60-day Federal Register Notice

Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0891; Docket No. CDC–2018–
0045]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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, Treatment,
Appeals & Reimbursement.
DATES: CDC must receive written
comments on or before July 10, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
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.
SUMMARY:

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

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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 Leroy A.
Richardson, 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

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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; and
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.
5. Assess information collection costs.
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

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22067

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 WTCRelated Health Condition for Coverage
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 (three) 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

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Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices

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 (five) 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,

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 will 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.

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 one
hour. The burden estimate for
certification denial appeals is 90 hours.
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 one
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

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

FDNY Responder ..............................

World Trade Center Health Program
FDNY Responder Eligibility Application.
World Trade Center Health Program
Responder Eligibility Application
(Other than FDNY).
World Trade Center Health Program
Pentagon/Shanksville Responder.
World Trade Center Health Program
Survivor Eligibility Application (all
languages).
Postcard for new general responders in NY/NJ to select a clinic.
Physician Request for Certification ..
Denial Letter and Appeal Notification—Enrollment.
Disenrollment Letter and Appeal
Notification.
Denial Letter and Appeal Notification—Health Condition Certification.
Decertification Letter and Appeal
Notification.
Denial Letter and Appeal Notification—Treatment Authorization.
WTC Health Program Medical Travel Refund Request.
Form to designate a representative
Form to share member information
Outpatient prescription pharmaceuticals.
Reimbursement Denial Letter and
Appeal Notification.

General Responder ...........................
Pentagon/Shanksville Responder .....
WTC Survivor ....................................
General responder ............................

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Program Medical Provider ................
Responder (FDNY and General Responder)/Survivor.
Responder (FDNY and General Responder)/Survivor.
Responder (FDNY and General Responder)/Survivor.
Responder (FDNY and General Responder)/Survivor.
Responder (FDNY and General Responder)/Survivor.
Responder (FDNY and General Responder)/Survivor.
Designated Rep Form .......................
HIPAA Release .................................
Pharmacy ..........................................
Program Medical Provider ................

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Number of
responses per
respondent

Number of
respondents

Type of respondents

Fmt 4703

Sfmt 4703

Average
burden per
response
(in hours)

Total burden
(in hours)

45

1

30/60

23

2,475

1

30/60

1,238

630

1

30/60

315

1,350

1

30/60

675

2,475

1

15/60

619

20,000
45

1
1

30/60
30/60

10,000
23

3

1

30/60

1.5

60

1

90/60

90

5

1

90/60

7.5

26

1

90/60

39

10

1

10/60

2

30
30
150

1
1
261

15/60
15/60
1/60

7.5
7.5
653

600

1

30/60

300

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Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

Responder/Survivor/Advocate (physician).

Petition for the addition of health
conditions.

60

1

60/60

60

Total ...........................................

..........................................................

........................

........................

........................

14,061

Jeffrey M. Zirger,
Acting 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. 2018–10067 Filed 5–10–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0950; Docket No. CDC–2018–
0040]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS)
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
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
National Health and Nutrition
Examination Survey (NHANES).
NHANES programs produce descriptive
statistics, which measure the health and
nutrition status of the general
population.
DATES: CDC must receive written
comments on or before July 10, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0040 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
SUMMARY:

sradovich on DSK3GMQ082PROD with NOTICES

Number of
respondents

Type of respondents

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3. Enhance the quality, utility, and
clarity of the information to be
collected; and
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
Please note: Submit all comments through
technological collection techniques or
the Federal eRulemaking portal
other forms of information technology,
(regulations.gov) or by U.S. mail to the
e.g., permitting electronic submissions
address listed above.
of responses.
FOR FURTHER INFORMATION CONTACT: To
5. Assess information collection costs.
request more information on the
Proposed Project
proposed project or to obtain a copy of
The National Health and Nutrition
the information collection plan and
Examination Survey (NHANES), (OMB
instruments, contact Leroy A.
Control Number 0920–0950, Expiration
Richardson, Information Collection
Date 12/31/2019)—Revision — National
Review Office, Centers for Disease
Center for Health Statistics (NCHS),
Control and Prevention, 1600 Clifton
Centers for Disease Control and
Road NE, MS–D74, Atlanta, Georgia
Prevention (CDC).
30329; phone: 404–639–7570; Email:
[email protected].
Background and Brief Description
SUPPLEMENTARY INFORMATION: Under the
Section 306 of the Public Health
Paperwork Reduction Act of 1995 (PRA) Service (PHS) Act (42 U.S.C. 242k), as
(44 U.S.C. 3501–3520), Federal agencies amended, authorizes that the Secretary
must obtain approval from the Office of
of Health and Human Services (DHHS),
Management and Budget (OMB) for each acting through NCHS, shall collect
collection of information they conduct
statistics on the extent and nature of
or sponsor. In addition, the PRA also
illness and disability; environmental,
requires Federal agencies to provide a
social and other health hazards; and
60-day notice in the Federal Register
determinants of health of the population
concerning each proposed collection of
of the United States. The National
information, including each new
Health and Nutrition Examination
proposed collection, each proposed
Surveys (NHANES) have been
extension of existing collection of
conducted periodically between 1970
information, and each reinstatement of
and 1994, and continuously since 1999
previously approved information
by the National Center for Health
collection before submitting the
Statistics, CDC.
collection to the OMB for approval. To
NHANES programs produce
comply with this requirement, we are
descriptive statistics, which measure the
publishing this notice of a proposed
health and nutrition status of the
data collection as described below.
general population. With physical
The OMB is particularly interested in examinations, laboratory tests, and
comments that will help:
interviews, NHANES studies the
1. Evaluate whether the proposed
relationship between diet, nutrition and
collection of information is necessary
health in a representative sample of the
for the proper performance of the
United States.
functions of the agency, including
NHANES monitors the prevalence of
whether the information will have
chronic conditions and risk factors.
practical utility;
NHANES data are used to produce
national reference data on height,
2. Evaluate the accuracy of the
weight, and nutrient levels in the blood.
agency’s estimate of the burden of the
Results from more recent NHANES can
proposed collection of information,
be compared to findings reported from
including the validity of the
previous surveys to monitor changes in
methodology and assumptions used;
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.

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