Loren Data's SAM Daily™

FBO DAILY ISSUE OF JUNE 08, 2011 FBO #3483
SOLICITATION NOTICE

B -- Recruitment, Coordination & Management of Small Consctruction Business Owner Interviews for Exploring the OSH Needs of Small Construction Businesses in the Cincinnati, Ohio Area

Notice Date

6/6/2011
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541910 — Marketing Research and Public Opinion Polling
 

Contracting Office

Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Morgantown), 1095 Willowdale Road, Morgantown, West Virginia, 26505
 

ZIP Code

26505
 

Solicitation Number

000HCCEC-2011-98402
 

Archive Date

7/21/2011
 

Point of Contact

Rebecca S Mullenax, Phone: 304-285-5880, Kimberly P Groves, Phone: 304-285-5885
 

E-Mail Address

rmullenax@cdc.gov, kgroves@cdc.gov
(rmullenax@cdc.gov, kgroves@cdc.gov)
 

Small Business Set-Aside

N/A
 

Description

SOLICIATION NOTICE: The Centers for Disease Control and Prevention, National Institute of Occupational Safety and Health (NIOSH), 1090 Tusculum, Cincinnati, Ohio 45226-1938 has a requirement for services for recruitment, coordination and management of small construction business owner interviews for exploring the Occupational Safety and Health (OSH) of small construction businesses in the Cincinnati, Ohio area. This requirement is solicited as unrestricted. STATEMENT OF WORK Recruitment, Coordination and Management of Small Construction Business Owner Interviews for Exploring the OSH Needs of Small Construction Businesses in the Cincinnati, Ohio area I. Background Construction had the most fatal injuries of any sector, with 1,178 fatalities in 2006 (21% of total) (U.S. Dept. of Labor, 2008). More than 79% of construction businesses employ fewer than 10 employees (CPWR, 2007), and this establishment size experiences the highest fatality rate within construction (U.S. Dept. of Labor, 2008). The need for reaching this population with effective, affordable, and culturally appropriate training has been documented in publications and is increasingly becoming an institutional priority at NIOSH. This study will collect information from small construction business (SCB) owners with 10 or fewer employees regarding their businesses' specific OSH training needs, motivational factors, and preferred information sources and use it to develop recommendations for tailoring OSH training interventions for small businesses in the construction industry. II. Project Objectives To better understand the occupational safety and health (OSH) needs of small construction businesses (SCBs), and to inform methods that will successfully motivate SCB owners to seek OSH training relevant to their unique work situations, key-informant perceptions and opinions will be gathered via in-depth interviews with 30 small construction business owners with 10 or fewer employees in the greater Cincinnati, Ohio area. Data gathered from in-depth interviews will be used in subsequent phases of the study for the development of a survey to assess the occupational safety and health needs and motivators for seeking OSH information among small construction business owners. That is, the results of these interviews will be analyzed to identify common sets of responses, and these responses will be used in the development of a survey that will identify SCB owners businesses' specific training needs, motivational factors, and preferred information sources which will inform the design and implementation of future interventions. III. Scope of Work The purpose of this contract is to provide services for the recruitment, coordination and compensation of 30 interviews to small construction business owners regarding specific OSH training needs, motivational factors, and preferred information sources. NIOSH researchers will conduct the interviews, and the contractor will manage all other aspects of recruitment, scheduling, logistics, and participant compensation. The interviews will be administered in the Greater Cincinnati, Ohio area. Respondents for the interviews will be owners of small construction businesses with 10 or fewer employees. Within the scope of this contract, the logistics of recruiting participants for the interviews will include providing any compensation to the participants for their time. IV. Detailed Technical Requirements Summary of Tasks or Phases Task 1: Develop recruitment and interview coordination plan. Task 2: Recruit respondents, coordinate interviews, and compensate respondents. Description of Specific Tasks or Phases Task 1: Develop recruitment and interview coordination plan. The contractor will be responsible for developing a plan detailing how the recruitment for the interviews will occur. The plan should include details on recruiting methodology including, but not limited to, how potential participants will be identified and approached for participation in the study, examples of recruitment materials used in the study, planned geographic scope (within the Greater Cincinnati, Ohio area) of recruiting efforts. Particular attention will be given to how recruiting efforts will ensure that a broad range of sub-sectors within construction are represented in the sample. For example, no more than 3 respondents should be recruited from a specific subsector or NAICS code. The plan should also include details regarding the administration of the interview including, but not limited to, where the interview will be administered (i.e. in respondent's home, at a public location, at a scheduled time in an office, etc.), when the interview will take place, and when reminder communications will be delivered to respondents. Special attention will be given to how respondents' privacy will be protected during recruitment and the interview. The plan should also include a schedule for completion of the data collection. The interview instrument itself will be developed by the NIOSH researchers. The recruiters should be familiar with the local construction community and basic interview administration procedures. The contractor will host a one day workshop to provide an opportunity for NIOSH researchers to review the data collection tool with the recruiters to ensure basic questions by potential respondents can be adequately addressed. Basic questions may include inquiries regarding the purpose of the study or compensation procedures. The contractor will oversee general logistics of the workshop related to the host facility, including but not limited to: providing scheduling reminders and driving directions to participants and ensuring basic provisions (refreshments, lunch, and bathroom facilities). In addition, the contractor will be responsible for informing the NIOSH researchers of the recruiting plan and coordinating the day to day logistics of the data collection. Delivery, Review, and Payment The time frame for completion of task 1 is within 3 months of the award of this contract. The contractor will provide a written report of the recruitment plan and meet with NIOSH researchers to discuss/modify the plan as necessary. The contractor will also provide a proposed schedule for the data collection. The contractor must also confirm its capability (i.e., demonstrate a mechanism) to provide compensation to the respondents at the conclusion of each interview. The NIOSH project officer will review the report and confirm that the requirements have been met. Upon acceptance of the recruitment plan, partial payment of 20% of the contract award may be authorized. Task 2: Recruit respondents, coordinate interviews, and compensate respondents. Task 2 will not begin until the NIOSH project officer notifies the contractor that OMB approval has been obtained. This may result in a delay of approximately 6-9 months from the date of contract award. The contractor will follow the approved task 1 recruitment plan to recruit respondents and coordinate 30 interviews with small construction business owners from a broad range of construction subsectors to identify the unique OSH training needs, motivational factors, and preferred information sources. SCB owner respondents should be currently operating a construction business with 10 or fewer employees in the Greater Cincinnati, Ohio area. The contractor will be responsible for managing all logistics related to the data collection including but not limited to; ensuring that the respondents meet the qualifications specified in the apporved recruitment plan, providing a detailed interview schedule including interviewee contact information, date, location, and time, and providing compensation to interviewees for their time and travel expenses. All travel in accordance with Federal Travel Regulations. Recruitment will be performed until a minimum of 30 interviews have been completed. The contractor must also be able to set up a mechanism for providing each respondent with compensation for his/her time. Delivery, Review, and Payment The time frame for completion of task 2 is within 3 months of the notification of OMB approval. Partial payment may be authorized following completion of data collection and submission of completed compensation accounting for each group of 10 respondents in the study until a maximum of 3 payments is achieved. Billing for partial payment in task 2 may be submitted following the delivery of completed compensation accounting records for each group of 10 participants. The NIOSH project officer will confirm from the completed interview instruments that all the scheduled interviews have been administered so that payment may be authorized. Upon receipt of the final 10 compensation accounting reports will confirm the completion of task 2 and the contract as a whole so that the final payment for the balance of the contract may be authorized. Description of End Products/deliverables Task 1: Recruitment and interview coordination plan. Task 2: Completed compensation accounting report for respondents. May be subdivided into as many as 3 payments (one following the submission of each group of 10 completed respondent compensation records.) V. Reporting Schedule Task 1: Recruitment and interview coordination plan. within 3 months of award date* Task 2: Completed compensation accounting report for respondents. May be subdivided into as many as 3 payments (one following the submission of each groupof 10 completed respondent compensation records.) within 3 months of OMB approval* *Note: Due to potential delays related to mandated Office of Management and Budget oversight review timelines may need to be extended. VI. Special Considerations In order to ensure the quality of the data the contractor will have 1) strong ties to the construction industry in the Greater Cincinnati area, 2) past experience recruiting participants for occupational safety and health research in the construction industry in the Greater Cincinnati, Ohio area, and 3) past experience recruiting small businesses for participation in occupational safety and health research. TOTAL_____________________________ All quotes will be due on June 21, 2011. No verbal or written requests for copies will be accepted. It is the responsibility of perspective offerors to stay abreast of additional postings regarding this solicitation at the FedBizOpps internet site. No government-wide notes apply. All vendors must be registered in the Central Contractor Registry (CCR) prior to an award of a Federal contract. The website is: www.ccr.gov. All responsible responsive sources may submit an offer which shall be considered by the agency Solicitation ~ Non Commercial Service < $100,000 (as of March 25, 2008) 52.204-8 -- Annual Representations and Certifications (Jan 2006) (a) (1) The North American Industry classification System (NAICS) code for this acquisition is ____________ [insert NAICS code]. (2) The small business size standard is ____________ [insert size standard]. (3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees. (b) (1) If the clause at 52.204-7, Central Contractor Registration, is included in this solicitation, paragraph (c) of this provision applies. (2) If the clause at 52.204-7 is not included in this solicitation, and the offeror is currently registered in CCR, and has completed the ORCA electronically, the offeror may choose to use paragraph (c) of this provision instead of completing the corresponding individual representations and certification in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes: [ ] (i) Paragraph (c) applies. [ ] (ii) Paragraph (c) does not apply and the offeror has completed the individual representations and certifications in the solicitation. (c) The offeror has completed the annual representations and certifications electronically via the Online Representations and Certifications Application (ORCA) website at http://orca.bpn.gov. After reviewing the ORCA database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. FAR Clause Title Date Change Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on ORCA. (End of Provision) 52.213-4 -- Terms and Conditions -- Simplified Acquisitions (Other Than Commercial Items) (Dec 2007) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses that are incorporated by reference: (1) The clauses listed below implement provisions of law or Executive order: (i) 52.222-3, Convict Labor (June 2003) (E.O. 11755). (ii) 52.222-21, Prohibition of Segregated Facilities (Feb 1999) (E.O. 11246). (iii) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (iv) 52.222-50, Combating Trafficking in Persons (Aug 2007) (22 U.S.C. 7104(g)). (v) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2006) (E.o.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). (vi) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553). (vii) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78). (2) Listed below are additional clauses that apply: (i) 52.232-1, Payments (Apr 1984). (ii) 52.232-8, Discounts for Prompt Payment (Feb 2002). (iii) 52.232-11, Extras (Apr 1984). (iv) 52.232-25, Prompt Payment (Oct 2003). (v) 52.233-1, Disputes (July 2002). (vi) 52.244-6, Subcontracts for Commercial Items (Mar 2007). (vii) 52.253-1, Computer Generated Forms (Jan 1991). (b) The Contractor shall comply with the following FAR clauses, incorporated by reference, unless the circumstances do not apply: (1) The clauses listed below implement provisions of law or Executive order: (i) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2006) (E.O. 13126). (Applies to contracts for supplies exceeding the micro-purchase threshold.) (ii) 52.222-20, Walsh-Healey Public Contracts Act (DEC 1996) (41 U.S.C. 35-45) (Applies to supply contracts over $10,000 in the United States, Puerto Rico, or the U.S. Virgin Islands). (iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006) (38 U.S.C. 4212) (Applies to contracts of $100,000 or more). (iv) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793) (Applies to contracts over $10,000, unless the work is to be performed outside the United States by employees recruited outside the United States.) (For purposes of this clause, United States includes the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.) (v) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006) (38 U.S.C. 4212) (Applies to contracts of $100,000 or more). (vi) 52.222-41, Service Contract Act of 1965, (Nov 2007) (41 U.S.C. 351, et seq.) (vii) 52.223-5, Pollution Prevention and Right-to-Know Information (Aug 2003) (E.O. 13148) (Applies to services performed on Federal facilities). (viii) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b) (Unless exempt pursuant to 23.204, applies to contracts when energy-consuming products listed in the ENERGY STAR® Program or Federal Energy Management Program (FEMP) will be- (A) Delivered; (B) Acquired by the Contractor for use in performing services at a Federally-controlled facility; (C) Furnished by the Contractor for use by the Government; or (D) Specified in the design of a building or work, or incorporated during its construction, renovation, or maintenance.) (ix) 52.225-1, Buy American Act-Supplies (June 2003) (41 U.S.C. 10a-10d) (Applies to contracts for supplies, and to contracts for services involving the furnishing of supplies, for use within the United States or its outlying areas, if the value of the supply contract or supply portion of a service contract exceeds the micro-purchase threshold and the acquisition-- (A) Is set aside for small business concerns; or (B) Cannot be set aside for small business concerns (see 19.502-2), and does not exceed $25,000.) (x) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003). (Applies when the payment will be made by electronic funds transfer (EFT) and the payment office uses the Central Contractor Registration (CCR) database as its source of EFT information.) (xi) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999). (Applies when the payment will be made by EFT and the payment office does not use the CCR database as its source of EFT information.) (xii) 52.247-64 Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. App. 1241). (Applies to supplies transported by ocean vessels (except for the types of subcontracts listed at 47.504(d).) (2) Listed below are additional clauses that may apply: (i) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Sep 2006) (Applies to contracts over $30,000). (ii) 52.211-17, Delivery of Excess Quantities (Sep 1989) (Applies to fixed-price supplies). (iii) 52.247-29, F.o.b. Origin (Feb 2006) (Applies to supplies if delivery is f.o.b. origin). (iv) 52.247-34, F.o.b. Destination (Nov 1991) (Applies to supplies if delivery is f.o.b. destination). (c) FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es): FAR: http://farsite.hill.af.mil/vffara.htm http://www.arnet.gov/far/ HHSAR: http://farsite.hill.af.mil/vfhhsara.htm (d) Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. The Government must exercise its post acceptance rights -- (1) Within a reasonable period of time after the defect was discovered or should have been discovered; and (2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item. (e) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence, such as acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence. (f) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges that the Contractor can demonstrate to the satisfaction of the Government, using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred that reasonably could have been avoided. (g) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience. (h) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract. (End of Clause) Online Representations and Certification Application (ORCA) (Dec 2005) All potential Contractors are required to complete electronic annual representations and certifications at http://orca.bpn.gov in conjunction with registration in the Central Contractor Registration (CCR) database per FAR 4.1102 and FAR 4.1201. Certifications in ORCA are required prior to the submission of contract proposals. (a) Contractors shall update the representations and certifications submitted to ORCA as necessary, but at least annually, to ensure they are kept current, accurate, and complete. All Contractors with current contracts shall notify the Contracting Officer in writing when changes are made to ORCA. The representations and certifications are effective until one year from date of submission or update to ORCA. (End of provision) Certification (May 1998) TO BE COMPLETED BY THE OFFEROR: (The Offeror must check or complete all appropriate boxes or blanks in the Representations and Certifications contained herein). The Representations and Certifications must be executed below, by an individual authorized to bind the offeror. The offeror makes the forgoing Representations and Certifications as a part of its proposal. ____________________________________________ ___________________________ (Name of offeror) (Solicitation Number) ____________________________________________ ___________________________ (Signature of Authorized Individual) (Date) _____________________________________________________________________________________ (Typed Name of Authorized Individual) Note: The penalty for making false statements in offerors is prescribed in 18 U.S.C. 1001. (End of provision) Basis of Award - Single Award Subject to the provisions contained herein, the Government reserves the right to award on the basis of the initial offer received, without discussions, in accordance with FAR 13.106 -- Soliciting Competition, Evaluation of Quotations or Offers, Award and Documentation Award will be made to those acceptable, responsible offerors whose proposal offers the best value to the Government, price and other technical factors considered. (End of Provision) 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, suggests possible lines of inquiry, or otherwise completes 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) Contracting Officer (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. (End of Clause) Clauses Included By Reference: FAR Clause Description Application 52.204-7 Central Contractor Registration (July 2006) 52.219-14 Limitations on Subcontracting (Dec 1996) Applies to purchase orders that are set aside for 8(a) 52.219-28 Post-Award Small Business Program Representation. (June 2007) 52.222-43 Fair Labor Standards Act and Service Contract Act -- Price Adjustment (Multiple Year and Option Contracts) (Nov 2006) Applies when 52.222-41 is included and the purchase order contains options 52.223-6 Drug-Free Workplace (May 2001) 52.227-1 52.233-3 Authorization and Consent (Dec 2007) Protest After Award (Aug 1996) 52.242-15 Stop-Work Order (Aug. 1989) 52.242-17 Government Delay of Work (Apr 1984) 52.243-1 Changes -- Fixed Price (Aug 1987) 52.243-1 Alternate I Applies to all non professional services purchase orders 52.243-1 Alternate III Applies to all professional services purchase orders 52.246-1 Contractor Inspection Requirements (Apr 1984) 52.246-25 Limitation of Liability -- Services (Feb 1997) 52.249-1 Termination for Convenience of the Government (Fixed-Price) (Short Form) (Apr 1984) 52.249-4 Termination for Convenience of the Government (Services) (Short Form) (Apr 1984) 52.249-8 Default (Fixed-Price Supply and Service) (Apr 1984) HHSARClause Description Application 352.270-6 Publications and Publicity Clause Description Applicable when checked 52.219-3 Notice of Total HUBZone Set-Aside (Jan 1999) 0 52.219-6 Notice of Total Small Business Set-Aside (June 2003) 0 52.219-20 Notice of Emerging Small Business Set-Aside (Jan 1991) 0 52.219-27 Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) 0   Special Circumstances ~Human Subjects 352.270-8 Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (January 2006) (a) Copies of the Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR Part 46, are available from the Office for Human Research Protections (OHRP), Bethesda, Maryland 20892. The regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by HHS. (b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR Part 46. (c) Activities in which the only involvement of human subjects will be in one or more of the categories set forth in 45 CFR 46.101(b)(1-6) are exempt from coverage. (d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal. The OPDIV will make a final determination of whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the proposal. In doubtful cases, prior consultation with OHRP, (telephone: 301-496-7014), is recommended. (e) In accordance with 45 CFR Part 46 prospective Contractors being considered for award shall be required to file with OHRP an acceptable Assurance of Compliance with the regulations, specifying review procedures and assigning responsibilities for the protection of human subjects. The initial and continuing review of a research project by an institutional review board shall assure that the rights and welfare of the human subjects involved are adequately protected, that the risks to the subjects are reasonable in relation to the potential benefits, if any, to the subjects and the importance of the knowledge to be gained, and that informed consent will be obtained by methods that are adequate and appropriate. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information can be accessed at the OHRP Web site: http://www.hhs.gov/ohrp/. (f) It is recommended that OHRP be consulted for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision) 352.270-9 Restriction on Use of Human Subjects (January 2006) Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Contractor shall not expend funds under this award for research involving human subjects or engage in any human subjects research activity prior to the receipt by the Contracting Officer of a certification that the research has been reviewed and approved by the Institutional Review Board (IRB) designated under the Contractor's Federal-wide assurance of compliance. This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors. (End of clause) Protection of Human Subjects (January 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 from the list of those contractors with approved Health and Human Services Human Subject Assurances. (End of clause)   Special Circumstances ~Privacy Act ~ Included when applicable Clause Description Applicable when checked 52.224-1 Privacy Act Notification (Apr 1984) 0 52.224-2 Privacy Act (Apr 1984) 0 352.270-11 Privacy Act (January 2006) 0 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. (End of Clause) Special Circumstances ~ Confidentiality of Information ~ Included when applicable Clause Description Applicable when checked 352.224-70 Confidentiality of Information (January 2006) 0
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/MNIOSH/000HCCEC-2011-98402/listing.html)
 

Record

SN02465296-W 20110608/110606234937-d53f094a22dabbf2b635affe6c615ea0 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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