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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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tablet, 2.68 mg, was withdrawn from 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withdrawn for reasons of safety or 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withdrawn for reasons of safety or 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 83887 

Method.’’ 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 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 the office in processing your 

requests. The draft 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 draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Segal, 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 document entitled 

‘‘Recommendations for the 

Development of Blood Collection, 

Processing, and Storage Systems for the 

Manufacture of Blood Components 

Using the Buffy Coat Method.’’ This 

guidance 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 BC method. This guidance is 

intended for manufacturers of blood 

collection, processing, and storage 

systems. 

Blood and blood components must be 

prepared in a manner consistent with 

the instructions provided by the 

manufacturer (21 CFR 606.65(e)), 

including the directions provided in the 

instructions for use of the approved or 

cleared collection, processing, and 

storage system. To prepare blood 

components using the BC method, blood 

establishments must use blood 

collection, processing and storage 

systems approved or cleared for such 

use. However, blood collection, 

processing, and storage systems 

currently marketed in the United States 

are only approved or cleared for the 

preparation of blood components from 

Whole Blood (WB) using the platelet 

rich plasma method, and none are yet 

approved or cleared for the preparation 

of blood components using the BC 

method. 

This guidance provides 

recommendations to manufacturers who 

wish to obtain FDA approval or 

clearance to market blood collection, 

processing, and storage systems 

intended for the manufacture of blood 

components using the BC method. With 

the availability of such systems, blood 

establishments in the United States 

would have the option of manufacturing 

WB-derived blood components using 

the BC method. 

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 ‘‘Recommendations for the 

Development of Blood Collection, 

Processing, and Storage Systems for the 

Manufacture of Blood Components 

Using the Buffy Coat Method.’’ 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 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, 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. 2024–24098 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–2022–D–2061] 

Review of Drug Master Files in 

Advance of Certain Abbreviated New 

Drug Application Submissions Under 

Generic Drug User Fee Amendments; 

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 ‘‘Review 

of Drug Master Files in Advance of 

Certain ANDA Submissions Under 

GDUFA.’’ This guidance provides 

information and recommendations on 

the Generic Drug User Fee Amendments 

(GDUFA) III program enhancements 

agreed upon by the Agency and industry 

in ‘‘GDUFA Reauthorization 


khammond on DSKJM1Z7X2PROD with NOTICES