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 

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: 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 

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, 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 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

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

States ................................................ Weekly (Automated) ......................... 50 52 20/60 867 

States ................................................ Weekly (Non-automated) ................. 10 52 2 1,040 

States ................................................ Weekly (DMI Implementation) .......... 50 52 4 10,400 

States ................................................ Annual .............................................. 50 1 75 3,750 

States ................................................ One-time Addition of Diseases and 

Data Elements.

50 1 2 100 

Territories .......................................... Weekly (Automated) ......................... 5 52 20/60 87 

Territories .......................................... Weekly, Quarterly (Non-automated) 5 56 20/60 93 

Territories .......................................... Weekly (DMI Implementation) .......... 5 52 4 1,040 

Territories .......................................... Annual .............................................. 5 1 5 25 

Territories .......................................... One-time Addition of Diseases and 

Data Elements.

5 1 4 20 

Freely Associated States .................. Weekly (Automated) ......................... 3 52 20/60 52 

Freely Associated States .................. Weekly, Quarterly (Non-automated) 3 56 20/60 56 

Freely Associated States .................. Annual .............................................. 3 1 5 15 

Freely Associated States .................. One-time Addition of Diseases and 

Data Elements.

3 1 2 6 

Cities ................................................. Weekly (Automated) ......................... 2 52 20/60 35 

Cities ................................................. Weekly (Non-automated) ................. 2 52 2 208 

Cities ................................................. Weekly (DMI Implementation) .......... 2 52 4 416 

Cities ................................................. Annual .............................................. 2 1 75 150 

Cities ................................................. One-time Addition of Diseases and 

Data Elements.

2 1 2 4 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–2274] 

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. 

ACTION: Notice of availability. 

SUMMARY: 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 


lotter on DSK11XQN23PROD with NOTICES1