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SOURCES SOUGHT NOTICE (Acquisition of Services for the Surveillance in Recipients of Human Growth Hormone) AGENCY: The National Institutes of Health, National Institutes of Diabetes and Digestive and ... SOURCES SOUGHT NOTICE (Acquisition of Services for the Surveillance in Recipients of Human Growth Hormone) AGENCY: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) TITLE: Acquisition of Services for the Surveillance in Recipients of Human Growth Hormone PROPOSED SOLICITATION NUMBER: NICHD-23-051 PROJECT SERVICE CODE: R499 – SUPPORT PROFESSIONAL: OTHER This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time. The purpose of this notice is to obtain information regarding: (1) the availability and capability of all 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 according 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: In the late 1950s, it was determined that human growth hormone (hGH) was effective in treating growth hormone deficiency, and the only source of hGH was cadaver pituitary glands. Large numbers of pituitaries were needed to generate an adequate supply of hormone for deficient patients. Between 1963 and 1985, the National Hormone and Pituitary Program (NHPP) extracted and distributed hGH from approximately 1.4 million human pituitary glands and distributed it to more than 250 physicians with approved research protocol requests. In 1985, three deaths due to Creutzfeldt-Jakob Disease (CJD) were reported in young adults who had received hGH through the NHPP. The Federal Government terminated distribution of hGH through the NHPP and began a follow-up study of all NHPP hGH recipients. The main objective of this study was to investigate the possible association between human cadaver-derived hGH and CJD. This study was funded by the NIH and conducted by Westat, Inc., first through a contract with the Centers for Disease Control and Prevention (CDC) and subsequently through a Purchase Order with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Guidance for this study was provided by the CDC, NIDDK, NICHD, NINDS and the Food and Drug Administration (FDA). Representatives from each of these agencies formed an Interagency Coordinating Committee on Human Growth Hormone and Creutzfeldt Jakob Disease (chaired by the NIDDK Director) The study activities of the follow-up study were divided into four phases: • Phase 1 – Collection of identifying information on members of the NHPP cohort. This information was obtained from treatment centers and treating physicians. • Phase 2 – Convening of an Advisory Panel to make recommendations on study design for follow-up of cohort. • Phase 3 – Tracing of all NHPP hGH patients to obtain current contact information of patients and/or their families. Telephone surveys were conducted to collect data on patients’ current health status and details regarding hGH treatment. More detailed information was collected on deceased hGH recipients and on patients reporting neurological symptoms that could be associated with CJD. • Phase 4 – Data cleaning, editing and analysis as well as follow-up of the NHPP cohort for additional deaths. For confirmed deaths, medical records and pathology slides (when available) are retrieved for review. Phase 4 also includes maintenance and updating of patient files. Phases 1, 2 and 3 have been completed, and Phase 4 is ongoing. It is expected that Phase 4 will continue through June 2028. Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government, as needed to perform all of the tasks under the Statement of Work below. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS: STATEMENT OF WORK: A. General Description The contractor for the proposed project shall perform the epidemiological follow-up of a cohort of 6,284 persons treated for growth failure with hGH distributed by the NHPP (see JAMA 1991; 265:880-884 and JAMA 1993; 270: 2829-2832). The primary purpose of this project is to monitor the magnitude of CJD occurrence among the NHPP hGH recipients by identification of deaths by periodic searches of the National Death Index (NDI) combined with investigation of these deaths through reviews of medical records, death certificates and brain pathology. Another purpose of this study is to monitor the overall and disease-specific mortality rates of this cohort who received NHPP hGH. The contractor shall collect records and maintain data on any individuals in this group in which CJD or suspected CJD is reported to the Government. This project will also provide for extending data collection, editing, cleaning, and analysis on: (1) mortality rates; (2) incidence of illnesses of special interest in this cohort; (3) the possible association of CJD with receipt of specific lots of hGH or batches of pituitaries used to make hGH; and (4) other issues on which potentially helpful information is available in study files such as reported endocrine and psychosocial outcomes. This study will also facilitate maintaining and updating files on the cohort of recipients, and making information available as needed. B. Detailed Technical Requirements/Tasks to be Performed Task 1 The contractor shall organize and maintain existing hard copy and computer disk and tape files on the members of the cohort and on study activities. Files shall be maintained in a manner to ensure their security and accessibility. The types of files available on the cohort include patient listings from NHPP applications, information from physicians and treatment centers, including abstracts on individual patients, and tracing information on patients, including information from a telematch service, postmasters, tracing letters, tracing contacts with individuals identified in the interviews, notifications of address changes from recipients and family members, and other tracing techniques. There is also interview information from the patients and/or their family members, as well as correspondence and records of telephone communications with many of these individuals. There are death certificates and medical records from patients who died or who had leukemia or a serious neurologic disease, as well as records related t the review of these records. There are records of autopsies and brain pathology and records related to review of brain tissue by consultants to the study. There are also previous applications for NDI searches and results of earlier NDI searches, including follow-up efforts to obtain death certificates from State Health departments and authorizations from next-of-kin for release of medical records. There are records on which lots of hormone individual patients may have received, based on information supplied by physicians and records of which hormone preparations were sent to specific physicians and treatment centers. There is information on special requests by families, such as requests that particular family members not be contracted. Task 2 The contractor shall update files with information supplied by members of the cohort or their physicians. Members of the cohort may contact the contractor directly, or through the Government, to provide information of medical problems, changes in their phone number or address, or to request information related to hGH administration through the NHPP. The contractor shall maintain records of correspondence or telephone conversations with hGH recipients supplied by the Government. Task 3 The contractor shall update mailing addresses of members of the cohort and provide mailing labels for Government updates to hGH recipients and family members. The contractor shall periodically conduct Postmaster address correction mailings or, when Government mailings are returned and the Post Office cannot provide addresses, contact individuals whose names were provided in the interviews as sources of information if needed to locate hGH recipients. More extensive tracing efforts may be required for individual recipients, particularly to locate next-of-kin for authorization to obtain medical records on deceased hGH recipients identified through the NDI. Task 4 The contractor shall identify and investigate deaths in the cohort and conduct periodic NDI searches to determine vital status on members on the cohort. The Government anticipates a need to conduct NDI searches as tapes become available during the period of performance of this contract for deaths through 2007. For all deaths identified through NDI searches or reported from other sources, the contractor shall obtain a copy of the patient’s death certificate, authorization from next-of-kin to obtain medical records, and a copy of the hospital record where the death occurred, including the autopsy records and brain pathology slides, if available. The brain pathology slides shall be reviewed independently for evidence of CJD by two neuropathologists with expertise in CJD. The neuropathologists’ assessments and the available medical records shall be reviewed for completeness by the Government. At the direction of the Contracting Officer’s Representative, additional records may be requested from treating physicians or hospitals, and medical records may be requested from treating physicians or hospitals, and medical records may be sent to one or more neurologists with expertise in CJD for review for evidence of CJD. The Government will approve all neurologists or neuropathologists selected for review of records or slides. A report on CJD and other diseases specific mortality shall be submitted to the Government within six months of each NDI search. Task 5 The contractor shall investigate the possible association of CJD with specific preparations of hGH or batches of pituitaries from which the hGH was derived. For hGH recipients with CJD, the contractor shall assist the Government in collecting information from physicians and treatment centers on specific hormone preparations the patient received. Based on records of specific shipments of hGH preparations to physicians or centers which treated each patient and the patient’s dates of treatment, probable exposures to each lot and batch produced prior to 1977 have been assigned for members of the cohort including the 15 CJD cases. Periodically, at the request of the Government, the contractor shall conduct an analysis to determine whether any single lot of hormone or batch of pituitaries can be identified as being at increased risk for transmission of CJD. The contractor shall provide expertise to assist Government scientists in design of the analysis. The contractor shall make recommendations to the Government on how this analysis should be performed with regard to hypotheses to be tested about specific preparations and study design to address the issue of multiple comparisons. Task 6 The contractor shall edit, clean, and manipulate study data for reports on: (1) CJD and other disease specific mortality rates in the cohort as compared to standardized mortality data (adjusted for age, race, and sex) of other U.S. populations; (2) the incidence of illnesses of special interest in this cohort, such as leukemia; (3) the possible association of CJD with receipt of specific lots of hGH and/or batches of pituitaries used to make hGH; and (4) endocrine or other outcomes reported for the cohort. The contractor shall document data sets created and data analyses performed and provide this documentation upon request of the Government at the termination of the contract. C. Reporting Requirements In addition to any scientific, technical and lay reports detailed above in the Statement of Work, the contractor shall prepare and submit typewritten Quarterly Reports and a Final Report as follows: Quarterly Technical Progress Report This report shall include the current status of the project and the activities planned for the next quarter of performance, as well as a statement of any problems encountered, that could endanger contract performance. This report must provide a detailed summation of the work accomplished during the reporting period and shall be submitted within ten calendar days of completion of each quarter. Final Technical Progress Report This report shall include a detailed summation of all the work performed during the entire contract period of performance and shall be in sufficient detail to describe comprehensively the results achieved. This report shall be submitted by the completion date of the contract period of performance. D. Deliverables The contractor shall prepare and submit the following reports during performance of the project as indicated below: ITEM DESCRIPTION QUANTITY DELIVERY DATE 1. Quarterly Progress 6 Quarterly, beginning Reports three months after contract award. 2. Report on CJD and 2 No later than (NLT) other disease specific six months after the mortality. completion of each NDI search. 3. Documentation of data 2 NLT the contract sets created and data completion date. Analyses 4. All records subject 2 NLT the contract to the Privacy Act completion date. 5. Final report 2 NLT the contract completion date. This Sources Sought is for an organization or institution to provide the NIDDK with Services for the Surveillance in Recipients of Human Growth Hormone. All qualified small businesses, 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; interested in submitting a corporate capability statement should demonstrate their capability to provide equipment that meets the characteristics above. PERIOD OF PERFORMANCE The period of performance for this requirement is: Base: 7/1/2023 – 6/30/2024 Option Year 1: 7/1/2024 – 6/30/2025 Option Year 2: 7/1/2025 – 6/30/2026 Option Year 3: 7/1/2026 – 6/30/2027 Option Year 4: 7/1/2027 – 6/30/2028 SPECIAL INSTRUCTIONS: The vendor will be evaluated on their quoted services meeting the specifications under section SALIENT / REQUIRED FEATURES AND SPECIFICATIONS. If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The associated NAICS code is 541690, with the small business size standard of $15.00. All respondents are requested to identify their firm's size and type of business. Interested firms responding to this Sources Sought Notice should adhere to the following: (a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger. (b) Small business concerns that possess the capabilities necessary to undertake the efforts should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented. Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer Representative and Contracting Officers. (c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NICHD-23-051. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 9:00 AM (Eastern Prevailing Time) seven (7) calendar days (including date of submission to https://sam.gov) after posting of the Small Business Sources Sought Notice. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.