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
Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices 15209 

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– 

2021–D–1051 for ‘‘Clinical 

Pharmacology Considerations for 

Antibody-Drug Conjugates.’’ 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)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Rajanikanth Madabushi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903, 301–796–1537, 

Rajanikanth.Madabushi@fda.hhs.gov; or 

James Myers, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Clinical Pharmacology Considerations 

for Antibody-Drug Conjugates.’’ An ADC 

is a type of therapeutic biologic product 

that is composed of a small-molecule 

component and an antibody component 

conjugated together by a chemical 

linker. An antibody or antibody 

fragment carrier is selected or 

engineered against a specific antigen of 

interest present on the target, which is 

ideally unique to the disease state being 

treated (e.g., a tumor-specific antigen). 

In general, when the antibody or 

antibody fragment binds to its target 

antigen, the ADC is internalized through 

physiological mechanisms (e.g., 

endocytosis), at which point the smallmolecule drug or payload moiety is 

released either upon exposure to the 

low pH of the lysosome or by 

degradation of the antibody/linker by 

lysosomal enzymes. The released smallmolecule drug then exerts its effect in 

the targeted cell (e.g., the cells 

expressing the specific antigen of 

interest) while ideally minimizing the 

effect on healthy cells (e.g., cells that do 

not express the specific antigen of 

interest). 

ADCs combine the selectivity of an 

antibody or antibody fragment with the 

potency of a small molecule. Therefore, 

development of ADCs requires careful 

consideration of the differences between 

the clinical pharmacology of the 

antibody or antibody fragment and the 

small molecule. This guidance 

addresses 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 DDIs. 

This guidance finalizes the draft 

guidance of the same title issued on 

February 8, 2022 (87 FR 7184). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include: (1) updates to 

guidance terminology to provide clarity, 

(2) additional FDA guidance references 

included in support of existing guidance 

text, and (3) additional considerations 

provided for ADC dosing strategies. In 

addition, editorial changes were made 

to improve clarity. 

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 ‘‘Clinical 

Pharmacology Considerations for 

Antibody-Drug Conjugates.’’ 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. Paperwork Reduction Act of 1995 

While this guidance contains no 

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 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 312 for 

submission of investigational new drug 

applications have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

part 314 for submission of new drug 

applications have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

part 601 for submission of biologic 

license applications have been approved 

under OMB control number 0910–0338. 

The collections of information in 21 

CFR 201.56 and 201.57 pertaining to the 

content and format requirements of 

labeling for prescription drug products 

and biological products have been 

approved under OMB control number 

0910–0572. The collections of 

information in 21 CFR part 211 


ddrumheller on DSK120RN23PROD with NOTICES1
15210 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices 

pertaining to current good 

manufacturing practice requirements 

have been approved under OMB control 

number 0910–0139. The collections of 

information in 21 CFR part 58 

pertaining to good laboratory practice 

for nonclinical laboratory studies have 

been approved under OMB control 

number 0910–0119. 

III. Electronic Access

Persons with access to the internet

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://

www.regulations.gov. 

Dated: February 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–04375 Filed 2–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: Pursuant to section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold a 

meeting that will be open to the public. 

Information about SACHRP, the full 

meeting agenda, and instructions for 

linking to public access will be posted 

on the SACHRP website at https://

www.hhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

DATES: The meeting will be held on 

Wednesday, March 20, 2024 from 11:00 

a.m. until 4:30 p.m., and Thursday,

March 21, 2024, from 11:00 a.m. until

4:00 p.m. (times are tentative and

subject to change). The confirmed times

and agenda will be posted on the

SACHRP website as this information

becomes available.

ADDRESSES: This meeting will be held

via webcast. Members of the public may

also attend the meeting via webcast.

Instructions for attending via webcast

will be posted at least one week prior 

to the meeting at https://www.hhs.gov/ 

ohrp/sachrp-committee/meetings/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: Julia 

Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; telephone: 240–453– 

8141; fax: 240–453–6909; email address: 

SACHRP@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary for Health, on 

issues and topics pertaining to or 

associated with the protection of human 

research subjects. 

The Subpart A Subcommittee (SAS) 

was established by SACHRP in October 

2006 and is charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment. 

The Subcommittee on Harmonization 

(SOH) was established by SACHRP at its 

July 2009 meeting and charged with 

identifying and prioritizing areas in 

which regulations and/or guidelines for 

human subjects research adopted by 

various agencies or offices within HHS 

would benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. The SACHRP meeting 

will open to the public at 11:00 a.m., on 

Wednesday, March 20, 2023, followed 

by opening remarks from Julie 

Kaneshiro, Acting Director of OHRP and 

Dr. Douglas Diekema, SACHRP Chair. 

The meeting will begin with a 

discussion of the draft recommendation, 

Ethical and Regulatory Considerations 

for the Inclusion of LGBTQI+ 

Populations in HHS Human Subjects 

Research. This topic is a continuation of 

the discussion and speaker panel 

presented at the October 2023 SACHRP. 

This will be followed by discussion of 

Considerations for Uninformative 

Research. The first day will adjourn at 

approximately 4:30 p.m. The second 

day of the meeting, March 21st, will 

begin at 11:00 with a discussion of 

Interpretation of the Best-interests 

Standard for the Retention of Subjects in 

Human Subjects Research that Has Been 

Halted or Suspended. Other topics may 

be added; for the full and updated 

meeting agenda, see http://

www.dhhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. The meeting will 

adjourn by 4:00 p.m., March 21, 2024. 

Time will be allotted for public 

comment on both days of the meeting. 

The public may submit written public 

comment in advance to SACHRP@

hhs.gov no later than midnight March 

14th, 2023, ET. Written comments will 

be shared with SACHRP members and 

may read aloud during the meeting. 

Comments which are read aloud are 

limited to three minutes each. Public 

comment must be relevant to topics 

being addressed by the SACHRP. 

Dated: February 23, 2024. 

Julia G. Gorey, 

Executive Director, SACHRP, Office for 

Human Research Protections. 

[FR Doc. 2024–04343 Filed 2–29–24; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government Owned Inventions 

Available for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Inquiries related to this licensing 

opportunity should be directed to: 

Andrew Burke Ph.D., Technology 

Transfer Manager, NCI, Technology 

Transfer Center, email: burkear@

mail.nih.gov or phone: (240) 276–5484. 

SUPPLEMENTARY INFORMATION: 

NIH Reference Number: E–251–2023– 

0. 

Title: T Cell Receptors Targeting 

EGFR L858R mutation on HLA– 

A*11:01 + Tumors. 

Tumor-specific mutated proteins can 

create neoepitopes, mutation-derived 

antigens that distinguish tumor cells 

from healthy cells, which are attractive 

targets for adoptive cell therapies. 

However, the process of precisely 

identifying the neoepitopes to target is 

complex and challenging. One method 

to identify such neoepitopes is Mass 

Spectrometry (MS) when used in 

conjunction with elution of peptides 

bound to a specific Human Leukocyte 

Antigen (HLA) allele. Using MS in this 


ddrumheller on DSK120RN23PROD with NOTICES1