Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Notices 84353 

adequate time for interested persons to 

submit comments without significantly 

delaying guidance on these important 

issues. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Chemical Analysis for 

Biocompatibility Assessment of Medical 

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of the draft guidance may do so by 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 ‘‘Chemical Analysis 

for Biocompatibility Assessment of 

Medical 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 GUI00020037 and complete 

title to identify the guidance you are 

requesting. 

Dated: October 17, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24447 Filed 10–21–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–3903] 

Drug Interaction Information in Human 

Prescription Drug and Biological 

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Format; Draft Guidance for Industry; 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 Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Drug 

Interaction Information in Human 

Prescription Drug and Biological 

Product Labeling.’’ The draft guidance is 

intended to assist applicants in 

developing the DRUG INTERACTIONS 

section of labeling as described in FDA 

regulations for the content and format of 

labeling for human prescription drug 

and biological products. The purpose of 

the draft guidance is to provide 

recommendations on what information 

to include in, and how to present and 

organize the information within, the 

DRUG INTERACTIONS section of 

labeling for human prescription drug 

and biological products to enhance 

communication of clinically significant 

drug interactions and facilitate the safe 

and effective use of prescription drugs 

by healthcare practitioners. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 21, 2025 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– 

2024–D–3903 for ‘‘Drug Interaction 

Information in Human Prescription 

Drug and Biological Product Labeling; 

Draft Guidance for Industry.’’ 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://


ddrumheller on DSK120RN23PROD with NOTICES1
84354 Federal Register / Vol. 89, No. 204 / Tuesday, October 22, 2024 / Notices 

1 21 CFR 201.56(a) and (d) and 201.57(c)(8). This 

guidance applies to drugs, including biological 

products that are regulated as drugs. For the 

purpose of this guidance, ‘‘drug product’’ or ‘‘drug’’ 

will be used to refer to human prescription drug 

and biological products that are regulated as drugs. 

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 the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), 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. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Grillo, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–0591; 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 draft guidance for industry entitled 

‘‘Drug Interactions Section of Labeling 

for Human Prescription Drug and 

Biological Products—Content and 

Format.’’ The draft guidance is intended 

to assist applicants in developing the 

DRUG INTERACTIONS section of the 

Prescribing Information labeling as 

described in FDA regulations for the 

content and format of labeling for 

human prescription drug and biological 

products.1

Prescription drug labeling must 

contain a summary of the essential 

information necessary for safe and 

effective use of the drug and is a 

primary tool for FDA to communicate 

drug interaction information to 

healthcare practitioners. Effective 

communication of drug interaction 

information informs the optimal use of 

the drug and the healthcare 

practitioner’s clinical decision-making 

(e.g., prescribing decisions or 

management instructions). 

The purpose of this guidance is to 

provide recommendations on what 

information to include in, and how to 

present and organize the information 

within, the DRUG INTERACTIONS 

section of prescription drug labeling to 

enhance communication of clinically 

significant drug interactions and 

facilitate the safe and effective use of 

prescription drugs by healthcare 

practitioners. This guidance also 

provides illustrative examples of the 

content and format of drug interaction 

information in prescription drug 

labeling. 

In addition, the guidance includes an 

FDA website (https://www.fda.gov/ 

CYPandTransporterInteractingDrugs) as 

one resource that health care 

practitioners can use to view examples 

of clinical substrates, inhibitors, and 

inducers of Cytochrome P–450 (CYP) 

enzymes and substrates and inhibitors 

of transporters. FDA is seeking input 

regarding the utility of this website as a 

resource that health care practitioners 

can reference to find examples of 

clinical substrates, inhibitors, and 

inducers of CYP enzymes and substrates 

and inhibitors of transporters. FDA is 

also seeking input on ways to describe 

drug interactions in labeling, 

specifically when drugs have numerous, 

clinically relevant drug interactions 

(e.g., azole antimycotics) that require 

listing many interactions. In addition, 

FDA is seeking input on ways to 

describe complex drug-interaction 

scenarios, including but not limited to: 

• Concurrent inhibition of an enzyme 

and a transporter by a drug; 

• Concurrent inhibition and 

induction of a drug’s metabolic pathway 

by one or more enzymes; 

• Increased inhibition of drug 

elimination by use of inhibitors of more 

than one enzyme that metabolizes the 

drug; 

• Inhibition of an enzyme other than 

the genetic polymorphic enzyme in poor 

metabolizers taking a substrate 

metabolized by both enzymes; 

• Effect of enzyme/transporter 

inhibitors in subjects with organ 

impairment; and 

• Two drugs acting as both 

precipitant and object of a drug 

interaction. 

The draft guidance, when finalized, 

will represent the current thinking of 

FDA on ‘‘Drug Interaction Information 

in Human Prescription Drug and 

Biological Product Labeling.’’ 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 parts 314 and 

601 are approved under OMB control 

numbers 0910–0001 and 0910–0338, 

respectively. The collections of 

information in 21 CFR parts 201.56 and 

201.57 have been approved under OMB 

control number 0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.regulations.gov, https://

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

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

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

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Dated: October 16, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24442 Filed 10–21–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Request for Public 

Comments on Draft Recommendations 

for the HRSA-Supported Women’s 

Preventive Services Guidelines 

Relating to Screening and Counseling 

for Intimate Partner and Domestic 

Violence, Breast Cancer Screening for 

Women at Average Risk, and Patient 

Navigation for Breast and Cervical 

Cancer Screening 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 


ddrumheller on DSK120RN23PROD with NOTICES1