SPECIAL NOTICE
A -- Request for Information (RFI): Establishment of a database on excipients used in pediatric formulations
- Notice Date
- 6/9/2010
- Notice Type
- Special Notice
- 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 Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-BPCA-RFI-2010-12
- Archive Date
- 7/23/2010
- Point of Contact
- Elizabeth J Osinski, Phone: 301-435-6947
- E-Mail Address
-
eo43m@nih.gov
(eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information (RFI): Establishment of a database on excipients used in pediatric formulations ------------------------------------------------------------------------------------------------------------------------------------------------------- Notice Number: NIH-NICHD-BPCA-RFI-2010-12 Announcement Type: Special Notice Key Dates Release Date: Response Date: Issued by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) Background The Obstetric and Pediatric Pharmacology Branch (OPPB) within The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is involved with the planning and implementation of the Best Pharmaceuticals for Children Act (BPCA) 2007 (http://bpca.nichd.nih.gov/ ). The BPCA 2007 authorizes the NICHD, in consultation with the U.S. FDA and experts in pediatric research, to identify therapeutic gaps in pediatric diseases, disorders or conditions in which more complete knowledge of treatment strategies, including drugs and biologics, may be beneficial to the pediatric population. The lack of adequate pediatric formulations has been identified as a major obstacle for the study and use of drugs in children. While concern has been focused on the medicinal component of the drug formulations administered, the history of drug toxicity in children has several examples of pediatric tragedies that have their origins in the excipients employed rather than the drugs used in the formulation preparation. In 2006 NICHD created the United States Pediatric Formulations Initiative (US PFI) to address safety issues and problems associated with the lack of adequate pediatric Formulations (Clin. Ther.2008;30 (11) 2097-2101). A similar Pediatric Formulation Initiative was created in 2008 in the European Union. (EU PFI). The US and EU-PFIs are working together to examine the risks of excipients in pediatrics and to, identify gaps in safety information, and ultimately create and maintain a pediatric excipients database that is available to drug sponsors, scientists and the public. For this purpose a joint EU-US PFIs Excipients Working Group has been formed to develop a strategy for conducting a high-level scientific literature review to scope out acceptable excipients for children. Secondly, the working group will determine a prioritization process for selected excipients based on: the strength of the literature evidence; broad applicability across the pharmaceutical industry; and, potential for endorsement in Europe, US and worldwide following regulatory screening. A number of issues have thus far emerged related to determination on how estimates have been made of acceptable recipients exposure, the availability of developmental toxicology information, and identification of gaps in information and knowledge. The Specialized Information Services of the National Library of Medicine (NLM) has joined the pediatric excipients initiative as a co-sponsor, to provide advice about how best to structure the search of those items that are difficult to search, search for untapped sources of information, suggestion of toxicology experts, participate in the searching process and to discuss the availability of resources and support at NLM. Development of an excipients database in pediatrics: Minimal Data Base Elements. The joint EU-US PFIs Excipients Working Group has concluded that a simple search will not produce the needed information and that a clearly defined focus will yield meaningful information. At this time the clinical consequences of excipient exposure in children are largely unknown. In addition an accepted daily and cumulative intake of recipients have not been established in pediatrics A detailed review will be needed define and establish the scope of knowledge gaps, update data on purported toxicities, and identify excipients that may impose a toxicity risk if included in pediatric formulations. The data base structure will follow a modular model. The initial step wills the creation of a minimal database module to which other components will be added.. Overall purpose of the excipients data base in pediatrics •To characterize the prevalence and spectrum of symptoms and/or laboratory findings of clinically significant toxicity. •To identify knowledge gaps and needed studies or providing the basis for the development of hypothesis-driven safety or toxicity studies. •To conduct a high-level scientific literature review of the pharmacology, toxicology and safety data of a selected group of excipients used in pediatric formulations. •To identify developmental pharmacology/toxicology findings of clinical significance. •To determine the relationship between exposure and evidence of clinically significance toxicity in the pediatric age group as a whole, or in pediatric subpopulations. Purpose of this RFI The purpose of this RFI is to seek input from potential users on the data elements and information to be collected in a minimal and expanded Data Base of excipients used in pediatric formulations. This is a time-sensitive Request for Information that will be used to obtain knowledge and information for project planning purposes only.This is a Request for Information (RFI) NOT a solicitation for proposals, applications, proposal abstracts, or quotations. This RFI should not be construed as an obligation in any way on the part of the United States (U.S.) Federal government. The Federal Government will not pay for the preparation of any information submitted and/or for the government's use of that information. Additionally, the government cannot guarantee the confidentiality of the information provided. (See Confidentiality Section below)..Information Requested The NIH is especially interested in concrete and relevant suggestions to the following questions in order to determine the pediatric excipient database structure that satisfies the needs of potential users. Questions 1.Which of the following match your role function (s)? -Formulation Scientist -Toxicologist -Other preclinical scientist (please specify) -Clinical trial investigator -Drug Safety/Pharmacovigilance Officers -Other clinical scientist (please specify) -Health care worker -Librarian, Information specialists -Regulatory affairs -Other (please specify) 2.Which of the following most closely matches the organization you work in : -Government (specify agency) -Industry -Academia -Healthcare -Other (Please specify) 3.How often you and other individuals performing the role/function(s) in the group that you chose in answer to question 1, need access to excipients toxicity and safety information? -Yes, daily -Yes, weekly -Yes, monthly -Yes, less frequently -Never 4.The information regarding the safety and toxicity of pharmaceutical excipients can be used in many ways. Please check the main reason (s) why you and other individuals performing the role/function (s) you selected in answer to question 1, use this information. -Research and/or Development -Clinical risk assessment & patient care -Teaching/Education -Community /Advocacy -Regulatory affairs -Retrieve information for others (e.g. library searching) -Other (please specify_________) 5.How would you and other individuals in your group typically obtain the excipients safety and toxicity information you need? Rank 1-6, with 1 being what you would do first: -Use the Internet (which is the main source(s) you use? Please specify) -Use your Library -Use internal Databases -Consult a colleague -Use Information Services -Contact Professional Society -Other (Please specify____________) 6. Do you or have to refer to multiple sources to get necessary information? -Yes, often -Yes, sporadically -Never 7.As a potential user would it be valuable to have access to a single online source where all safety and toxicity information is available on excipients likely to be used in pediatric medicine development? -Yes -No 8.Our initial approach would be to have a minimal database with the potential to expand with more information in later phases. The data elements listed below would be included as a part of this initial minimal database. GENERAL INFORMATION: CAS No Synonyms Physicochemical excipient characterization Pharmacopoeial status Regulatory status Functional classification HUMAN FIELDS Demographic (age, gender etc) Administration/Exposure (E.g., Route, dose, concentration, duration etc) Safety/Tolerability/Adverse effects findings by organ/system (e.g. GI, CVS, respiratory, etc.) Other information 1. Pharmacokinetics/ADME 2. PK/PD relationship Acceptable daily intake NON HUMAN FIELDS Age. Juvenile/Adult) Species (e.g. rat, mouse, dog, non human primates.) Administration/Exposure (e.g. Route, dose, concentration, duration etc) Toxicity findings by organ/system (eg. Genotoxicity, hepatotoxicity etc,) Other Information. Toxicokinetics Dose information (Eg., MTD, LD, NOEL, NOAEL). In Vitro Data 8 What type of specific information should be included in these categories as part of a pediatric excipients minimal data set.? 9.What data/information elements should be part of an expanded data base? 10.What type of information on excipients used in pediatric formulations is difficult to obtain or not available from existing sources? 11.What format should the information in the proposed database be used? -Free flowing text (literature citation with text summarizing the article) with basic search facility. -Structured/tabular format with advanced search facility (eg.query builder) 12.How users of the data base can participate in the development of a single online source -By joining US PFI work or ad hoc groups -By offering help in populating the database( e.g.sponsors sharing or donating unpublished/in-house data) -By participating in any future database expansion. -Other ( please suggest) -No applicable How to Submit a Response Please provide your response to this Request for Information (RFI) no later than July 8, 2010. Responses should be submitted as an e-mail attachment in PDF format. Please limit responses to 10 pages or less. E mails should be sent to Elizabeth Osinski, Contracting Officer at eo43m@nih.gov. Please indicate “NIH-NICHD-BPCA-RFI- 10-12” as the subject line for your email. NICHD will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission. However, responses to the RFI submitted may be reflected in future solicitation(s). NICHD reserves the right to contact any responder that responds to this RFI for the sole purpose of enhancing NICHDs understanding of your RFI submission. The collected information will be analyzed and may appear in reports “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. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. 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. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. 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).” Inquiries: Specific scientific questions about this RFI should be provided in writing and directed to the following individual. No questions will be entertained via telephone contact. Elizabeth Osinski Contracting Officer Eo43m@nih.gov 301-435-6947 Contracting Office Address: Contracts Management Branch 6100 Executive Blvd., suite 7A07, MSC7510 Bethesda, Maryland 20892-7510 (If Express Mail, use Rockville, MD., 20852)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-BPCA-RFI-2010-12/listing.html)
- Place of Performance
- Address: N/A, United States
- Record
- SN02172341-W 20100611/100609234825-a529ee70074b22c8a1d41c97c85a4b00 (fbodaily.com)
- Source
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