60d FRN - published NOV2024

93296

Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices

Dated: November 21, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–27679 Filed 11–25–24; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–25–0728; Docket No. CDC–2024–
0095]

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 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.
This data collection provides the official
source of statistics in the United States
for nationally notifiable conditions.
DATES: CDC must receive written
comments on or before January 27,
2025.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2024–
0095 by either of the following methods:
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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,

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ADDRESSES:

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Jkt 265001

Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road, NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; 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
National Notifiable Diseases
Surveillance System (OMB Control No.
0920–0728, Exp. 3/31/2027)—
Revision—Office of Public Health Data,
Surveillance, and Technology
(OPHDST), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Public Health Services Act (42
U.S.C. 241) authorizes CDC to
disseminate nationally notifiable
condition information. The National
Notifiable Diseases Surveillance System
(NNDSS) is based on data collected at

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the State, territorial and local levels
because 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, under
which a set of uniform criteria used to
define a disease for public health
surveillance to enable public health
officials to classify and count cases
consistently across reporting
jurisdictions.
CDC requests a three-year approval for
a Revision for the NNDSS (OMB Control
No. 0920–0728, Exp. 03/31/2027) to: (1)
receive case notification data for Chagas
disease, yersiniosis (non-pestis), and
injuries related to firearms, new
conditions under standardized
surveillance; and (2) receive new
disease-specific data elements for
toxoplasmosis and congenital
toxoplasmosis. Like all other conditions
NNDSS receives data for, CSTE voted to
add the standardized public health case
definition of these cases and data
elements. Revising the NNDSS
information collection to include these
cases is necessary for NNDSS to receive
these voluntary data as standardized
case information. Data submission from
reporting jurisdictions on these and all
other NNDSS conditions is voluntary.
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
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,

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93297

Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
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

for modernizing surveillance systems as
part of CDC’s Data Modernization
Initiative (DMI) 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
the addition of case notification data for
Chagas disease, yersiniosis (non-pestis),
and injuries related to firearms, new
conditions under standardized
surveillance; and the addition of new
disease-specific data elements for
toxoplasmosis and congenital
toxoplasmosis. The estimated annual
burden for the 257 respondents is
18,354 hours.

(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
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

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

States
States
States
States
States

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

Territories
Territories
Territories
Territories
Territories

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

Freely
Freely
Freely
Freely

Associated
Associated
Associated
Associated

States
States
States
States

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

Cities
Cities
Cities
Cities
Cities

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

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

50
10
50
50
50

52
52
52
1
1

20/60
2
4
75
2

867
1,040
10,400
3,750
100

5
5
5
5
5

52
56
52
1
1

20/60
20/60
4
5
4

87
93
1,040
25
20

3
3
3
3

52
56
1
1

20/60
20/60
5
2

52
56
15
6

2
2
2
2
2

52
52
52
1
1

20/60
2
4
75
2

35
208
416
150
4

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

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

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

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

18,354

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2024–27691 Filed 11–25–24; 8:45 am]

[Docket No. FDA–2024–D–2274]

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BILLING CODE 4163–18–P

Food and Drug Administration

Transitional Enforcement Policy for
Ethylene Oxide Sterilization Facility
Changes for Class III Devices;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:

Food and Drug Administration,

HHS.

18:03 Nov 25, 2024

Total burden
(in hours)

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.

VerDate Sep<11>2014

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Form name

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ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Transitional
Enforcement Policy for Ethylene Oxide
Sterilization Facility Changes for Class
III Devices.’’ This guidance provides
information regarding FDA
recommendations and general
principles to be referenced by holders of
premarket approval applications (PMAs)
and humanitarian device exemptions
(HDE) for class III devices sterilized by

SUMMARY:

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