Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled World Trade Center Health Program Enrollment, Petitions, Designated Representative/HIPAA Authorization, and Member Satisfaction. Data collection is designed to provide healthcare monitoring and treatment to responders of the 9/11/2001 terrorist attacks at the World Trade Center in New York City, the Pentagon in Washington, DC, and Shanksville, Pennsylvania, as well as survivors in the New York City area.

DATES:

CDC must receive written comments on or before June 29, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0045 by any of the following methods:

Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Proposed Project

World Trade Center Health Program Enrollment, Petitions, Designated Representative/HIPAA Authorization, and Member Satisfaction. (OMB Control No. 0920-0891, Exp. 12/31/2021)—Revision—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

NIOSH seeks to request OMB approval to revise the currently approved information collection activities that support the World Trade Center (WTC) Health Program. The James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347, as amended by Pub. L. 114-113) created the WTC Health Program to provide medical monitoring and treatment benefits 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, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors).

Since its inception in 2011, the WTC Health Program has been approved to collect information from applicants and program members (enrolled WTC responders and survivors) concerning enrollment, appointment of a designated representative or third party, and petitions regarding adding a new WTC-related health condition in order to determine coverage under the Program. The current approved total estimated burden is 14,063 hours annually (OMB Control No. 0920-0891, Exp. December 31, 2021).

The WTC Health Program has determined that some existing forms need to be updated (WTC Health Program Applications for Enrollment and Designated Representative Appointment/Designated Representative HIPAA Authorization Forms). For this revision, the burden hours on the WTC Health Program Applications for Enrollment increased due to an expected increase of application volume. The Program updated the enrollment applications for plain language and improved processing. We estimate 15,837 individuals will submit either a FDNY (+95 from previous package), General Responder (+3,740 from previous package), Pentagon/Shanksville Responder (−388 from previous package), or WTC Survivor (+7,881 from previous package) application annually. The applications will take approximately 0.5 hours to complete. The burden estimate for the applications is 7,919 hours. This is an increase from 2018 when the estimated annualized burden was 2,251.

Of the Applications for Enrollment we expect to receive each year, CDC estimates 3,830 (+1,355 from 2018) are General Responder applications from the NY/NJ area, and will have to select which clinic they would like to visit. It is expected that it will take the member 0.25 hours to complete the postcard. The burden hours for the General Responder Clinic Postcard is 958 hours (+339 hours from 2018).

The Program finds it necessary to update and add new forms to allow applicants and Program members to grant permission to share information with a designated representative or third person about an individual's application or case. We estimate that 1,300 applicants and members will submit a Designated Representative Appointment Form and Designated Representative HIPAA Authorization Form annually. These forms will take approximately 0.25 hours to complete. The burden estimate for these forms is 650 hours. This is an increase from 2018 when the estimated annualized burden was 16.

For this Revision, new information collections related to WTCHP General HIPAA Authorization to Third Parties, HIPAA Authorization for Deceased Individuals, Designated Representative Revocation, and Member Satisfaction Survey should be added.

The Program proposes to extend this information collection to account for adding the WTCHP HIPAA Authorization for Deceased Individuals (+8 burden hours), WTCHP General HIPAA Authorization to Third Parties (+8 burden hours), and Designated Representative Revocation Form (+4 burden hours). The WTCHP HIPAA Authorization for Deceased Individuals was created so a family member and/or personal representative of a deceased applicant or member can request program documentation and/or medical records related to the deceased applicant/member. The WTCHP General HIPAA Authorization to Third Parties was created for members to give the Program permission to share information about their case with a third party, such as a lawyer. The Designated Representative Revocation Form was created for members who wish to remove or replace a currently appointed designated representative. We estimate that 30 applicants or members will submit a WTCHP HIPAA Authorization for Deceased Individuals, 30 applicants will submit a WTCHP General HIPAA Authorization to Third Parties form, and 15 applicants or members will submit a Designated Representative Revocation Form annually. These forms will take no longer than 0.25 hours to complete. The total burden estimate for the WTCHP HIPAA Authorization for Deceased Individuals form is eight hours. The total burden estimate for the WTCHP General HIPAA Authorization to Third Parties form is eight hours. The total burden estimate for the Designated Representative Revocation Form is four hours.

The Program also finds it necessary to add a Member Satisfaction Survey. This survey is for WTC Health Program members and asks for feedback about their satisfaction in the Program, at their clinic, and how they would like to receive Program communications. It is estimated that the Program will send 110,000 surveys a year. The response rate for previous member satisfaction surveys have been approximately 6%. Therefore, it is estimated that the Program will receive 6,600 surveys a year. The survey should take no longer than 0.5 hours to complete for a burden estimate of 3,300 burden hours.

In this Revision, the Program finds it necessary to remove documents that do not require OMB clearance from the information collection. A portion of the decrease in annualized burden (−46,260 hours) is due to adjusting the burden table to only include documents that are required for OMB Clearance. Some documents were removed because they are letters and there is no requirement for the public to fill them out. These documents are being included as supporting documentation. The letters removed are as follows:

• Denial Letter and Appeal Notification—Enrollment (−23 hours)
• Disenrollment Letter and Appeal Notification—Enrollment (−2 hours)
• Decertification Letter and Appeal Notification—Denial and Decertification Exposure (−8 hours)
• Denial Letter and Appeal Notification—Health Condition Certification (−90 hours)
• Denial Letter and Appeal Notification—Treatment Authorization (−39 hours)
• Reimbursement Denial Letter and Appeal Notification—Providers (−300 hours)

Another portion of the decrease in annualized burden (−10,655 hours) is due to removing forms that are not public and are filled out by Program physicians and contractors for the purpose of providing medical care. These forms are as follows:

• Physician Request for Certification (WTC-3) (−10,000 hours)
• WTC Health Program Medical Travel Refund Request (−2 hours)
• Outpatient prescription pharmaceuticals (−653 hours)

The Petition for the Addition of a New WTC-Related Health Condition for Coverage was previously approved in 2018. The burden hours for the Petition form decreased from 60 to 35 as the Program has received less petitions than anticipated in 2018. The Zadroga Act identified a list of health conditions for which individuals who are enrolled in the WTC Health Program may be monitored or treated [Title XXXIII, § 3312(a)(3)]; those conditions are reiterated and expanded in the associated WTC Health Program regulations at 42 CFR 88.15. Under WTC Health Program regulations (42 CFR 88.16), interested parties may submit a petition to request that a new health condition be added to the list of conditions specified in § 88.15. The forms should take no longer than one hour to complete for a burden estimate of 35 burden hours.

CDC requests OMB Clearance for three years. The total estimated annualized burden hours are 12,882.