83884 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 

are hereby withdrawn as of November 

18, 2024. Introduction or delivery for 

introduction into interstate commerce of 

Helium, USP, without an approved new 

drug application or an approved new 

animal drug application violates 

sections 505(a), 512(a), 301(a), and 

301(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(a), 

360b(a)(1), 331(a), and 331(d)). Any 

Helium, USP manufactured by Linde, 

Inc. pursuant to these applications that 

is in inventory on November 18, 2024 

may continue to be dispensed until the 

inventories have been depleted or the 

drug product has reached its expiration 

date or otherwise become violative, 

whichever occurs first. 

Dated: October 9, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24106 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2303] 

Core Patient-Reported Outcomes in 

Cancer Clinical Trials; 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 ‘‘Core 

Patient-Reported Outcomes in Cancer 

Clinical Trials.’’ This final guidance 

provides recommendations to sponsors 

regarding the collection of a core set of 

patient-reported clinical outcomes 

(herein referred to as core patientreported outcomes) in cancer clinical 

trials and related considerations for 

instrument selection and trial design. 

This final guidance focuses on patientreported outcome (PRO) measures and 

is specific to registration trials for anticancer therapies intended to 

demonstrate an effect on survival, tumor 

response, or delay in the progression of 

a malignancy. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 18, 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– 

2020–D–2303 for ‘‘Core PatientReported Outcomes in Cancer Clinical 

Trials.’’ 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. 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: 

Vishal Bhatnagar, Oncology Center of 

Excellence, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2113, Silver Spring, 

MD 20993–0002, 240–402–3696; 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– 

402–7910. 

SUPPLEMENTARY INFORMATION: 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 83885 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Core Patient-Reported Outcomes in 

Cancer Clinical Trials.’’ This final 

guidance provides recommendations to 

sponsors regarding the collection of a 

core set of PROs in cancer clinical trials 

and related considerations for 

instrument selection and trial design. 

The final guidance recommendations 

supplement previous guidance on use of 

PRO measures in clinical trials by 

providing additional considerations 

specific to the cancer clinical trial 

setting. The final guidance is intended 

to facilitate generation of high-quality 

data on a core set of patient-reported 

symptom and functional impacts that 

are important contributors to a patient’s 

health-related quality of life. 

Although this final guidance focuses 

on PRO measures, some of the 

recommendations may be relevant to 

other clinical outcome assessments (i.e., 

clinician-reported outcome, observerreported outcome, performance 

outcome) in cancer clinical trials. The 

final guidance is specific to registration 

trials for anti-cancer therapies intended 

to demonstrate an effect on survival, 

tumor response, or delay in the 

progression of a malignancy. 

Cancer clinical trials typically employ 

standardized efficacy assessments using 

overall survival and tumor measures, 

and safety assessments provided by 

clinician reporting of adverse events. 

FDA acknowledges the added value of 

incorporating PRO measurement of 

symptoms and functional impacts into 

the benefit/risk assessment in 

appropriately designed trials; however, 

heterogeneity in PRO assessment 

strategies has lessened the regulatory 

utility of PRO data from cancer trials. 

Systematic assessment of a core set of 

PROs can facilitate high-quality data on 

patient-reported symptoms and 

functional impacts. In published 

literature, FDA authors have previously 

described a core set of PROs that may 

be important contributors to a patient’s 

health-related quality of life and that 

may be sensitive to the effect of the 

disease and treatment under study. 

FDA is issuing this final guidance to 

provide FDA’s current thinking on the 

core PROs, considerations for 

instrument selection to measure the core 

PROs, trial design considerations such 

as assessment frequency, and labeling 

considerations. The core PROs 

recommended in the guidance are 

disease-related symptoms, symptomatic 

adverse events, overall side effect 

impact summary measure, physical 

function, and role function. 

In the Federal Register of June 10, 

2021 (86 FR 30944), FDA announced the 

availability of the draft guidance of the 

same title dated June 2021. FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include 

recommendations to consult FDA when 

selecting adverse events for reporting, 

edits to include hematological 

malignancies, and minor, editorial 

changes to improve clarity. 

This final guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This final guidance represents the 

current thinking of FDA on ‘‘Core 

Patient-Reported Outcomes in Cancer 

Clinical Trials.’’ 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 (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 312 have been approved 

under OMB control number 0910–0014; 

the collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001; and 

the collections of information in 21 CFR 

part 601 have been approved under 

0910–0338. 

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, or https://

www.regulations.gov. 

Dated: October 11, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24111 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–P–0761] 

Determination That TAVIST 

(Clemastine Fumarate) Tablet, 2.68 

Milligrams, Was Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that TAVIST 

(clemastine fumarate) tablet, 2.68 

milligrams (mg), was not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

this drug product, and it will allow FDA 

to continue to approve ANDAs that refer 

to the product as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: Awo 

Archampong-Gray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6243, 

Silver Spring, MD 20993–0002, 301– 

796–0110, Awo.Archampong-Gray@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

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

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 


khammond on DSKJM1Z7X2PROD with NOTICES