15202 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

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. 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 (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision with change of a 

currently approved collection; Title of 

Information Collection: Collection of 

Prescription Drug Data from MA–PD, 

PDP and Fallout Plans/Sponsors for 

Medicare Part D Payments; Use: The 

PDE data is used in the Payment 

Reconciliation System to perform the 

annual Part D payment reconciliation, 

any PDE data within the Coverage Gap 

Phase of the Part D benefit is used for 

invoicing in the CGDP, and the data are 

part of the report provided to the 

Secretary of the Treasury for Section 

9008. 

Sections 11001 through 11004 of the 

Inflation Reduction Act of 2022 

establish a Medicare Drug Negotiation 

Program for high-expenditure drugs. 

Section 11102 of the Inflation Reduction 

Act of 2022 establishes a Part D inflation 

rebate by manufacturers of certain single 

source drugs and biologicals with prices 

increasing at a rate faster than the rate 

of inflation. CMS will use data reported 

under sections 1860D–15(c)(1)(C) and 

(d)(2), in part, to rank drugs by total 

expenditures under Part D in order to 

select drugs for negotiation and to 

identify units to calculate inflation 

rebates. 

The information users will be 

pharmacy benefit managers (PBMs), 

third party administrators and 

pharmacies, and the PDPs, MA–PDs, 

Fallbacks, and other plans that offer 

coverage of outpatient prescription 

drugs under the Medicare Part D benefit 

to Medicare beneficiaries. The 

statutorily required data is used 

primarily for payment and is used for 

claim validation as well as for other 

legislated functions such as quality 

monitoring, program integrity and 

oversight. In addition, the PDE data are 

used to support operations and program 

development. Form Number: CMS– 

10174 (OMB control number: 0938– 

0982); Frequency: Monthly; Affected 

Public: Private sector and Federal 

Government; Number of Respondents: 

856; Total Annual Responses: 

1,499,064,780; Total Annual Hours: 

62,918. (For policy questions regarding 

this collection contact Shelly Winston at 

410–786–3694.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Indirect 

Medical Education and Direct Graduate 

Medical Education; Use: Section 

1886(d)(5)(B) of the Social Security Act 

requires additional payments to be 

made under the Medicare Prospective 

Payment System (PPS) for the indirect 

medical educational costs a hospital 

incurs in connection with interns and 

residents (IRs) in approved teaching 

programs. In addition, title 42, part 413, 

sections 75 through 83 implement 

section 1886(d) of the Act by 

establishing the methodology for 

Medicare payment for the costs of direct 

graduate medical educational activities. 

The information collected on IRs is 

used by Part- A Medicare 

Administrative Contractors (MAC) to 

verify the number of IRs FTE used in the 

calculation of Medicare payments for 

IME and GME. The IR data submitted by 

the hospitals to the MACs is uploaded 

into CMS’ Intern and Resident 

Information System (IRIS) database to 

identify duplicate FTEs reported for any 

IR. 

The MACs use the information 

collected on IRs to ensure that all 

program payments for IME and GME are 

accurate and are in accordance with 

Medicare regulations. The IR data 

submitted by the hospitals to the MACs 

are used to audit the Medicare cost 

reports filed by the hospitals. Form 

Number: CMS–R–64 (OMB control 

number: 0938–0456); Frequency: 

Monthly; Affected Public: Private sector 

and Federal Government; Number of 

Respondents: 1,245; Total Annual 

Responses: 1,245; Total Annual Hours: 

2,490. (For policy questions regarding 

this collection contact Owen Osaghae at 

410–786–7550.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–04341 Filed 2–29–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

061 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a publication containing 

modifications the Agency is making to 

the list of standards FDA recognizes for 

use in premarket reviews (FDA 

Recognized Consensus Standards). This 

publication, entitled ‘‘Modifications to 

the List of Recognized Standards, 

Recognition List Number: 061’’ 

(Recognition List Number: 061), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: Submit either electronic or 

written comments on the notice at any 

time. These modifications to the list of 

recognized standards are applicable 

March 1, 2024. 

ADDRESSES: You may submit comments 

on the current list of FDA Recognized 

Consensus Standards 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices 15203 

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– 

2004–N–0451 for ‘‘Food and Drug 

Administration Modernization Act of 

1997: Modifications to the List of 

Recognized Standards, Recognition List 

Number: 061.’’ 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. FDA will

consider any comments received in

determining whether to amend the

current listing of modifications to the

list of recognized standards, Recognition

List Number: 061.

• 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. 

An electronic copy of Recognition List 

Number: 061 is available on the internet 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. See section 

IV for electronic access to the searchable 

database for the current list of FDArecognized consensus standards, 

including Recognition List Number: 061 

modifications and other standardsrelated information. Submit written 

requests for a single hard copy of the 

document entitled ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 061’’ to Terry 

Woods, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Silver Spring, MD 20993, 

301–796–2503. Send one self-addressed 

adhesive label to assist that office in 

processing your request or fax your 

request to 301–847–8144. 

FOR FURTHER INFORMATION CONTACT: 

Terry Woods, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Silver Spring, MD 20993, 

301–796–2503, CDRHStandardsStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background

Section 204 of the Food and Drug

Administration Modernization Act of 

1997 (Pub. L. 105–115) amended section 

514 of the Federal Food, Drug, and 

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

360d). Amended section 514 of the 

FD&C Act allows FDA to recognize 

consensus standards developed by 

international and national organizations 

for use in satisfying portions of device 

premarket review submissions or other 

requirements. 

In the Federal Register of September 

14, 2018 (83 FR 46738), FDA announced 

the availability of a guidance entitled 

‘‘Appropriate Use of Voluntary 

Consensus Standards in Premarket 

Submissions for Medical Devices.’’ The 

guidance describes how FDA has 

implemented its standards recognition 

program and is available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

appropriate-use-voluntary-consensusstandards-premarket-submissionsmedical-devices. Modifications to the 

initial list of recognized standards, as 

published in the Federal Register, can 

be accessed at https://www.fda.gov/ 

medical-devices/standards-andconformity-assessment-program/federalregister-documents. 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

Agency maintains on its website HTML 

and PDF versions of the list of FDA 

Recognized Consensus Standards, 

available at https://www.fda.gov/ 

medical-devices/standards-andconformity-assessment-program/federalregister-documents. Additional 

information on the Agency’s Standards 

and Conformity Assessment Program is 

available at https://www.fda.gov/ 

medical-devices/device-advicecomprehensive-regulatory-assistance/ 

standards-and-conformity-assessmentprogram. 

II. Modifications to the List of

Recognized Standards, Recognition List

Number: 061

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the Agency 

is recognizing for use in premarket 

submissions and other requirements for 

devices. FDA is incorporating these 

modifications to the list of FDA 

Recognized Consensus Standards in the 

Agency’s searchable database. FDA is 

using the term ‘‘Recognition List 

Number: 061’’ to identify the current 

modifications. 

In table 1, FDA describes the 

following modifications: (1) the 

withdrawal of standards and their 

replacement by others, if applicable; (2) 

the correction of errors made by FDA in 

listing previously recognized standards; 

and (3) the changes to the 


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supplementary information sheets of 

recognized standards that describe 

revisions to the applicability of the 

standards. 

In section III, FDA lists modifications 

the Agency is making that involve new 

entries and consensus standards added 

as modifications to the list of recognized 

standards under Recognition List 

Number: 061. 

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

A. Anesthesiology 

1–73 ............ 1–162 ISO 10651–4 Second edition 2023–03 Lung ventilators—Part 4: Particular 

requirements for user-powered resuscitators.

Withdrawn and replaced with newer 

version. 

1–105 .......... 1–163 ISO 80601–2–72 Second edition 2023–06 Medical electrical equipment— 

Part 2–72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients.

Withdrawn and replaced with newer 

version. 

1–118 .......... 1–164 ISO 5361 Fourth edition 2023–11 Anaesthetic and respiratory equipment—Tracheal tubes and connectors.Withdrawn and replaced with newer 

version. 

1–141 .......... 1–165 ISO 80601–2–13 Second edition 2022–04 Medical electrical equipment— 

Part 2–13: Particular requirements for basic safety and essential performance of an anaesthetic workstation.

Withdrawn and replaced with newer 

version. 

B. Biocompatibility 

2–94 ............ 2–302 ASTM F981–23 Standard Practice for Assessment of Muscle and Bone 

Tissue Responses to Long-Term Implantable Materials Used in Medical 

Devices.

Withdrawn and replaced with newer 

version. 

2–237 .......... 2–303 ISO 10993–17 Second edition 2023–09 Biological evaluation of medical 

devices—Part 17: Toxicological risk assessment of medical device constituents.

Withdrawn and replaced with newer 

version. 

C. Cardiovascular 

3–105 .......... ...................... IEC 60601–2–25 Edition 2.0 2011–10 Medical electrical equipment—Part 

2–25: Particular requirements for the basic safety and essential performance of electrocardiographs.

Extent of recognition. 

3–126 .......... ...................... IEC 60601–2–27 Edition 3.0 2011–03 Medical electrical equipment—Part 

2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)].

Extent of recognition. 

3–138 .......... 3–189 ASTM F2942–19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents.Withdrawn and replaced with newer 

version. 

D. Dental/Ear, Nose, and Throat (ENT) 

4–137 .......... 4–309 ISO 6877 Third edition 2021–09 Dentistry—Endodontic obturating materials.Withdrawn and replaced with newer 

version. 

4–151 .......... 4–310 ISO 22112 Second edition 2017–08 Dentistry—Artificial teeth for dental 

prostheses.

Withdrawn and replaced with newer 

version. 

4–188 .......... 4–311 ISO 9917–2 Third edition 2017–09 Dentistry—Water-based cements— 

Part 2: Resin-modified cements.

Withdrawn and replaced with newer 

version. 

4–190 .......... 4–312 ANSI/ASA S3.35–2021 American National Standard Method for Method of 

Measurement of Performance Characteristics of Hearing Aids Under 

Simulated Real-Ear Working Conditions.

Withdrawn and replaced with newer 

version. 

4–218 .......... 4–313 ISO 27020 Second edition 2019–06 Dentistry—Brackets and tubes for 

use in orthodontics.

Withdrawn and replaced with newer 

version. 

4–221 .......... 4–314 ISO 7494–2 Third edition 2022–07 Dentistry—Stationary dental units and 

dental patient chairs—Part 2: Air, water, suction and wastewater systems.

Withdrawn and replaced with newer 

version. 

4–224 .......... 4–315 ISO 24234 Third edition 2021–08 Dentistry—Dental Amalgam ................... Withdrawn and replaced with newer 

version. 

4–238 .......... 4–316 ISO 20127 Second edition 2020–08 Dentistry—Physical properties of 

powered toothbrushes.

Withdrawn and replaced with newer 

version. 

4–244 .......... 4–317 ISO 8325 Third edition 2023–03 Dentistry—Test methods for rotary instruments.Withdrawn and replaced with newer 

version. 

4–246 .......... 4–318 ISO 20749 Second edition 2023–06 Dentistry—Pre-capsulated dental 

amalgam.

Withdrawn and replaced with newer 

version. 

4–257 .......... 4–319 ISO 17730 Second edition 2020–09 Dentistry—Fluoride varnishes ............ Withdrawn and replaced with newer

version. 

4–280 .......... ...................... ANSI/ADA Standard No. 117–2018 Fluoride varnishes ............................... Withdrawn with transition. See 4– 

319. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

E. General I (Quality Systems/Risk Management) (QS/RM) 

No new entries at this time. 

F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 

No new entries at this time. 

G. General Hospital/General Plastic Surgery (GH/GPS) 

6–338 .......... 6–497 ASTM D7866–23 Standard Specification for Radiation Attenuating Protective Gloves.Withdrawn and replaced with newer 

version. 

H. In Vitro Diagnostics (IVD) 

7–235 .......... 7–318 CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents.Withdrawn and replaced with newer 

version. 

7–304 .......... 7–319 CLSI M23 6th Edition Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters.Withdrawn and replaced with newer 

version. 

I. Materials 

8–171 .......... 8–605 ASTM F1609–23 Standard Specification for Calcium Phosphate Coatings 

for Implantable Materials.

Withdrawn and replaced with newer 

version. 

8–412 .......... 8–606 ASTM F2537–23 Standard Practice for Calibration of Linear Displacement 

Sensor Systems Used to Measure Micromotion.

Withdrawn and replaced with newer 

version. 

8–437 .......... 8–607 ASTM F2082/F2082M–23 Determination of Transformation Temperature 

of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery.

Withdrawn and replaced with newer 

version. 

8–451 .......... 8–608 ASTM F2214–2023 Standard Test Method for In Situ Determination of 

Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE).

Withdrawn and replaced with newer 

version. 

8–475 .......... 8–609 ASTM F2026–23 Standard Specification for Polyetheretherketone (PEEK) 

Polymers for Surgical Implant Applications.

Withdrawn and replaced with newer 

version. 

8–483 .......... 8–610 ASTM F601–23 Standard Practice for Fluorescent Penetrant Inspection of 

Metallic Surgical Implants.

Withdrawn and replaced with newer 

version. 

J. Nanotechnology 

No new entries at this time. 

K. Neurology 

No new entries at this time. 

L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) 

No new entries at this time. 

M. Ophthalmic 

No new entries at this time. 

N. Orthopedic 

11–83 .......... ...................... ISO 13402 First edition 1995–08–01 Surgical and dental hand instruments—Determination of resistance against autoclaving, corrosion and 

thermal exposure.

Transferred. See 4–320. 

11–276 ........ 11–402 ASTM F1798–21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies 

Used in Spinal Arthrodesis Implants.

Withdrawn and replaced with newer 

version. 

11–281 ........ ...................... ASTM F1672–14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis.Withdrawn with transition. See 11– 

400. 

11–299 ........ ...................... ASTM F2068–15 Standard Specification for Femoral Prostheses—Metallic 

Implants.

Withdrawn with transition. See 11– 

401. 

11–301 ........ ...................... ASTM F2091–15 Standard Specification for Acetabular Prostheses .......... Withdrawn with transition. See 11– 

401. 

11–303 ........ 11–403 ASTM F3047M–23 Standard Guide for High Demand Hip Simulator Wear 

Testing of Hard-on-Hard Articulations.

Withdrawn and replaced with newer 

version. 

11–321 ........ 11–404 ASTM F2887–23 Standard Specification for Total Elbow Prostheses ......... Withdrawn and replaced with newer 

version. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

11–334 ........ 11–405 ASTM F1829–23 Standard Test Method for Static Evaluation of Anatomic 

Glenoid Locking Mechanism in Shear.

Withdrawn and replaced with newer 

version. 

11–335 ........ 11–406 ASTM F3141–23 Standard Guide for Total Knee Replacement Loading 

Profiles.

Withdrawn and replaced with newer 

version. 

11–341 ........ 11–407 ASTM F3140–23 Standard Test Method for Cyclic Fatigue Testing of 

Metal Tibial Tray Components of Unicondylar Knee Joint Replacements.

Withdrawn and replaced with newer 

version. 

11–377 ........ ...................... ASTM F2083–21 Standard Specification for Knee Replacement Prosthesis.Withdrawn with transition. See 11– 

400. 

O. Physical Medicine 

No new entries at this time. 

P. Radiology 

12–348 ........ ...................... IEC 60601–2–54 Edition 2.0 2022–09 Medical electrical equipment—Part 

2–54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.

Extent of recognition. 

12–349 ........ 12–352 NEMA PS 3.1–3.20 2023e Digital Imaging and Communications in Medicine (DICOM) set.Withdrawn and replaced with newer 

version. 

Q. Software/Informatics 

No new entries at this time. 

R. Sterility 

14–141 ........ 14–589 ISO 14644–4 Second edition 2022–11 Cleanrooms and associated controlled environments—Part 4: Design, construction and start-up.Withdrawn and replaced with newer 

version. 

14–379 ........ 14–590 ISO 14644–8 Third edition 2022–06 Cleanrooms and associated controlled environments—Part 8: Assessment of air cleanliness by chemical concentration (ACC).Withdrawn and replaced with newer 

version. 

14–390 ........ 14–591 ISO 14644–10 Second edition 2022–05 Cleanrooms and associated controlled environments—Part 10: Assessment of surface cleanliness for 

chemical contamination.

Withdrawn and replaced with newer 

version. 

14–427 ........ 14–592 ISO 13408–1 Third edition 2023–08 Aseptic processing of health care 

products—Part 1: General requirements.

Withdrawn and replaced with newer 

version. 

14–516 ........ 14–593 ASTM F3039–23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration.Withdrawn and replaced with newer 

version. 

14–530 ........ 14–594 ISO 11607–1 Second edition 2019–02 [Including ADM1:2023] Packaging 

for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including 

Amendment 1 (2023)].

Withdrawn and replaced with newer 

version. 

14–531 ........ 14–595 ISO 11607–2 Second edition 2019–02 [Including AMD1:2023] Packaging 

for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].

Withdrawn and replaced with newer 

version. 

14–573 ........ 14–596 ASTM F88/F88M–23 Standard Test Method for Seal Strength of Flexible 

Barrier Materials.

Withdrawn and replaced with newer 

version. 

S. Tissue Engineering 

No new entries at this time. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

III. Listing of New Entries 

In table 2, FDA provides the listing of 

new entries and consensus standards 

added as modifications to the list of 

recognized standards under Recognition 

List Number: 061. These entries are of 

standards not previously recognized by 

FDA. 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition No. Title of standard 1 Reference No. and date 

A. Anesthesiology 

1–166 ................. Gas mixers for medical use—Stand-alone gas mixers. ............................................ ISO 11195 Second edition 2018–01. 


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TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and date 

B. Biocompatibility 

No new entries at this time. 

C. Cardiovascular 

3–190 ................. Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840–2.ISO/PAS 7020 First edition 2023–05. 

D. Dental/ENT 

4–320 ................. Surgical and dental and instruments—Determination of resistance against 

autoclaving, corrosion and thermal exposure.

ISO 13402 First edition 1995–08. 

4–321 ................. Dentistry—Intraoral camera ....................................................................................... ISO 23450 First edition 2021–03. 

4–322 ................. Dentistry—Machinable ceramic blanks ..................................................................... ISO 18675 First edition 2022–05. 

4–323 ................. Dentistry—Polymer-based composite machinable blanks ........................................ ISO 5139 First edition 2023–05. 

4–324 ................. Dentistry—Polymer-based luting materials containing adhesive components ......... ISO/TS 16506 First edition 2018–03. 

E. General I (QS/RM) 

No new entries at this time. 

F. General II (ES/EMC) 

No new entries at this time. 

G. GH/GPS 

No new entries at this time. 

H. IVD 

7–320 ................. Validation of Assays Performed by Flow Cytometry ................................................. CLSI H62 1st Edition. 

I. Materials 

No new entries at this time. 

J. Nanotechnology 

18–24 ................. Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles ......... ASTM E2524–22. 

K. Neurology 

No new entries at this time. 

L. OB-Gyn/G/Urology 

9–150 ................. Copper-bearing contraceptive intrauterine devices—Requirements and tests ......... ISO 7439 Fourth edition 2023–04. 

M. Ophthalmic 

No new entries at this time. 

N. OrthopedicX 

11–400 ............... Non-active surgical implants—Joint replacement implants—Specific requirements 

for knee-joint replacement implants.

ISO 21536 Third edition 2023–07. 

11–401 ............... Non-active surgical implants—Joint replacement implants—Specific requirements 

for hip-joint replacement implants.

ISO 21535 Third edition 2023–07. 

11–408 ............... Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and 

Deformation Under High Flexion.

ASTM F2777–23. 

11–409 ............... Standard Test Methods for Determining the Static Failure Load of Ceramic Knee 

Femoral Components.

ASTM F3495–23. 

O. Physical Medicine 

No new entries at this time. 

P. Radiology 

12–353 ............... American National Standard for Safe Use of Lasers ................................................ ANSI Z136.1–2022. 


ddrumheller on DSK120RN23PROD with NOTICES1
15208 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and date 

Q. Software/Informatics

13–129 ............... Software and systems engineering—Software testing—Part 1: General concepts ISO/IEC/IEEE 29119–1 Second edition 

2022–01. 

13–130 ............... Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2–1: Particular requirements for forensic data logging.ANSI/AAMI 2700–2–1:2022. 

13–131 ............... Standard for medical device security—Security risk management for device manufacturers.ANSI/AAMI SW96:2023. 

R. Sterility

14–597 ............... Water Quality for Processing Medical Devices ......................................................... ANSI/AAMI ST108:2023. 

S. Tissue Engineering

No new entries at this time. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

IV. List of Recognized Standards

FDA maintains the current list of FDA

Recognized Consensus Standards in a 

searchable database that may be 

accessed at https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. Such 

standards are those that FDA has 

recognized by notice published in the 

Federal Register or that FDA has 

decided to recognize but for which 

recognition is pending (because a 

periodic notice has not yet appeared in 

the Federal Register). FDA will 

announce additional modifications and 

revisions to the list of recognized 

consensus standards, as needed, in the 

Federal Register once a year, or more 

often if necessary. 

V. Recommendation of Standards for

Recognition by FDA

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation, to 

CDRHStandardsStaff@fda.hhs.gov. To 

be considered, such recommendations 

should contain, at a minimum, the 

information available at https://

www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process. 

Dated: February 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–04376 Filed 2–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1051] 

Clinical Pharmacology Considerations 

for Antibody-Drug Conjugates; 

Guidance for Industry; 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 for industry entitled ‘‘Clinical 

Pharmacology Considerations for 

Antibody-Drug Conjugates,’’ which 

provides recommendations for the 

development of antibody-drug 

conjugates (ADCs). Specifically, this 

guidance addresses the FDA’s current 

thinking regarding clinical 

pharmacology considerations and 

recommendations for ADC development 

programs, including bioanalytical 

methods, dose selection and adjustment, 

dose- and exposure-response analysis, 

intrinsic factors, QTc assessments, 

immunogenicity, and drug-drug 

interactions (DDIs) for ADCs with a 

cytotoxic small-molecule drug or 

payload. Currently, there are no final 

FDA guidances outlining the clinical 

pharmacology considerations for ADCs. 

This guidance finalizes the draft 

guidance of the same title issued on 

February 8, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 1, 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 


ddrumheller on DSK120RN23PROD with NOTICES1