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These estimates include any time
spent by separately incorporated
subsidiaries and other entities affiliated
with the ultimate parent companies that
receive the information requests.
Estimated Average Burden per Year
Per Request: 196 hours.
(a) Information requests to the four
largest recipients 6 of the Commission’s
information request, at a per request
average each year of 400 hours = 2,400
hours, cumulatively, per year; and
(b) Information requests to nine
additional respondents, of smaller size,
at a per request average each year of 60
hours = 540 hours, cumulatively, per
year.
Estimated Annual Labor Cost:
$294,000.
Estimated Capital or Other Non-Labor
Cost: de minimis.
Request for Comment
Your comment—including your name
and your state—will be placed on the
public record of this proceeding.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, such as anyone’s Social
Security number; date of birth; driver’s
license number or other state
identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure that your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . is privileged or
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Josephine Liu,
Assistant General Counsel for Legal Counsel.
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[FR Doc. 2020–23515 Filed 10–22–20; 8:45 am]
BILLING CODE 6750–01–P

collection of information during that period,
including . . . separately incorporated subsidiaries
or affiliates.’’).
6 There are two tobacco companies that receive
both a cigarette Order and a smokeless tobacco
Order. Thus, this would equate to six requests for
burden analysis.

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–0728; Docket No. CDC–2020–
0096]

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 National Notifiable Diseases
Surveillance System—Revision—Center
for Surveillance, Epidemiology and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
The purpose of this data collection is to
provide the official source of statistics
in the United States for nationally
notifiable conditions. Data will be used
to monitor the occurrence and spread of
nationally notifiable conditions. Data
will be gathered through electronic
submissions of case notifications to CDC
from public health departments from 50
states, New York City, Washington DC,
five U.S. territories, and three freely
associated states.
DATES: CDC must receive written
comments on or before December 22,
2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0096 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.
SUMMARY:

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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; 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.
FOR FURTHER INFORMATION CONTACT:

Proposed Project
National Notifiable Diseases
Surveillance System (OMB Control No.
0920–0728, Exp. 04/30/2023)—
Revision—Center for Surveillance,
Epidemiology and Laboratory Services
(CSELS), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Public Health Services Act (42
U.S.C. 241) authorizes CDC to

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Federal Register / Vol. 85, No. 206 / Friday, October 23, 2020 / Notices
disseminate nationally notifiable
condition information. The National
Notifiable Diseases Surveillance System
(NNDSS) is based on data collected at
the state, territorial and local levels as
a result of legislation and regulations in
those jurisdictions that require health
care providers, medical laboratories,
and other entities to submit healthrelated data on reportable conditions to
public health departments. These
reportable conditions, which include
infectious and non-infectious diseases,
vary by jurisdiction depending upon
each jurisdiction’s health priorities and
needs. Each year, the Council of State
and Territorial Epidemiologists (CSTE),
supported by CDC, determines which
reportable conditions should be
designated nationally notifiable or
under standardized surveillance.
CDC requests a three-year approval for
a Revision for the NNDSS (OMB Control
No. 0920–0728, Expiration Date 04/30/
2023). This Revision includes requests
for approval to: (1) Receive case
notification data for Multisystem
Inflammatory Syndrome (MIS)
associated with Coronavirus Disease
2019 (COVID–19); (2) receive new
disease-specific data elements for
Anthrax, Brucellosis,
Campylobacteriosis, Cholera,
Cryptosporidiosis, Hansen’s Disease,
Leptospirosis, Melioidosis, MIS
associated with COVID–19, COVID–19,
S. Paratyphi Infection, S. Typhi
Infection, Salmonellosis, STEC,
Shigellosis, and Vibriosis; and (3)
Receive new vaccine-related data
elements for all conditions.
The NNDSS currently facilitates the
submission and aggregation of case
notification data voluntarily submitted
to CDC from 60 jurisdictions: public
health departments in every U.S. state,
New York City, Washington DC, five

available through CDC WONDER and
data.cdc.gov. Annual summaries of
finalized nationally notifiable disease
data are published on CDC WONDER
and data.cdc.gov and disease-specific
data are published by individual CDC
programs.
The burden estimates include the
number of hours that the public health
department uses to process and send
case notification data from their
jurisdiction to CDC. Specifically, the
burden estimates include separate
burden hours incurred for automated
and non-automated transmissions,
separate weekly burden hours incurred
for modernizing surveillance systems as
part of NNDSS Modernization Initiative
(NMI) implementation, separate burden
hours incurred for annual data
reconciliation and submission, and
separate one-time burden hours
incurred for the addition of new
diseases and data elements. The burden
estimates for the one-time burden for
reporting jurisdictions are for the
addition of case notification data for
MIS associated with COVID–19; diseasespecific data elements for Anthrax,
Brucellosis, Campylobacteriosis,
Cholera, Cryptosporidiosis, Hansen’s
Disease, Leptospirosis, Melioidosis, MIS
associated with COVID–19, COVID–19,
S. Paratyphi Infection, S. Typhi
Infection, Salmonellosis, STEC,
Shigellosis, and Vibriosis; and vaccine
data elements for all diseases. The
estimated annual burden for the 257
respondents is 18,954 hours. The cost of
the information collection is $830,400.
The total burden hours increased from
18,414 to 18,954 since the last revision
because there were more diseasespecific data elements added in this
revision as compared to the last
revision.

U.S. territories (American Samoa, the
Commonwealth of Northern Mariana
Islands, Guam, Puerto Rico, and the U.S.
Virgin Islands), and three freely
associated states (Federated States of
Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau). This information is shared
across jurisdictional boundaries and
both surveillance and prevention and
control activities are coordinated at
regional and national levels.
Approximately 90% of case
notifications are encrypted and
submitted to NNDSS electronically from
already existing databases by automated
electronic messages. When automated
transmission is not possible, case
notifications are faxed, emailed,
uploaded to a secure network or entered
into a secure website. All case
notifications that are faxed or emailed
are done so in the form of an aggregate
weekly or annual report, not individual
cases. These different mechanisms used
to send case notifications to CDC vary
by the jurisdiction and the disease or
condition. Jurisdictions remove most
personally identifiable information (PII)
before data are submitted to CDC, but
some data elements (e.g., date of birth,
date of diagnosis, county of residence)
could potentially be combined with
other information to identify
individuals. Private information is not
disclosed unless otherwise compelled
by law. All data are treated in a secure
manner consistent with the technical,
administrative, and operational controls
required by the Federal Information
Security Management Act of 2002
(FISMA) and the 2010 National Institute
of Standards and Technology (NIST)
Recommended Security Controls for
Federal Information Systems and
Organizations. Weekly tables of
nationally notifiable diseases are

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

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States
States
States
States
States

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

Territories
Territories
Territories
Territories
Territories

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

Freely Associated States ..................
Freely Associated States ..................
Freely Associated States ..................

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18:09 Oct 22, 2020

Weekly (Automated) .........................
Weekly (Non-automated) .................
Weekly (NMI Implementation) ..........
Annual ..............................................
One-time Addition of Diseases and
Data Elements.
Weekly (Automated) .........................
Weekly, Quarterly (Non-automated)
Weekly (NMI Implementation) ..........
Annual ..............................................
One-time Addition of Diseases and
Data Elements.
Weekly (Automated) .........................
Weekly, Quarterly (Non-automated)
Annual ..............................................

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Number of
responses per
respondent

Number of
respondents

Form name

Fmt 4703

Sfmt 4703

Average
burden per
response
(in hr)

Total burden
(in hr)

50
10
50
50
50

52
52
52
1
1

20/60
2
4
75
12

867
1,040
10,400
3,750
600

5
5
5
5
5

52
56
52
1
1

20/60
20/60
4
5
12

87
93
1,040
25
60

3
3
3

52
56
1

20/60
20/60
5

52
56
15

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Federal Register / Vol. 85, No. 206 / Friday, October 23, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hr)

Total burden
(in hr)

Form name

Freely Associated States ..................

One-time Addition of Diseases and
Data Elements.
Weekly (Automated) .........................
Weekly (Non-automated) .................
Weekly (NMI Implementation) ..........
Annual ..............................................
One-time Addition of Diseases and
Data Elements.

3

1

12

36

2
2
2
2
2

52
52
52
1
1

20/60
2
4
75
12

35
208
416
150
24

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

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

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

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

18,954

Cities
Cities
Cities
Cities
Cities

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

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–23454 Filed 10–22–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–148]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.

SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondent

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18:09 Oct 22, 2020

Jkt 253001

Comments must be received by
December 22, 2020.

DATES:

When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ___, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Call the Reports Clearance Office at
(410) 786–1326.

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:

Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).

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CMS–R–148 Limitations on Provider
Related Donations and Health Care
Related Taxes, Medicaid and
Supporting Regulations in 42 CFR
433.68 Through 433.74
Under the 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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Limitations on
Provider Related Donations and Health
Care Related Taxes, Medicaid and
Supporting Regulations in 42 CFR
433.68 through 433.74; Use: States may
elect to submit a waiver to CMS for the
broad based and/or uniformity
requirements for any health care related
tax program which does not conform to
the broad based and uniformity
requirements. It is also the
responsibility of each State to
demonstrate that their tax program(s) do
not violate the hold harmless provision.
For a waiver to be approved and a
determination that the hold harmless
provision is not violated, States must
submit written documentation which
satisfies the regulatory requirements.

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