Hearing Draft.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2009-N-11203

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

05/06/2009

6. REQUISITION/PURCHASE NO.

000HCCGD-2009-68515

Centers for Disease Control and Prevention (PGO)

Acquisition & Assistance Field Branch

4676 Columbia Parkway

Cincinnati, OH 45226-1922

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 3 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in aft North Facilities, 1090 Tusculum, Cincinnati, OH 45226 until 2:00p local time 06/08/2009 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Dwight D. Favors

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(513) 533-8137

C. E-MAIL ADDRESS

Dyf3@cdc.gov

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

Centers for Disease Control and Prevention (PGO)

Acquisition & Assistance Field Branch

4676 Columbia Parkway, Cincinnati, OH 45226-1922

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-498-4050

Atlanta, GA 30329-4018

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

Determine if 8 kHz is sufficiently reliable as an audiometric test frequency to be incorporated as a standard test frequency during the annual audiometric monitoring component of a hearing loss prevention program.

1 Job

Option 1 Option Year 1 Items:

Determine if 8 kHz is sufficiently reliable as an audiometric test frequency to be incorporated as a standard test frequency during the annual audiometric monitoring component of a hearing loss prevention program.

1 Job

Option 2 Option Year 2 Items:

Determine if 8 kHz is sufficiently reliable as an audiometric test frequency to be incorporated as a standard test frequency during the annual audiometric monitoring component of a hearing loss prevention program.

1 Job

There are no clauses/provisions included in this section.

Section C - Description/Specification/Work Statement

C.1 Statement of Work (Jul 1999)

Determination of the Variability of 8 kHz as an Audiometric Test Frequency Relative to 0.5, 1, 2, 3, 4, and 6kHz

BACKGROUND

Presently, 6 kHz is the highest required test frequency in most U.S. hearing conservation audiometric monitoring programs. Without testing at 8 kHz, it is not possible to determine the presence or absence of a notch at 6 kHz. Worse yet, without testing at 8 kHz, a 6 kHz notch would mimic the appearance of age-related hearing loss (presbyacusis). Because audiologists and occupational hearing conservation technicians are currently taught to look for a 4 kHz notch, it is likely that a noise-induced hearing loss manifested by a 6 kHz notch would be misdiagnosed as presbyacusis. The results of the recent National Health and Nutrition Examination Survey (NHANES) on the hearing of American adults has found the noise notch may occur more commonly at 6 kHz rather than at other frequencies where noise notches may also occur, i.e., 3 and 4 kHz. In a subset of 175 noise-exposed male participants in the NHANES survey, 99 were found to have notches at 6 kHz vs. 14 and 62 at 3 and 4 kHz respectively.

Presently, there is resistance to incorporating 8 kHz as a standard test frequency because of a widely held belief that it is not possible to obtain reliable 8 kHz hearing thresholds. The physiological dimensions and acoustic resonances of the external auditory meatus not withstanding, this belief is not substantiated by data; however, it has assumed an unwarranted acceptance among the audiological community as being true. Pilot analyses of NIOSH data collected during a study of hearing among auto plant workers have demonstrated 8 kHz hearing threshold measures to actually be more reliable than some of the current standard audiometric test frequencies. The proposed effort will be designed to compare the reliability of 8 kHz to current required audiometric test frequencies. If the viability of 8 kHz as a reliable test frequency can be demonstrated, i.e., if 8 kHz hearing thresholds can be measured as accurately as thresholds at other frequencies, then this effort will overcome existing resistance to the use of 8 kHz.

PROJECT OBJECTIVES

This effort shall determine if 8 kHz is sufficiently reliable as an audiometric test frequency to be incorporated as a standard test frequency during the annual audiometric monitoring component of a hearing loss prevention program.

This shall be accomplished by:

1. Determining the relative reliability of pure tone hearing thresholds as a function of repeated measures taken on the same day.

2. Determining the relative reliability of pure tone hearing thresholds as a function of repeated measures taken on different days.

3. Quantifying the extent to which the reliability of 8 kHz hearing thresholds are similar to or different from hearing thresholds at 0.5, 1, 2, 3, 4, and 6 kHz, for both males and females between the ages of 20 and 69.

SCOPE OF WORK

NIOSH wishes to determine if 8 kHz is more or less reliable as an audiometric test frequency than 0.5, 1, 2, 3, 4, or 6 kHz.

Databases used to develop current hearing damage risk criteria were based on hearing surveys conducted in the 1960s. These surveys did not include 8 kHz as a test frequency. Thus, this initiative will be designed to obtain hearing thresholds on a cross section of adult males and females in their 3rd, 4th, 5th, 6th, and 7th decades of life.

The number of subjects to be tested will be approximately 500. To obtain comparative reliability measures, multiple repeat audiograms will be obtained. This will include immediate retests (as recommended by NIOSH) to determine the existence of a significant change in hearing threshold. It will also include multiple retests on different days. In addition to 8 kHz, current standard audiometric test frequencies (500, 1000, 2000, 3000, 4000, and 6000 Hz) will also be tested. A total of 5000 audiograms will be obtained.

Subjects

The successful bidder shall be responsible for recruiting subjects and for screening prospective subjects to ensure they are qualified to participate in this effort. Qualification criteria are listed below. These are not necessarily an exhaustive list of subject qualification criteria. Prospective bidders may wish to address other subject qualification criteria felt to be relevant to the performance of the tasks required of each subject.

There shall be 100 subjects in each of five age ranges:

1. 20-29

2. 30-39

3. 40-49

4. 50-59

5. 60-69

There shall be 50 males and 50 females in each of these five age groups, for a total of 500 subjects.

Subjects must meet the following criteria:

1. Subjects shall have hearing thresholds equal to or better than 70 dB HTL in both ears at 0.5, 1, 2, 3, 4, 6, and 8 kHz.

2. There shall be no more than a 30 dB interaural difference at any test frequency.

3. The external auditory meatus shall be sufficiently clear of cerumen to permit otoscopic inspection of the entire tympanic membrane. Potential subjects noted to have excess cerumen may elect to have their family physician remove the cerumen. In such cases, potential subjects may be permitted to re-apply for this study.

4. Middle ear function shall be normal as evidenced by both normal appearance upon otoscopic inspection and tympanometry. Both otoscopic inspection and tympanometry shall be performed on each day of testing to ensure normal middle ear function throughout the period in which the subject is participating in this effort.

5. Subjects must be capable of performing the psychophysical task associated with the hearing threshold measurement function of the audiometer.

6. If a subject is unable to read English well enough to read the subject consent form, he or she must be sufficiently fluent in English to understand the consent form which would be read to him or her. Likewise, since the audiometric instructions are automatically played to the subjects by the audiometer, subjects must understand spoken English well enough to understand these instructions.

7. Although the successful bidder shall assess the occupational and recreational noise exposure history of each subject, there shall be no qualifying requirement regarding noise exposure history.

Data Collection

Data collection shall proceed in three options:

1. In Base Contract, hearing thresholds for 200 male subjects shall be obtained. These subjects shall be between the ages of 20 and 59, specifically, 50 males between the ages of 20 and 29, 50 males between the ages of 30 and 39, 50 males between the ages of 40 and 49, and 50 males between the ages of 50 and 59.

2. In Option I, hearing thresholds for 200 female subjects shall be obtained. These subjects shall be between the ages of 20 and 59, specifically, 50 females between the ages of 20 and 29, 50 females between the ages of 30 and 39, 50 females between the ages of 40 and 49, and 50 females between the ages of 50 and 59.

3. In Option II, hearing thresholds for 100 subjects shall be obtained . These subjects shall be between the ages of 60 and 69. There shall be 50 male subjects and 50 female subjects.

Institutional Review Board Approval The successful bidder shall be responsible for obtaining appropriate Institutional Review Board (IRB) approval to use human subjects. The NIOSH Human Subjects Review Board may elect to review and approve said IRB approval. It shall be the responsibility of the successful bidder to obtain a signed consent form from the subject prior to their participation as a test subject. It shall be the responsibility of the successful bidder to ensure appropriate privacy for all subject data.

Procedures Each subject shall be given 10 hearing tests. On any given day, subjects shal be given no more than 2 audiograms. These two audiograms may be (but are not required to be) administered back-to-back. All 10 audiograms must be taken within a time period not to exceed 14 days.

Prior to each hearing test, subjects shall listen to the instructions provided by the audiometer as played to them through the headphones. All audiometry shall be performed using supra-aural headphones provided by NIOSH.

The successful bidder shall control potential confounding variables that could interfere with the reliability and validity of audiometric and tympanometric tests. For example, eyeglasses and earrings shall be removed during testing. Subjects shall not have anything in their mouth (e.g., chewing gum) during testing. It is especially important that the successful bidder control for possible test order effects. Likewise, it is very important that the successful bidder shall ensure background noise levels do not interfere with the measurement of hearing threshold levels.

The successful bidder shall be responsible for data analysis. This shall include effects of age, sex, test frequency, presence or absence of tinnitus, ear canal volume (as determined by tympanometry), size of the opening to the external auditory meatus as determined by an earplug sizing gauge, history of noise exposure, test order, and test frequency.

REPORTING SCHEDULE

Interim Reports

Upon each completion of 50 subjects, the contractor shall provide a report of test results for both individual and grouped hearing threshold measurements. This shall include but not be limited to measures of central tendency (e.g., mean and median hearing threshold levels) and measures of variance for each audiometric frequency according to the prescribed age categories for both males and females. This report shall include summary statistics on ear canal size for both individual and grouped data.

Final Report Within 90 days following completion of data collection, a final report shall be completed, and the balance of payment shall be made to the contractor. The final report shall describe the results so that NIOSH may make appropriate recommendations regarding the viability and suitability of 8 kHz as an audiometric test frequency for use in hearing conservation audiometric monitoring.

Additional Report Requirements All reports shall be submitted in Microsoft Word “.doc” format. Microsoft Excel shall be used to report tabular data. Additional software may be used to report data subject to approval by the project officer. A hard copy and an electronic copy of all reports shall be submitted to the NIOSH Project Officer, Dr. Mark Stephenson. The file(s) for the electronic reports shall be submitted on a compact disk (CD or a thumb drive). In accordance with Department of Health and Human Services requirements, all electronic files shall be compatible with Section 508 of the Americans With Disabilities Act in order to assure the data are accessible to the visually impaired and physically handicapped. Mail the hard and electronic copies to:

Dr. Mark Stephenson

4676 Columbia Pkwy, Mail Stop C-27

Cincinnati, Ohio 45226-1998 mstephenson@cdc.gov

NIOSH shall retain ownership of all data and publication rights. However, opportunities for joint publication may be available.

It shall be noted that continuation of this effort in years 2 and 3 are contingent upon the NIOSH Project Officer receiving currently approved funding allocation to continue this effort in each of those years.

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the Project Officer) at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance

F.1 Deliverable(s) Schedule (Jul 1999)

The Contractor shall deliver, within the time frames specified, all items to the Project Officer at the address shown in Section G, and to the Contracting Officer at the address shown on the face page of the contract.

REPORTING REQUIREMENTS AND DELIVERABLES

Interim Reports

Upon each completion of 50 subjects, the contractor shall provide a report of test results for both individual and grouped hearing threshold measurements. This shall include but not be limited to measures of central tendency (e.g., mean and median hearing threshold levels) and measures of variance for each audiometric frequency according to the prescribed age categories for both males and femailes. This report shall include summary statistics on ear canal size for both individual and grouped data.

Final Report Within 90 days following completion of data collection, a final report shall be completed, and the balance of payment shall be made to the contractor. The final report shall describe the results so that NIOSH may make appropriate recommendations regarding the viability and suitability of 8 kHz as an audiometric test frequency for use in hearing conservation audiometric monitoring.

Additional Report Requirements All reports shall be submitted in Microsoft Word “.doc” format. Microsoft Excel shall be used to report tabular data. Additional software may be used to report data subject to approval by the project officer. A hard copy and an electronic copy of all reports shall be submitted to the NIOSH Project Officer, Dr. Mark Stephenson. The file(s) for the electronic reports shall be submitted on a compact disk (CD or a thumb drive). In accordance with Department of Health and Human Services requirements, all electronic files shall be compatible with Section 508 of the Americans With Disabilities Act in order to assure the data are accessible to the visually impaired and physically handicapped. Mail the hard and electronic copies to:

Dr. Mark Stephenson

4676 Columbia Pkwy, Mail Stop C-27

Cincinnati, Ohio 45226-1998 mstephenson@cdc.gov

NIOSH shall retain ownership of all data and publication rights. However, opportunities for joint publication may be available.

(End of Clause)

F.2 Period of Performance (Jul 1999)

The period of performance shall be a base period of one (1) year with options for two (2), one (1) year periods.

(End of Clause) Section G - Contract Administration Data

G.1 Project Officer (Jul 1999)

Performance of the work hereunder shall be subject to the technical directions of the designated Project Officer for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggest possible lines of inquiry, or otherwise complete the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government Project Officer is not authorized to change any of the terms and conditions of this contract. Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the delegation memorandum for the Project Officer. Any changes in Project Officer delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

(End of Clause)

G.2 Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.3 Evaluation of Contractor Performance (Service) (Jan 2000)

(a) Purpose

In accordance with FAR 42.1502, the Contractor's performance will be periodically evaluated by the Government, in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

(b) Performance Evaluation Period

The Contractor's performance will be evaluated at least annually.

(c) Evaluators

The performance evaluation will be completed jointly by the Project officer and the Contracting officer.

(d) Performance Evaluation Factors

The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled Performance Evaluation Report.

(e) Contractor Review

A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation. The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements Between the Government and the Contractor

Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information

The completed evaluation will not be released to other than Government personnel and the contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated as well as impede the efficiency of Government operations.

(h) Source Selection Information

Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period

The agency will retain past performance information for a maximum period of three years after completion of contract performance for the purpose of providing source selection information for future contract awards.

G.4 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.5 Payment by Electronic Funds Transfer (Dec 2005) (Dec 2005)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (404) 498-4050.

(c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

G.6 Invoice Submission - (Mar 2006)

(a) The Contractor shall submit the original contract invoice/voucher to the shown below:

The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 3033

Or – The Contractor may submit the original invoice/voucher via facsmile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall submit 2 copies of the invoice/voucher to the cognizant contracting office previously identified in this contract. These invoices/voucher copies shall be addressed to the attention of the Contracting Officer.

(c) The Contractor is FORMCHECKBOX , is not FORMCHECKBOX required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c)(1).

(13) DUNS + 4 Number

(End of Clause)

Section H - Special Contract Requirements H.1 FAR 352.270-5 Key Personnel (Jan 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)

H.2 Key Personnel Listing

Key Personnel Name

Title

H.3 HHSAR 352.270-8b Protection of Human Subjects (Jan 2006)

(a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Office of Public Health and Science (OPHS). The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

(b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall be deemed to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

(c) If at any time during the performance of this contract, the Contracting Officer determines, in consultation with the OHRP, OPHS, ASH, that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OHRP, OPHS, ASH, terminate this contract in a whole or in part, and the Contractor’s name may be removed form the list of those contractors with approved Health and Human Services Human Subject Assurances.

(End of clause)

H.4 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999)

The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for 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 or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

H.5 Smoke Free Environment (Jul 1999)

In compliance with Department of Health and Human Services (DHHS) regulations, all contractor personnel performing work within CDC/ATSDR facilities shall observe the CDC/ATSDR smoke-free working environment policy at all times. This policy prohibits smoking in all CDC/ATSDR buildings and in front of buildings which are open to the public. This policy is also applicable to contractor personnel who do not work full-time within CDC/ATSDR facilities, but are attending meetings within CDC/ATSDR facilities.

H.6 Representations, Certifications and Other Statements of Offerors (Jul 1999)

The Representations, Certifications and Other Statements of Offerors submitted by dated are hereby incorporated by reference, with the same force and effect as if they were given in full text.

H.7 Privacy Act Applicability (Apr 2000)

(a) Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at

(b) The Project Officer is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.

(c) The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act system notice provided in Section J, List of Attachments.

H.8 Data Subject to Confidentiality Requirements (May 1998)

The type(s) of data subject to the clause at 352.224-70, Confidentiality of Information, which has been incorporated by reference in Section I, are as follows:

Following are the requirements for handling these data:

H.9 Year 2000 Compliance (Jul 1999)

Unless elsewhere exempted, information technology (if any) to be acquired under this contract/purchase order, which will be required to perform date/time processing involving dates subsequent to December 31, 1999, shall be Year 2000 compliant as defined in Federal Acquisition Regulation Part 39.002.

H.10 Non-Disclosure Agreement for Contractor and Contractor Employees (Mar 2006)

(a) The contractor shall prepare and submit a Non-Disclosure Agreement (NDA) to the Contracting Officer prior to access of government information or the commencement of work at CDC.

(b) The NDA made part of this clause, exhibit I and II , is required in service contracts where positions and/or functions proposed to be filled by contractor’s employees will have access to non-public and procurement-sensitive information. The NDA also requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with CDC employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with the CDC), and members of the public. The Federal Acquisition Regulation (FAR) 37.114 (c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

(c) The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

(d) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign a NDA and it is submitted to the Contracting Officer prior to commencement of their work with the CDC.

(e) Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information maybe discussed.

(f) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement.

EXHIBIT I

Centers for Disease Control and Prevention (CDC) Contractor Non-Disclosure Agreement

I. Non-public Information

[Name of contractor] understands that in order to fulfill the responsibilities pursuant to [Contract name and number] between the Centers for Disease Control and Prevention and [Name of CDC contractor] dated [date], employees of [contractor] will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which can

HYPERLINK "http://www.hyperdictionary.com/dictionary/not" not be disclosed without the prior written consent of the CDC.

In order to properly safeguard non-public information, [contractor] agrees to ensure that prior to being granted access to government information or the commencement of work for the CDC, whichever is applicable, all employees will sign a Non-Disclosure Agreement (NDA) provided by the CDC prior to beginning work for the CDC. Contractor agrees to submit to the contracting official the original signed copies of NDAs signed by the contractor’s employees in accordance with the instructions provided by the contracting official. Failure to provide signed NDAs in accordance with this agreement and instructions provided by the contracting official could delay or prevent the employee from commencing or continuing work at the CDC until such agreement is signed and returned to the contracting official.

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee any non-public information that the employee may obtain in connection with the performance of the employee’s responsibilities to the CDC.

II. Procurement-Sensitive Information

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, other than an authorized Government employee, any procurement-sensitive information gained while in connection with fulfilling the employee’s responsibilities at the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of government personal involved in the solicitation; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

Contractor understands and agrees that employee access to any procurement-sensitive information may create a conflict of interest which will preclude contractor from becoming a competitor for any acquisition(s) resulting from this information. Therefore, if an employee participates in any discussions relating to procurement-sensitive information, assists in developing any procurement-sensitive information, or otherwise obtains any procurement-sensitive information during the course of performing duties at the CDC, contractor understands and agrees that contractor are be excluded from competing for any acquisition(s) resulting from this information.

III. Identification of Non-Government Employees

Contractor understands that its employees are not agents of the Government. Therefore, unless otherwise directed in writing by the CDC, contractor agrees to assist and monitor employee compliance with the following identification procedures:

A. At the beginning of interactions with CDC employees, employees of other governmental entities, members of the public, or the media (when such communication or interaction relates to the contractor’s work with the CDC), contractors’ employees will identify themselves as an employee of a contractor.

B. Contractors’ employees will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages, in connection with contractual duties to the CDC:

Employee’s name Name of contractor Center or office affiliation Centers for Disease Control and Prevention

C. At the beginning of telephone conversations or conference calls, contractors’ employees will identify themselves as an employee of a contractor.

D. Contractors should not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises. The only other exception is when a CDC management official has granted permission to use the CDC logo.

E. Contractors’ employees will program CDC voice mail message to identify themselves as an employee of a contractor.

I understand that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records. Contractor acknowledges that contractor has read and fully understands this agreement.

Name of contractor: ___________________________________

Signature of Authorized Representative of Contractor:_________________________________

Date:________________

Copies retained by: contracting official and contractor

EXHIBIT II

Centers for Disease Control and Prevention (CDC) Contractors’ Employee Non-Disclosure Agreement

I. Non-Public Information

I understand that in order to fulfill my responsibilities as an employee of [Name of CDC contractor], I will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which can

HYPERLINK "http://www.hyperdictionary.com/dictionary/not" not be disclosed without the prior written consent of the CDC.

I [Name of Employee], agree to use non-public information only in performance of my responsibilities to the CDC. I agree further that I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any non-public information that I may obtain in connection with the performance of my responsibilities to the CDC.

II. Procurement-Sensitive Information

I further agree that unless I have prior written permission from the CDC, I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any procurement-sensitive information gained in connection with the performance of my responsibilities to the CDC. I specifically agree not to disclose any non-public, procurement-sensitive information to employees of my company or any other organization unless so authorized in writing by the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Requests for Contract (RFC), and Requests for Proposal (RFP); Responses to RFPs, including questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of government personal involved in the acquisition; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

I understand and agree that my access to any procurement-sensitive information may create a conflict of interest which will preclude me, my current employer, or a future employer from becoming a competitor for any resulting government acquisition derived from this information. Therefore, if I participate in any discussions relating to procurement-sensitive information, assist in developing any procurement-sensitive information, or otherwise obtain any procurement-sensitive information during the course of performing my duties at the CDC, I understand and agree that I, my current employer, and any future employer(s) are excluded from competing for any resulting acquisitions.

III. Special Non-Disclosure Clause for Contractors with Access to CDC Grants Management and Procurement-Related Information Technology Systems

In addition to complying with the non-disclosure requirements and safeguards stated above, I understand that my authorization to use CDC’s grants management and procurement systems is strictly limited to the access and functions necessary for the performance of my responsibilities to the CDC and which have been approved in advance by the CDC. I understand that I am not authorized to enter procurement requests for any requirements pertaining to contracts or subcontracts held by me or my employer.

IV. Identification as a Non-Government Employee

I understand that as an employee of a government contractor, I represent an independent organization and I am not an agent of the Government. Therefore, I agree that unless I have prior written authorization from the CDC, I will, at the beginning of interactions with CDC employees, employees of other governmental entities, members of the public, or the media (when such communication or interaction relates to the contractor’s work with the CDC), identify myself as an employee of a contractor. I further agree to use the following identification procedures in connection with my work at the CDC:

A. I will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages:

Employee’s name Name of contractor Center or office Affiliation Centers for Disease Control and Prevention

B. I will identify myself as an employee of a contractor at the beginning of telephone conversations or conference calls;

C. I will not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises; the only other exception is when a CDC management official has granted permission to use the CDC logo.

D. I will program my CDC voice mail message to identify myself as a contractors’ employee.

I understand that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records. I acknowledge that I have read and fully understand this agreement.

Name of contractor: ___________________________________

Name of Employee:___________________________

Signature of Employee:_________________________________

Date:________________

Copies retained by: contracting official, contractor, and Employee

H.11 HHS Standard Security Configuration Language (Jan 2009)

Contractor computers containing HHS data shall be configured with the applicable Federal Desktop Core Configuration (FDCC) (http://nvd.nist.gov/fdcc/index.cfm), and shall have and maintain the latest operating system patch level and anti-virus software level.

1. The Contractor shall apply approved security configurations to information technology that is used to process information on behalf of the Department, its Operating Divisions (OPDIVs) and Staff Divisions (STAFFDIVs).

Such approved security configurations…