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 


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93298 Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 

ethylene oxide (EtO) whose products are 

affected by the potential, actual, or 

temporary stop or reduction of 

operations at a sterilization facility, if 

they wish to have FDA consider 

whether the exercise of enforcement 

discretion relating to the 

implementation of certain types of 

sterilization site changes is appropriate. 

FDA is issuing this guidance to provide 

an enforcement discretion policy to help 

proactively address manufacturing 

limitations or supply chain issues due 

to disruptions caused by closures or 

potential closures of sterilization 

facilities that use EtO as a medical 

device sterilant during the time in 

which manufacturers are transitioning 

to compliance with certain new 

requirements. FDA believes that the 

enforcement discretion policy described 

in this guidance may help address 

concerns during this time related to 

potential sterile medical device impacts 

affecting certain devices sterilized by 

EtO, help mitigate possible 

interruptions in sterile device 

processing, and help maintain adequate 

supplies of finished sterile medical 

devices. This guidance has been 

implemented without prior comment, 

but it remains subject to comment in 

accordance with the Agency’s good 

guidance practices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 26, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–D–2274 for ‘‘Transitional 

Enforcement Policy for Ethylene Oxide 

Sterilization Facility Changes for Class 

III Devices.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Transitional 

Enforcement Policy for Ethylene Oxide 

Sterilization Facility Changes for Class 

III Devices’’ to the Office of Policy, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5441, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

FOR FURTHER INFORMATION CONTACT: 

Michael Hoffmann, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4110, Silver Spring, 

MD 20993–0002, 301–796–6476; or 

James Myers, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry and FDA 

staff entitled ‘‘Transitional Enforcement 

Policy for Ethylene Oxide Sterilization 

Facility Changes for Class III Devices.’’ 

FDA plays a critical role in helping to 

protect the medical device supply chain 

and to prevent and mitigate potential 

medical product impacts. As part of this 

work, FDA closely monitors the supply 

chain effects of closures and potential 

closures of sterilization facilities that 

use EtO gas to sterilize medical devices 

prior to their use. For many medical 

devices, sterilization with EtO may be 

the only method that effectively 

sterilizes and does not damage the 

device during the sterilization process. 

To help maintain patient access to 


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Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 93299 

sterile medical devices and mitigate 

risks to the sterile device supply chain, 

FDA has been developing solutions to 

avoid potential device impacts during 

the time in which manufacturers are 

transitioning to compliance with certain 

new requirements for the use of EtO as 

a sterilant. 

FDA believes that the temporary 

enforcement discretion policy set forth 

in this guidance may help address 

urgent public health concerns related to 

potential sterile medical device impacts 

affecting certain devices sterilized by 

EtO. Specifically, this guidance is 

intended to provide information 

regarding what guiding principles FDA 

will consider and what types of 

information submitted by industry 

would be helpful to FDA to determine, 

on a case-by-case basis, whether to not 

object to sterilization site changes 

geared specifically to PMA and HDE 

holders of approved class III devices 

sterilized by EtO prior to the approval 

of a PMA or HDE supplement. This 

approach is intended to help firms more 

quickly and proactively manage the 

possible timeframes associated with 

implementing changes in the 

manufacturing site and any processes, 

methods, procedures, qualifications, 

and validations to help minimize 

impacts to the supply chain for EtOsterilized class III devices. Further, this 

document is intended to be considered 

alongside other applicable FDA 

guidance documents, such as 

‘‘Manufacturing Site Change 

Supplements: Content and 

Submission,’’ (hereafter ‘‘Site Change 

Supplement Guidance’’) issued 

December 17, 2018. 

This guidance is being implemented 

without prior public comment because 

FDA has determined that prior public 

participation for this guidance is not 

feasible or appropriate (see section 

701(h)(1)(c) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

371(h)(1)(C)) and 21 CFR 10.115(g)(2)). 

The immediate implementation of this 

guidance document is necessary to help 

protect the sterile device supply chain 

and is in the interest of proposing a less 

burdensome policy consistent with 

public health. FDA believes that the 

enforcement discretion policy described 

in this guidance may mitigate possible 

interruptions in sterile device 

processing and help maintain adequate 

supplies of finished sterile medical 

devices. Expedited sterilization site 

changes may be needed due to ongoing 

changes in the medical device 

sterilization landscape to reduce the 

likelihood of impact for certain EtO 

sterilized devices due to a potential, 

actual, or temporary stop or reduction of 

operations at a sterilization facility that 

sterilizes those devices. Although this 

policy is being implemented 

immediately without prior comment, it 

remains subject to comment in 

accordance with FDA’s good guidance 

practices regulation (21 

CFR 10.115(g)(3)(D)). FDA will consider 

all comments received and revise the 

guidance document as appropriate. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Transitional 

Enforcement Policy for Ethylene Oxide 

Sterilization Facility Changes for Class 

III Devices.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘Transitional 

Enforcement Policy for Ethylene Oxide 

Sterilization Facility Changes for Class 

III Devices’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number GUI00007027 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information in 

the following table have been approved 

by OMB: 

21 CFR Part; Guidance; or FDA Form Topic OMB control No. 

814, subparts A through E ....................................................... Premarket approval ................................................................. 0910–0231 

814, subpart H ......................................................................... Humanitarian Use Devices; Humanitarian Device Exemption 0910–0332 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions and Early Payor Feedback Request Programs for Medical Devices.0910–0756 

820 ........................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

807, subparts A through D ...................................................... Electronic Submission of Medical Device Registration and 

Listing.

0910–0625 

Dated: November 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–27661 Filed 11–25–24; 8:45 am] 

BILLING CODE 4164–01–P 


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