2016 Database PRA Renewal Supporting Statement Final

INFORMATION COLLECTION REQUEST

Supporting Statement

Publicly Available Consumer Product Safety Information

Database Final Rule

RIN 3041-AC87

A. Justification

1. Circumstances Necessitating Information Collection

The Consumer Product Safety Commission (CPSC, Commission) issued a final rule in 75 Federal Register 76832 that established a Publicly Available Consumer Product Safety Information Database (Database) with the effective date of January 10, 2011. Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) amended the Consumer Product Safety Act (CPSA) to require the Commission to establish and maintain a publicly available, searchable database on the safety of consumer products, and other products or substances regulated by the Commission. The final rule interprets various statutory requirements in section 6A of the CPSA pertaining to the information to be included in the Database, and also establishes provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the Database; and dealing with confidential and materially inaccurate information.

2. How, by Whom, and for What Purpose Information Used

The primary purpose of this information collection is to populate the publicly searchable Database of consumer product safety information mandated by section 6A of the CPSA. The Database information collection has four components: reports of harm, manufacturer comments, branding information, and the Small Batch Manufacturer Registry (SBMR).

Reports of Harm: Reports of harm communicate information regarding an injury, illness, or death, or any risk (as determined by the Commission) of injury, illness, or death, relating to the use of a consumer product. Reports can be submitted to the CPSC by consumers; local, State, or Federal government agencies; health care professionals; child service providers; public safety entities; and others. Reports may be submitted in one of three ways: via the CPSC website (www.saferproducts.gov), by telephone via a CPSC call center, or by e-mail, fax, or mail using the incident report form (available for download or printing via the CPSC website). Reports may also originate as a free-form letter or e-mail. Submitters must consent to inclusion of their report of harm in the publicly searchable Database.

Manufacturer Comments: A manufacturer or private labeler may submit a comment related to a report of harm if the report of harm identifies the manufacturer or private labeler and the CPSC transmits such report of harm to the manufacturer. Manufacturer comments may be submitted through the business portal, by e-mail, mail, or fax. The business portal is a feature of the Database that allows manufacturers who register on the business portal to receive reports of harm and comment on such reports through the business portal. Use of the business portal expedites the receipt of reports of harm and business response times.

A manufacturer may request that the Commission designate information in a report of harm as confidential. Such a request may be made using the business portal, e-mail, mail, or fax. Additionally, any person or entity reviewing a report of harm or a manufacturer’s comment (either before or after publication in the Database) and who believes that the report contains materially inaccurate information, may request that the report or comment, or portions of the report or comment, be excluded from the Database. Such a request may be submitted by e-mail, mail, or fax, and registered businesses also may utilize the business portal for such requests.

Branding Information: Using the business portal, registered businesses may voluntarily submit branding information to assist CPSC in correctly and timely routing reports of harm involving their products to them. Brand names may be licensed to another entity for use in labeling consumer products manufactured by that entity. CPSC’s understanding of licensing arrangements for consumer products can help to give the correct manufacturer timely notification of a report of harm.

Small Batch Manufacturers Registry: The business portal also contains the SBMR, which is the online mechanism by which small batch manufacturers (as defined in the CPSA) can identify themselves to obtain relief from certain third party testing requirements for children’s products. To register as a small batch manufacturer and receive relief from third party testing, a business must attest that the company’s total gross revenue and the number of units of the covered product manufactured both fall within the statutory limits.

3. Consideration of Information Technology

All collections may be submitted electronically through either the use of e-mail or the CPSC’s website at www.saferproducts.gov.

4. Efforts to Identify Duplication and Similar Information Already Available

The CPSC has historically accepted incident reports from consumers and others that describe harm or risks of harm related to consumer products (OMB Approval No. 3041-0029).  These reports were forwarded to manufacturers and such manufacturers could submit comments to the CPSC in response.  In 2011 CPSC launched the publicly searchable Database on www.SaferProducts.gov and updated forms for collecting reports of harm and for manufacturer comments.

Forms to collect reports of harm are similar to the incident report forms in use prior to Database development.  Staff developed additional report forms for the Database so that manufacturers could submit comments and file claims alleging confidential information or a material inaccuracy, as required by section 6A of the CPSA.  The business portal also contains forms to submit brand information and to register as a small batch manufacturer. Before implementation of the Database, there was no system for obtaining this kind of information directly from manufacturers, so no duplication exists.

The Database changed the way the Commission makes reports of harm and manufacturer comments available to the public.  Before implementing the Database in 2011, neither incident reports nor manufacturer comments were generally made available to the public.  As the explicit purpose of the Database mandated by the CPSIA is for a database on the safety of consumer products that is publicly available, searchable, and accessible through the CPSC website, the information collected for the Database is made public.

5. Impact on Small Business

The Small Business Administration generally considers a manufacturer of consumer product to be a small business if it has fewer than 500 employees; this definition applies to over 94 percent of manufacturing firms in the United States. However, the only small businesses that may submit comments under this information collection are those to which the CPSC forwards a report of harm. Because of their smaller sales volumes, small manufacturers are less likely to receive an incident report and, hence, experience any impacts. Therefore, it is unlikely that the collection of reports and manufacturer comments and claims will affect a substantial number of small businesses.

A business, when registering on the CPSC business portal, will have the option to request to be considered as a small batch manufacturer if: (i) total gross revenue from sales of consumer products in the previous calendar year is less than $1 million (gross revenue includes revenue from the sale of consumer products by other businesses the registering company controls or is controlled by) and, (ii) the business manufactures no more than 7,500 of a covered product in the previous calendar year. However, designation as a small batch manufacturer does not have any effect on whether a company receives a report of harm. The registry is used to track manufacturers who claim a statutory exemption from the obligation to third party test children’s products. Small businesses cannot seek exemption from receipt of reports of harm.

6. Consequences of Less Frequent Information Collection and Technical or Legal Obstacles

Failure to provide the information would prevent the CPSC from being able to establish and maintain the publicly searchable Database that is required by the section 6A of the CPSA.

7. Consistency with the guidelines in 5 CFR 1320.5(d)(2)

The Database final rule is consistent with the guidelines in 5 CFR 1320.5(d)(2).

8. Publication and Consultation Outside the Agency

Before finalizing the Commission’s rule at 16 C.F.R. part 1102 and implementing the Database, the Commission sought stakeholder feedback on establishing a publicly searchable database. Specifically, the Commission: (a) submitted a detailed implementation plan for the Database to Congress on September 10, 2009, (b) held a public hearing on establishing the Database on November 10, 2009, (c) CPSC staff conducted a two-day workshop on January11 and 12, 2010 to seek public input and invited comments in conjunction with the workshop; and (d) issued a proposed rule on May 24, 2010 to elicit additional comments (75 FR 29157).

A notice soliciting comments on the Commission’s intent to request an extension of a previously approved collection of data was published in the FR on August 19, 2016. One comment was received.

9. Payment or Gift to Respondents

The CPSC has not and will not provide any payment or gifts to respondents.

10. Confidentiality of Information

In the case of both reports of harm and manufacturer comments, the submitter must consent to the use of the information in the Database before the CPSC posts it to the internet Database. Otherwise, the information submitted will be subject to the Freedom of Information Act and its exemptions to public disclosure.

In addition, a manufacturer that receives a report of harm may review that report for information containing or relating to a trade secret or other matter referred to in 18 USC § 1905 or that is subject to 5 USC § 552(b)(4). The manufacturer may request that a portion(s) of the report of harm be designated as confidential information. If the CPSC determines that information in a report of harm is confidential, the CPSC will notify the manufacturer, will redact the confidential information from the report of harm, and then will publish the altered report of harm in the Database.

11. Sensitive Questions

No questions of a sensitive nature are asked.

12. Estimates of Burden Hours and Explanation

We estimate the burden of this collection of information as follows:

Table 1 – Estimated Annual Reporting Burden for Reports of Harm

Collection Type	No. of Respdnts	Response Frequency1	Total Annual Responses	Minutes per Response	Total Burden, in Hours2
Reports of Harm – submitted through website	6,582	1.03	6,790	12	1,358
Reports of Harm – submitted by phone	2,632	1.01	2,643	10	441
Reports of Harm – submitted by mail, e-mail, fax	780	6.67	5,206	20	1,735
TOTAL	9,994		14,639		3,534

Table 2 – Estimated Annual Reporting Burden for Manufacturer Submissions

Collection Type	No. of Respdnts	Response Frequency1	Total Annual Responses	Minutes per Response	Total Burden, in Hours2
Manufacturer Comments – submitted through website	532	6.23	3,317	117	6,468
Manufacturer Comments – submitted by mail, e-mail, fax	283	1.22	346	147	848
Requests to Treat Information as Confidential – submitted through website	12	1.08	13	42	9
Requests to Treat Information as Confidential – submitted by mail, e-mail, fax	0	n/a	0	72	0
Requests to Treat Information as Materially Inaccurate – submitted through website	131	1.82	238	165	655
Requests to Treat Information as Materially Inaccurate – submitted by mail, e-mail, fax	79	1.06	84	195	273
Voluntary Brand Identification	829	1.48	1,228	10	205
Small Batch Manufacturer Identification	2,208	1	2,208	10	368
TOTAL	4,074		7,434		8,826

Based on the data set forth in tables 1 and 2 above, the annual reporting cost is estimated to be $719,381. This estimate is based on the sum of two estimated total figures for reports of harm and manufacturer submissions. The estimated number of respondents and responses are based on the actual responses received in FY 2015. We assume that the number of responses and respondents will be similar in future years.

Reports of Harm: Table 1 sets forth the data used to estimate the burden associated with submitting reports of harm. We had previously estimated the time associated with the electronic and telephone submission of reports of harm at 12 and 10 minutes, respectively, and because we have had no indication that these estimates are not appropriate or accurate, we used those figures for present purposes as well. We estimate that the time associated with a paper or PDF form would be 20 minutes, on average.

To estimate the costs for submitting reports of harm we multiplied the estimated total burden hours associated with reports of harm (1,358 hours + 441 hours + 1,735 hours = 3,534 hours) by an estimated total compensation for all workers in private industry of $32.06 per hour,³ which results in an estimated cost of $113,300 (3,534 hours x $32.06 per hour = $113,300).

Manufacturer Submissions: Table 2 sets forth the data used to estimate the burden associated with manufacturers’ submissions to the Database. We had observed that a large percentage of the general comments come from a few businesses and assumed that the experience of a business that submits many comments each year would be different from one that submits only a few. Accordingly, we divided all responding businesses into three groups based on the number of general comments submitted in FY 2015, and then selected several businesses from each group to contact. The first group we contacted consisted of businesses that submitted 50 or more comments in FY 2015, accounting for 31 percent of all general comments received. The second group we contacted included businesses that submitted 6 to 49 comments, accounting for 39 percent of all general comments received. The last group contacted included businesses that submitted no more than five comments, accounting for 30 percent of all general comments received.⁴ We asked each company how long it typically takes to research, compose, and enter a comment or a claim of materially inaccurate information.

To estimate the burden associated with submitting a general comment regarding a report of harm through the business portal, we averaged the burden provided by each company within each group and then calculated a weighted average from the three groups, weighting each group by the proportion of comments received from that group. We found that the average time to submit a general comment regarding a report of harm is 117 minutes based on the data in Table 3 (((15 minutes + 45 minutes + 30 minutes + 15 minutes) / 4 companies)*.31 + ((105 minutes + 45 minutes + 150 minutes + 15 minutes) / 4 companies)*.39 + ((240 minutes + 60 minutes + 480 minutes) / 3 companies)*.30 = 117 minutes).

Table 3 – Estimated Burden to Enter a General Comment in the Database

Group	Company	General Comments
Group 1 (>=50 comments)	Company A Company B Company C Company D	15 minutes 45 minutes 30 minutes 15 minutes
Group 2 (6-49 comments)	Company A Company B Company C Company D	105 minutes 45 minutes 150 minutes 15 minutes
Group 3 (<= 5 comments)	Company A Company B Company C	240 minutes 60 minutes 480 minutes

Registered businesses generally submit comments through our website. Unregistered businesses submit comments by mail, e-mail, or fax. We estimate that submitting comments in this way takes a little longer because we often must ask the businesses to amend their submissions to include the required certifications. Thus, we estimated that on average, comments submitted by mail, e-mail, or fax take 30 minutes longer than those submitted through our website (117 minutes + 30 minutes = 147 minutes).

The submission of a claim of materially inaccurate information is a relatively rare event for all respondents, so we averaged all responses together. Eight of the businesses contacted had submitted claims of materially inaccurate information. We found that the average time to submit a claim that a report of harm contains a material inaccuracy is 165 minutes ((30 minutes + 90 minutes + 45 minutes + 90 minutes + 60 minutes + 660 minutes + 45 minutes + 300 minutes) / 8 companies = 165 minutes).

Registered businesses generally submit claims through the business portal. Unregistered businesses submit claims by mail, e-mail, or fax. We estimate that submitting claims in this way takes a little longer because we often must ask the businesses to amend their submission to include the required certifications. Thus, we estimated that on average, claims submitted by mail, e-mail, or fax take 30 minutes longer than those submitted through our website (165 minutes + 30 minutes = 195 minutes).

The submission of a claim of confidential information is a relatively rare event for all respondents, so we averaged all responses together. Five of the businesses contacted had submitted claims of confidential information. We found that the average time to submit a claim that a report of harm contains confidential information is 42 minutes ((45 minutes + 15 minutes + 60 minutes + 30 minutes + 60 minutes) / 5 companies = 42 minutes).

Registered businesses generally submit confidential information claims through the business portal. Unregistered businesses submit confidential information claims by mail, e-mail, or fax. We estimate that submitting claims in this way takes a little longer because we often must ask the businesses to amend their submission to include the required certifications. Thus, we estimate that a confidential information claim submitted by mail, e-mail, or fax would take 30 minutes longer than those submitted through our website (42 minutes + 30 minutes = 72 minutes).

For voluntary brand identification, we estimate that a response would take 10 minutes on average. Most responses consist only of the brand name and a product description. In many cases a business will submit multiple entries in a brief period of time and we can see from the date and time stamps on these records that an entry often takes less than two minutes. CPSC staff enters the same data in a similar form based on our own research, and that experience was also factored into our estimate.

For small batch manufacturer identification, we estimate that a response would take 10 minutes on average. The form consists of three check boxes and the information should be readily accessible to the respondent.

The responses summarized in Table 2 are generally submitted by manufacturers. To avoid underestimating the cost associated with the collection of this data, we assigned the higher hourly wage associated with a manager or professional in goods-producing industries to these tasks. To estimate the cost of manufacturer submissions we multiplied the estimated total burden hours in Table 2 (8,826 hours) by an estimated total compensation for a manager or professional in goods-producing industries of $68.67 per hour,⁵ which results in an estimated cost of $606,081 (8,826 hours x $68.67 per hour = $606,081).

Therefore, the total estimated annual cost to respondents is $719,381 ($113,300 burden for reports of harm + $606,081 burden for manufacturer submissions = $719,381).

13. Annual Cost to Respondents

There are no capital costs or operating and maintenance costs associated with this collection of information.

14. Annual Cost to the Government

We estimate the annualized cost to the CPSC to be $954,531. This figure is based on the costs for four categories of work for the Database: Reports of Harm, Materially Inaccurate Information Claims, Manufacturer Comments, and Small Batch Identification. Each category is described below. No government cost is associated with Voluntary Brand Identification because this information is entered directly into the Database by the manufacturer with no processing required by the government. The information assists the government in directing reports of harm to the correct manufacturer. We did not attempt to calculate separately the government cost for claims of confidential information because the number of claims is so small. The time to process these claims is included with claims of materially inaccurate information.

Reports of Harm: The Reports of Harm category includes many different tasks. Some costs related to this category are from two data entry contracts. Tasks related to these contracts include clerical coding of the report, such as identifying the type of consumer product reported and the appropriate associated hazard, as well as performing quality control on the data in the report. Contractor A spends an estimated 5,267 hours per year performing these tasks. With an hourly rate of $33.31 for contractor services, the annual cost to the government of contract A is $175,444. Contractor B spends an estimated 2,539 hours per year performing these tasks. With an hourly rate of $58.09 for contractor services, the annual cost to the government of contract B is $147,491.

The Reports of Harm category also includes sending consent requests for reports when necessary, processing that consent when received, determining whether a product is out of CPSC’s jurisdiction, and confirming that pictures and attachments do not have any personally identifiable information. The Reports category also entails notifying manufacturers when one of their products is reported, completing a risk of harm determination form for every report eligible for publication, referring some reports to a Subject Matter Expert (SME) within the CPSC for a determination on whether the reports meet the requirement of having a risk of harm, and determining whether a report meets all the statutory and regulatory requirements for publication. Detailed costs are:

Table 4 – Estimated Costs for Reports of Harm Task

Grade Level	Number of Hours (Annual)	Total Compensation per Hour	Total Annual Cost
Contract A	5,267	$33.31	$175,444
Contract B	2,539	$58.09	$147,491
7	200	$34.78	$6,956
9	300	$42.69	$12,807
12	5,528	$61.91	$342,238
13	428	$73.37	$31,402
14	1,068	$86.99	$92,905
Total	15,330		$809,243

Materially Inaccurate Information (MII) Claims: The MII claims category includes reviewing and responding to claims, participating in meetings where the claims are discussed, and completing a risk of harm determination on reports when a company alleges that a report does not describe a risk of harm.

Table 5 – Estimated Costs for MII Claims Task

Grade Level	Number of Hours (Annual)	Total Compensation per Hour	Total Annual Cost
12	275	$61.91	$17,025
13	167	$73.37	$12,253
14	323	$86.99	$28,098
15	50	$101.99	$5,100
SES	50	$109.97	$5,499
Total	865		$67,975.00

Manufacturer Comments: The Comments category includes reviewing and accepting or rejecting comments.

Table 6 – Estimated Costs for Manufacturer Comments Task

Grade Level	Number of Hours (Annual)	Total Compensation per Hour	Total Annual Cost
12	62	$61.91	$3,838
13	109	$73.37	$7,997
Total	171		$11,835

Small Batch Manufacturer Identification: The Small Batch Manufacturer Identification category includes time spent posting the list of small batch registrations, as well as answering manufacturers’ questions on registering as a Small Batch company and what the implications to that company of small batch registration.

Table 7 – Estimated Costs for Small Batch Task

Grade Level	Number of Hours (Annual)	Total Compensation per Hour	Total Annual Cost
15	642	$101.99	$65,478
Total	642		$65,478

We estimate the annualized cost to the CPSC of $954,531 by adding the four categories of work related to the Database summarized in Tables 4 through 7 (Reports of Harm ($809,243) + MII Claims ($67,975) + Manufacturer Comments ($11,835) + Small Batch Identification ($65,478) = $954,531).

15. Changes in Burden

This information collection renewal request based on an estimated 12,360 burden hours per year for the Database is a decrease of 7,485 hours since this collection of information was last approved by OMB in 2013. The decrease in burden is due primarily to the fact that the number of incoming reports of harm has decreased, and the number claims based on those reports has decreased as well. While comments did not decline significantly, they did shift to the more efficient online submission types. There was a large increase in small batch manufacturer activity, which has been rising steadily for years. However, this increase was not large enough to offset the decreases in other areas.

16. Publication of Information Being Collected

The purpose of this information collection is to populate the publicly searchable Database of consumer product safety information mandated by section 6A of the CPSA. Submitters of both reports of harm and manufacturer comments provide their information to the CPSC, and must consent before the CPSC will post the information to the publicly available Database. Once posted to the Database, the information will be searchable by the public.

17. Exemption for Display of Expiration Date

The agency does not seek an exemption from displaying the expiration date.

18. Exemption to Certification Statement

N/A.

B. Statistical Methods

The information collection requirements do not employ statistical methods.

1 Frequency of responses is calculated by dividing the number of responses by the number of respondents.

2 Numbers have been rounded.

3 U.S. Department of Labor, Bureau of Labor Statistics, Table 9 of the Employer Costs for Employee Compensation (ECEC), Private Industry, goods-producing and service-providing industries, by occupational group, June 2016 (data extracted on 06/23/2016 from http://www.bls.gov/news.release/ecec.t09.htm

4 In the last group one company was excluded as an outlier.

5 U.S. Department of Labor, Bureau of Labor Statistics, Table 9 of the Employer Costs for Employee Compensation (ECEC), Private Industry, goods-producing and service-providing industries, by occupational group, June 2016 (data extracted on 06/23/2016 from http://www.bls.gov/news.release/ecec.t09.htm

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