Proposed Data Collection Submitted for Public Comment and Recommendations, 93296-93297 [2024-27691]

Download as PDF 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, lotter on DSK11XQN23PROD with NOTICES1 ADDRESSES: VerDate Sep<11>2014 18:03 Nov 25, 2024 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 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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, E:\FR\FM\26NON1.SGM 26NON1 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] lotter on DSK11XQN23PROD with NOTICES1 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 Jkt 265001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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: E:\FR\FM\26NON1.SGM 26NON1

Agencies

[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93296-93297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27691]


-----------------------------------------------------------------------

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

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: 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.

ADDRESSES: 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, 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: [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;
    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 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 
health-related 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,

[[Page 93297]]

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 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 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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
States........................  Weekly                        50              52           20/60             867
                                 (Automated).
States........................  Weekly (Non-                  10              52               2           1,040
                                 automated).
States........................  Weekly (DMI                   50              52               4          10,400
                                 Implementation).
States........................  Annual..........              50               1              75           3,750
States........................  One-time                      50               1               2             100
                                 Addition of
                                 Diseases and
                                 Data Elements.
Territories...................  Weekly                         5              52           20/60              87
                                 (Automated).
Territories...................  Weekly,                        5              56           20/60              93
                                 Quarterly (Non-
                                 automated).
Territories...................  Weekly (DMI                    5              52               4           1,040
                                 Implementation).
Territories...................  Annual..........               5               1               5              25
Territories...................  One-time                       5               1               4              20
                                 Addition of
                                 Diseases and
                                 Data Elements.
Freely Associated States......  Weekly                         3              52           20/60              52
                                 (Automated).
Freely Associated States......  Weekly,                        3              56           20/60              56
                                 Quarterly (Non-
                                 automated).
Freely Associated States......  Annual..........               3               1               5              15
Freely Associated States......  One-time                       3               1               2               6
                                 Addition of
                                 Diseases and
                                 Data Elements.
Cities........................  Weekly                         2              52           20/60              35
                                 (Automated).
Cities........................  Weekly (Non-                   2              52               2             208
                                 automated).
Cities........................  Weekly (DMI                    2              52               4             416
                                 Implementation).
Cities........................  Annual..........               2               1              75             150
Cities........................  One-time                       2               1               2               4
                                 Addition of
                                 Diseases and
                                 Data Elements.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          18,354
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-27691 Filed 11-25-24; 8:45 am]
BILLING CODE 4163-18-P


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