World Trade Center Supptg Stmt A PA_VA application 11 7 13

World Trade Center Health Program Enrollment & Appeals -- Pentagon & Shanksville, Pennsylvania Responders

Supporting Statement- Part A

Laurie Breyer

Project Officer

November 3, 2013

National Institute for Occupational Safety and Health

Office of the Director

1600 Clifton Rd, MS E-20

Phone: 404-498-2500

Table of Contents

A. Justification

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

9. Explanation of Any Payment or Gift to Respondents

10. Assurance of Confidentiality Provided to Respondents

11. Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers/Capital Costs

14. Annualized Cost to the Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

17. Reason(s) Display of OMB Expiration Date is Inappropriate

18. Exceptions to Certification for Paperwork Reduction Act Submissions

Appendices

Appendix A Zadroga Act

Appendix B 60 day FRN

Appendix C, C1 Appeal to Eligibility & Denial Letter

Appendix D WTC Health Program Medical Travel Refund Request

Appendix E, E1 Appeals Regarding Certification of Health Cond. & Denial Letter

Appendix F, F1 Appeals Regarding Treatment & Denial Letter

Appendix G Outpatient prescription pharmaceuticals

Appendix H World Trade Center Health Program Pentagon & Shanksville, Pennsylvania Responder Eligibility Application

Appendix I Response to 60-day FRN public comment

Appendix J Interim Final Rule (RIN 0920–AA48)

Appendix K IRB email

A. Justification

1. Circumstances Making the Collection of Information Necessary

This is a request for a new ICR which was originally approved as an emergency clearance (0920-0962, exp. date 10/31/13) from the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). The proposed collection will collect enrollment and appeals data as required by the James Zadroga 9/11 Health and Compensation Act of 2010 (Appendix A-Zadroga Act). Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) by adding Title XXXIII, which establishes the World Trade Center (WTC) Health Program. The WTC Health Program is administered in part by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), and provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, Pennsylvania, and at the Pentagon, and to eligible survivors of the New York City attacks. Section 3311(a)(2)(C) of the PHS Act authorizes the WTC Program Administrator (Administrator) to develop eligibility criteria for enrollment of Shanksville, Pennsylvania and Pentagon responders. Pentagon and Shanksville responders who believe they may be eligible for enrollment in the Program must complete an enrollment form. The following information includes the definition of each population:

• A Pentagon responder is someone who was a member of a fire or police department (whether fire or emergency personnel, active or retired),¹ worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on November 19, 2001.

• A Shanksville responder is someone who was a member of a fire or police department (whether fire or emergency personnel, active or retired),¹ worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on October 3, 2001.

The enrollment form will collect general contact information as well as information regarding the 9/11 disaster area experience. In order to reduce the burden on the respondents, the WTC Health Program will make the form available to be downloaded from the internet or obtained in hard copy and submitted by mail. The enrollment forms will be available for download on the NIOSH website at http://www.cdc.gov/wtc/.

This request began as an emergency clearance which was warranted because it is essential that individuals who wish to apply to the WTC Health Program or appeal a determination made by the WTC Program Administrator have the opportunity to do so as soon as eligibility criteria for Pentagon and Shanksville, Pennsylvania responders are promulgated. Eligibility criteria are being promulgated by Interim Final Rule became effective on May 1, 2013.

2. Purpose and Use of Information Collection

This information is being collected in order to determine the eligibility of Pentagon and Shanksville, Pennsylvania responders as well as to provide program participants with the opportunity to appeal. This includes individuals’ names, mailing address, telephone number, date of birth, and gender (Appendix H). This information will be shared with the WTC Program Administrator and will be kept in a secure manner. The information provided will also be shared with the Federal Bureau of Investigation in order to be matched against the Terrorist watchlist. The Terrorist watchlist is included to incorporate the statutory requirement that no individual whose name is on the watchlist maintained by the Federal government shall qualify to become a WTC responder.

WTC Health Program applicants and enrolled participants have two opportunities to appeal decisions made by the WTC Program Administrator. The first opportunity to appeal arises after a determination that an applicant does not meet the eligibility requirements for a WTC-responder (the term "WTC-responder" includes all responders in New York, Shanksville, Pennsylvania, and at the Pentagon). In the notification letter explaining the determination, the applicant will be advised that an appeal can be requested by submitting in writing their name, contact information, and an explanation for the basis of the appeal. Program participants will also have the opportunity to appeal a decision not to certify a WTC-related health condition or provide treatment. In the notification letter explaining the determination, the applicant will be advised that an appeal can be requested by submitting in writing their name, contact information, and an explanation for the basis of the appeal.

This information collection request also accounts for reimbursement claims from pharmacies to the Program (there is no corresponding form for this transaction; see below); and the travel expenses of WTC responders who travel more than 250 miles to a nationwide network provider for medically necessary treatment (Appendix D). Those individuals may be provided necessary and reasonable transportation and other expenses. Also included within this request is the burden estimate for the approximately 540-1,467 Pentagon and Shanksville WTC responders who are expected to enroll in the Program.

3. Use of Improved Information Technology and Burden Reduction

Due to the fact that the eligibility forms require a signature, they may be collected via hard copy, scan, or fax. The appeal letter must be submitted in writing.

4. Efforts to Identify Duplication and Use of Similar Information

This is not a new program. All of the forms in Appendices C-E are currently approved by OMB through 0920-0891, exp. 12/31/2014 and 0920-0962, exp. 10/31/2015. However, 0920-0962 was initiated through an emergency clearance ICR so although the data is currently approved, a new must be submitted for a three-year approval.

5. Impact on Small Businesses or Other Small Entities

There will be no impact on small business.

6. Consequences of Collecting the Information Less Frequent Collection

Without collection of these data, NIOSH will not be able to implement the provisions of the Act, to establish the process for an individual to apply to the WTC Health Program, obtain an initial health evaluation, monitoring, and treatment, and appeal eligibility and treatment decisions.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A 60-day Federal Register Notice was published in the Federal Register on September 4, 2013, vol. 78, No. 171, pp. 54471-54472. There was one public comment (Appendix I).

B. This application form was created by mirroring the existing OMB approved forms for responders and survivors in New York. NIOSH consulted with the Steering Committees for both the Responder Program and the Survivor Program during monthly meetings in July, August, September, and October 2011.These Steering Committees are made up of affected stakeholders who represent the Centers of Excellence providing services to eligible WTC responders and survivors; representatives of labor organizations for firefighters, police, other New York City employees, and recovery and cleanup workers; representatives of residents, students, and WTC area employees; and representatives of New York City. Comments about the forms were received from both groups and incorporated into the appropriate application forms. An issue that could not be resolved during consultation was a request by the Steering Committees to administer the application forms over the phone by guiding the applicants through all parts of the forms. Since the applicant is required to sign the form and attest to the truthfulness of the information, it was deemed necessary for the applicant to complete the form. However, the forms contain an offer of phone assistance to answer applicants’ questions.

9. Explanation of any Payment/Gift to Respondents

Not applicable.

10. Assurance of Confidentiality Provided to Respondents

This submission has been reviewed by CDC’s Information Collection Review Office (ICRO), who determined that the Privacy Act does apply. The applicable System of Records Notice is 09-20-0147, “Occupational Health Epidemiological Studies and EEOICPA Program Records, and WTC Health Program Records”.

Information in identifiable form will be collected in the enrollment forms. This includes individual’s name, date of birth, last four digits of the Social Security number, driver’s license number, phone number, and mailing address. Access to data will be limited to authorized NIOSH project staff and authorized Computer Sciences Corporation (CSC) contractors. All electronic data will be stored on secure servers accessible only with passwords. Computer Sciences Corporation will be required to follow equivalent procedures.

Respondents will be informed about the intended uses of the information collection and plans for sharing the information on the World Trade Center Health Program Pentagon & Shanksville, Pennsylvania Responder Eligibility Application.

Respondents will be informed of the voluntary nature of their response, and will be further notified that failure to include information requested on the form may result in delay or denial of enrollment.

11. Justification for Sensitive Questions

The last four digits of Social Security numbers may be needed for checking against the Terrorist watch list. This information will be collected and shared with the FBI. This procedure is required by the Zadroga Act; however, all respondents will be made aware that providing the last four digits of SSN’s is voluntary and failure to provide this information will not result in any individual being denied for the program. This information appears on the enrollment form (Appendix H).

12. Estimates of Annualized Burden Hours

World Trade Center Health Program Pentagon & Shanksville, Pennsylvania Responder Eligibility Application (Appendix H): We expect to receive approximately 1,605 applications in the first year. The application is expected to take 30 minutes to complete.

Eligibility Denial Letter and Appeal Notification- example (Appendix C and C1): Of the 1,605 applications we expect to receive per year, we expect that 2.5 percent will fail due to ineligibility. We further assume that 10 percent of those individuals (4 respondents) will appeal the decision.

Appeals regarding certification of health conditions- example (Appendix E and E1): We expect that program participants will request certification for 874 health conditions each year. Of those 874, we expect that 1 percent (<1) will be denied certification by the WTC Program Administrator. We further expect that such a denial will be appealed 95 percent of the time.

Appeals regarding treatment-example (Appendix F and F1): Of the projected 454 enrollees who will receive medical care, it is estimated that 3 percent (14) will appeal a determination by the WTC Health Program that the treatment being sought is not medically necessary. We estimate that the appeals letter will take no more than 30 minutes.

Outpatient prescription pharmaceuticals (Appendix G): Pharmacies will electronically transmit reimbursement claims to the WTC Health Program (there is no form for this submission). HHS estimates that 4 pharmacies will submit reimbursement claims for 1,058 prescriptions per year, or 265 per pharmacy; we estimate that each submission will take 1 minute. The following data elements will be collected for pharmacy reimbursement: pharmacy name, pharmacy address, drug name, prescription number, patient name, patient ID number, and cost.

WTC Health Program Medical Travel Refund Request (Appendix D): WTC responders who travel more than 250 miles to a nationwide network provider for medically necessary treatment may be provided necessary and reasonable transportation and other expenses. These individuals may submit a travel refund request form, which should take respondents 10 minutes to complete. HHS expects no more than 1 claim per year.

12A. Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Pentagon or Shanksville, Pennsylvania Responder	World Trade Center Health Program Pentagon & Shanksville, Pennsylvania Responder Eligibility Application	1,605	1	30/60	803
Pentagon or Shanksville, Pennsylvania Responder	Appeals to Eligibility Denial	4	1	30/60	2
Pentagon or Shanksville, Pennsylvania Responder	Appeals regarding certification of health conditions	1	1	30/60	.5
Pentagon or Shanksville, Pennsylvania Responder	Appeals regarding treatment	14	1	30/60	7
Pharmacies	Outpatient prescription pharmaceuticals	4	265	1/60	18
Pentagon or Shanksville, Pennsylvania Responder	WTC Health Program Medical Travel Refund Request	1	1	10/60	.5
Total					831

Values are rounded up to the nearest hour/half-hour.

12B. Estimated Annualized Burden Costs

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Pentagon or Shanksville, Pennsylvania Responder (application)	803	$27.16*	$21,809
Pentagon or Shanksville, Pennsylvania Responder (eligibility denial appeal )	2	$27.16*	$54.32
Pentagon or Shanksville, Pennsylvania Responder (health conditions appeals)	.5	$27.16*	$14
Pentagon or Shanksville, Pennsylvania Responder (treatment appeals)	7	$27.16*	$190
Pharmacy technician	18	$14.43**	$260
Pentagon or Shanksville, Pennsylvania Responder (travel expenses)	.5	$27.16*	$14

*Data from Bureau of Labor Statistics May 2011 Metropolitan and Nonmetropolitan Area Occupational Employment and Wage Estimates, Washington-Arlington-Alexandria, DC-VA-MD-WV

** Data from Bureau of Labor Statistics May 2011 Healthcare Practitioners and Technical Occupations

13. Estimates of other Total Annual Cost Burden to Respondents or Record Keepers/Capital Costs

There are no additional recordkeeping/capital costs.

14. Annualized Cost to Federal Government

Type of Federal employee support	Total Burden Hours	Hourly Wage Rate	Total Federal Costs
Contractor (review of eligibility forms)	803	$25.00	$20,075
Medical and non-medical staff (review of healthcare and eligibility appeals, physician determination)	443.5	$100.00	$44,350
Total	$64,425

15. Explanation for Program Changes or Adjustments

This is a new data collection.

16. Plans for Tabulation and Publication and Project Time Schedule

Data collection began upon promulgation of Pentagon and Shanksville, Pennsylvania eligibility criteria. An interim final rule was published in the Federal Register on March 28, 2013 vol. 78, No. 60 pp. 18855-18865 (Appendix J).

17. Reason(s) Display of OMB Expiration Date is Inappropriate

Not applicable.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

1 Police department means any law enforcement department or agency, whether under Federal, state, or local jurisdiction, responsible for general police duties, such as maintenance of public order, safety, or health, enforcement of laws, or otherwise charged with prevention, detection, investigation, or prosecution of crimes.