Supporting Statement A_Veteran Toxic Exposure Screening_PACT Act Section 603_Emergency PRA Clearance_09012022 (Final)

SUPPORTING STATEMENT TEMPLATE A

Veteran Toxic Exposure Screening (PACT Act – Section 603)

OMB Control Number 2900-NEW

Request for Emergency PRA Clearance

A. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary. Identify legal or administrative requirements that necessitate the collection of information.

The Honoring our PACT Act of 2022 (P.L. 117-168) requires VA to incorporate a screening for all Veterans enrolled in VA healthcare to help determine potential toxic exposures during active military, naval, air, or space service as part of a health care screening. The statute requires VA to begin screening all Veterans enrolled in VHA health care no later than 90 days after enactment of the PACT Act, which is November 8, 2022, and every five years thereafter.

To ensure efficacy of the screening tool and ease of use by screeners, the project team will conduct a pilot test of the toxic exposure screening tool with a sampling from targeted clinical areas and sites for 10 days. The goal is to collect feedback and best practices to use in refining the screening tool and training to increase best chance for success. The pilot testing is scheduled to begin on September 6, 2022.

An emergency Paperwork Reduction Act (PRA) clearance is requested because VA must begin screening all enrolled Veterans no later than November 8, 2022. The use of regular OMB PRA clearance procedures will not allow for VA to carry out the requirements of the law by the Congressionally mandated deadline or conduct a pilot test of the screening tool prior to implementation.

2. Indicate how, by whom, and for what purposes the information is to be used; indicate actual use the agency has made of the information received from current collection.

Information collected during the toxic exposure screening will be included in the Veteran’s electronic health record and will be used to connect Veterans with resources, services, and benefits available, as well as provide guidance that Veterans be engaged in ongoing care or establish care in VA or the community to address their exposure concerns.

VA will use several different methods of gathering information from Veterans through the toxic exposure screening, including VHA staff or community care staff administering the screening during a health care appointment, VHA staff administering at other Veteran touch point events (e.g., screening blitz event), and Veterans completing the screening independently before being contacted by VHA staff for follow up. Veterans have the option of declining the toxic exposure screening.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

Data collection will be accomplished electronically by a VHA staff member when engaging with a Veteran. Data will be input into the Veteran’s electronic health record.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

This is a new screening that has not been completed previously, therefore no duplication currently exists.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

Because these are applications for individual benefits, no small businesses or other small entities are impacted by the information collection.

6. Describe the consequences to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

VA would not be responsive to the needs of the patient and to the legal requirement to release of information if information were collected less frequently. The Honoring our PACT Act requires VA collect this information every five years.

7. Explain any special circumstances that would cause an information collection to be conducted more often than quarterly or require respondents to prepare written responses to a collection of information in fewer than 30 days after receipt of it; submit more than an original and two copies of any document; retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years; in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study and require the use of a statistical data classification that has not been reviewed and approved by OMB.

There are no such special circumstances.

8. a. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the sponsor’s notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the sponsor in responses to these comments. Specifically address comments received on cost and hour burden.

This is not applicable if there is no requirement to publish a Federal Register Notice (FRN) prior to OMB approving an emergency PRA clearance for this information collection.

Following approval of an emergency PRA clearance, VA will process this information collection for a regular three-year PRA clearance. At that time, VA will submit the requisite 60-day and 30-day FRNs for publication in the Federal Register.

b. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, clarity of instructions and recordkeeping, disclosure or reporting format, and on the data elements to be recorded, disclosed or reported. Explain any circumstances which preclude consultation every three years with representatives of those from whom information is to be obtained.

VA is legally obligated to collect this information beginning November 8, 2022, per the Honoring our PACT Act.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

No payment or gift is provided to respondents.

10. Describe any assurance of privacy, to the extent permitted by law, provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

Assurances of privacy are contained in 38 U.S.C. 5701 and 7332. Respondents are informed that the information collected will become part of the Consolidated Health Record that complies with the Privacy Act of 1974. These forms are part of the system of records identified as 24VA19 “Patient Medical Record – VA” as set forth in the Compilation of Privacy Act Issuances via online GPO access at http://www.gpoaccess.gov/privacyact/index.html.

11. Provide additional justification for any questions of a sensitive nature (Information that, with a reasonable degree of medical certainty, is likely to have a serious adverse effect on an individual's mental or physical health if revealed to him or her), such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private; include specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

This tool was developed by VA clinicians, C&P Directors, Registry Clinicians and other clinicians involved in the care of Veterans with exposure concerns, with input from DMA, PCS, OGC and others for the purpose of:

• Meeting the requirements of Section 603 of the PACT Act

• Taking the Section 603 “Screening Mandate” one step further by building into the process five supportive actions for each screened Veteran that will link them with benefits, registry programs, and other services regardless of the setting in which the screening occurs.

The administrator of the screening obtains consent from the Veteran before proceeding.

12. Estimate of the hour burden of the collection of information:

a. The anticipated number of annual respondents, frequency of responses, annual hour burden, and explanation for each form is reported as follows:

	No. of respondents	x No. of responses	x No. of minutes	÷ by 60 =	Number of Burden Hours
Toxic Exposure Screening	1,660,000	1 = 1,660,000	5 = 8.3M min		~ 138,333 hrs

b. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13.

This request covers only one screening survey.

c. Provide estimates of annual cost to respondents for the hour burdens for collections of information. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included in Item 14.

The respondent population for the toxic exposure screening are Veterans enrolled in VA health care. VA cannot make assumptions about the population of respondents because of the variability of factors, such as the educational background and wage potential of respondents.  Therefore, VHA used general wage data to estimate the respondents’ costs associated with completing the information collection.

The Bureau of Labor Statistics (BLS) gathers information on full-time wage and salary workers.  According to the latest available BLS data, the mean hourly wage is $28.01 based on the BLS wage code – “00-0000 All Occupations.”  This information was taken from the following website: https://www.bls.gov/oes/current/oes_nat.htm.  

Legally, respondents may not pay a person or business for assistance in completing the information collection. Therefore, there are no expected overhead costs for completing the information collection. VHA estimates the total cost to all respondents to be $3,874,707.33 (138,333 burden hours x $28.01 per hour).

13. Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12 and 14).

a. There are no capital, start-up, operation, or maintenance costs.

b. Cost estimates are not expected to vary widely. The only cost is that for the time of the respondent.

c. There is no anticipated recordkeeping burden beyond that which is considered usual and customary.

14. Provide estimates of annual cost to the Federal Government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operation expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from Items 12, 13, and 14 in a single table.

As a new program, these are estimates of the annual cost to the Federal Government. As the program matures the estimates will be revised. The majority of the Federal Government costs will be incurred by existing VHA staff. The estimated annual cost of Toxic Exposure Screening to the Federal Government is $41,511,300.

Action	Cost per Hour	Hours	Total
Development of Screening Tool (VHA Clinical Application Coordinator)	$78/hr	160 hours	$2,480
Screening of Veteran (Title 38 and Hybrid Title 38 frontline staff at VA medical centers)	$100/hr (average of GS, Hybrid, and Title 38 staff cost)	415,000 hours	$41,500,000
Data Analysis (VHA Data Analyst)	$44.10/hr (GS 13)	200 hours	$8,820

15. Explain the reason for any burden hour changes or adjustments reported in items 13 or 14.

This is a new collection, and all burden hours are considered a program increase.

16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

VA does not intend to publish this data.

17. If seeking approval to omit the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

VA will include the expiration date on the information collection.

18. Explain each exception to the certification statement identified in Item 19, “Certification for Paperwork Reduction Act Submissions,” of OMB 83-I.

There are no exceptions.

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