OMB0029_NEISS_Supporting_Statement_2016_final

Supporting Statement for Collection of Information

Follow-up Activities for Product-Related Injuries

A. Justification

1. Information to be collected and circumstances that make the collection of information necessary

Section 5(a) of the Consumer Product Safety Act (CPSA)(15 U.S.C. § 2054(a)) requires the Commission to collect information related to the cause and prevention of death, injury and illness associated with consumer products. The Commission conducts continuing studies and investigations of deaths, injuries, diseases, other health impairments, and economic losses resulting from incidents involving consumer products. The Commission obtains information about product-related deaths, injuries and illnesses from a variety of sources, including news outlets, death certificates, consumer complaints, and medical facilities.

The Commission also operates a surveillance system known as the National Electronic Injury Surveillance System (NEISS) that provides timely data on consumer product-related injuries treated in a statistically valid sample of hospital emergency departments in the U.S. The Commission also uses the NEISS system to collect information on childhood poisonings in support of the Poison Prevention Packaging Act of 1970.

From these sources, the Commission 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) or via telephone. CPSC plans to begin conducting investigations via internet-based questionnaires in the next year to supplement the telephone interviews. On-site investigations are usually made in cases where the Commission 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 contact with state and local officials, including police, coroners and fire investigators, and others with knowledge of the incident.

Through Interagency Agreements, the Commission also uses the NEISS system to collect information on all injuries for the Centers for Disease Control and Prevention (CDC All Injury Program), and on non-crash motor vehicle-related injuries for the National Highway and Transportation Safety Administration (NHTSA). The CDC All Injury Program includes several studies: Adverse Drug Events, Assaults, Firearms, Self-Inflicted Violence, and Work-Related Injuries.

2. Use and sharing of collected information

The Commission uses the information from this collection to support development and improvement of voluntary standards; proceedings for the development of mandatory standards and regulations; information and education campaigns; and administrative and judicial proceedings for enforcement of the statutes, standards, and regulations administered by the Commission. The information informs the Commission in its efforts to remove unsafe products from channels of distribution and consumers' homes and provides information to the public about the safety of consumer products.

No records released to the public contain personally identifiable information; geographic and personal identifiers have been masked.

3. Use of information technology (IT) in information collection

All NEISS data are reported electronically, and NEISS respondents directly submit data to CPSC through the internet on laptops provided by CPSC. Information for follow-up investigations from NEISS and other sources are collected through traditional face-to-face or telephone interviews with consumers, witnesses, and other knowledgeable parties such as fire, police, and healthcare professionals. CPSC plans to begin offering follow-up investigations via e-mail or internet-based questionnaire. This will allow respondents to choose a preferred method of contact and potentially improve response rates.

4. Efforts to identify duplication

There is no other national surveillance system of product-related injuries, childhood poisonings, and other injuries treated in emergency departments. The detailed information obtained from hospital emergency records about incidents associated with consumer products is not available from any other source.

5. Impact on small business

This collection of information is voluntary and does not have a disproportionate impact on small businesses.

6. Consequences to Federal program or policy activities if collection is not

conducted or is conducted less frequently

If this information were not collected or were collected less frequently, the Commission and other agencies that rely on this data would lack timely and detailed information to identify new hazards and to support rulemaking proceedings, efforts to develop or improve voluntary standards, actions to obtain correction of products that present a substantial product hazard, and informational campaigns.

7 (a). Special circumstances requiring respondents to report information more often than quarterly or to prepare responses in fewer than 30 days

Timely reporting of consumer product-related injuries and childhood poisonings treated in emergency departments is necessary to identify, investigate, and respond to new or changing hazards. In FY2015, 50% of the NEISS records were received within 6 days of treatment and 90% within 30 days.

7 (b). Special circumstances requiring the use of a statistical data classification that has not been reviewed and approved by OMB

NEISS does not currently collect information on race and ethnicity in the format recommended by OMB. Race is collected using OMB’s recommended categories under a variable called ‘RACE’. Ethnicity and a free text response to race are collected under a variable called ‘RACEOTH’.

8. Agency’s Federal Register Notice and related information

A notice in the Federal Register was published June 22, 2016. (81 FR 40677) No comments were received.

9. Decision to provide payment or gift

NEISS respondents enter into contracts with CPSC and are compensated for their efforts. See Section 12(a) for details of the estimated burden and costs. A number of persons are contacted through a telephone interview to provide further information about selected injuries or incidents associated with consumer products of special interest to CPSC. See Section 12(b) for details of the estimated burden and costs. In general, respondents are not compensated for participating in a telephone interview. However, CPSC may pay up to 500 people per year at $25 - $50 per response. CPSC would only begin offering payments in the event the response rate to telephone interviews began to decline below an acceptable level.

10. Assurance of confidentiality

If a person requested to provide information about a product-related injury or incident claims that any information submitted to the Commission is trade secret or confidential business information, that information is subject to the Commission's procedures for withholding confidential information from public disclosure codified at 16 C.F.R. Part 1015, subpart B. If such information is requested under provisions of the Freedom of Information Act, the person who provided the information is notified and given the opportunity to respond and seek judicial relief prior to the Commission's release of the information. In addition, any accident or investigation report made under the CPSA by an officer or employee of the Commission shall be made available to the public in a manner that will not identify any injured person or any person treating him, without the consent of the person so identified.

11. Questions of a sensitive nature

The Commission’s staff takes care to design interview guides so that persons who witness or are injured in incidents associated with consumer products are not requested to provide any information of a sensitive nature.

12 (a). Estimate of hour burden to NEISS respondents

The NEISS system collects information on consumer product related incidents and other injuries from about 100 hospitals in the United States. 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 each day takes about 10 minutes. Each record takes 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 additional special study information takes about 90 seconds per record. Respondents also spend about 36 hours per year in related activities (training, evaluations, and communicating with other hospital staff).

In FY2015, there were 137 NEISS respondents (total hospitals and CPSC contractors). These NEISS respondents reviewed an estimated 5.05 million emergency department records and reported 739,673 total cases (359,475 consumer-product related injuries for CPSC, and 380,198 other injuries for the CDC All Injury Program). The table below lists the number of reported cases, and the number of reported cases with additional special study information.

Total NEISS Cases Reported	739,673
Consumer Product-Related Injuries	359,475
CDC All Injury Program	380,198
Special Studies Reported (subset of above)
Child Poisoning (CPSC)	4,476
Adverse Drug Events (CDC)	27,736
Assaults (CDC)	34,767
Firearm-Related Injuries (CDC)	5,682
Self-Inflicted Violence (CDC)	8,910
Work-Related Injuries (CDC)	40,670
Motor Vehicle Non-Crash Injuries (NHTSA)	12,909

The total burden hours for all NEISS respondents are estimated to be 81,210 for FY2015. The average burden hour per respondent is 593 hours. However, the total burden hour on each respondent varies due to differences in size of the hospital (e.g., small rural hospitals versus large metropolitan hospitals). The smallest hospital reported 202 cases with a burden of about 111 hours, while the largest hospital reported 60,405 cases with a burden of about 4,222 hours.

The total costs to NEISS respondents for FY2015 are estimated to be $3,271,620.61 per year. NEISS respondents enter into contracts with CPSC and are compensated for these costs. The average cost per respondent is estimated to be about $23,880. The average cost per burden hour is estimated to be $40.29 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 between $1,199 at a small rural hospital and $281,953 at the largest metropolitan hospital.

12 (b). Estimate of hour burden to other respondents

The staff conducts face-to-face interviews of about 220 persons each year. On average, an on-site interview takes about 4.5 hours. The staff also conducts about 1760 in-depth investigations by telephone. Each in-depth telephone investigation requires about 20 minutes. The staff is planning to conduct about 200 internet-based questionnaires per year that require about 20 minutes each.

The Commission staff estimates 1,643 annual burden hours on these respondents: 989 hours for face-to-face interviews; 587 hours for in-depth telephone interviews, and 67 hours for internet-based questionnaires.

The Commission’s staff estimates the value of the time required for reporting is $32.82 an hour (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 2016, Table 9, Total compensation for all sales and office workers in goods-producing industries: http://www.bls.gov/ncs). At this valuation, the estimated annual cost to the public is about $53,923.

13. Estimate of other total annual cost burden to respondents or recordkeepers

The only costs to respondents from this collection of information are those described in item 12, above.

14. Estimate of annualized costs to the Federal government

The annual cost to the government of the collection of the NEISS information is estimated to be about $4.9 million a year. This estimate includes $3.3 million in compensation to NEISS respondents described in section 12(a) above. This estimate also includes $1.603 million for about 150 professional staff months each year. The estimate of professional staff months includes the time required to: oversee NEISS operations (e.g., administration, training, quality control); prepare questionnaires, interviewer guidelines, and other instruments and instructions used to collect the information; conduct face-to-face and telephone interviews; and evaluate responses obtained from interviews and completed forms. Each month of professional staff time costs the Commission about $10,683.83. This is based on a GS-12 mid-level salaried employee. The average yearly wage rate for a mid-level salaried GS-12 employee in the Washington, DC metropolitan area (effective as of January 2016) is $87,821 (GS-12, step 5). This represents 68.5 percent of total compensation (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 2016, Table 1, percentage of wages and salaries for all civilian management, professional, and related employees: http://www.bls.gov/ncs/). Adding an additional 31.5 percent for benefits brings average yearly compensation for a mid-level salaried GS-12 employee to $128,206.

15. Program changes or adjustments

This request for the approval of an estimated 82,853 (81,210 NEISS and 1,643 other) burden hours per year is an increase of 37,845 hours since this collection of information was last approved by OMB in 2013. The increase in the burden hours is largely due to the inclusion of information collected through NEISS for other federal agencies through Interagency Agreements (CDC, NHTSA), which were not otherwise accounted for by those agencies.  In order to account for all the burden hours associated with the NEISS information collection, we have added those hours to the collection of information. The increase in burden hours also includes the increase associated with offering internet-based questionnaires in addition to in-person and telephone interviews.

This information collection request excludes the burden associated with other publicly available Consumer Product Safety Information Databases, such as internet complaints, Hotline, and MECAP reports, which is accounted for under OMB control number 3041-0146. This information request collection also excludes the burden associated with follow-up investigations conducted by other federal agencies.

16. Plans for tabulation and publication

The Commission provides yearly reports of NEISS data to the public on its website. NEISS data are also available for public use through the CPSC website. The Commission publishes results from some of its investigations of product-related injuries and incidents in Federal Register notices during rulemaking proceedings, and in safety alerts, news releases, and other informational materials that are disseminated to the general public, voluntary standards groups, firms, and trade associations. The Commission has no specific plan to publish all of the data obtained from this collection of information.

17. Rationale for not displaying the expiration date for OMB approval

Not applicable.

18. Exception to the certification statement

Not applicable.

B. Collection of Information Employing Statistical Methods

1. The potential respondent universe includes patients treated in statistically selected hospitals participating in NEISS to report emergency department treated product-related and other injuries. The affiliated NEISS hospitals report about 740,000 emergency department visits annually using existing information extracted from hospital records. Of those reported visits, about 360,000 are consumer product-related cases. Since hospital record data are limited, further information is frequently necessary, and about 2,000 of these cases are selected for further investigation.

The potential respondent universe also includes individuals involved with incidents recorded in newspaper articles, consumer complaints, death certificates, coroner reports and any other injury sources which may be reported to the Commission. These other data sources contribute over 61,000 cases annually, of which about 1,500 are selected for further investigation.

2. Cases associated with categories of interest are selected daily from the hundreds of incident reports received each day by the Commission. Commission investigators call to interview or to arrange to visit the victim or others to determine specific details about the accident sequence. Information collected from the victim, family member, witness, or others is reported on an investigation form designed for this purpose.

When less than 100 percent of the surveillance cases are selected for investigation, the universe of cases is stratified by relevant factors such as type of injury or consumer product involved and a simple random sample of cases is selected.

The estimation procedure for probability surveys involves multiplying the original surveillance case weight by the case weight appropriate for the follow-back investigation. Normally, the latter is the reciprocal of the probability of selection, adjusted where needed for non-response.

3. About 65 percent of the victims involved in the selected incidents are successfully contacted. Of those contacted, about 84 percent agree to voluntarily provide information on the circumstances of the incident. For probability surveys, responses are weighted to account for non-responses. The results from probability surveys can be generalized to the universe studied.

4. No tests of procedures or methods will be undertaken.

5. Contact for collection and analysis of NEISS data:

Thomas Schroeder

U.S. Consumer Product Safety Commission

4330 East West Highway

Bethesda, MD 20814

301-504-7431

Consultants originally involved in the statistical design of the National Electronic Injury Surveillance System:

Joseph Waksbergh (deceased) Westat, Inc.

J. Michael Brick 1650 Research Blvd.

David Marker Rockville, Maryland 20850

301-251-1500