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 Department of Health and Human Services Agency for Healthcare Research and Quality
 AGENCY: Agency for Healthcare Research and Quality, HHS.
 ACTION: Notice.
 SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: 
                        *“Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).”*
 DATES: Comments on this notice must be received by February 19, 2019.
 ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at 
                        *doris.lefkowitz@AHRQ.hhs.gov*. Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
 FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at 
                        *doris.lefkowitz@AHRQ.hhs.gov*.


SUPPLEMENTARY INFORMATION: Proposed Project Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP) In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. The Healthcare Cost and Utilization Project (HCUP, pronounced “H-Cup”) is a vital resource helping the Agency achieve its research agenda, thereby furthering its goal of improving the delivery of health care in the United States. HCUP is a family of health care databases and related software tools and products developed through a Federal-
                    ( print page 64836)
                    State-Industry partnership and sponsored by AHRQ. HCUP includes the largest collection of longitudinal hospital care data in the United States, with all-payer, encounter-level information beginning in 1988. The HCUP databases are annual files that contain anonymous information from hospital discharge records for inpatient care and certain components of outpatient care, such as emergency care and ambulatory surgeries. The project currently releases seven types of databases created for research use on a broad range of health issues, including cost and quality of health services, medical practice patterns, access to health care programs, and outcomes of treatments at the national, State, and local market levels. HCUP also produces a large number of software tools to enhance the use of administrative health care data for research and public health use. Software tools use information available from a variety of sources to create new data elements, often through sophisticated algorithms, for use with the HCUP databases. HCUP's objectives are to: Create and enhance a powerful source of national, state, and all-payer health care data.
                    Produce a broad set of software tools and products to facilitate the use of HCUP and other administrative data.
                    Enrich a collaborative partnership with statewide data organizations (that voluntarily participate in the project) aimed at increasing the quality and use of health care data.
                    Conduct and translate research to inform decision making and improve health care delivery. This project is being conducted by AHRQ through its primary contractor and subcontractor, IBM Watson Health and Social & Scientific Systems, Inc., pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the outcomes, cost, cost-effectiveness, and use of health care services and access to such services. 42 U.S.C. 299a(a)(3). Method of Collection The HCUP releases seven types of databases for public research use: (1) The National Inpatient Sample (NIS) is the largest all-payer inpatient care database in the United States, yielding national estimates of hospital inpatient stays. The NIS approximates 20 percent of the discharges from all U.S. community hospitals and contains data from approximately 7 million hospital stays each year. NIS data releases are available for purchase from the HCUP Central Distributor for data years beginning in 1988. (2) The Kids' Inpatient Database (KID) is the only all-payer inpatient care database for children in the United States. The KID was specifically designed to permit researchers to study a broad range of conditions and procedures related to child health issues. The KID contains a sample of 2 to 3 million discharges for children age 20 and younger from more than 4,200 U.S. community hospitals. KID data releases are available every third year starting in 1997. (3) The Nationwide Emergency Department Sample (NEDS) is the largest all-payer ED database in the United States. It is constructed to capture information both on ED visits that do not result in an admission and on ED visits that result in an admission to the same hospital. The NEDS contains more than 31 million unweighted records for ED visits at about 950 U.S. community hospitals and approximates a 20-percent stratified sample of U.S. hospital-based EDs. NEDS data releases are available beginning with data year 2006. (4) The State Inpatient Databases (SID) contain the universe of inpatient discharge abstracts from data organizations in 48 States and the District of Columbia that currently participate in the SID. Together, the SID encompass approximately 97 percent of all U.S. community hospital discharges. Most States that participate in the SID make their data available for purchase through the HCUP Central Distributor. Files are available beginning with data year 1990. (5) The State Ambulatory Surgery and Services Databases (SASD) contain encounter-level data from ambulatory surgery and other outpatient services from hospital-owned facilities. In addition, some States provide data for ambulatory surgery and outpatient services from nonhospital-owned facilities. Currently, 35 States participate in the SASD. Files are available beginning with data year 1997. (6) The State Emergency Department Databases (SEDD) contain data from hospital-owned emergency departments (ED) for visits that do not result in a hospitalization. Currently, 38 States participate in the SEDD. Files are available beginning with data year 1999. (7) A new database called the Nationwide Readmissions Database (NRD) is planned for release in late 2019. The NRD is designed to support various types of analyses of national readmission rates. This database addresses a large gap in health care data—the lack of nationally representative information on hospital readmissions. The NRD is a calendar-year, discharge-level database constructed from the HCUP State Inpatient Databases (SID). To support AHRQ's mission to improve health care through scientific research, HCUP databases and software tools are disseminated to users outside of the Agency through a mechanism known as the HCUP Central Distributor at 
                    *https://www.hcup-us.ahrq.gov/​tech_​assist/​centdist.jsp*. The HCUP Central Distributor assists qualified researchers to access uniform research data across multiple states with the use of one application process. The HCUP databases disseminated through the Central Distributor are referred to as “restricted access public release files”; that is, they are publicly available, but only under restricted conditions. This information collection request is for the activities associated with the HCUP database application process, not the collection of health care data for HCUP databases. The activities associated with this application include: (1) HCUP Application. All persons requesting access to the HCUP databases must complete an application at 
                    *https://distributor.hcup-us.ahrq.gov/​*. Applications for HCUP State databases require a brief description of the planned research use to ensure that the intended use is consistent with HCUP policies and with the HCUP Data Use Agreement (DUA). Paper versions of all application packages are also available for downloading at 
                    *http://www.hcup-us.ahrq.gov/​tech_​assist/​centdist.jsp*. (2) HCUP DUA Training. All persons wanting access to the HCUP databases must complete an online training course. The purpose of the training is to emphasize the importance of data protection, reduce the risk of inadvertent violations, and describe the individual's responsibility when using HCUP data. The training course can be accessed and completed online at 
                    *http://www.hcup-us.ahrq.gov/​techassist/​dua.jsp*. (3) HCUP DUA. All persons wanting access to the HCUP databases must sign a data use agreement. An example DUA for the Nationwide databases is available at 
                    *http://www.hcup-us.ahrq.gov/​team/​NationwideDUA.jsp*. HCUP databases are released to researchers outside of AHRQ after the completion of required training and submission of an application that includes a signed HCUP DUA. In addition, before restricted access public release state-level databases are released, AHRQ must review and approve the applicant's statement of intended use to ensure that the planned use is consistent with HCUP policies and with the HCUP DUA. Fees are set 
                    ( print page 64837)
                    for databases released through the HCUP Central Distributor depending on the type of database. The fee for sale of state-level data is determined by each participating Statewide Data Organization and reimbursed to those organizations. Information collected in the HCUP Application process will be used for two purposes only: 1. Business Transaction: In order to deliver the HCUP databases and software, contact information is necessary for shipping some types of HCUP data on disk (or any other media used in the future). 2. Enforcement of the HCUP DUA: The HCUP DUA contains several restrictions on use of the data. Most of these restrictions have been put in place to safeguard the privacy of individuals and establishments represented in the data. For example, data users can only use the data for research, analysis, and aggregate statistical reporting and are prohibited from attempting to identify any persons in the data. Contact information on HCUP DUAs is retained in the event that a violation of the DUA takes place. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden associated with the applicants' time to order any of the HCUP databases. An estimated 1,500 persons will order HCUP data annually. Each of these persons will complete an application (10 minutes), the DUA training (15 minutes) and a DUA (5 minutes). The total burden is estimated to be 750 hours annually. Exhibit 2 shows the estimated annualized cost burden associated with the applicants' time to order HCUP data. The total cost burden is estimated to be $29,662 annually. Exhibit 1—Estimated Annualized Burden Hours
Form name
Number of 
                             respondents
Number of 
                             responses per  
                             respondent
Hours per
                             response
Total burden hoursHCUP Application Form
1,500
1
10/60
250HCUP DUA Training
1,500
1
15/60
375HCUP DUA
1,500
1
5/60
125Total
4,500
na
na
750
 Exhibit 2—Estimated Annualized Cost Burden
Form name
Number of 
                             respondents
Total 
                             burden hours
Average hourly wage rate *
Total cost 
                             burdenHCUP Application Form
1,500
250
$39.55
$9,887HCUP DUA Training
1,500
375
39.55
14,831HCUP DUA
1,500
125
39.55
4,944Total
4,500
750
na
29,662* Based upon the mean of the average wages for Life Scientists, All Other (19-1099), National Compensation Survey:Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor Statistics. 
                        *http://www.bls.gov/​oes/​current/​oes_​nat.htm#b29-0000*.
 Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Francis D. Chesley, Jr., Acting Deputy Director.


[FR Doc. 2018-27359 Filed 12-17-18; 8:45 am] BILLING CODE 4160-90-P