SOURCES SOUGHT
A -- Quality Assessment Support For Conduct of Audits & Inspections for NTP
- Notice Date
- 11/7/2013
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIHES2013166-WH
- Point of Contact
- WANDA M. HOLLIDAY, Phone: 919-541-0943, Juanita A Campbell, Fax: 301-451-5400
- E-Mail Address
-
hollida1@niehs.nih.gov, campbellj@niehs.nih.gov
(hollida1@niehs.nih.gov, campbellj@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Small Business Sources Sought Notice QUALITY ASSESSMENT SUPPORT FOR CONDUCT OF AUDITS AND INSPECTIONS FOR THE NATIONAL TOXICOLOGY PROGRAM (NTP) This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The National Toxicology Program (NTP; part of the National Institute for Environmental Health Sciences, NIEHS) is responsible for evaluating the toxic and carcinogenic potential of environmental agents that may pose a health hazard to citizens of the United States. The NTP accomplishes this by conducting toxicology and carcinogenicity studies on a variety of chemical, physical and biological agents as well as analyses of literature data. The NTP requires quality assessment support to aid the NTP in managing the overall quality of NTP studies, data and reports. Quality assessment support work is currently being conducted under contract N01-ES-45517 held by Dynamac Corporation. Purpose and Objectives The purpose of the NTP Quality Assessment support contract is to conduct audits and inspections of various aspects of NTP studies in order to identify areas in the conduct and documentation of studies that merit attention, correction or improvement. Findings from these audits and inspections will be communicated to NTP staff and management so they may be addressed; this process will aid the NTP in managing the overall quality of NTP studies, data and reports. The NTP requires support for the conduct of audits of NTP reports, laboratory reports, pathology tables, and electronic information as well as site visit support for monitoring work in progress at contract toxicology laboratories. Project requirements Quality assessment audits/inspections shall be assigned by the NTP Contract Officer's Representative (COR) based on NTP priorities. Note that the distribution and total number of audits/inspections may vary from year to year depending on the needs of the NTP. The different types of audits/inspections to be conducted under the contract are briefly described below. The toxicology and carcinogenesis studies and ancillary activities that will comprise the majority of the audits/inspections to be performed under the contract involve primarily the disciplines of chemistry, animal care, toxicology and pathology. The following types of procedures, records, data and results are anticipated to require audit/inspection: chemistry (identity, purity, homogeneity and stability; dose formulation/preparation, analysis, and stability; biological sample collection/analysis); inhalation exposure generation and monitoring; animal husbandry (receipt, quarantine, randomization, and environmental conditions); in life toxicity (clinical observations, body weights); functional reproductive, immunological and neurological effects; biochemical and molecular endpoints; genetic toxicity data; gross and histopathology data; teratology data; procedures used to capture and process data; data trails; statistical analysis data; in vitro evaluations. • Audit of an NTP Report: Assesses the accuracy, consistency and completeness of the factual information, qualitative and quantitative, presented in an NTP Report by comparing it to original study records submitted to the NTP. For most types of data, a 100% audit is required. As an exception, a partial audit of large data sets is typically conducted, with findings potentially triggering a more extensive (up to 100%) audit. • Audit of a Laboratory Report: Assesses the accuracy, consistency and completeness of the factual information, qualitative and quantitative, presented in a laboratory report by comparing it to original study records submitted to the NTP. For most types of data, a 100% audit is required. As an exception, a partial audit of large data sets is typically conducted, with findings potentially triggering a more extensive (up to 100%) audit. • Audit of Pathology Tables: Assesses the accuracy and completeness of all of the NTP-authorized diagnostic changes made during the peer review process by auditing the post-peer review laboratory information management system individual animal pathology tables against the peer review documentation. In addition, the diagnoses for a subset (currently 5%) of the animals for which no update was indicated shall be audited, by comparing pre-peer review tables to post-peer review tables, to ensure the overall data continuity and stability of unchanged diagnoses. • Audit of Electronic Information: Assesses the overall quality of electronic information (NTP public website or related websites) either by comparing the electronically available information to original study records or other primary sources or by comparing information in two or more electronic sources to determine consistency of factual information. • Site-visit support for monitoring work in progress at Contract Toxicology Laboratories: The contractor shall accompany NTP staff (including the NTP COR) on quality assessment site visits to assess the extent to which study conduct complies with relevant contractual standards, including the NTP Specifications and Federal Good Laboratory Practice (GLP) regulations. Quality assessment site visits shall typically include inspections of study procedures as they are being performed, inspections of equipment and facilities, and audits of data for studies that are in progress. Specific details about the design, conduct and reporting of NTP studies can be found in the current Specifications for the Conduct of Studies to Evaluate the Toxic and Carcinogenic Potential of Chemical, Biological and Physical Agents in Laboratory Animals for the National Toxicology Program (http://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ToxCarSpecsJan2011.pdf) and the current Specifications for the Conduct of Studies to Evaluate the Reproductive and Developmental Toxicity of Chemical, Biological and Physical Agents in Laboratory Animals for the National Toxicology Program (http://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ReproSpecsMay2011_508.pdf). Specifications are not currently available for other types of studies/endpoints reported by the NTP; however, additional information on these types of studies/endpoints will be provided to the quality assessment support Contractor as necessary. In addition, examples of recent NTP reports can be found on the NTP public website (http://ntp.niehs.nih.gov/go/pubs). The principal investigator shall be an employee of the contractor, shall be considered key personnel and shall manage all aspects of the contract. Because there is potential for conflict of interest, personnel assigned to this contract, as well as subcontractors or consultants, shall not be in any way associated with NTP testing contracts that have performed the work being audited. Audits of NTP reports and laboratory reports require access to study records that are stored at the NTP archives. Accordingly much of work done under this contract will be performed at the NTP archives. In addition, the contractor will pick up/drop off audit materials at the NTP COR's office, as well as meet with the NTP COR and other NTP staff as appropriate. Both the NTP and the NTP archives are currently located in Research Triangle Park, NC) and frequent (weekly to daily) travel to these locations will be required. Anticipated level of effort and period of performance Award of a cost-reimbursement, level of effort type contract is contemplated. The total estimated level of effort is anticipated to be between approximately 5,000 and 10,000 labor hours per year, including options, depending on the needs of the NTP. The Base Contract is anticipated from September 1, 2014 to August 31, 2015 with nine optional one-year periods of performance. If all options are exercised the period of performance shall extend through August 31, 2023. Other important considerations Electronic documents and reports are anticipated to be included in the deliverables of the resultant contract. When acquiring Electronic and Information Technology (EIT), the government is obligated to meet the accessibility standards at 36 CFR Part 1194 and Section 508 of the Rehabilitation Act of 1973. Section 508 service requirements for Information Content are applicable for this requirement and must address 36 CFR Part 1194, Subpart D, Information, Documentation and Support. Information about Section 508 is available at http://www.section508.gov/. Electronic report deliverables shall be Section 508 compliant according to checklists at http://www.hhs.gov/web/508/index.html under "Helpful Resources. In some cases, there may be accommodations for which the PO/COR will provide information annually. Capability statement / Information sought. Interested organizations are required to submit an electronic copy of their capability statement that clearly details the ability to perform the aspects of the notice described above in the "project requirements" section, as concisely as possible. The information should be provided in Microsoft Word or Adobe PDF format and should not exceed fifteen (15) pages in length. The capability statement should be submitted electronically to: hollida1@niehs.nih.gov. TELEPHONE AND FACSIMILE RESPONSES WILL NOT BE ACCEPTED. Responses should include information regarding: (a) staff expertise, including availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; and (d) corporate experience and management capability. Each response should also include the following business information: DUNS number Organization Name Company Address Point of Contact (including name, title, addresses, telephone number, fax number and Email address) Business size pursuant to the applicable NAICS code Socio-economic status pursuant to the applicable NAICS code (e.g., 8(a), HUBZone, VOSB, SDVOSB, WOSB, or SDB) Partnering or Teaming Agreements (if applicable) Standard product brochures will not be considered a sufficient response to this sources sought synopsis. Telephone and facsimile responses will NOT be accepted. All information must be received by NIEHS no later than: November 22, 2013, 3:00 PM, EST. Submit all questions in writing, via email to: hollida1@niehs.nih.gov. All questions must be submitted no later than 4:30 p.m. EST on November 14, 2013. Telephone inquiries will NOT be accepted. " Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)." Interested offerors may register at http://www.fedbizopps.gov to receive notification when the solicitation and any amendments are issued and available for downloading. Please note that the General Services Administration provides the notification service as a convenience and does not guarantee that notifications will be received by all persons on the mailing list. Therefore, we recommend that you monitor the FedBizOpps site for all information relevant to desired acquisitions. If the Internet option is not available to you, you may receive a hard copy of the solicitation and any amendments (via U.S. Mail) by emailing your request to hollida1@niehs.nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIHES2013166-WH/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03230010-W 20131109/131107234013-aeb6389928405c24fd48f938fcaee15a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |