[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Pages 73108-73110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25579]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0891; Docket No. CDC-2016-0099]


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 to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
revision to the ``World Trade Center Health Program Enrollment, 
Treatment, Appeals & Reimbursement'' information collection approved 
under OMB Control Number 0920-0891, which allows the collection of 
information from Program members and affiliated medical providers for 
the purpose of determining eligibility and providing treatment services 
in accordance with the James Zadroga 9/11 Health and Compensation Act 
of 2010.

DATES: Written comments must be received on or before December 23, 
2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0099 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of proposed 
revisions to an existing data collection as described below.
    Comments are invited on: (a) Whether the proposed revisions to an 
existing collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed revised collection of 
information; (c) ways to enhance the quality, utility, and clarity of 
the information to be collected; (d) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques or other forms of information 
technology; and (e) estimates of capital or start-up costs and costs of 
operation, maintenance, and purchase of services to provide 
information. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose 
or provide information to or for a Federal agency. This includes the 
time needed to review instructions; to develop, acquire, install and 
utilize technology and systems for the purpose of collecting, 
validating and verifying information, processing and maintaining 
information, and disclosing and providing information; to train 
personnel and to be able to respond to a collection of information, to 
search data sources, to complete and review the collection of 
information; and to transmit or otherwise disclose the information.

Proposed Project

    World Trade Center Health Program Enrollment, Treatment, Appeals & 
Reimbursement (OMB Control No. 0920-0891, Expires 09/30/2018)--
Revision--National Institute for Occupational Safety and Health, 
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).
    This request also seeks to incorporate the World Trade Center 
Health Program Petition for the addition of a New WTC-Related Health 
Condition for Coverage

[[Page 73109]]

under the WTC Health Program package (0920-0929) into the existing 
approval, World Trade Center Health Program Enrollment, Appeals, 
Reimbursement, & Petitions (OMB Control No. 0920-0891). Upon approval, 
OMB Control number 0920-0929 will be discontinued.
    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 eligibility and 
enrollment, appointment of a designated representative, medical care, 
travel reimbursement, and appeal of adverse Program decisions. The WTC 
Health Program is also currently approved to collect information from 
Program medical providers, including health condition certification 
requests and pharmaceutical claims. Currently-approved total estimated 
burden is 13,594 hours annually. See OMB Control No. 0920-0891, exp. 
September 30, 2018.
    The WTC Health Program has determined that some existing forms need 
to be updated, and new information collections related to a recent 
rulemaking should be added.
    Changes to WTC Health Program regulations in 42 CFR part 88 will 
require the extension of existing information collections. 
Specifically, 42 CFR 88.13 establishes procedures for the appeal of 
Program decisions to disenroll Program members and deny enrollment to 
applicants. Appeals of enrollment denial decisions, which include the 
submission of appeal request letters, are currently approved; the 
Program proposes to extend this information collection to account for 
the burden of requests for appeal of disenrollment decisions. Of the 
over 70,000 Program members, we expect that 0.014 percent (10) will be 
subsequently disenrolled from the Program. Of those, we expect that 30 
percent (3) will appeal the disenrollment decisions. We estimate that 
the disenrollment appeal requests will take no more than 0.5 hours per 
respondent. The annual burden estimate is 1.5 hours.
    Section 42 CFR 88.21 establishes procedures for the appeal of WTC 
Health Program decisions to decertify a WTC-related health condition, 
deny certification, and deny treatment authorization. Appeals of health 
condition certification denials and treatment authorization denials, 
which include the submission of appeal request letters, are currently 
approved; the Program proposes to extend this information collection to 
account for the burden of requests for appeal of decertification 
decisions. The information collection would also be expanded to allow 
Program members to provide additional information and/or an oral 
statement. Of the estimated 51,472 Program members who have at least 
one health condition certification, we estimate that 0.02 percent (10) 
will be decertified, and 50 percent (5) of those will appeal a 
decertification. We estimate that the appeal request letter will take 
no more than 0.5 hours per respondent. Providing additional information 
and/or an oral statement will take no more than 1 hour per respondent. 
The annual burden estimate for decertification appeals is 7.5 hours. We 
estimate that Program members request certification for 20,000 health 
conditions each year. Of those 20,000, we estimate that 1 percent (200) 
of certification requests are denied by the WTC Health Program. We 
further expect that 30 percent of denied certifications, or 60 
individuals, will be appealed. We estimate that the appeals letter 
takes no more than 30 minutes and providing additional information and/
or an oral statement will take no more than 1 hour. The burden estimate 
for certification denial appeals is 90 hours. Finally, of the projected 
51,472 Program members who receive medical care, we estimate that 0.05 
percent (26) 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 and providing 
additional information and/or an oral statement will take no more than 
1 hour. The burden estimate for treatment authorization denial appeals 
is 39 hours.
    Finally, 42 CFR 88.23 establishes procedures for the appeal of a 
WTC Health Program decision to deny reimbursement to a Program medical 
provider for treatment determined not to be medically necessary. 
Accordingly, the Program proposes the addition of information collected 
in the appeal request. We estimate that of the nearly 52,000 Program 
providers, we estimate that 1.15 percent (600) annually will be denied 
reimbursement for treatment found to be not medically necessary or in 
accordance with treatment protocols, and will appeal the decision. We 
estimate that the appeal letter will take no more than 0.5 hours to 
compile. The burden estimate for treatment reimbursement denial appeals 
is 300 hours.
    The Program also finds it necessary to add a new form to allow 
applicants and Program members to grant permission to share information 
with a third person about an individual's application or case. We 
estimate that 30 applicants and members will submit a Health Insurance 
Portability and Accountability Act (HIPAA) Release Form annually. The 
form is expected to take no longer than 0.25 hours to complete. The 
burden estimate for the HIPAA Release form is 7.5 hours.
    In addition to describing those burden estimates revised by this 
action, the estimated annualized burden hours for those collection 
instruments not subject to revision in this action are included in the 
table below.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
FDNY Responder................  World Trade                   45               1           30/60              23
                                 Center Health
                                 Program FDNY
                                 Responder
                                 Eligibility
                                 Application.
General Responder.............  World Trade                2,475               1           30/60           1,238
                                 Center Health
                                 Program
                                 Responder
                                 Eligibility
                                 Application
                                 (Other than
                                 FDNY).
Pentagon/Shanksville Responder  World Trade                  630               1           30/60             315
                                 Center Health
                                 Program
                                 Pentagon/
                                 Shanksville
                                 Responder.
WTC Survivor..................  World Trade                1,350               1           30/60             675
                                 Center Health
                                 Program
                                 Survivor
                                 Eligibility
                                 Application
                                 (all languages).

[[Page 73110]]

 
General responder.............  Postcard for new           2,475               1           15/60             619
                                 general
                                 responders in
                                 NY/NJ to select
                                 a clinic.
Program Medical Provider......  Physician                 20,000               1           30/60          10,000
                                 Request for
                                 Certification.
Responder (FDNY and General     Denial Letter                 45               1           30/60              23
 Responder)/Survivor.            and Appeal
                                 Notification--E
                                 nrollment.
Responder (FDNY and General     Disenrollment                  3               1           30/60             1.5
 Responder)/Survivor.            Letter and
                                 Appeal
                                 Notification.
Responder (FDNY and General     Denial Letter                 60               1           90/60              90
 Responder)/Survivor.            and Appeal
                                 Notification--H
                                 ealth Condition
                                 Certification.
Responder (FDNY and General     Decertification                5               1           90/60             7.5
 Responder)/Survivor.            Letter and
                                 Appeal
                                 Notification.
Responder (FDNY and General     Denial Letter                 26               1           90/60              39
 Responder)/Survivor.            and Appeal
                                 Notification--T
                                 reatment
                                 Authorization.
Responder (FDNY and General     WTC Health                    10               1           10/60               2
 Responder)/Survivor.            Program Medical
                                 Travel Refund
                                 Request.
Designated Rep Form...........  Form to                       10               1           15/60               3
                                 designate a
                                 representative.
HIPAA Release.................  Form to share                 10               1           15/60               3
                                 member
                                 information.
Pharmacy......................  Outpatient                   150             261            1/60             653
                                 prescription
                                 pharmaceuticals.
Program Medical Provider......  Reimbursement                600               1           30/60             300
                                 Denial Letter
                                 and Appeal
                                 Notification.
Responder/Survivor/Advocate     Petition for the              60               1           60/60              60
 (physician).                    addition of
                                 health
                                 conditions.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          14,052
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-25579 Filed 10-21-16; 8:45 am]
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