SSN_75N94026R00004_1.pdf

Sources Sought Notice

“AUD Registry and Data Analysis”

National Institute on Alcohol and Alcohol Abuse (NIAAA)

75N94026R00002

Description:

This notice is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

This is a Sources Sought (SS) notice issued for market research purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time and no award will be made on the basis of responses received to this Sources Sought notice.

The applicable NAICS code for this requirement is 541715, “Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)” with a small business size standard of 1,000 employees or less.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking capability statements from organizations of all business sizes. Please state whether your business size is small under the NAICS 541715(small business size standard is fewer than 1,000 employees) with experience in maintaining and updating a health registry of at least 1.3M patients with diagnosis of Alcohol Use Disorder (AUD) or alcohol misuse, updating Electronic Health Records (EHR) and providing analysis of said data. If a prospective offeror does not have experience or access to this size database and type of data, please do not respond to this notice.

Background:

Alcohol Use Disorder (AUD) is a devastating disease, resulting in a myriad of medical, psychological, social, and economic problems. Approximately 14.4 million Americans have a diagnosable AUD, causing 88,000 deaths annually and costing the United States (US) society more than $249 billion dollars.

Over the past two decades, advances have been made in developing pharmacological and behavioral interventions for alcohol dependence. Currently, three medications are approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence-disulfiram, oral and extended-release injectable naltrexone, and acamprosate. In addition, several behavioral therapies have demonstrated efficacy including cognitive behavioral therapy, motivational enhancement therapy, twelve-step facilitation therapy, couples therapy, brief interventions, contingency management, and mindfulness therapy. Because of the heterogeneity of AUD, not all of these behavioral and pharmacological therapies are effective in every patient and in every circumstance. Instead, a menu of medications-each of which shows efficacy in certain groups of patients-might offer the best option.

Clinicians would then have a wide variety of medications and behavioral therapies from which to choose and could target those drugs that are most effective to each individual patient-in short, precision medicine.

As described above, large body of evidence has demonstrated the effectiveness of treatment for Alcohol Use Disorder (AUD). However, there is a dearth of evidence about what happens after an individual completes treatment successfully, a period commonly referred to as recovery. To move this important area of research forward and guide the provision of AUD treatment, NIAAA recently developed a definition that describes recovery as a process through which an individual pursues both remission from AUD and cessation from heavy drinking. The definition is as follows:

"Recovery is a process through which an individual pursues both remission from AUD and cessation from heavy drinking. An individual may be considered "recovered" if both remission from AUD and cessation from heavy drinking are achieved and maintained over time. For those experiencing alcohol-related functional impairment and other adverse consequences, recovery is often marked by the fulfillment of basic needs, enhancements in social support and spirituality, and improvements in physical and mental health, quality of life, and other dimensions of well-being. Continued improvement in these domains may, in turn, promote sustained recovery."

Since researchers and healthcare professionals are using a variety of recovery definitions, NIAAA recovery definition allows everyone to be using the same one. NIAAA is encouraging researchers and healthcare providers to use this definition in conducting recovery research in monitoring the recovery of their patients following treatment.

Although there are many treatment sites across the United States to treat AUD, there is little follow-up with the patients after they complete short-term, circumscribed treatment programs (< 90 days). Unlike other diseases like cancer, there is no registry established in the treatment of AUD to follow patients.

The purpose of this contract is to update and analyze a registry of patients with diagnosis of AUD or alcohol misuse by leveraging comprehensive electronic health record (EHR)-based data (currently using data within Kaiser Permanente Northern California (KPNC)). KPNC is an integrated health care system that provides primary and specialty care (including addiction medicine and psychiatry) internally and has a mature, fully developed EHR system, Kaiser Permanente HealthConnect™, that stores data collected throughout the full course of patient care since 2005. Longitudinal, multi-dimensional patient-level data can be obtained (including health service utilization, diagnoses, medications, laboratory tests, and responses to health questionnaires), providing a unique opportunity to study the onset and progression of alcohol problems, care provided during all phases (i.e., follow-up, management, continuity of care), and long-term outcomes such as recovery. The registry has the ability to evaluate the full course of alcohol problems, longitudinally and comprehensively, including early identification, initiation and engagement in treatment (including psychiatry, addiction medicine, and pharmacotherapy), and long-term outcomes (e.g., drinking, physical and mental well-being), which are critical to understanding recovery.

The planned acquisition is a follow-on requirement to active contract 75N94021C00003 awarded to Kaiser FDN Research Institute with a period of performance 9/22/2021 through 9/21/2026.

A contract with a period of five years (commencing 9/22/2026) is being contemplated to continue registry maintenance, registry of patients, Electronic Health Records (EHR) and providing analysis of said data.

Project Requirements Include:

1. Conduct various analyses using the data collected from the EHR. Examples of analyses that may be requested:

I. How different domains of personal and social consequences correlate with patterns of drinking to predict different relapse trajectories.

II. Characterizing the recovery processes among the heterogenous population of AUD patients.

III. Identifying and evaluating mediators and moderators of recovery in AUD subtypes.

IV. Charactering the utilization and effectiveness of treatment for AUD and its mediators/moderators.

2. Continue to update and refresh data in the KPNC Adult Alcohol Registry for the length of this contract. The registry will include all data elements as described in the Alcohol Registry manual and provided by the NIAAA during the active contract. The registry data will also be expanded to include on-site administrations of injectable medications (e.g., naltrexone).

3. Examine, through analyses, recovery (using current NIAAA definition) for this extended period. For example:

I. Use the KPNC Adult Alcohol Registry and the KPNC Opioid Registry of all individuals who have received an opioid prescription during the same period to examine alcohol recovery in the context of receiving opioids for pain.

II. Use the KPNC Adult Alcohol Registry to investigate utilization and effectiveness of treatment for AUD and its mediators/moderators

III. Document increases in drinking during the COVID-19 period and examine relationships to relapse and (short-term) recovery.

4. Prepare, submit and present all NIAAA requested analyses at a mutually convenient time as determined by the COR and KPNC Pl (expectations are for 2 per year).

5. Obtain and provide IRB approval for research conducted under this contract prior to initiating any human subjects research.

6. Quarterly teleconferences with the COR and NIAAA Medications Development staff.

7. Annual progress reporting of the activities conducted under the contract.

Information Requested:

1. Experience: An outline of previous work specific to the requirements and tasks listed above;

2. Personnel: Name, professional qualifications and specific experience of scientist and/or technical personnel who may be assigned as principal investigator and other key positions;

3. Facilities: Availability and description of facilities and equipment required to conduct the analyses; and

4. Other: Any other specific and relevant information that would improve the Government’s consideration and evaluation of the information presented is desirable.

The Capability Statement Must Demonstrate the Ability to:

Organizations that possess the capabilities necessary to undertake the efforts described 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.

Information Submission Instructions:

The offeror shall provide an electronic version only of their response to this notice. Responses shall include the organization's name, address, point of contact, size of business pursuant according to the North American Industrial Classification Code (NAICS) and must address all the technical information requested.

The page limit is 15 pages using a font size 10 or larger. Responses will assist the Government in selecting the appropriate acquisition mechanism.

This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a Request for Proposals. The Government DOES NOT intend to award a contract based on responses under this announcement. Interested parties shall not be reimbursed for costs associated with preparation of their responses. Any proprietary information should be so marked. Interested organizations presenting a Capability Statement in response to this Sources Sought a n n o u n c e m e n t must identify their size status.

AII capability statements sent in response to this 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 Sources Sought 75N94026R00002. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 5:00 PM (Eastern Standard Time) on January 29, 2026. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME

WILL NOT BE CONSIDERED.

Please send responses to this Sources Sought announcement via e-mail to:

Sarah Bank, Contracting Officer NICHD Office of Acquisitions, ARB, NIAAA Team E-MAIL: sarah.bank@nih.gov

Primary Point of Contact:

Sarah Bank Contracting Officer NICHD Office of Acquisitions, ARB, NIAAA Team sarah.bank@nih.gov

Secondary Point of Contact:

mailto:sarah.bank@nih.gov mailto:sarah.bank@nih.gov

Lisa Schaupp Section Chief NICHD Office of Acquisitions, ARB, NIAAA Team lisa.schaupp@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 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 to allow the Government to determine the organization's qualifications to perform the work. 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 solicitation may be published to SAM.gov Contract Opportunities. 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).

mailto:lisa.schaupp@nih.gov