Agency Forms Undergoing Paperwork Reduction Act Review, 7386-7387 [2021-01915]
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7386
Federal Register / Vol. 86, No. 17 / Thursday, January 28, 2021 / Notices
did not do so, making the company
liable under the rule.7
The Health Breach Notification Rule
was first issued more than a decade ago,
but the explosion in connected health
apps make its requirements more
important than ever. While we would
prefer to see substantive limits on firms’
ability to collect and monetize our
personal information, the rule at least
ensures that services like Flo need to
come clean when they experience
privacy or security breaches. Over time,
this may induce firms to take greater
care in collecting and monetizing our
most sensitive information.
Conclusion
We are pleased to see a notice
provision in today’s proposed order, but
there is much more the FTC can do to
protect consumers’ data, and hold
accountable those who abuse it. Where
Congress has given us rulemaking
authority, we should use it.8 And where
we have rules already on the books, we
should enforce them. Here, the Health
Breach Notification Rule will have its
intended effect only if the FTC is
willing to enforce it.
We believe enforcing the rule was
warranted here, and we respectfully
dissent from the Commission’s failure to
do so. Particularly as we seek more
authority from Congress in the privacy
space, it is critical we demonstrate we
are prepared to use the authorities we
already have.
[FR Doc. 2021–01697 Filed 1–27–21; 8:45 am]
BILLING CODE 6750–01–P
7 See 16 CFR 318.7 (stating that a violation of the
rule constitutes a violation of a trade regulation
rule). Notably, California’s recent action against a
similar fertility-tracking app charged with similar
privacy violations included a $250,000 civil
penalty. Press Release, Cal. Att’y Gen., Attorney
General Becerra Announces Landmark Settlement
Against Glow, Inc.—Fertility App Risked Exposing
Millions of Women’s Personal and Medical
Information (Sep. 17, 2020), https://oag.ca.gov/
news/press-releases/attorney-general-becerraannounces-landmark-settlement-against-glow-inc%E2%80%93.
8 We have previously articulated opportunities to
make use of our existing authorities when it comes
to data protection. See Statement of Commissioner
Rohit Chopra Regarding the Report to Congress on
the FTC’s Use of Its Authorities to Protect
Consumer Privacy and Security, Comm’n File
P065404 (June 18, 2020), https://www.ftc.gov/
public-statements/2020/06/statementcommissioner-rohit-chopra-regarding-reportcongress-ftcs-use-its; Remarks of Commissioner
Rebecca Kelly Slaughter at Silicon Flatirons, The
Near Future of U.S. Privacy Law, University of
Colorado Law School (Sep. 6, 2019), https://
www.ftc.gov/system/files/documents/public_
statements/1543396/slaughter_silicon_flatirons_
remarks_9-6-19.pdf.
VerDate Sep<11>2014
17:16 Jan 27, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–0909]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled CDC Diabetes
Prevention Recognition Program (DPRP)
to the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on June 15, 2020, to obtain
comments from the public and affected
agencies. CDC received 30 unique sets
of public comments. Within the 30 sets
of comments, there were 126 questions/
comments answered by CDC. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
CDC Diabetes Prevention Recognition
Program (DPRP) (OMB Control No.
0920–0909, Exp. 02/28/2021)—
Revision—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC’s Division of Diabetes
Translation (DDT) established and
administers the National Diabetes
Prevention Program’s (National DPP)
Diabetes Prevention Recognition
Program (DPRP), which recognizes
organizations that deliver diabetes
prevention programs according to
evidence-based requirements set forth in
the ‘Centers for Disease Control and
Prevention Diabetes Prevention
Recognition Program Standards and
Operating Procedures’ (DPRP
Standards). Additionally, the Centers for
Medicare and Medicaid Services (CMS)
Medicare Diabetes Prevention Program
(MDPP) expansion of CDC’s National
DPP was announced in early 2016,
when the Secretary of Health and
Human Services determined that the
Diabetes Prevention Program met the
statutory criteria for inclusion in
Medicare’s expanded list of healthcare
services for beneficiaries (https://
innovation.cms.gov/initiatives/
medicare-diabetes-prevention-program/
). This is the first time a preventive
service model from the CMS Innovation
(CMMI) Center has been expanded.
After extensive testing of the DPP model
in 17 sites across the U.S. in 2014–2016,
CMS proposed the MDPP in Sections
1102 and 1871 of the Social Security
Act (42 U.S.C. 1302 and 1395hh
§ 424.59), authorizing CDC-recognized
organizations to prepare for enrollment
as MDPP suppliers beginning in January
2018 in order to bill CMS for these
services. Only organizations in good
standing with the CDC DPRP are eligible
as MDPP suppliers. CDC continues to
work with CMS to support the MDPP.
CDC requests an additional three
years of OMB approval to continue
collecting the information needed to
administer the DPRP and information
E:\FR\FM\28JAN1.SGM
28JAN1
7387
Federal Register / Vol. 86, No. 17 / Thursday, January 28, 2021 / Notices
needed by CMS to support the MDPP
benefit. Based on experience with the
DPRP from 2011–2020, including data
analysis, and feedback from applicant
organizations and internal and external
partners, CDC plans to revise the DPRP
Standards and the associated
information collection.
Key changes are a direct result of
DPRP data analyses and discussion with
National DPP stakeholders, including
those serving vulnerable populations.
Key changes allow for the optional
collection of Hemoglobin A1C levels,
and for weight/physical activity minutes
to be combined (a new method), to
determine Full recognition; the required
collection of Application Delivery Mode
questions; revised organizational type
information; program enrollment
motivation/enrollment source
information; adding Gender; and the
removal of Session ID. Three data
elements have been minimally revised
and no other data elements have been
added to the one-time application form;
and, three have been revised, one has
been deleted, and four have been added
to the evaluation data elements, as per
below:
Application Form
(1) Delivery Mode- follow-up questions
(revised)
(2) Class Type (revised)
(3) Organization Type (revised)
Evaluation Data Elements
(4) Enrollment Motivation (new)
(5) Enrollment Source (revised)
(6) Session ID (deleted)
(7) HBA1C Value (new)
(8) Participant’s Gender (new)
During the period of this Revision,
CDC estimates receipt of approximately
300 DPRP application forms per year.
The estimated burden per one-time, upfront application response is one hour.
CDC further estimates receipt of semiannual evaluation data (two hours at
each submission) from the new 300
organizations per year plus existing
organizations who also submit semi-
annual evaluation data. The total
estimated average annualized evaluation
burden to respondents is 8,700 hours.
This includes an estimate of the time
needed to extract and compile the
required data records and fields from an
existing electronic database, review the
data, create or enter a data file in the
required format (i.e., CSV file), and
submit the data file via the National
DPP website for upload into the DPRP
Data Portal. The estimated burden per
response is modest since the
information requested for DPRP
recognition is routinely collected by
most organizations that deliver lifestyle
change programs for their own internal
evaluation and possible insurance
reimbursement purposes, including
Medicare under the MDPP benefit.
Participation in the DPRP is voluntary,
data are de-identified, no Personally
Identifiable Information (PII) is
collected by CDC, and there are no costs
to respondents other than their time.
CDC is requesting a three-year approval.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Public sector organizations that deliver type 2
diabetes prevention programs.
Private sector organizations that deliver type
2 diabetes prevention programs.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–01915 Filed 1–27–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Requirement for Negative PreDeparture COVID–19 Test Result or
Documentation of Recovery From
COVID–19 for all Airline or Other
Aircraft Passengers Arriving Into the
United States From Any Foreign
Country
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of Agency Order.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
SUMMARY:
VerDate Sep<11>2014
17:16 Jan 27, 2021
Number of
respondents
Form name
Jkt 253001
DPRP
DPRP
DPRP
DPRP
Application Form .................................
Evaluation Data ...................................
Application Form .................................
Evaluation Data ...................................
Human Services (HHS) announces an
Agency Order requiring negative predeparture COVID–19 test results or
documentation of recovery from
COVID–19 for all airline or other aircraft
passengers arriving into the United
States from any foreign country. This
Order was signed by the CDC Director
on January 25, 2021 and supersedes the
previous Order signed by the CDC
Director on January 12, 2021.
DATES: This Order was effective January
26, 2021.
FOR FURTHER INFORMATION CONTACT:
Jennifer Buigut, Division of Global
Migration and Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H16–4, Atlanta,
GA 30329. Email: dgmqpolicyoffice@
cdc.gov.
This
Order prohibits the introduction into
the United States of any aircraft
passenger departing from any foreign
country unless the passenger: (1) Has a
negative pre-departure test result for
SARS–CoV–2, the virus that causes
COVID–19 (Qualifying Test); or (2)
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
90
630
210
1470
Number of
responses per
respondent
1
2
1
2
Average
burden per
response
(in hours)
1
2
1
2
written or electronic documentation of
recovery from COVID–19 after previous
SARS–CoV–2 infection in the form of a
positive viral test result and a letter
from a licensed health care provider or
public health official stating that the
passenger has been cleared for travel
(Documentation of Recovery).
This Order supersedes the previous
Order signed by the CDC Director on
January 12, 2021. This Order further
clarifies the exemption categories for
federal law enforcement and U.S.
Department of Defense (DOD) personnel
observing DOD precautions to prevent
the transmission of COVID–19 during
travel. This Order also replaces the
previous language concerning the ability
of airlines and aircraft operators to
request specific waivers and replaces it
with a limited humanitarian exemption
category allowing individuals and
organizations to request an exemption.
To be eligible for this limited
humanitarian exemption, the individual
or organization must demonstrate both:
(1) Exigent circumstances where
emergency travel is required to preserve
health and safety (e.g., emergency
E:\FR\FM\28JAN1.SGM
28JAN1
Agencies
[Federal Register Volume 86, Number 17 (Thursday, January 28, 2021)]
[Notices]
[Pages 7386-7387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01915]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-0909]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled CDC Diabetes Prevention Recognition Program
(DPRP) to the Office of Management and Budget (OMB) for review and
approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on June 15,
2020, to obtain comments from the public and affected agencies. CDC
received 30 unique sets of public comments. Within the 30 sets of
comments, there were 126 questions/comments answered by CDC. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
CDC Diabetes Prevention Recognition Program (DPRP) (OMB Control No.
0920-0909, Exp. 02/28/2021)--Revision--National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
CDC's Division of Diabetes Translation (DDT) established and
administers the National Diabetes Prevention Program's (National DPP)
Diabetes Prevention Recognition Program (DPRP), which recognizes
organizations that deliver diabetes prevention programs according to
evidence-based requirements set forth in the `Centers for Disease
Control and Prevention Diabetes Prevention Recognition Program
Standards and Operating Procedures' (DPRP Standards). Additionally, the
Centers for Medicare and Medicaid Services (CMS) Medicare Diabetes
Prevention Program (MDPP) expansion of CDC's National DPP was announced
in early 2016, when the Secretary of Health and Human Services
determined that the Diabetes Prevention Program met the statutory
criteria for inclusion in Medicare's expanded list of healthcare
services for beneficiaries (https://innovation.cms.gov/initiatives/medicare-diabetes-prevention-program/). This is the first time a
preventive service model from the CMS Innovation (CMMI) Center has been
expanded. After extensive testing of the DPP model in 17 sites across
the U.S. in 2014-2016, CMS proposed the MDPP in Sections 1102 and 1871
of the Social Security Act (42 U.S.C. 1302 and 1395hh Sec. 424.59),
authorizing CDC-recognized organizations to prepare for enrollment as
MDPP suppliers beginning in January 2018 in order to bill CMS for these
services. Only organizations in good standing with the CDC DPRP are
eligible as MDPP suppliers. CDC continues to work with CMS to support
the MDPP.
CDC requests an additional three years of OMB approval to continue
collecting the information needed to administer the DPRP and
information
[[Page 7387]]
needed by CMS to support the MDPP benefit. Based on experience with the
DPRP from 2011-2020, including data analysis, and feedback from
applicant organizations and internal and external partners, CDC plans
to revise the DPRP Standards and the associated information collection.
Key changes are a direct result of DPRP data analyses and
discussion with National DPP stakeholders, including those serving
vulnerable populations. Key changes allow for the optional collection
of Hemoglobin A1C levels, and for weight/physical activity minutes to
be combined (a new method), to determine Full recognition; the required
collection of Application Delivery Mode questions; revised
organizational type information; program enrollment motivation/
enrollment source information; adding Gender; and the removal of
Session ID. Three data elements have been minimally revised and no
other data elements have been added to the one-time application form;
and, three have been revised, one has been deleted, and four have been
added to the evaluation data elements, as per below:
Application Form
(1) Delivery Mode- follow-up questions (revised)
(2) Class Type (revised)
(3) Organization Type (revised)
Evaluation Data Elements
(4) Enrollment Motivation (new)
(5) Enrollment Source (revised)
(6) Session ID (deleted)
(7) HBA1C Value (new)
(8) Participant's Gender (new)
During the period of this Revision, CDC estimates receipt of
approximately 300 DPRP application forms per year. The estimated burden
per one-time, up-front application response is one hour. CDC further
estimates receipt of semi-annual evaluation data (two hours at each
submission) from the new 300 organizations per year plus existing
organizations who also submit semi-annual evaluation data. The total
estimated average annualized evaluation burden to respondents is 8,700
hours. This includes an estimate of the time needed to extract and
compile the required data records and fields from an existing
electronic database, review the data, create or enter a data file in
the required format (i.e., CSV file), and submit the data file via the
National DPP website for upload into the DPRP Data Portal. The
estimated burden per response is modest since the information requested
for DPRP recognition is routinely collected by most organizations that
deliver lifestyle change programs for their own internal evaluation and
possible insurance reimbursement purposes, including Medicare under the
MDPP benefit. Participation in the DPRP is voluntary, data are de-
identified, no Personally Identifiable Information (PII) is collected
by CDC, and there are no costs to respondents other than their time.
CDC is requesting a three-year approval.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Public sector organizations that DPRP Application Form... 90 1 1
deliver type 2 diabetes prevention DPRP Evaluation Data.... 630 2 2
programs.
Private sector organizations that DPRP Application Form... 210 1 1
deliver type 2 diabetes prevention DPRP Evaluation Data.... 1470 2 2
programs.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-01915 Filed 1-27-21; 8:45 am]
BILLING CODE 4163-18-P