JOFOC_PR_07127.docx

Justification for Other than Full and Open Competition

Justification for Other than Full and Open Competition "Source Selection Information — see FAR 2.101 and 3.104"

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. Centers for Disease Control and Prevention

b. Sponsoring organization.

NIOSH/HELD/PPRB

c. Project Officer information.

Yong Qian, PhD

NIOSH/HELS/PPRB

MS L-2015

1095 Willowdale Road, Morgantown, WV 26505 Yaci2cdc.gov 304-285-6286

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

Contract to support a nanotoxicology research program designed to identify engineered nanoparticle-induced toxicity. The contractor will study laser printer-emitted particle (PEP)-induced prolong pulmonary and cardiovascular effects in rats via whole-body inhalation exposure and determine the clearance and translocation of PEPs in rats via intratracheal instillation. A novel exposure-generation system, Printer Exposure Generation System ("PEGS"), will be employed to produce PEPs to mimic the real-world exposure atmospheres.

Project background.

In FY2016, the Phase 1 study consisted of the following research conducted by the servicing agency: particle generation, characterization and fractionation, in vitro dosimetric determination, in vitro toxicity investigation in multiple cell lines, pilot study in in vivo evaluation of PEPinduced cardiovascular effects via inhalation. In the proposed Phase 2 study, emphasis will be given on biokinetics of inhaled PEPs, other PEPtargeted organ toxicity, and prolong PEP exposure-induced cardiopulmonary responses studies.

The unique physicochemical properties of engineered nanomaterials (ENMs) are being exploited for use in a growing variety of commercial nano-enabled products (NEPs), including electronics, cosmetics, and structural materials, as well as a wide variety of products for medical applications. Numerous in vitro and in vivo studies have investigated the possible adverse effects of inhalation exposure to pristine ENMs during synthesis and handling by workers and consumers. However, human exposure is not limited to pristine ENMs, but also includes a wide variety of particles released from NEPs across their life cycle, including consumer use and disposal. Therefore, these results cannot be correlated to exposures at consumer level since the test particles used are not representative of the "real world" exposure of consumers to PEPs.

Indeed, the potential for exposure from such life cycle particulate matter ("LCPM") may exceed that of pristine engineered nanoparticles ("ENPs").

Moreover, the physico-chemical properties and toxicological profiles of LCPM may differ greatly from those of pristine ENPs. Despite the potential for LCPM exposure, most nanotoxicological studies have focused on pristine ENPs, and toxicological evaluation of LCPM has been limited. NIOSH and the EPA have therefore recommended life cycle analyses in their nanotechnology research programs. Most importantly, the servicing agencies need to develop a methodology that can link real world LCPM exposures to toxicology and cardiopulmonary risk. This study will specifically address this important research gap.

Numerous epidemiologic studies have shown strong associations between inhalation of ambient particulate matter ("PM") and cardiovascular mortality and morbidity, with mortality from cardiovascular causes exceeding that from respiratory causes. Animal studies also indicate that the cardiovascular system may be more sensitive to pulmonary exposure to PM than the lung. To date, however, most nanotoxicology studies have focused primarily on the pulmonary effects of ENP exposure. This contract will address the cardiopulmonary effects of ENP exposure.

Researchers at Harvard Public Health's Center for Nanotechnology and Nanotoxicology developed an exposure generation system, Printer Exposure Generation System ("PEGS"), to monitor and assess nanoparticle emissions during use of printer. NIOSH and Harvard have been working together for the last four years to study the presence of ENMs in toner formulations currently in use in laser printers and assess safety implications during consumer use. In this study, researchers at Harvard will study emitted PEP-induced cardiovascular and other organ effects resulting from the use of laser printers and the biokinetics of inhaled PEPs.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

a. Project title.

Phase 2: Case study of printer-emitted engineered nanoparticles (PEPs) specific to- in vivo biokinetic, cardiovascular, and other targeted organ studies,

b. Project description.

The complete project description is provided in the Statement of Work.

Briefly, this research project is to study laser printer-emitted particle (PEP)-induced prolong pulmonary and cardiovascular effects in rats via whole-body inhalation exposure and determine the clearance and translocation of PEPs in rats via intratracheal instillation. A novel exposure-generation system, Printer Exposure Generation System ("PEGS"), will be employed to produce real-world PEPs to mimic the realworld exposure atmospheres. It will best be accomplished by using an exposure generation system, Printer Exposure Generation System (PEGS), to monitor and assess nanoparticle emissions during use of printer at Harvard University. Moreover, researchers at Harvard University have conducted the PEPs research for NIOSH for several years. The current project is built on the data base created from the previous projects conducted by the researchers at Harvard University.

• Requirement type x Research & development (R&D) q R & D support services q Support services (non-R&D) q Supplies/equipment q Information technology (IT) q Construction q Architect-engineer (A & E) services q Design-build q Other (specify):

• Type of action.

x New requirement q Follow-on q Other (specify):

• Proposed contract/order type.

x Firm-fixed-price q Other fixed-price (specify, e.g., fixed-price award-fee, fixedprice incentive-fee):

q Cost-plus-fixed-fee q Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee):

q Time and materials q Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements):

q Other (specify):

q Completion Form U Term form

• Acquisition identification number. .

c. Total estimated dollar value and performance/delivery period.

The total estimated dollar value of the acquisition is $270,000.

Payment will be based on satisfactory completion of the deliverables as described in the Statement of Work.

4. Identification of the statutory authority permitting other than full and open competition.

x This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(_) as set forth in Federal Acquisition Regulation (FAR) 6.302- .

q This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

q This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

The Harvard Public Health's Center for Nanotechnology and Nanotoxicology Harvard T.H. Chan School of Public Health Harvard University 665 Huntington Avenue Building 1, Room 1310B Boston, Massachusetts 02115

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This contract will address the following NIOSH priority goals: 1) conduct research to contribute to the understanding of the toxicology and internal dose of emerging ENMs; 2) evaluate acute and chronic effects in the cardiopulmonary system and in other organ systems and tissues; and 3) determine rates of clearance of these nanoparticles after pulmonary exposure and translocation to systemic organs. The contractor will employ novel exposure-generation systems to produce real-world PEPs exposure atmospheres and develop an integrated multi-tier experimentalcomputational screening approach to assess toxicological outcomes with emphasis on cardiopulmonary responses.

The Harvard Public Health's Center for Nanotechnology and Nanotoxicology team developed an exposure generation system, Printer Exposure Generation System (PEGS), to monitor and assess nanoparticle emissions during use of printer. This Harvard research group has conducted the PEPs research for NIOSH for several years.

The current project is built on the data base created from the previous projects conducted by this research group.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Most of the PEP-related in vitro studies performed have used bulk toner particles and concluded that exposures caused delayed pulmonary clearance which led to increased super oxide radicals, cell growth, and cyto- and genotoxicity.

Moreover, long-term exposure to the toner material resulted in chronic inflammation, fibrosis and tumor growth in rat lungs. These studies suggest toxicity of toner powder; however, these results cannot be correlated to current exposures since the test particles used are not representative of the "real world" exposure to PEPs. The Harvard Public Health's Center for Nanotechnology and Nanotoxicology team developed an exposure generation system, Printer Exposure Generation System (PEGS), to monitor and assess nanoparticle emissions during use of printer. These well-characterized real-world PEPs aerosols can be directed to exposure chambers for inhalation studies, or collected for physicochemical characterization and use in in vitro or animal instillation experiments.

In FY2016, the Phase 1 study consisted of the following research conducted by the servicing agency: particle generation, characterization and fractionation, in vitro dosimetric determination, in vitro toxicity investigation in multiple cell lines, pilot study in in vivo evaluation of PEP-induced cardiovascular effects via inhalation. In the proposed Phase 2 study, emphasis will be given on biokinetics of inhaled PEPs, other PEP-targeted organ toxicity, and prolong PEP exposureinduced cardiopulmonary responses studies. Based on the search of PubMed and Google, we believe that there are no other research groups that are comparable to the unique expertise of the Harvard Public Health's Center for Nanotechnology and Nanotoxicology for research.

the Government will be fair and reasonable.

This contract is non-severable. The contractor developed an exposure generation system, Printer Exposure Generation System (PEGS), to monitor and assess nanoparticle emissions during use of printer. With this PEGS, they will study biokinetics of inhaled PEPs, other PEP-targeted organ toxicity, and prolong PEP exposure-induced cardiopulmonary responses studies. They have been studying the toxicological effects of PEPs for NIOSH for several years and thus, there should be few obstacles to initiating, managing, successfully conducting, and completing this study.

It is anticipated that we need 24 months to complete this project.

The costs of equipment and supplies and indirect costs will be assessed by Harvard University and will be included. The Contracting Officer will determine whether the anticipated cost/price to the Government is fair and reasonable based on the current market information.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

We have performed extensive literature search through PubMed and Google search. As previous determined, most of the PEPs-related in vitro and in vivo studies performed have used bulk toner particles. These studies suggest toxicity of toner powder; however, these results cannot be correlated to current exposures since the test particles used are not representative of the "real world" exposure to PEPs. Harvard Public Health's Center for Nanotechnology and Nanotoxicology developed an exposure generation system, Printer Exposure Generation System (PEGS), to monitor and assess nanoparticle emissions during use of printer. These well-characterized real-world PEPs aerosols can be directed to exposure chambers for inhalation studies, or collected for physicochemical characterization and use in in vitro or animal instillation experiments. Moreover, the contractor will study biokinetics of inhaled PEPs, other PEP-targeted organ toxicity, and prolong PEP exposure-induced cardiopulmonary responses studies. To our knowledge, there are no other research groups that are comparable to Harvard Public Health's Center for Nanotechnology and Nanotoxicology's unique research expertise.

9. Any other facts supporting the use of other than full and open competition.

None.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

There are no future plans to acquire the same type of data.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Yong Qian, PhD

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date Chief of the Contracting Office Head of the Contracting Activity

15. Competition Advocate signature.

Official Name & Title Signature Date Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date HHS Senior Procurement Executive