Collection of Information; Proposed Extension of Approval; Comment Request-Follow-Up Activities for Product-Related Injuries Including the National Electronic Injury Surveillance System (NEISS)

Download PDF
Federal RegisterJul 20, 2021
86 Fed. Reg. 38315 (Jul. 20, 2021)

AGENCY:

Consumer Product Safety Commission.

ACTION:

Notice.

SUMMARY:

As required by the Paperwork Reduction Act of 1995, the Consumer Product Safety Commission (CPSC or Commission) requests comments on a proposed extension of approval for an information collection to obtain data on consumer product-related injuries, and follow-up activities for product-related injuries. The Office of Management and Budget (OMB) previously approved the collection of information under OMB Control No. 3041-0029. CPSC will consider all comments received in response to this notice before requesting an extension of approval of this collection of information from OMB.

DATES:

Submit written or electronic comments on the collection of information by September 20, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CPSC-2009-0102, by any of the following methods:

Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The CPSC does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

Mail/hand delivery/courier Written Submissions: Submit comments by mail/hand delivery/courier to: Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504-7479; email: cpsc-os@cpsc.gov.

Instructions: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing.

Docket: For access to the docket to read background documents or comments received, go to: http://www.regulations.gov,, and insert the docket number, CPSC-2009-0102, into the “Search” box, and follow the prompts. A copy of the supporting statement, “PRI ICR 2021 60-day” will be made available under Supporting and Related Materials.

FOR FURTHER INFORMATION CONTACT:

For further information or a copy of the supporting statement contact: Bretford Griffin, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7037, or by email to: bgriffin@cpsc.gov.

SUPPLEMENTARY INFORMATION:

A. Background

Section 5(a) of the Consumer Product Safety Act, 15 U.S.C. 2054(a), requires the CPSC to collect information related to the causes and prevention of death, injury, and illness associated with consumer products. That section also requires the CPSC to conduct continuing studies and investigations of deaths, injuries, diseases, other health impairments, and economic losses resulting from accidents involving consumer products.

The CPSC obtains information about product-related deaths, injuries, and illnesses from a variety of sources, including newspapers, death certificates, consumer complaints, and medical facilities. In addition, the CPSC receives information through its internet website through forms reporting on product-related injuries or incidents. The CPSC also operates the National Electronic Injury Surveillance System (NEISS), which provides statistical data on consumer product-related injuries treated in hospital emergency departments in the United States. The CPSC also uses the NEISS system to collect information on childhood poisonings, in accordance with the Poison Prevention Packaging Act of 1970.

From these sources, CPSC staff selects cases of interest for further investigation, by contacting persons who witnessed or were injured in incidents involving consumer products. These investigations are conducted on-site (face-to-face), by telephone, or by the internet. On-site investigations are usually made in cases where CPSC staff needs photographs of the incident site, the product involved, or detailed information about the incident. This information can come from face-to-face interviews with persons who were injured or who witnessed the incident, as well as via contact with state and local officials, including police, coroners, and fire investigators, and others with knowledge of the incident.

Through interagency agreements, the CPSC also uses the NEISS system to collect information on injuries for the Centers for Disease Control and Prevention (CDC) under the NEISS All Injury Program (NEISS-AIP). The NEISS-AIP is a sub-sample of approximately two-thirds of the full NEISS sample. In addition to the standard data variables collected on all NEISS injuries, the NEISS-AIP collects variables on several studies for CDC (Firearm-Related Injuries, Adverse Drug Events, Assaults, Self-Inflicted Violence, and Work-Related Injuries) and one study on non-crash, motor vehicle-related injuries for the National Highway and Transportation Safety Administration (NHTSA).

The current NEISS probability sample was drawn and recruited in 1995-1996, and implemented in 1997. The current NEISS sample consists of 96 hospital emergency departments grouped into four strata, based on size, as measured by the annual number of emergency department (ED) visits, and a fifth stratum for children's hospitals. When a hospital stops participating in the NEISS, staff recruits a hospital of similar size and geographic location as a replacement. If a participating hospital closes, it is not replaced, because its closure is presumed to represent other hospitals that have closed nationally. As of January 1, 2021, there are currently 81 hospitals participating in the NEISS.

In September 2019, CPSC contracted with Westat, Inc., under CPSC contract 61320619F0134, to give the agency an independent statistical assessment of the NEISS and the NEISS-AIP samples. The primary focus of this contract was to analyze the advantages and disadvantages of keeping, expanding, or resampling the current samples of NEISS and NEISS-AIP hospitals. Westat recommended that CPSC redesign the NEISS sample, and, consistent with that recommendation, CPSC is revising its sampling methodology.

David Marker, Jim Green, Frost Hubbord, Richard Valliant, “Statistical Assessment of the NEISS and NEISS-AIP Samples: Final Technical Report,” Westat Inc., September 24, 2020.

In the redesigned NEISS sample, CPSC staff uses a resampling method that maximizes the probability of retaining as many of the current NEISS hospitals as possible, while maintaining the statistical integrity of the NEISS. Among eligible hospital emergency departments, some have migrated from one stratum to another; others have come into existence since the last resampling of the NEISS, or ceased to exist. The method used in resampling the NEISS is an extension of the Keyfitz procedures for stratified simple random samples. Staff identified several advantages of retaining as many of the current NEISS hospitals as possible, including: (1) The contracting, data collection, and quality-control mechanisms already exist in the hospitals in the current sample; (2) it is a cost-effective procedure; and (3) there is less disruption in trend analysis. The new NEISS sample will contain a mixture of current NEISS hospitals, along with new hospitals recruited to join the NEISS, as follows:

J. Michael Brick, David R. Morganstein, Charles, L. Wolter, “Additional Uses for Keyfitz Selection,” Westat Inc., 1987. ( http://www.asasrms.org/Proceedings/papers/1987_140.pdf ).

New NEISS Sample

Stratum NEISS redesign 2021 NEISS: reporting (retained) 2021 NEISS: reporting (dropped) 2021 NEISS: replacements (retained) 2021 NEISS: replacements (dropped) New
Small 43 30 0 8 3 5
Medium 26 14 1 1 0 11
Large 12 11 8 0 1 1
Very Large 11 9 0 2 0 0
Children's 8 7 1 0 0 1
Total 100 71 10 11 4 18

CPSC recognizes that one of the advantages of a long-running NEISS sample is the ability to track trends across time, and updating the NEISS sample will impact that analysis. An overlap, or bridge period, during which data are collected from the old and the new samples, can adjust for any time series that crosses over two NEISS samples. CPSC plans to conduct a 12-month overlap as part of the implementation of the new NEISS sample. Having a full 12-month overlap period accounts better for seasonality of some consumer product-related injuries. By comparing estimates calculated from both samples, it is possible to adjust (backcast) old estimates to be consistent with the new sample. The overlap period will consist of all of calendar year 2023, but it is dependent on the successful recruitment of the 11 replacement and 18 new hospitals. If NEISS hospital recruitment is successful, the overlap period will run all of calendar year 2023. The national estimates for 2023 will be calculated using the new NEISS sample with historical estimates from 2022, and prior years “backcast” to adjust for the sample update. If NEISS hospital recruitment is delayed, and the 12-month overlap period spans July 2023 through June 2024, then 2023 national estimates will be calculated using the old NEISS sample, and 2024 national estimates would use the new NEISS sample.

OMB previously approved the collection of information concerning product-related injuries under control number 3041-0029. OMB's most recent extension of approval will expire on July 31, 2022. However, to reflect CPSC's revised sampling methodology and resulting changes to the associated burden hours, CPSC is providing notice in this document prior to the expiration date, and now proposes to request an extension of approval of this updated collection of information.

B. NEISS Estimated Burden

The NEISS system collects information on consumer product-related incidents and other injuries from a statistical sample of hospitals in the United States. The number of hospitals participating in CY 2021 through CY 2024 will fluctuate from the current 81 reporting, to as high as 110.

Respondents to NEISS include hospitals that directly report information to NEISS, and hospitals that allow access to a CPSC contractor who collects the data. Collecting emergency department records for review, correcting error messages, and other tasks takes from 2.5 to 6 hours weekly. Each record requires about 30 seconds to review. Coding and reporting records that involve consumer products or other injuries takes about 2 minutes per record. Coding and reporting on additional special study information (Adverse Drug Effects) takes about 2 minutes and 90 seconds per record for other special studies. Respondents also spend about 8 to 36 hours per year in related activities (training, evaluations, and communicating with other hospital staff).

During CY 2023, assuming there will be a total of 110 hospitals participating in the NEISS, with an estimated 160 NEISS respondents (total hospitals and CPSC contractors), these NEISS respondents will review an estimated 6 million emergency department records and report 1.2 million total cases (470,000 consumer product-related injuries for CPSC, and 730,000 other injuries for the NEISS-AIP). The table below lists the estimated number of reported cases, and the estimated number of reported cases with additional special study information.

Total NEISS Cases Reported 1.2 million
Consumer Product-Related Injuries 470,000
CDC NEISS-AIP 730,000
Special Studies Reported (subset of above)
Child Poisoning (CPSC) 5,000
Adverse Drug Events (CDC) 94,000
Assaults (CDC) 84,000
Firearm-Related Injuries (CDC) 12,000
Self-Inflicted Violence (CDC) 22,000
Work-Related Injuries (CDC) 54,000
Motor Vehicle Non-Crash Injuries (NHTSA) 17,000

The total burden hours for all NEISS respondents are estimated to be 130,000 for CY 2023. The average burden hours per respondent is 800 hours. However, the total burden hours on each respondent varies, due to differences in the sizes of the hospitals (e.g., small rural hospitals versus large metropolitan hospitals). The smallest hospital will report an estimated 250 cases, with a burden of about 150 hours; while the largest hospital will report an estimated 60,000 cases, with a burden of about 4,500 hours.

The total costs to NEISS respondents for CY 2023 are estimated at $6.5 million. NEISS respondents enter into contracts with CPSC and are compensated for these costs. The average cost per respondent is estimated to be $41,000. The average cost per burden hour is estimated to be $50 per hour (including wages and overhead). However, the actual cost to each respondent varies, due to the type of respondent (hospital versus CPSC contractor), size of hospital, and regional differences in wages and overhead. Therefore, the actual annual cost for any given respondent may vary from $3,000 for a small rural hospital, up to $450,000 for the largest metropolitan hospital.

C. Other Burden Hours

In cases that require more information regarding product-related incidents or injuries, CPSC staff conducts face-to-face interviews with approximately 375 persons each year. On average, an on-site interview takes about 4.5 hours. CPSC staff also conducts about 2,000 in-depth investigations (IDIs) by telephone annually using a Computer Assisted Telephone Interview (CATI) or self-administered Computer Assisted internet Interview (CAII) questionnaires. Each CATI or CAII IDI requires about 20 minutes. CPSC staff estimates 2,355 annual burden hours on these respondents: 1,688 hours for face-to-face interviews; 667 hours for in-depth telephone or internet interviews. CPSC's staff estimates the value of the time required for reporting is $38.60 an hour (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 2021: https://www.bls.gov >new.release >ecec.toc.htm). At this valuation, the estimated annual cost to the public is about $90,903. The cost to the government for the collection of this NEISS information is estimated to be about $8.9 million a year. This estimate includes $6.5 million in compensation to NEISS respondents, as described above.

This information collection request excludes the burden associated with other publicly available Consumer Product Safety Information Databases, such as internet complaints, Hotline, and Medical Examiners and Coroners Alert Project (MECAP) reports, which are approved under OMB control number 3041-0146. This information collection request also excludes the burden associated with follow-up investigations conducted by other federal agencies.

D. Request for Comments

The CPSC solicits written comments from all interested persons about the proposed collection of information. The CPSC specifically solicits information relevant to the following topics:

  • Whether the collection of information described above is necessary for the proper performance of the CPSC's functions, including whether the information would have practical utility;
  • Whether the estimated burden of the proposed collection of information is accurate;
  • Whether the quality, utility, and clarity of the information to be collected could be enhanced; and
  • Whether the burden imposed by the collection of information could be minimized by use of automated, electronic, or other technological collection techniques, or other forms of information technology.

Alberta E. Mills,

Secretary, Consumer Product Safety Commission.

[FR Doc. 2021-15385 Filed 7-19-21; 8:45 am]

BILLING CODE 6355-01-P