60d FRN - published 30APR2021

Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–09094 Filed 4–29–21; 8:45 am]
BILLING CODE 4163–18–P

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
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, 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

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(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).

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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 WTCrelated 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

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Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Notices

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

• 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)

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)

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.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

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

World Trade Center Health Program, FDNY Responder Eligibility
Application for Enrollment.
World Trade Center Health Program, Responder Eligibility Application for Enrollment (Other than
FDNY).

General Responder ...........................

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Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

140

1

30/60

70

6,215

1

30/60

3,108

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Federal Register / Vol. 86, No. 82 / Friday, April 30, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name

Pentagon/Shanksville Responder .....

Designated (DR) Representative
Revocation Form.

World Trade Center Health Program, Pentagon/Shanksville Responder Application for Enrollment.
World Trade Center Health Program, Survivor Eligibility Application for Enrollment (all languages).
Clinic Selection Postcard for new
general responders in NY/NJ to
select a clinic.
Petition for the addition of health
conditions.
Designated Representative Appointment Form.
HIPAA Release Form to allow the
sharing of member information
with a third party.
Member Satisfaction Survey ............
WTCHP HIPAA Authorization for
Deceased Individuals.
WTCHP General HIPAA Authorization to Third Parties.
DR form that removes the members
current designated representative.

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

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

WTC Survivor ....................................
General responder ............................
Responder/Survivor/Advocate (physician).
Program Members ............................
Program Members ............................
Program Members ............................
General Public ..................................
General Public ..................................

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Assessing the Implementation
and Cost of High-Quality Early Care
and Education: Field Test, OMB 0970–
0499
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:

The Administration for
Children and Families (ACF) at the U.S.
Department of Health and Human
Services (HHS) seeks approval to collect
new information to use in testing
measures of the implementation and
costs of high-quality early care and
education as part of the project,
Assessing the Implementation and Cost

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Number of
responses per
respondent

Number of
respondents

Type of respondents

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Total burden
(in hours)

242

1

30/60

121

9,240

1

30/60

4,620

3,830

1

15/60

958

35

1

1

35

1,300

1

15/60

325

1,300

1

15/60

325

6,600
30

1
1

30/60
15/60

3,300
8

30

1

15/60

8

15

1

15/60

4

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

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

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

12,882

of High-Quality Early Care and
Education (ECE–ICHQ). The study
received approval for a field test to
validate and improve the psychometric
properties of these measures in
November 2019. This request is to add
a measure to the approved field test to
help further assess the associations
between measures of implementation,
cost, and quality.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained, and comments may be
forwarded by emailing
OPREinfocollection@acf.hhs.gov.
Alternatively, copies can also be
obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF seeks approval to

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Average
burden per
response
(in hours)

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collect new information to use in testing
measures of the implementation and
costs of high-quality early care and
education as part of the ECE–ICHQ
project. The project’s goal is to create a
technically sound and feasible
instrument that will provide consistent,
systematic measures of the
implementation and costs of education
and care in center-based settings that
serve children from birth to age 5. The
resulting measures will inform research,
policy, and practice by improving
understanding of variations in what
centers do to support quality, their
associated costs, and how resources for
ECE may be better aligned with
expectations for quality. The study
received approval for a field test to
validate and improve the psychometric
properties of these measures in
November 2019. For all previously
approved materials for this study, see
https://www.reginfo.gov/public/do/
PRAOMBHistory?ombControlNumber=
0970-0499. This request is to add a
measure to the approved field test to
help further assess the associations
between measures of implementation,
cost, and quality. The field test and this
additional measure will include only
remote data collection.
Respondents: Teachers and aids.

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