LactMed

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. The North American Industry Classification System (NAICS) Code is 541690 with a small business size standard of $15 million. This Sources Sought Notice is for informational and planning purposes only and shall not be construed as an obligation or commitment by the Government. This notice is intended strictly for Market Research ONLY. BACKGROUND: The National Library of Medicine's (NLM) LactMed, is a searchable database of records on drugs and other chemicals, including herbals and diagnostic agents, and their use during lactation. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. Suggested therapeutic alternatives to those drugs are provided, where appropriate. Lactmed, https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm is a component of NLM's Toxicology Data Network (TOXNET), a Web-based collection of resources covering toxicology, chemical safety, environmental health and can be accessed at http://toxnet.nlm.nih.gov. NLM's Toxicology and Environmental Health Information Program (TEHIP), where TOXNET resides organizationally, offers additional databases with information on other aspects of drugs, including their pharmacology and toxicology; these include the Drug Information Portal, Pillbox and the Dietary Supplement Label Database. Bibliographic information related to drugs may be found in the TOXLINE database. LactMed can be searched together with TOXNET's other databases in a multi-database environment to obtain other relevant information about drugs. OBJECTIVES: The objective of this requirement is to continue to expand and enhance LactMed, a database on possible adverse effects of prescription and non-prescription drugs, relevant herbals, nutraceuticals and diagnostic agents in infants that result from transmission during human breastfeeding. As a work in progress, LactMed will continue to expand with additional drugs and begin to integrate vitamin and mineral monographs into its content. Future plans call for enhancement with other substances, such as industrial chemical and radiation. PROJECT REQUIREMENTS: The Contractor will compile the world's professional and scientific literature relating to the use of drugs and related products during human lactation and organize this literature into a professionally acceptable system for ease of access to monographs on specific drugs and, where appropriate, to classes of pharmacologic and/or therapeutic agents. Drug names should be at the generic level and include, at a minimum, United States Adopted Names. Further, the Contractor must be willing to have such data placed in the public domain, without any intellectual property right constraints or fees imposed with respect to its use. While the database will become the property of NLM, this will not preclude the Contractor from reconfiguring or otherwise using the source data for preparing other information products or publications. The database content must be fully supported by an evidence-based approach that involves critical case evaluations of reports in peer-reviewed literature. The database needs to be a principal focus of the Contractor who needs to have a high level of professionally recognized expertise in drugs and lactation. NLM is seeking both to continue to build the database with new records, including vitamins and minerals, and to maintain the existing records to ensure consistency and data currency. New and updated information will be input via the SIS SSEUS data entry system. The Contractor will comprehensively review the literature and conduct necessary online searches and therefore, must be conversant with searching a broad range of bibliographic and other databases. At a minimum, database records should include the drug names specified above, drug class (es), pharmacologic and pharmacokinetic data such as drug concentrations in breast milk and infant serum, time course of such levels, and weight-adjusted percent of maternal dose in breast milk. When it can be determined from case report evaluations and other analyses of published literature, it should also provide possible drug effects on maternal lactation and in breast-fed infants, indicating a quantifiable probable causation. Information should also be provided with respect to those drugs that present no safety problems where published literature specifically makes that determination. All drug data within records must follow the approved drug record template at http://toxnet.nlm.nih.gov/help/LactMedRecordFormat.htm, and be referenced to available source references. ANTICIPATED PERIOD OF PERFORMANCE: It is anticipated that the period of performance will be for one year from the date of award with two additional one-year option periods. CAPABILITY STATEMENT/INFORMATION SOUGHT: Because of the high public health significance of the LactMed database, its importance to mothers and infants, and the need to ensure highly accurate and scientifically credible information and guidance, this project should be overseen by a world class expert on the effects of drugs on breastfeeding. The Contractor should have a strong background in reviewing the scientific literature on drugs and lactation and be familiar in building online databases in this or related areas. The Contractor should also be able to summarize retrieved data to offer guidance for breastfeeding mothers and their physicians on the advisability of continuing with certain medications and be able to suggest alternative products where warranted. Interested firms responding to this Sources Sought Notice must adhere to the following: Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirement. The capability statement should be complete and contain sufficient detail for the Government's requirement. The capability statement should be complete and contain sufficient detail for the Government to make an informed decision regarding capabilities; however, the statement should not exceed 10 pages. The capability statement must identify the responder's business type and size; DUNS number; NAICS Code, and technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers and e-mail addresses. All capability statements must be submitted electronically no later than 12:00pm local prevailing time on May 31, 2016, to Lisa Josephowitz at josephol@mail.nih.gov. 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 the information provided by respondents for any purpose deemed necessary and legally appropriate. 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 solicitiation may be published in Federal Business Opportunities (FedBizOpps). 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 information in any resultant solicitation.