MODIFICATION
R -- Systematic Literature Summaries, Assessments, Syntheses, and Meta Analyses
- Notice Date
- 6/9/2004
- Notice Type
- Modification
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD200406
- Response Due
- 6/23/2004
- Archive Date
- 7/8/2004
- Point of Contact
- Susan Nsangou, Contract Specialist, Phone 301-435-8867, Fax 301-4023676,
- E-Mail Address
-
nsangous@mail.nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number for the announcement is NICHD 2004-06 and this announcement is issued as a request for proposal (RFP). This announcement and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2001-23. This requirement is a total small business set-aside and the associated NAICS code is 541690 and small business size standard is $6.0 million. The National Institute of Child Health and Human Development (NICHD) in the National Institutes of Health (NIH) has a requirement for Systematic Literature Summaries, Assessments, Syntheses and Meta-Analyses. The Best Pharmaceuticals for Children Act (BPCA) of 2002 directs the Secretary of the Department of Health and Human Services (DHHS), acting through the Director of the National Institutes of Health (NIH) and in consultation with the Commissioner of the Food and Drug Administration (FDA) and experts in pediatric research, to develop and prioritize a list of drugs for which pediatric clinical studies are needed. The BPCA requires the NIH to develop, prioritize and publish in the Federal Register an annual list of approved drugs for which: 1. There is an approved Abbreviated New Drug Application (ANDA). 2. There is a submitted ANDA that could receive FDA approval. 3. There is no patent protection or market exclusivity for an existing New Drug Application (NDA.) 4. There is referral for inclusion on the list regardless of market protection. The BPCA legislation states: CONSIDERATION OF AVAILABLE INFORMATION- In developing and prioritizing the list under paragraph (1), the Secretary shall consider, for each drug on the list-- (A) the availability of information concerning the safe and effective use of the drug in the pediatric population; (B) whether additional information is needed; (C) whether new pediatric studies concerning the drug may produce health benefits in the pediatric population; and (D) whether reformulation of the drug is necessary. In addition, the BPCA legislative language identifies the group of drugs eligible for consideration, essentially off-patent medications, for which ?additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population?. Annual lists were published in the Federal Register in January 2003 and February 2004, with a mid-cycle list published in August 2003. The Government has a requirement for the expertise and resources necessary to conduct assessments of the available literature, and systematic reviews of the literature on scientific questions related to implementation of BPCA. The reviews shall center primarily on prescription medications used by the pediatric populations, but may also include topics related to the conduct of clinical trials in pediatric populations, (e.g., a systematic review of the literature regarding consent processes in pediatric clinical trials.) The ontractor shall be required to analyze questions, as specified by the Government, which can be addressed by meta-analysis, and address areas where meta-analysis can be used to inform the labeling process. This task shall be followed by further meta-analyses conducted to answer specific questions regarding pharmacokinetics and pharmacodynamics (PK/PD), efficacy and safety of prescription drugs in pediatric populations. The Contractor shall develop and maintain a searchable database, updated on an annual basis, comprising the literature of case reports, case series, observational studies and clinical trials for off-patent drugs used by the pediatric population. BPCA requires NICHD to participate in FDA?s preparation of Written Requests by providing scientific input. These Written Requests may potentially become future requirements for pediatric clinical studies. An end result of this process may be to prepare INDs (FDA regulatory documents) leading to drug labeling changes. Each of these activities requires literature synthesis, and many shall require meta-analyses. In infrequent situations, where outside experts state that sufficient data are available to lead directly to comments on labeling changes (without further study), NICHD shall require a complete meta-analysis of efficacy and/or safety data to produce quantitative estimates of efficacy and/or safety. The Contractor shall maintain a central data base of documents pertaining to the literature, and simultaneously adapt the literature syntheses to the needs at each step of the BPCA process. This shall require a high level scientific input in design, conduct, and interpretation of each literature search and its products: systematic literature reviews and/or meta-analyses. There may be instances when systematic reviews and/or meta-analyses are needed to address methodological questions regarding the conduct of pediatric clinical trials, for instance, to summarize approaches to randomization, the consent process, or other questions of study design. In order to assess the availability of information about individual off-patent drugs, the Government has a requirement for state-of-the art systematic reviews of the literature. In order to develop and prioritize the annual list, the Government will specify to the Contractor the drugs under consideration. The reviews shall be systematic, follow a validated methodology for search and synthesis, provide documentation, and produce literature syntheses that address the needs for further study. From an annual list of approximately 200 off-patent drugs as published in the Federal Register, the Government will identify a group (estimated not-to exceed 35) of drugs requiring initial assessments of the literature. The Government anticipates selecting 12 each year as prioritized for further study. . The Government requires continual expansion and updating of literature reviews throughout the process of developing Written Requests, preparing solicitations, developing clinical trials and submitting data for regulatory labeling. Smaller groups of drugs will require more extensive literature reviews and meta-analyses, as described below. The Contractor shall perform the following services from the annual list: 1) Initial assessment of literature - 35 drugs/year. The Contractor shall perform a comprehensive assessment of the literature using a standardized search methodology, and documenting the search methodology. The work shall include all information about the drug in neonates and children under the age of 18. The assessment of the literature shall include a quantitative enumeration of the total number of references regarding the drug, as well as sub-totals for the following categories: case-reports and case series, observational studies, and clinical trials. A separate enumeration will be made by content of the references for the following sub-categories: PK/PD data, pharmacoepidemiology (patterns of use), efficacy, and safety. Pharmacoepidemiology shall include: indications for using the drug in pediatric populations, inpatient and outpatient frequency of use, age, sex and race/ethnicity patterns of use. The contractor shall develop a summary format to assess the quality and availability of data regarding PK/PD, efficacy and safety for each drug, and to identify research questions requiring further study for scientific of regulatory (labeling) purposes. 2) Systematic literature review - 24 drugs as specified by the Government. The Contractor shall conduct a systematic review of the literature, involving abstraction/extraction of data in the articles identified in item 1, and summarizing findings in tables and text. These syntheses shall be used to inform detailed discussion of drugs under consideration to be included in the priority list published each January. The syntheses shall be circulated to expert consultants (Government and non-Government) to assist them in formulating recommendations for prioritization. 3) Expanded literature review as background for Written Request process - 12 drugs as specified by the Government. The Contractor shall expand the systematic reviews prepared under item 2 and provide a literature synthesis to be used as background for NICHD scientists working with FDA to prepare the Written Request for a specified drug. The emphasis of the literature synthesis shall be to provide information regarding research needs, and information needed in designing a study such as estimates of effect, estimates of adverse events, and measurement of outcomes. 4) Expanded literature review as background for Project Officer - 12 drugs as specified by the Government The Contractor shall expand on the systematic reviews prepared under item 3 and prepare a literature synthesis to be used as background for NICHD Project Officers preparing future requirements which may become pediatric clinical studies. 5) Literature synthesis for regulatory requirements (IND process) - 6 drugs/indication combinations as specified by the Government The Contractor shall expand on the systematic reviews prepared under item 4 to provide a finished document that may be submitted by NICHD to FDA as part of the IND process. 6) Meta-analyses - 3 drug/indication combinations as specified by the Government The Contractor shall conduct meta-analyses of specific questions regarding PK/PD, efficacy and/or safety. These meta-analyses shall be provided to scientific experts to determine the feasibility and best course of action for initiating a label change based on the published data and the meta-analysis. The meta-analyses need to be comparable in quality to those published in the best peer reviewed journals. The Government anticipates the publication of the meta-analysis in peer-reviewed journals. 7) Meta-analysis ? 1 methodologic issue in pediatric clinical trials as specified by the Government. The Contractor shall conduct a meta-analysis of methodologic issues in pediatric clinical trials. 8) The Contractor shall develop and maintain a searchable data base that accumulates information abstracted/extracted during the period of performance of the contract, 9) The Contractor shall document all methodologies and provide documentation to NICHD in electronic form. It is anticipated that this requirement shall be for a base year and up to an additional four one-year option period(s.) Offerors are instructed to include in their proposal, their prices for the base year and up to an additional four one-year option period(s.) The NICHD has an annual requirement for: Initial assessment of literature - 35 drugs/year; Systematic literature review - 24 drugs as specified by the Government; Expanded literature review as background for Written Request process - 12 drugs as specified by the Government; Expanded literature review as background for Project Officer - 12 drugs as specified by the Government; Literature synthesis for regulatory requirements (IND process) - 6 drugs/indication combinations as specified by the Government; and Meta-analysis ? 1 methodologic issue in pediatric clinical trials as specified by the Government. FAR 52.212-1, Instructions to Offerors-Commercial applies to this acquisition. FAR 52.212-2, Evaluation-Commercial Items, shall be used, and the specific evaluation criteria are: Understanding the requirement/Technical approach (45 points) Documented soundness and practicality of technical approach for carrying out each of the designated requirements specified in the Statement of Work, for performing literature searches, extracting data, synthesizing literature, documentation of methods, and report preparation, with adequate explanation, details and justification. Management/Personnel (30 points) Demonstrated experience, qualifications and availability of all senior and mid-level professional staff to successfully carry out their proposed specific responsibilities. Demonstrated experience of management in conducting multiple projects of similar scope and complexity. Organizational experience, facilities and resources (25 points) Corporate experience, facilities, commitment and organizational structure that will allow accomplishment of the tasks requested in an efficient and timely manner, evidenced in part by: expertise with respect to similar projects, including dates and sponsors, specific responsibilities with respect to these projects, and evidence of meeting performance standards, and by a list of publications resulting from such activities. Offerors are required to include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. FAR 52.212-4, Contract Terms and Conditions-Commercial Items, and FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items apply to this acquisition. Proposals are due June 23, 2004 by 12 noon EST and shall be delivered to Susan Nsangou, Contracting Officer, Contracts Management Branch, National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda, MD 20892-7510. IF EXPRESS MAIL, offerors shall use ROCKVILLE, MD 20852. For information regarding the solicitation, contact Susan Nsangou, Contracting Officer, Contracts Management Branch, National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda, MD 20892-7510. Phone 301 435 8867 Email nsangous@mail.nih.gov. **********AMENDMENT #01 DATED JUNE 9, 2004 TO SOLICITATION NICHD200406. The Solicitation NICHD200406 is hereby amended to clarify the applicable clauses in FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items. The Contracting Officer indicates that the clauses 52.219-6, Notice of Total Small Business Set-Aside and 52.232-33, Payment by Electronic Funds Transfer - Central Contractor Registration are incorporated by reference. Full text versions of the clauses can be found on www.arnet.gov/far. The due date for responses remains June 23, 2004. The due date HAS NOT BEEN EXTENDED.
- Place of Performance
- Address: Requirement shall be performed on site at contractors facilities
- Record
- SN00600822-W 20040611/040609211817 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |