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
83886 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

TAVIST (clemastine fumarate) tablet, 

2.68 mg, is the subject of NDA 017661, 

held by Novartis Pharmaceuticals Corp. 

and initially approved on February 25, 

1977. TAVIST (clemastine fumarate) 

tablet, 2.68 mg, is indicated for the relief 

of symptoms associated with allergic 

rhinitis such as sneezing, rhinorrhea, 

pruritus, and lacrimation. It is also 

indicated for the relief of mild, 

uncomplicated allergic skin 

manifestations of urticaria and 

angioedema. 

TAVIST (clemastine fumarate) tablet, 

2.68 mg, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. In a letter 

dated February 13, 2004, Novartis 

Consumer Health, Inc., requested 

withdrawal of NDA 017661 for TAVIST 

(clemastine fumarate). In the Federal 

Register of March 4, 2005 (70 FR 

10651), FDA announced that it was 

withdrawing approval of NDA 017661, 

effective April 4, 2005. 

Pharmobedient Consulting, LLC, 

submitted a citizen petition dated 

February 21, 2024 (Docket No. FDA– 

2024–P–0761), under 21 CFR 10.30, 

requesting that the Agency determine 

whether TAVIST (clemastine fumarate) 

tablet, 2.68 mg, was withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that TAVIST (clemastine 

fumarate) tablet, 2.68 mg, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that TAVIST (clemastine 

fumarate) tablet, 2.68 mg, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of TAVIST 

(clemastine fumarate) tablet, 2.68 mg, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list TAVIST (clemastine 

fumarate) tablet, 2.68 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: October 9, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24103 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–D–2732] 

Recommendations for the 

Development of Blood Collection, 

Processing, and Storage Systems for 

the Manufacture of Blood Components 

Using the Buffy Coat Method; 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 

document entitled ‘‘Recommendations 

for the Development of Blood 

Collection, Processing, and Storage 

Systems for the Manufacture of Blood 

Components Using the Buffy Coat 

Method.’’ The draft guidance document 

provides recommendations on the 

development of blood collection, 

processing, and storage systems (e.g., 

blood bags with anticoagulant and 

additive solutions, empty bags for 

platelet pooling) used for the 

manufacture of blood and blood 

components intended for transfusion 

using the buffy coat (BC) method. This 

guidance is intended for manufacturers 

of blood collection, processing, and 

storage systems. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 17, 2024 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–2732 for ‘‘Recommendations 

for the Development of Blood 

Collection, Processing, and Storage 

Systems for the Manufacture of Blood 

Components Using the Buffy Coat 


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