6574 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01926 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1041] 

Immunogenicity Information in Human 

Prescription Therapeutic Protein and 

Select Drug Product Labeling— 

Content and Format; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Immunogenicity Information in 

Human Prescription Therapeutic 

Protein and Select Drug Product 

Labeling—Content and Format.’’ This 

draft guidance provides 

recommendations for incorporating 

clinically relevant immunogenicity 

information into the labeling of 

products having immunogenicity 

assessments. Appropriate inclusion and 

consistent placement of 

immunogenicity information in the 

Prescribing Information helps to make 

clinically relevant information 

accessible to the health care practitioner 

and promotes the safe and effective use 

of prescription drug and biological 

products. When finalized, the 

recommendations in this guidance will 

supersede the immunogenicity labelingspecific recommendations in the 

guidances for industry entitled 

‘‘Labeling for Biosimilar Products’’ and 

‘‘Clinical Pharmacology Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 5, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2021–D–1041 for ‘‘Immunogenicity 

Information in Human Prescription 

Therapeutic Protein and Select Drug 

Product Labeling—Content and 

Format.’’ 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 the draft 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 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Eric 

Brodsky, Center for Drug Evaluation and 

Research, Food and Drug 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 6575 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6485, Silver Spring, 

MD 20993, 301–796–0855; or Stephen 

Ripley, 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 draft guidance for industry entitled 

‘‘Immunogenicity Information in 

Human Prescription Therapeutic 

Protein and Select Drug Product 

Labeling—Content and Format.’’ 

Evaluation of a therapeutic protein 

product’s and certain select drug 

products’ immunogenicity (e.g., risk of 

developing anti-drug antibodies, 

including neutralizing antibodies) and 

its potential clinical impact generally 

plays an important role in the 

assessment of the product’s safety and 

effectiveness for each proposed 

indication. Because some, but not all, 

anti-drug antibodies have been 

associated with safety concerns or loss 

of effectiveness, FDA believes that 

presenting immunogenicity information 

in a consistent manner would enable 

health care practitioners to more easily 

differentiate products associated with 

anti-drug antibodies having clinical 

effect(s) from products with anti-drug 

antibodies that do not have a clinically 

meaningful effect on pharmacokinetics, 

pharmacodynamics, safety, or 

effectiveness. 

This draft guidance recommends the 

use of a dedicated Immunogenicity 

subsection (subsection 12.6) under the 

CLINICAL PHARMACOLOGY section. 

Information and statements to include 

in this subsection (e.g., data on antidrug antibody incidence, clinical 

pharmacologic effects of anti-drug 

antibodies) are described in the draft 

guidance, along with recommended 

content to include in other sections of 

the labeling (e.g., summary of anti-drug 

antibody-associated effects on safety 

and/or effectiveness in the WARNINGS 

AND PRECAUTIONS, ADVERSE 

REACTIONS, and/or CLINICAL 

STUDIES sections, as applicable). The 

labeling recommendations are based on: 

(1) Adequacy of the methodology for 

detection of anti-drug antibodies, (2) 

sufficiency of available data to draw 

clinical conclusions, and (3) whether 

the anti-drug antibodies have clinically 

significant effect(s). In addition to 

recommendations on presentation of 

known immunogenicity information, 

this draft guidance also provides 

recommendations for consistently 

stating when such information is 

unknown, if appropriate. The draft 

guidance also provides procedural 

information, including 

recommendations for updating 

immunogenicity information in the 

Prescribing Information of applicable 

approved products. 

When finalized, this guidance will 

supersede the immunogenicity labelingspecific recommendations from the 

guidance for industry entitled ‘‘Clinical 

Pharmacology Section of Labeling for 

Human Prescription Drug and Biological 

Products—Content and Format’’ 

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

media/74346/download). When 

finalized, this guidance will also 

supersede the recommendations in 

section IV.C.3., ADVERSE REACTIONS, 

Immunogenicity, of the guidance for 

industry entitled ‘‘Labeling for 

Biosimilar Products’’ (available at 

https://www.fda.gov/media/96894/ 

download), including the statement 

‘‘Immunogenicity information for 

therapeutic protein products is usually 

placed in a subsection in the ADVERSE 

REACTIONS section entitled 

Immunogenicity’’ and statements 

recommended for inclusion as the first 

paragraph in the ADVERSE 

REACTIONS subsection that precedes 

the immunogenicity data. FDA has 

verified the website addresses as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Immunogenicity Information in 

Human Prescription Therapeutic 

Protein and Select Drug Product 

Labeling—Content and Format.’’ 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 new 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 600 have 

been approved under OMB control 

number 0910–0308. The collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. The collections of 

information in 21 CFR 201.56 and 

201.57 have been approved under OMB 

control number 0910–0572. The 

collections of information related to 

pharmacology data have been approved 

under OMB control number 0910–0014. 

The collections of information 

submitting biologics license 

applications under section 351(k) of the 

Public Health Service Act have been 

approved under OMB control number 

0910–0719. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft 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: January 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02348 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–2398] 

Population Pharmacokinetics; 

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 

‘‘Population Pharmacokinetics.’’ This 

guidance assists sponsors in the 

application of population 

pharmacokinetics (population PK) 

during the drug development process to 

inform drug use and includes FDA’s 

current thinking on the data and model 

requirements for population PK 

analyses submitted as part of new drug 

applications (NDAs), biologic license 

applications (BLAs), and abbreviated 

new drug applications (ANDAs). This 

guidance also provides expectations 

regarding the format and content of the 

population PK report, as well as any 


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