sent to the COR as soon as shipped sample arrives.

Task 0007:

Maintain accurate DNA samples inventory. Depending on the volume of research, option to assess specimen degradation when appropriate.

Task 0008:

Provide an end-of-year report of inventory and management of the samples, including number of sample shipments, how many returned samples are received, freezer usage and how many freezers are required, and any problems encountered and what corrective steps were taken.

Task 0009:

Dispose of DNA samples as requested by DHANES. Prior to disposing of the samples, the contractor shall provide a cost proposal for the work required to the COR and not perform work without having written approval from the COR. If approved by the COR, the Contract will be modified to add the necessary funding.

The services described in Task 0002 – 0009 are repeated for each option year.

VI. GOVERNMENT FURNISHED MATERIALS

No government furnished materials are required for or shall be provided on this contract.

VII. PERIOD OF PERFORMANCE

The period of performance is for one (1) Base Year and four (4) twelve-month option years.

VIII. DELIVERABLES

The Contractor shall deliver, within the time frames specified, to the COR at the address shown in Section G, and copies of Item(s) to the Contracting Officer at the address shown on the face page of the contract.

Specific deliverables and dates to be accomplished are listed below:

Deliverables Due by

1. Provide inventory report after 30 days after receipt of DNA

DNA samples are received samples

2. Yearly inventory files 30 days after End of each yearly

PoP to include start and year final inventory at end of year

IX. PERFORMANCE BASED MATRIX

Performance-based Matrix – Firm Fixed Price – Genetic Plating

Desired End Result
Feature(s) of end result to be surveilled (Indicator).
The required performance level for each feature (Standard).
Quality Assurance
Incentives/Payment-Quality Link

Arrange for receipt of up to 70,000 DNA samples. Store DNA samples in -70 or -80 degree freezer or in liquid nitrogen

Delivery of initial inventory file and operations manual

Prepare 96-well aliquot plates of normalized DNA samples and QA/QC and ship as required.

Yearly report including sample inventory, sample receipt, sample shipment, and freezer usage (e.g. number of freezers operating, number inoperable, etc.)

Proper shipping procedures and regulations are followed. Thawing does not occur. Freezers are maintained to meet the necessary requirements at all times.

Completed inventory report and operations manual.

Proper QA/QC specifications are met. Proper shipping procedures and regulations are followed. Thawing does not occur.

Accuracy & Timeliness

Operational settings for safety and security of DNA samples in a secured environment.

Inventory of samples complete one month after delivery of specimens

QA/QC specifications. Operational settings for safety and security of DNA samples in a secured environment.

One month after end of the annual Period of Performance.

Continuous electronic system monitoring with notification capability, e.g. alarm.

Surveillance system will be primarily NCHS observations.

1. Positive incentives:

a. Payment of contract labor rate for satisfactory service.

b. Contractor performance evaluated using the automated Contractor Performance Assessment Reporting System (CPARS). The evaluation will be considered when future AGENCY contract selections are made.

2. Payment is linked to quality through FAR 52.246-4 Inspection of Services—Fixed-Price.

X. OTHER CONTRACT REQUIREMENTS

Government Data Rights

The Government shall have unlimited rights in all data, software and supporting materials acquired under this contract. Under no circumstances shall the contractor place a copyright that will in any way limit the Government’s use of any of the materials for which the contractor develops, provides and/or receives payment under this contract. The Contractor shall not provide any government data, documents, information, or licensed material in any form to sources not authorized by NCHS without written approval during the period of performance of this requirement and any time afterwards. Execution of non-disclosure statements will be required.

Identification and Disposition of Data The Contractor guarantees that no data collected under this contract will be used for purposes other than those specified in the contract unless approved by the NCHS COR. The contractor guarantees that it will not tabulate, analyze, release or use the data without prior written approval of the COR and the NCHS Confidentiality Officer. The Contractor will release all tabulations and reports solely to the Contracting Officer Representative (COR) or designee. All data collected, records, files (interim and final), and tables remaining in the custody of the Contractor at the close of this contract shall be returned to the custody of the responsible COR or designee, and no copies (either preliminary, interim or final) shall be maintained by the Contractor, with the exception of quality control data. Copies of quality control data may be maintained in the contracting office. If method development is done as part of this project, the Contractor may keep that data.

Confidentiality Concerns

NCHS data accessed under this task order are collected under confidentiality statutes including the Privacy Act of 1974 (5 U.S.C. 552a) and Section 308(d) of the Public Health Service Act [42 U.S.C. 242m(d)] which prohibits NCHS from using any personal information for any purpose other than what was described during the informed consent process and from sharing that information with anyone not clearly identified during the informed consent process. Additionally, NCHS data are protected by Title III, the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), of the Foundations for Evidence-Based Policymaking Act of 2018 which was codified in 2019 (Pub. L. No. 115-435, 132 Stat. 5529). CIPSEA provides for stiff fines and imprisonment for violations of confidentiality. Persons who willfully disclose the NCHS confidential information accessed under this contract in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both. CIPSEA reinforces laws such as the Privacy Act and Section 308(d) of the Public Health Service Act, which guarantees that data provided to CDC\NCHS shall not be disclosed without the respondent’s consent.

The tasks outlined in this Statement of Work comply with the Confidential Information Protection and Statistical Efficiency (CIPSEA) Act Implementation Guidelines (https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/inforeg/proposed_cispea_guidance.pdf, page 32). This is the most recent CIPSEA implementation guidance published by the Office of Management and Budget. The guidance includes an Appendix A entitled, Requirements for Contracts and Written Agreements for Agents Acquiring or Accessing Confidential Information under CIPSEA. It states that federal contracts that require the collection of confidential information must contain certain details about how the confidential information will be handled. All data collection, handling, transmittal, and storage procedures must comply with CDC/NCHS regulations for the protection of subjects. A Designated Agent Agreement (DAA) between NCHS and the contractor may be required.

The contractor (and any subcontractor) may be required to ensure that all such staff complete NCHS Confidentiality training at https://www.cdc.gov/nchs/training/confidentiality/training/ and sign the NCHS Nondisclosure Affidavit annually. The contractor (and any subcontractor) may be required to prepare and submit a memo to the NCHS Contracting Officer (COR) that lists all persons who have completed NCHS Confidentiality training and have also signed the NCHS Nondisclosure Affidavit. The contractor (and any subcontractor) may be required to send the COR paper and electronic copies of the NCHS Confidentiality training certificates with each person’s name on it and the date the training was completed as well as the signed copies of the Nondisclosure Affidavits. After the first memo is submitted, the contractor (and any subcontractor) may be required to submit a memo bi-annually, as specified by the COR, listing all persons completing tasks under the contract and the dates they completed NCHS Confidentiality training and signed the NCHS Nondisclosure Affidavit.

If electronic reports are provided by the vendor, then the following is applicable:

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.21, .22, .31, and .41. In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

APPENDIX A:

PACKING AND SHIPPING PROCEDURES

Packing and shipping of NHANES DNA sample must comply with Federal regulations (Federal Register, 49 CFR 173.199 for Category B biological substances). Link is provided below.

https://ecfr.io/Title-49/Section-173.199

Packing and shipping of NHANES DNA sample must comply with Federal regulations (Federal Register, Vol. 45, No. 141-Monday, July 21, 1980, Part 72 – Interstate Shipment of Etiologic Agents). Non-infectious DNA and RNA are “Not Restricted in the U.S., even if genetically modified.

Shipping material typically includes:

Insulated Foam Shipping Kit

Tab locking literature mailers for the secondary receptacle

Dry Ice Labels

“This Side Up” labels

Dry ice

Absorbent material under pad

Ziploc bags

Bubble wrap

Definitions:

Primary Receptacle: A labeled, primary, watertight, leak-proof receptacle containing the specimen. The receptacle is wrapped in enough absorbent material to absorb all fluid in case of breakage. (Examples: 96 well plate, cryovial, micro packaging vial, etc.)

Secondary Receptacle: A second durable, watertight, leak-proof receptacle to enclose and protect the primary receptacle(s). Several wrapped primary receptacles may be placed in one secondary receptacle. Sufficient additional absorbent material must be used to cushion multiple primary receptacles. (Examples: Ziploc bag, shipping canister, etc.)

Outer Shipping Package: The secondary receptacle is placed in an outer shipping package which protects it and its contents from outside influences such as physical damage and water while in transit. (Examples: Cardboard box, Styrofoam box, etc.)

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Dec 2019)

The Offeror shall not complete the representation in this provision if the Offeror has represented that it “does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument” in the provision at 52.204-26, Covered Telecommunications Equipment or Services-Representation, or in paragraph (v) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items.

(a) Definitions. As used in this provision—

“Covered telecommunications equipment or services”, “critical technology”, and “substantial or essential component” have the meanings provided in clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Contractors are not prohibited from providing—

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services”.

(d) Representation. The Offeror represents that it □ will, □ will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation.

(e) Disclosures. If the Offeror has represented in paragraph (d) of this provision that it “will” provide covered telecommunications equipment or services”, the Offeror shall provide the following information as part of the offer—

(1) A description of all covered telecommunications equipment and services offered (include brand; model number, such as original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable);

(2) Explanation of the proposed use of covered telecommunications equipment and services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b) of this provision;

(3) For services, the entity providing the covered telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known); and

(4) For equipment, the entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

(End of provision)

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019)

(a) Definitions. As used in this clause—

Covered foreign country means The People’s Republic of China.

Covered telecommunications equipment or services means–

(1)Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2)For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3)Telecommunications or video surveillance services provided by such entities or using such equipment; or

(4)Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means–

(1)Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2)Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled-

(i)Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii)For reasons relating to regional stability or surreptitious listening;

(3)Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4)Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5)Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6)Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

(b) Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. The Contractor is prohibited from providing to the Government any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in Federal Acquisition Regulation 4.2104.

(c) Exceptions. This clause does not prohibit contractors from providing—

(1)A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2)Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(d)Reporting requirement.

(1)In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, or the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are established procedures for reporting the information; in the case of the Department of Defense, the Contractor shall report to the website at https://dibnet.dod.mil. For indefinite delivery contracts, the Contractor shall report to the Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in the case of the Department of Defense, identify both the indefinite delivery contract and any affected orders in the report provided at https://dibnet.dod.mil.

(2)The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause

(i)Within one business day from the date of such identification or notification: the contract number; the order number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial and Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number, manufacturer part number, or wholesaler number); item description; and any readily available information about mitigation actions undertaken or recommended.

(ii)Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: any further available information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of covered telecommunications equipment or services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.

(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial items.

(End of clause)

CDC37.0001 Non-Personal Services (Jun 2020)

(a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled "Contractor Identification and Safeguarding of Non-Public Information". No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the terms and conditions herein. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of the terms herein shall be included in all subcontracts at any tier.

(d) The terms and conditions above do not limit the Government's rights under other terms of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

FAR 52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of the end of the current period of performance.

FAR 52.217-9 Option to Extend the Term of the Contract. (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 (months).

(End of clause)

FAR 52.216-19 ORDER LIMITATIONS (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than the the amount stated for Line Items, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor--

(1) For the Basic Year, any order for a single item in excess of 700 Boxes (Item 0001; 150 Hrs. (Item 0002); 78 Boxes (Item 000)3; 92 Boxes (Item 0004); 500 Each (Item 0006); 25 Each (Item 0007); 510 Each (Item 0008); 100 Each (Item 0009); 400 Boxes (Item 0010); 100 Boxes (Item 0011); 1 Job (Item 0012); 1 Each (Item 0013) and 10 Boxes (Item 14).

The Option Year requirements are the same as stated above for ordering quantities unless changed by Modification to the contract.

(2) Any order for a combination of items in excess of the amounts stated in (b) above. Any order for a single item in excess of amounts stated in (b) above.

(3) A series of orders from the same ordering office within __30____ days that together call for quantities exceeding the limitation in subparagraph (1) or (2) above.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) above.

(d) Notwithstanding paragraphs (b) and (c) above, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

File details come from the government source that posted it. Updated .