ATTACHMENT_B__SOW_FOR_DISPOSAL_OF_PHARMACEUTICAL_and_MEDICAL_SUPPLIES_.docx

ATTACHMENT B

DISPOSAL OF PHARMACEUTICAL/MEDICAL SUPPLIES

STATEMENT OF WORK (SOW)

1. GENERAL

The Department of Health and Human Service the Office of the Assistant Secretary for Preparedness and Response is seeking to establish a contract for processing and disposing any related pharmaceutical and medical waste that may arise out of non-returnable pharmaceuticals/ medical supplies for removal and disposal of these unused expired medical surgical supplies. This contract will be for removal of items from MSC MD: 6701 English Muffin Way, Frederick MD 21703. The Government's need for on-site servicing at Government facilities and off-site processing function at the contractor’s facility is imperative to assure optimum inventory control and to minimize the violation of laws and regulations, especially in the area of pharmaceutical waste disposal. Contractors shall be compliant with all applicable regulations related to hazardous waste handling.

2. AWARD

The Government intends to issue a Firm Fixed Price award; the period of performance is 60 days from the date of award. The Government will make the award based on the lowest-priced offer that is considered technically acceptable and whose service fees are determined fair and reasonable.

The proposed waste disposal price shall be a firm fixed price per pound based on the number of pounds associated with destruction of non-returnable pharmaceuticals and medical surgical supplies. Proposed fees/prices should cover all the contractor’s costs including, but not limited to, packaging, shipping, processing, EPA and any other applicable costs or fees incurred in performance of reverse distribution services.

3. REGULATORY COMPLIANCE

The Contractor shall be required to provide all plant, equipment, materials, and labor needed to process and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances and medical surgical supplies. The Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation; U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and DoD regulations. The Contractor shall also comply with applicable state/local regulations, and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries.

4.LICENSES, PERMITS, REGISTRATION, INSURANCE

All necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, permits, and any other requirements for individual contractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations.

The Contractor shall be a licensed DEA registrant to handle Schedule II-V Controlled Substances. A copy of all renewals shall be forwarded to the Contracting Officer for retention in the contract file.

5. SHIPPING/PROCESSING ARRANGEMENTS

HHS/ASPR will contact the Contractor directly to arrange for the shipping date. The Contractor shall provide all instructions, forms, labels, and DEA approved tamper-proof pouches needed to ship. The Contractor shall prepare a list of drugs removed from the pharmacy and the facility must validate the contents of the list for accuracy. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. The Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. Any and all costs associated with gaining access to a customer facility shall be the responsibility of the Contractor.

6. PHARMACEUTICALS INELIGIBLE FOR CREDIT FROM MANUFACTURER

The Contractor shall list all items (including non-controlled and controlled substances, and non-hazardous and hazardous substances) designated for disposal on a disposal manifest. This list will include at a minimum, the contract number, product name, National Drug Code (NDC) or catalog number, quantity, total estimated return value, and reason for non-eligibility for credit. Separate manifests shall be provided for the disposal of Schedule II – V controlled substances and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations. A Certificate of Destruction including the disposal date, destruction method, destruction location, disposal company name and proof of destruction affidavit shall be provided to the returning facility upon completion of destruction. All Manifests shall be provided to the returning facility within 30 calendar days of Contractor's item receipt, with the exception of the Certificate of Destruction/Affidavit which shall be provided within 30 days of the completion of destruction. Shipments to the Contractor that require transport to the disposal location shall be done via approved and licensed vehicles in accordance with Federal, state, and local laws and regulations where the processing will be completed. Contractor spills or releases of toxic/hazardous substances into the environment shall be reported to the returning facility immediately.

7 PAYMENTS

Payments to the Contractor for disposal processes, will be made at the time of award.

If Credits are received for disposed items, these credits will be sent to:

REFUNDS/ OVERPAYMENTS

Requirements

· Check Payable to “Department of Health and Human Services” or “Program Support Center”

· Reference the Purchase Order number and Invoice number (if the refund is for a specific invoice number)

· Mail Check to:

By USPS Department of Health and Human Services Program Support Center, Division of Financial Operations ATTN: Kelly Pace 12501 Ardennes Avenue, Suite 200 Rockville, MD 20857

By FedEx or UPS Department of Health and Human Services Program Support Center, Division of Financial Operations ATTN: Kelly Pace 12501 Ardennes Avenue, Suite 200 Rockville, MD 20852-1769

8. REPORTS

The Contractor shall provide a return detail report by manufacturer to each returning facility within 30 calendar days after processing for all credit returns. This report should include at a minimum, the contract number and applicable order or invoice number, product name, NDC or catalog number, lot or batch number, quantity, and actual return value. Also, the report shall include the cost for disposal; credit reports showing any credits received. The contractor shall also provide separate reports for Schedule II-V controlled substances and for hazardous waste.

9. TRACKING

The contractors shall provide a toll free phone number or/and a web-based service to track the process. At a minimum, the system shall include entry fields for Facility Name, Address, City, State, Zip Code, Contact Name, Phone Number, E-mail, DEA Number, Desired Pickup Date, Description of Disposal Items and Estimated Quantity. Also have a way of reporting from inception of product to disposal.

10.0 CONTRACT ADMINISTRATION DATA

10.1 GOVERNMENT POINTS OF CONTACT

Contracting Officer’s Representative: TBD Email:

Phone:

CONTRACTING OFFICER’S AUTHORITY

a. The Contracting Officer (CO) has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationships. Accordingly, the CO is the only individual who has the authority to enter into, administer, or terminate this contract. In addition, the CO is the only person authorized to approve charges to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, the said authority remains solely with the CO.

b. The CO may designate, in writing, representatives to perform functions required to administer this contract, however any implied or expressed actions taken by these representatives must be within the limits cited within the CO’s written designations. The CO shall provide the Contractor copies of all relevant written designations. If an individual alleges to be a representative of the CO and the Contractor has not received a copy of the document designating that representative, the Contractor shall refrain from action upon the representative’s requirements and immediately contact the CO to obtain a copy of the document designating that individual as a representative of the CO.

c. The Contractor shall immediately notify the CO for clarification when a question arises regarding the authority of any person acting for the CO under this contract.

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

a. The CO may designate other Government personnel (known as the COR) to act as his or her authorized representative for contract administration functions which do not involve changes to the scope, performance, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the CO, and will set forth the authorities and limitations of the representative(s) under the contract. The Contractor may be required to sign the COR Letter of Appointment to acknowledge the authorities and limitations of the COR assigned to the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the contract.

b. The Contractor shall immediately contact the CO if there is any question regarding authority of an individual to act as a representative of the CO under this contract.

10.2 INVOICES

All invoices shall be submitted via email to amcg.invoices@hhs.gov and copy the CO and the COR.

· All improper invoices will be returned to the contractor for further action

· Interest on Overdue Payment – Determination of interest due will be made in accordance with the provisions of the Prompt Payment Act.

· Payment due Date:

a. Unless otherwise specified in the contract, payments under this contract will be made on the 30th calendar day after the later of

i. The date of actual receipt of a proper invoice in the office designated to receive the invoice, or

ii. The date tasks are formally accepted by the Government.

b. If the services covered by a submitted invoice are rejected for failure to conform to the technical requirements of this contract, the provisions stated above (i and ii) will apply to the properly resubmitted documents.

To ensure a proper invoice, the invoice must include the following information and/or attached documentation:

1) Name of the business concern, invoice number and invoice date;

2) Contract number, or authorization for delivery of property of performance of services;

3) Description, price, and quantity and services actually delivered or rendered;

4) Shipping and payment terms;

5) Name (where practicable), title, phone number, and complete mailing address of responsible official to whom payment is to be sent; and

6) Other substantiating documentation or information as required by the contract.

10.3 REQUIREMENTS FOR HANDLING SENSITIVE/PROPRIETARY INFORMATION

Use of sensitive or proprietary information is not anticipated. If however, sensitive or proprietary information is a factor that the data clauses doesn’t cover, this will be discussed between HHS and the Contractor.

10.4 GOVERNMENT FURNISHED RESOURCES AND INFORMATION

The government will provide no facilities, supplies or services.

10.5 GOVERNMENT FURNISHED PROPERTY

The Government may provide government furnished property as specified on each individual task. The contractor shall comply with the conditions within FAR Clause 52.245-1 entitled “Government Property” which is located in the terms and conditions of this contract.

10.6 HOURS OF OPERATION

The HHS’s normal working hours 8:00 am to 5:00 pm EST/EDT Monday through Friday. Contractor staff should be available during these hours to consult with the Government as needed.

(1) Federal Holidays. The HHS will be closed, for the following holidays:

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Christmas

When one of the above-designated holidays falls on a Saturday, the preceding Friday will be observed as a legal holiday. When one of the above designated holidays falls on a Sunday, the following Monday will be observed as a legal holiday.

The President may designate other days as federal holidays. In the event that this occurs, government employees may not be available.

(2) Inclement Weather Days. In the event of inclement weather, the Contractor is responsible for listening to the public media to determine if the HHS has been closed because of the weather.

As a result of the fluid nature of activities and schedules, the Contractor is encouraged to coordinate work schedules with their ASPR business owner to accommodate support requirements, other personnel availability, meeting schedules, vacation schedules and leave schedules.

10.7 CONTRACTOR IDENTIFICATION

All Contractor personnel when attending meetings, sending emails, or participating on telephone calls shall identify themselves as contractor personnel. Identification in meetings and on telecom shall be at the beginning of the call or meeting to allow government personnel to excuse contractors if appropriate. Contractor personnel shall identify themselves with their company name in the signature block of emails.

10.8 PERFORMANCE/DELIVERY PERIOD

The period of performance under this contract shall be for 2 months, unless changed by modification

10.9 CONTRACT TYPE:

Firm Fixed Price

8.10 PLACE/LOCATION FOR PICKUP

MSC MD: 6701 English Muffin Way, Frederick MD 21703.

10.13 SECTION 508 - ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY

This SOW is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220). Specifically, subsection 508:

(a)(1) requires that when the Federal Government procures Electronic and Information Technology (EIT), the EIT must allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

(b) The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

(c) Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards (36 CFR 1194), as specified in the contract, as a minimum. If the Contracting Officer determines any furnished product or service is not in compliance with the contract, the Contracting Officer will promptly inform the contractor in writing. The contractor shall, without charge to the Government, repair or replace the noncompliant products or services within the period of time to be specified by the Government in writing. If such repair or replacement is not completed within the time specified, the Government shall have the following recourses:

1. Cancellation of the contract, delivery or task order, purchase or line item without termination liabilities; or

2. In the case of custom Electronic and Information Technology (EIT) being developed by a contractor for the Government, the Government shall have the right to have any necessary changes made or repairs performed by itself or by another firm for the noncompliant EIT, with the contractor liable for reimbursement to the Government for any expenses incurred thereby.

(d) The Contractor must ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

(e) For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the Contractor shall, at the discretion of the Government, make every effort to replace or upgrade it with a compliant equivalent product or service, if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

(f) Section 508 Compliance for Communications The Contractor shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents and this SOW the SOW shall take precedence. In addition, all contract deliverables are subject to these 508 standards as applicable. Regardless of format, all Web content or communications materials produced, including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant.

8.14 SECURITY REQUIREMENTS

All contractors, consultants, and experts are required to have a suitability determination conducted. If the contractor, consultant, or expert (regardless if the person is individually represented or a corporately represented) requires access to national security information in performing work for HHS, he or she must:

• Follow the National Industrial Security Program Operating Manual [PDF - 1.2MB] (NISPOM) guidance.

• Follow procedures with the Department of Defense to be granted a security clearance In accordance with departmental policy, individuals without a sponsoring organization are also required to have a suitability determination and should follow the same policies and procedures as federal employees and will be cleared by The Office of Security and Strategic Information (OSSI). Coordinate with the servicing PSR for the submission of the appropriate documentation. The National Security Handbook [PDF - 746KB], Chapter 12 on Contractor investigations provides additional guidance.

9.0 CONTRACT CLAUSES

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.

(End of clause) 52.227-14 Rights in Data—General (Dec 2007)

(a) Definitions. As used in this clause— “Computer database” or “database means” a collection of recorded information in a form capable of, and for the purpose of, being stored in, processed, and operated on by a computer. The term does not include computer software.

“Computer software”—

(1) Means

(i) Computer programs that comprise a series of instructions, rules, routines, or statements, regardless of the media in which recorded, that allow or cause a computer to perform a specific operation or series of operations; and

(ii) Recorded information comprising source code listings, design details, algorithms, processes, flow charts, formulas, and related material that would enable the computer program to be produced, created, or compiled.

(2) Does not include computer databases or computer software documentation.

“Computer software documentation” means owner’s manuals, user’s manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

“Data” means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information.

“Form, fit, and function data” means data relating to items, components, or processes that are sufficient to enable physical and functional interchangeability, and data identifying source, size, configuration, mating and attachment characteristics, functional characteristics, and performance requirements. For computer software it means data identifying source, functional characteristics, and performance requirements but specifically excludes the source code, algorithms, processes, formulas, and flow charts of the software.

“Limited rights” means the rights of the Government in limited rights data as set forth in the Limited Rights Notice of paragraph (g)(3) if included in this clause.

“Limited rights data” means data, other than computer software, that embody trade secrets or are commercial or financial and confidential or privileged, to the extent that such data pertain to items, components, or processes developed at private expense, including minor modifications.

“Restricted computer software” means computer software developed at private expense and that is a trade secret, is commercial or financial and confidential or privileged, or is copyrighted computer software, including minor modifications of the computer software.

“Restricted rights,” as used in this clause, means the rights of the Government in restricted computer software, as set forth in a Restricted Rights Notice of paragraph (g) if included in this clause, or as otherwise may be provided in a collateral agreement incorporated in and made part of this contract, including minor modifications of such computer software.

“Technical data” means recorded information (regardless of the form or method of the recording) of a scientific or technical nature (including computer databases and computer software documentation). This term does not include computer software or financial, administrative, cost or pricing, or management data or other information incidental to contract administration. The term includes recorded information of a scientific or technical nature that is included in computer databases (See 41 U.S.C. 403(8)).

“Unlimited rights” means the rights of the Government to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.

(b) Allocation of rights.

(1) Except as provided in paragraph (c) of this clause, the Government shall have unlimited rights in—

(i) Data first produced in the performance of this contract;

(ii) Form, fit, and function data delivered under this contract;

(iii) Data delivered under this contract (except for restricted computer software) that constitute manuals or instructional and training material for installation, operation, or routine maintenance and repair of items, components, or processes delivered or furnished for use under this contract; and

(iv) All other data delivered under this contract unless provided otherwise for limited rights data or restricted computer software in accordance with paragraph (g) of this clause.

(2) The Contractor shall have the right to—

(i) Assert copyright in data first produced in the performance of this contract to the extent provided in paragraph (c)(1) of this clause;

(ii) Use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, unless provided otherwise in paragraph (d) of this clause;

(iii) Substantiate the use of, add, or correct limited rights, restricted rights, or copyright notices and to take other appropriate action, in accordance with paragraphs (e) and (f) of this clause; and

(iv) Protect from unauthorized disclosure and use those data that are limited rights data or restricted computer software to the extent provided in paragraph (g) of this clause.

(c) Copyright—

(1) Data first produced in the performance of this contract.

(i) Unless provided otherwise in paragraph (d) of this clause, the Contractor may, without prior approval of the Contracting Officer, assert copyright in scientific and technical articles based on or containing data first produced in the performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. The prior, express written permission of the Contracting Officer is required to assert copyright in all other data first produced in the performance of this contract.

(ii) When authorized to assert copyright to the data, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number).

(iii) For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly by or on behalf of the Government. For computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public) by or on behalf of the Government.

(2) Data not first produced in the performance of this contract. The Contractor shall not, without the prior written permission of the Contracting Officer, incorporate in data delivered under this contract any data not first produced in the performance of this contract unless the Contractor—

(i) Identifies the data; and

(ii) Grants to the Government, or acquires on its behalf, a license of the same scope as set forth in paragraph (c)(1) of this clause or, if such data are restricted computer software, the Government shall acquire a copyright license as set forth in paragraph (g)(4) of this clause (if included in this contract) or as otherwise provided in a collateral agreement incorporated in or made part of this contract.

(3) Removal of copyright notices. The Government will not remove any authorized copyright notices placed on data pursuant to this paragraph (c), and will include such notices on all reproductions of the data.

(4) Release, publication, and use of data. The Contractor shall have the right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, except—

(1) As prohibited by Federal law or regulation (e.g., export control or national security laws or regulations);

(2) As expressly set forth in this contract; or

(3) If the Contractor receives or is given access to data necessary for the performance of this contract that contain restrictive markings, the Contractor shall treat the data in accordance with such markings unless specifically authorized otherwise in writing by the Contracting Officer.

(5) Unauthorized marking of data.

(1) Notwithstanding any other provisions of this contract concerning inspection or acceptance, if any data delivered under this contract are marked with the notices specified in paragraph (g)(3) or (g) (4) if included in this clause, and use of the notices is not authorized by this clause, or if the data bears any other restrictive or limiting markings not authorized by this contract, the Contracting Officer may at any time either return the data to the Contractor, or cancel or ignore the markings. However, pursuant to 41 U.S.C. 253d, the following procedures shall apply prior to canceling or ignoring the markings.

(i) The Contracting Officer will make written inquiry to the Contractor affording the Contractor 60 days from receipt of the inquiry to provide written justification to substantiate the propriety of the markings;

(ii) If the Contractor fails to respond or fails to provide written justification to substantiate the propriety of the markings within the 60-day period (or a longer time approved in writing by the Contracting Officer for good cause shown), the Government shall have the right to cancel or ignore the markings at any time after said period and the data will no longer be made subject to any disclosure prohibitions.

(iii) If the Contractor provides written justification to substantiate the propriety of the markings within the period set in paragraph (e)(1)(i) of this clause, the Contracting Officer will consider such written justification and determine whether or not the markings are to be cancelled or ignored. If the Contracting Officer determines that the markings are authorized, the Contractor will be so notified in writing. If the Contracting Officer determines, with concurrence of the head of the contracting activity, that the markings are not authorized, the Contracting Officer will furnish the Contractor a written determination, which determination will become the final agency decision regarding the appropriateness of the markings unless the Contractor files suit in a court of competent jurisdiction within 90 days of receipt of the Contracting Officer’s decision. The Government will continue to abide by the markings under this paragraph (e)(1)(iii) until final resolution of the matter either by the Contracting Officer’s determination becoming final (in which instance the Government will thereafter have the right to cancel or ignore the markings at any time and the data will no longer be made subject to any disclosure prohibitions), or by final disposition of the matter by court decision if suit is filed.

(2) The time limits in the procedures set forth in paragraph (e)(1) of this clause may be modified in accordance with agency regulations implementing the Freedom of Information Act (5 U.S.C. 552) if necessary to respond to a request thereunder.

(3) Except to the extent the Government’s action occurs as the result of final disposition of the matter by a court of competent jurisdiction, the Contractor is not precluded by paragraph (e) of the clause from bringing a claim, in accordance with the Disputes clause of this contract, that may arise as the result of the Government removing or ignoring authorized markings on data delivered under this contract.

(6) Omitted or incorrect markings.

(1) Data delivered to the Government without any restrictive markings shall be deemed to have been furnished with unlimited rights. The Government is not liable for the disclosure, use, or reproduction of such data.

(2) If the unmarked data has not been disclosed without restriction outside the Government, the Contractor may request, within 6 months (or a longer time approved by the Contracting Officer in writing for good cause shown) after delivery of the data, permission to have authorized notices placed on the data at the Contractor’s expense. The Contracting Officer may agree to do so if the Contractor—

(i) Identifies the data to which the omitted notice is to be applied;

(ii) Demonstrates that the omission of the notice was inadvertent;

(iii) Establishes that the proposed notice is authorized; and

(iv) Acknowledges that the Government has no liability for the disclosure, use, or reproduction of any data made prior to the addition of the notice or resulting from the omission of the notice.

(3) If data has been marked with an incorrect notice, the Contracting Officer may—

(i) Permit correction of the notice at the Contractor’s expense if the Contractor identifies the data and demonstrates that the correct notice is authorized; or

(ii) Correct any incorrect notices.

(7) Protection of limited rights data and restricted computer software.

(1) The Contractor may withhold from delivery qualifying limited rights data or restricted computer software that are not data identified in paragraphs (b)(1)(i), (ii), and (iii) of this clause. As a condition to this withholding, the Contractor shall—

(i) Identify the data being withheld; and

(ii) Furnish form, fit, and function data instead.

(2) Limited rights data that are formatted as a computer database for delivery to the Government shall be treated as limited rights data and not restricted computer software.

(3) [Reserved]

(8) Subcontracting.

The Contractor shall obtain from its subcontractors all data and rights therein necessary to fulfill the Contractor’s obligations to the Government under this contract. If a subcontractor refuses to accept terms affording the Government those rights, the Contractor shall promptly notify the Contracting Officer of the refusal and shall not proceed with the subcontract award without authorization in writing from the Contracting Officer.

(9) Relationship to patents or other rights.

Nothing contained in this clause shall imply a license to the Government under any patent or be construed as affecting the scope of any license or other right otherwise granted to the Government.

(End of clause)

Department of Health and Humans Services Acquisition Regulation (HHSAR) (48 CFR CHAPTER 3) Clauses

352.201-70 Paperwork Reduction Act (JAN 2006)

(a) This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (44 U.S.C 3501 et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer’s Technical Representative shall be guided by the provisions of 5 CFR Part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance.

(b) The Contractor shall not expend any funds or begin any data collection until OMB Clearance is received. Once OMB Clearance is received from the Contracting Officer’s Technical Representative, the Contracting Officer shall provide the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract.

(End of clause)

Definitions (January 2006)

(a) In accordance with 52.202–1(a)(1), substitute the following as paragraph (a):

‘‘(a) The term ‘‘Secretary’’ or ‘‘Head of the Agency’’ (also called ‘‘Agency Head’’) means the Secretary, Deputy Secretary, or any Assistant Secretary, Administrator or Commissioner of the Department of Health and Human Services; and the term ‘‘his/her duly authorized representative’’ means any person, persons, or board authorized to act for the Secretary.’’

(b) In accordance with 52.202–1(a)(1), add the following paragraph (h):

‘‘(h) The term ‘‘Contracting Officer’s Technical Representative” means the person who monitors the technical aspects of contract performance. The Contracting Officer’s Technical Representative is not authorized to issue any instructions or directions which cause any increase or decrease in the Statement of Work/Performance Work Statement/Specifications which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the Contracting Officer’s Technical Representative is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.’’ 352.203-70 Anti-Lobbying (January 2006)Pursuant to the current HHS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

(End of clause) 352.231-70 Salary Rate Limitation (January 2010)(a) Pursuant to the current and applicable prior HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the federal Executive Schedule Level I in effect on the date an expense is incurred.

(b) For purposes of the salary rate limitation, the terms ‘‘direct salary,’’ ‘‘salary,’’ and ‘‘institutional base salary’’ have the same meaning and are collectively referred to as ‘‘direct salary’’ in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs). (NOTE: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may bepaid with federal funds.)

(c) The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish contract or order funding.

(d) See the salaries and wages pay tables on the U.S. Office of Personnel Management website for federal Executive Schedule salary levels that apply to the current and prior periods.

(End of clause)

352.242-70 Key Personnel (January 2006) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

(End of clause)

FAR 52.212-4, Contract Terms and Conditions – Commercial Items applies to this acquisition.

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items to this acquisition.

FAR 52.212-1 Instruction to Offerors – Commerical applies to this acquisition.