HRSA MCHB IDIQ to Support the Advisory Committee on Heritable Disorders in Newborns and Children

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide research and development services to inform and support the work of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Advisory Committee on Heritable Disorders in Newborns and Children was established under the Public Health Service Act, Title XI, - 1111 (42 U.S.C. 300b-10,) as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014 (P.L. 113-240) . The Health Resources and Services Administration/Maternal and Child Health Bureau (HRSA/MCHB) provides coordination, management, and operational services to the Committee, with direction and guidance from the U.S. Department of Health and Human Services. The purpose of the Committee is to provide the Secretary with recommendations, advice, and technical information regarding the most appropriate application of technologies, policies, guidelines, and standards for: (a) effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders; and (b) enhancing the ability of state and local health agencies to provide for newborn and child screening, counseling, and health care services for newborns and children having, or at risk for, heritable disorders. Specifically, the Committee makes systematic evidence based recommendations on newborn screening for conditions that have the potential to significantly impact public health for all newborns including secondary conditions that may be identified as a result of the laboratory methods used for screening. The Contractor will be required to: 1. Provide expertise on the medical screenings for newborn and child medical/genetic conditions and associated clinical information, screening practices, treatment, public health impact, and evidence-based review processes in order to conduct research, advise/conduct discussions, produce reports, and make policy recommendations to the Committee. 2. Conduct systematic, evidence-based reviews of nominated newborn or children medical/genetic conditions to inform the Committee's decision making process when considering conditions for the Recommended Uniform Screening Panel (RUSP). 3. Develop a Methodology for Conducting a Cost Analysis of the Impact of Adding a New Medical/Genetic Condition to the RUSP. 4. Conduct a review of the current evidence-base review process to allow the Committee to make well-informed decisions within the timeline imposed by new legislation. 5. Develop consumer-friendly summaries of the Committee's Evidence-based condition reviews and decisions. 6. Develop a consumer-friendly guide of the condition review process. 7. Participate in Committee meetings in Washington DC to advise the Committee on newborn screening for newborn and child medical/genetic conditions and associated clinical information, screening practices, treatment, public health impact, and evidence-based review processes. Qualified contractors must satisfy the following minimum requirements. Provide a detailed description of your company's experience and demonstrated abilities to deliver each and every one (address each separately) of the following requirements: 1. Knowledge and expertise in the following: a. newborn and child medical/genetic conditions and associated clinical information, screening practices, treatment, public health impact; b. the complexities of systematic evidence-based reviews of rare, genetic conditions and its corresponding newborn screening test(s), confirmatory test(s), and treatment for inclusion on the Recommended Uniform Screening Panel. This includes defining the overarching framework and key questions of an evidence based review, assessing benefits and harms of screen for a condition at a population level; assessing State public health newborn screening programs' ability to implement screens of new conditions; c. an understanding of the processes and procedures of the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (Committee) and the legislation guiding the Committee. 2. Ability to supply personnel with adequate academic, professional and technical experience related to the purposes of the project. This should include education, professional experience and expertise, peer-reviewed articles on evidence reviews, newborn screening, genetic conditions, and/or other rare genetic disorders as well as previous work on national evidence-based review committees; 3. Demonstrated ability to conduct systematic evidence-based reviews of newborn and child medical/genetic conditions and their corresponding newborn screening test(s), confirmatory test(s), and treatment protocols; 4. Demonstrated ability to support Advisory Committee and produce high quality reports, presentations and other deliverables using both technical and non-technical language; 5. Demonstrated ability to work with federal staff and stakeholders from diverse organizations and with different backgrounds. Contract performance shall be at the Contractor's location. A fixed price indefinite delivery/indefinite quantity (IDIQ) contract is anticipated for 12 months with four 12-month option periods. This is a new requirement. The NAICS Code is 541720, with a small business size standard of [$20.5 million]. Interested potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 20 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541720 (size standard $20.5) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). Additional information on NAICS codes can be found at www.sba.gov 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) database (http://www.sam.gov) in order to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email by the Contract Specialist named below not later than 12:00 PM Eastern Standard time on Friday, May 29, 2015 for consideration. Responses to this announcement will not be returned, and there will not be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and HRSA may contact one or more respondents for clarifications or for information that will enhance the Government's understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.