OMB0029_Supporting Statement 2010

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. That legislation also requires the Commission to conduct 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 newspapers, 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 collects information on childhood poisonings through the NEISS system, in support of the Poison Prevention Packaging Act of 1970.

From these sources, the Commission staff selects cases of interest for further investigation by face-to-face or telephone interviews with persons who witnessed or were injured in incidents involving consumer products. 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.

2. Use and sharing of collected information and impact on privacy

The Commission uses this information 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. By these means, the Commission removes unsafe products from channels of distribution and consumers' homes and provides information to the public about the safety of consumer products.

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. The use of the internet to directly transmit data is a recent improvement from an older system where NEISS respondents submitted data electronically through dialup modems.

An estimated 52 percent of the detailed information collected outside of NEISS is obtained by use of electronic or other forms of information technology. Information may be reported electronically to the Commission through a toll-free telephone Hotline and internet web site. Information may also be collected through traditional face-to-face or telephone interviews with consumers, witnesses, and other knowledgeable parties such as fire, police, and healthcare professionals.

4. Efforts to identify duplication

There is no other national surveillance system of product-related injuries or childhood poisonings treated in emergency departments. The detailed information submitted by persons who have sustained injuries or who have witnessed or otherwise have knowledge about incidents associated with consumer products are not available from any other source.

5. Impact on small business

This collection of information is voluntary and does not have an 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 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 product-related injuries and childhood poisonings treated in emergency departments is necessary to identify, investigate, and respond to new or changing hazards. Therefore, respondents participating in the NEISS system are required by contract to report these injuries within 5 days of the emergency department visit.

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. In response to recent GAO recommendations, new choices were added to the NEISS data collection program in January 2010 to facilitate translation of race and ethnicity information into the OMB recommended categories. Efforts are also underway to create cross-referencing tables to the Federal standards for legacy data.

8. Agency’s Federal Register Notice and related information

A notice in the Federal Register was published December 1, 2009. 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 minimal number of persons who provide further information about selected injuries or incidents associated with consumer products of special interest to CPSC are paid for their responses. We may pay up to 500 people per year at $50.00 per response.

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 which 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 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 15 seconds to review. Coding and reporting records that involve consumer product related injuries takes about 2.5 minutes per record. Respondents also spend about 36 hours per year in related activities (training, evaluations, and communicating with other hospital staff).

In FY2008, there were 157 NEISS respondents (total hospitals and CPSC contractors). These NEISS respondents reviewed an estimated 3.4 million emergency department records and reported 371,507 consumer-product related injuries and 5,030 childhood poisoning-related injuries. The total burden hours for FY2008 are estimated to be 41,497. The average burden hour per hospital is 415 hours. However, the total burden hour on each hospital varies due to differences in size of the hospital (e.g., small rural hospitals versus large metropolitan hospitals). Therefore, the smallest hospital reported less than 200 cases with a burden of about 100 hours, while the largest hospital reported over 16,000 cases with a burden of about 1,300 hours.

The total costs to NEISS respondents for FY2008 are estimated to be $1.5 million 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 $15,000. The average cost per burden hour is estimated to be $36 per hour (including wages and overhead; Bureau of Labor Statistics, June 2009, Total Compensation Civilian Workers, Hospitals). 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 $2,600 at a small rural hospital and $75,000 at a large metropolitan hospital.

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

The staff conducts face-to-face interviews of approximately 915 persons each year. On average, an on-site interview takes about 4.5 hours. The staff also conducts about 3,466 in-depth investigations by telephone. Each in-depth telephone investigation requires approximately 20 minutes.

Additionally, the Commission’s hot-line staff interviews about 3,964 persons each year about incidents involving selected consumer products. On average, each of these interviews takes 10 minutes. The Commission also receives information from about 8,948 individuals each year who complete web forms reporting information about product-related injuries or incidents. The consumer use of these forms has increased since the last OMB clearance. These forms appear on the Commission’s internet web site and are printed in the Consumer Product Safety Review and other Commission publications. The staff estimates that completion of each form takes about 12 minutes.

The Commission staff estimates that this collection of information imposes a total annual hourly burden of 7,723 hours on all respondents: 4,118 hours for face-to-face interviews; 1,155 hours for in-depth telephone interviews; 661 hours for Hotline interviews; and 1,790 hours for completion of written web forms.

The Commission’s staff estimates the value of the time of respondents to this collection of information at $29.31 an hour (Bureau of Labor Statistics, June 2009, total Compensation, All workers). At this valuation, the estimated annual cost to the public is about $226,390.

13. Estimate of total annual cost burden to respondents

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 this collection of information is estimated to be about $6.4 million a year. This estimate includes $1.5 million in compensation to NEISS respondents described in section 12(a) above. This estimate also includes $4.9 million for about 354 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 $13,859.

15. Program changes or adjustments

This request for the approval of an estimated 49,705 burden hours per year (41,497 NEISS and 8,208 other) is an increase of 42,675 hours since this collection of information was last approved by OMB in 2006. A small portion of this increase (693 hours) is due to shifts in Commission data collection needs and increased consumer reporting through the Web site. The majority of the increase is due to the revised interpretation of OMB PRA reporting, requiring the inclusion of NEISS. NEISS is not a new activity and has been in existence since 1971. NEISS has been the core data system of CPSC's Directorate of Epidemiology since CPSC was activated in 1973.

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

The Commission does not request permission to avoid display of the expiration date of OMB approval of this information collection.

18. Exception to the certification statement

No exception is made to the certification statement.

B. Collection of Information Employing Statistical Methods

1. The potential respondent universe consists of patients treated in statistically selected hospitals participating in NEISS to report emergency department treated product-related injuries, and 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.

The affiliated NEISS hospitals report more than 370,000 consumer product related cases annually to the Commission using existing information extracted from hospital records. Since these data are limited, further information is frequently necessary, which involves a completed investigation via telephone and/or face-to-face in approximately 2,000 these cases. Other data sources contribute over 51,000 cases, of which approximately 2,200 are selected for 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. More than 60 percent of the victims involved in the selected accidents are successfully contacted. Of those contacted, more than 85 percent agree to voluntarily provide information on the accident situation. 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 Westat, Inc.

J. Michael Brick 1650 Research Blvd.

David Marker Rockville, Maryland 20850, 301-251-1500