[Federal Register Volume 86, Number 82 (Friday, April 30, 2021)]
[Notices]
[Pages 22967-22969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09095]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0891; Docket No. CDC-2021-0045]


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.

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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: 
[email protected].

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

[[Page 22968]]

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, Sec.  
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 Sec.  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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
FDNY Responder................  World Trade                  140               1           30/60              70
                                 Center Health
                                 Program, FDNY
                                 Responder
                                 Eligibility
                                 Application for
                                 Enrollment.
General Responder.............  World Trade                6,215               1           30/60           3,108
                                 Center Health
                                 Program,
                                 Responder
                                 Eligibility
                                 Application for
                                 Enrollment
                                 (Other than
                                 FDNY).

[[Page 22969]]

 
Pentagon/Shanksville Responder  World Trade                  242               1           30/60             121
                                 Center Health
                                 Program,
                                 Pentagon/
                                 Shanksville
                                 Responder
                                 Application for
                                 Enrollment.
WTC Survivor..................  World Trade                9,240               1           30/60           4,620
                                 Center Health
                                 Program,
                                 Survivor
                                 Eligibility
                                 Application for
                                 Enrollment (all
                                 languages).
General responder.............  Clinic Selection           3,830               1           15/60             958
                                 Postcard for
                                 new general
                                 responders in
                                 NY/NJ to select
                                 a clinic.
Responder/Survivor/Advocate     Petition for the              35               1               1              35
 (physician).                    addition of
                                 health
                                 conditions.
Program Members...............  Designated                 1,300               1           15/60             325
                                 Representative
                                 Appointment
                                 Form.
Program Members...............  HIPAA Release              1,300               1           15/60             325
                                 Form to allow
                                 the sharing of
                                 member
                                 information
                                 with a third
                                 party.
Program Members...............  Member                     6,600               1           30/60           3,300
                                 Satisfaction
                                 Survey.
General Public................  WTCHP HIPAA                   30               1           15/60               8
                                 Authorization
                                 for Deceased
                                 Individuals.
General Public................  WTCHP General                 30               1           15/60               8
                                 HIPAA
                                 Authorization
                                 to Third
                                 Parties.
Designated (DR) Representative  DR form that                  15               1           15/60               4
 Revocation Form.                removes the
                                 members current
                                 designated
                                 representative.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          12,882
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-09095 Filed 4-29-21; 8:45 am]
BILLING CODE 4163-18-P