EHR Worksheet for Veterans_Supporting Statement A_ revised 2020

SUPPORTING STATEMENT A

ENVIRONMENTAL HAZARDS REGISTRY (EHR) WORKSHEET – VA Form 10-10176

OMB CONTROL NUMBER 2900-NEW

A. JUSTIFICATION

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

Legal authority for this data collection is found under the following congressional mandates that authorize the collection of data that will allow measurement and evaluation of the Department of Veterans Affairs Programs, the goal of which is improved health care for veterans.

• Agent Orange Registry: Public Laws 102-4, 102-585 Section 703,100-687 and 38 United States Code (U.S.C.) 527, 38 U.S.C. 1116.

• Gulf War Registry: Public Laws 102-585, 103-446 and 38 U.S.C. 1117.

• Ionizing Radiation: Public Laws 102-585 Section 703, 100-687 and 38 U.S.C. 527, 38 U.S.C. 1116.

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.

VA Environmental Health Registry evaluations are free, voluntary medical assessments for Veterans who may have been exposed to certain environmental hazards during military service. Evaluations alert Veterans to possible long-term health problems that may be related to exposure specific to environmental hazards during their military service. The registry data may help VA understand and respond to these health problems more effectively and may be useful for research purposes.

Application can be made by VA researchers to use the data under strict Institutional Review Board control.

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.

Post Deployment Health Services (PDHS) plans to have this form electronically accessible to Environmental Health Coordinators and Clinicians once the EHR is in place. Until then, PDHS requests to consolidate 3 existing forms into one comprehensive form. Currently, VA is exploring the performance of limited registry examinations via telemedicine, in order to reduce Veterans’ need to travel and potentially reduce waiting times for exams. However, the forms would be the same and otherwise the process to collect and put data into the registry database will not change. Once the exam template is on their computer it can be used to import information more seamlessly into the Veteran patient record.

The new Environmental Health Registry (EHR) Worksheet, VA Form 10-10176, supersedes VA Form 10-9009 (June 2005), VA Form 10-9009A (March 2010) and VA Form 10-0020A (June 2005).

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.

Registry evaluations are unique in that information related to exposures specific to environmental hazards during their military service are assessed. These evaluations alert Veterans to possible long-term health problems that may be related to environmental hazard exposures during their military service. Therefore, there are no current VA examinations that collect this level of detailed information related to military exposures.

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

As 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 Veteran and to the congressional requirement if information were collected less frequently. Information is collected at a medical appointment and the time/date of this appointment is selected by the Veteran.

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.

The 60-day notice of Proposed Agency Information Collection Activity was published in the Federal Register on August 19, 2019 (84 FR 42993). VA/VHA received no comments in response to this notice.

The 30-day notice of Agency Information Collection Activity under OMB Review was published in the Federal Register on December 9, 2019 (84 FR 53570). VA/VHA received one comment in response to this notice.

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.

Outside consultation is conducted with the public through the 60- and 30-day Federal Register notices.

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.

If filed in the medical record: 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.

If filed in research records: Information on these forms will become part of a system of records which complies with the Privacy Act of 1974. This system is identified as "Veteran, Patient, Employee and Volunteer Research and Development Project Records-VA (34VA11)" as set forth in the Compilation of Privacy Act Issuances via online GPO access at http://www.gpoaccess.gov/privacyact/index.html

If filed in CHAMPA VA records: Respondents are informed that the information collected will become part of the CHAMPVA Record that complies with the Privacy Act of 1974. These forms are part of the system of the system of records identified as 54VA16 “Veteran’s Spouse or Dependent Civilian Health and Medical Care Records-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.

There are no questions of a sensitive nature.

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

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

VA Form 10-10176	No. of respondents	x No. of responses	x No. of minutes	÷ by 60 =	Number of Hours
Application/Survey	20,000	1 = 20,000	60 = 6000		20,000

The actual provider and coordinator time expected to be spent on exams is 20,000 hours annually and is performed at 150 VA locations, for about an average of 150 hours per VA site per year.

***These numbers already exist. This application/justification is provided for consolidation purposes of VA Form 10-9009, June 2005; VA Form 10-9009A, March 2010; and VA Form 10-0020A, June 2005. ***

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 form.

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.

Registry exams are free medical exams for Veterans.

VHA uses 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.  In accordance with the latest available BLS Occupational Wage Code Median Hourly (May 2019), the mean hourly wage is $25.72 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, and a person or business may not accept payment for assisting a respondent in completing the information collection. Therefore, there are no expected overhead costs. 

VHA estimates the total annualized cost to respondents to be $514,400.00 (20,000 burden hours x $25.72 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.

The estimated annual cost of VA Form 10-10176 to the Federal Government is $_4,000; consolidation of this form decreases the cost to print 3 separate exam forms. In addition, once the template is available on the computer, it can be imported into the EHR without transcribing.

The cost to print each form is $.20 -- and VA conducts 20,000 exams a year.

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

This is a new information collection, and all burden hours would normally be considered a program increase. However, this new form consolidates and eliminates three existing forms: VA Form 10-9009, June 2005; VA Form 10-9009A, March 2010; and VA Form 10-0020A, June 2005. Therefore, the burden hours are reduced from filling out three forms to filling out just one (worksheet) form.

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 as a whole or as a matter of course. However, individual application can be made under strict research protocols with full protection of Veteran identities.

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 seeks to minimize the cost to itself of collecting, processing and using the information by not displaying the expiration date. VA seeks an exemption that waives the displaying of the expiration date on this VA Form. The VA Form may be reproduced by the respondents and VA field facilities from the Internet and then stocked. If VA is required to display an expiration date, it would result in unnecessary waste of existing stock of the forms. Inclusion of the expiration date would place an unnecessary burden on the respondent (since they would find it necessary to obtain a newer version, while VA would have accepted the old one).

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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