8802 Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Labeling applicable to medical gas containers; §§ 201.161(b) and 201.328 260 1,663 432,380 0.17 (10 minutes) ..... 73,505 

Exemption from barcode requirements § 201.25(d) ...................................... 2 1 2 24 ............................. 48 

Safety labeling required under section 505(o)(4) of the FD&C Act, and rebuttal statement.36 1 36 6 ............................... 216 

Safety labeling changes; posting approved letter on application holder’s 

website.

351 1 351 4 ............................... 1,404 

Exceptions or alternatives to labeling requirements for human drug product 

held by SNS; § 201.26.

1 1 1 32 ............................. 32 

Hypertension claims; recommended labeling considerations ........................ 5 1 5 18 ............................. 90 

Total ........................................................................................................ ...................... .......................... 433,324 ................................... 1,913,896 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on our evaluation, we have 

retained the currently approved 

estimate that 414 applicants will 

prepare an average of 549 prescription 

drug labels annually and assume it will 

require 3,349 hours to design, test, and 

submit to FDA as part of a new drug 

application or a biologics license 

application. 

New medical gas containers must 

meet applicable requirements found in 

21 CFR part 211, as well as specific 

labeling requirements in § 201.328. 

Consistent with statutory authority 

under the Consolidated Appropriations 

Act, 2017 (Pub. L. 115–31), we have 

revised the information collection to 

include burden associated new medical 

gas labeling requirements under 

§ 201.161(b), established by final rule in 

the Federal Register of June 18, 2024 

(89 FR 51738). We estimate 260 

respondents will incur burden for the 

design, testing, production, and 

submission of labeling for new medical 

gas containers as established in 

§ 201.328 and assume an average of 10 

minutes (0.17) is required for these 

activities. 

Based on our evaluation, few requests 

for exemption from barcode 

requirements are received, and we have 

therefore made no changes to the 

currently approved estimate for this 

activity. Likewise, we have also retained 

the currently approved estimate for 

information collection activities 

associated with safety labeling 

requirements established in section 

505(o)(4) of the FD&C Act. Similarly, we 

retain the currently approved estimate 

for exceptions to labeling under 

§ 201.26; however, this activity was 

previously approved in OMB control 

number 0910–0614 and is a new 

element to the collection, adding 1 

response and 32 hours annually. 

Finally, we have combined activity 

elements associated with labeling 

recommendations regarding drugs 

products that include a hypertension 

indication as discussed in the 

applicable March 2011 guidance 

referenced above, reducing the overall 

estimate for this element by 4 hours 

annually. 

Dated: January 28, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–02154 Filed 1–30–25; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2024–D–3067; FDA– 

2024–D–3863] 

Guidance for Industry; 

Recommendations To Reduce the Risk 

of Transmission of Disease Agents 

Associated With Sepsis by Human 

Cells, Tissues, and Cellular and 

Tissue-Based Products; 

Recommendations To Reduce the Risk 

of Transmission of Mycobacterium 

Tuberculosis by Human Cells, Tissues, 

and Cellular and Tissue-Based 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The final guidances entitled 

‘‘Recommendations To Reduce the Risk 

of Transmission of Disease Agents 

Associated with Sepsis by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ and 

‘‘Recommendations To Reduce the Risk 

of Transmission of Mycobacterium 

Tuberculosis (Mtb) by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ are being revised to 

change the time by which FDA 

recommends implementation of the 

recommendations in the guidances. 

DATES: The announcement of these 

guidances is published in the Federal 

Register on February 3, 2025. 

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.’’ 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 8803 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–D–3067 for ‘‘Recommendations To 

Reduce the Risk of Transmission of 

Disease Agents Associated with Sepsis 

by Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps)’’ or 

the Docket No. FDA–2024–D–3863 for 

‘‘Recommendations To Reduce the Risk 

of Transmission of Mycobacterium 

Tuberculosis (Mtb) by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps),’’ as appropriate. 

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 guidances to the 

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 labels to 

assist that office in processing your 

requests. The guidances 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 

documents. 

FOR FURTHER INFORMATION CONTACT: 

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 

two revised final guidances, 

‘‘Recommendations to Reduce the Risk 

of Transmission of Disease Agents 

Associated with Sepsis by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ and 

‘‘Recommendations to Reduce the Risk 

of Transmission of Mycobacterium 

Tuberculosis (Mtb) by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps).’’ These guidance 

documents were originally published in 

the Federal Register on January 7, 2025 

(90 FR 1141; 90 FR 1170). Both 

guidances recommended that 

establishments making donor eligibility 

determinations (establishments) 

implement the recommendations in the 

guidances ‘‘as soon as feasible, but not 

later than 4 weeks after the guidance 

issue date.’’ 

FDA is revising final guidances 

‘‘Recommendations To Reduce the Risk 

of Transmission of Disease Agents 

Associated with Sepsis by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ and 

‘‘Recommendations To Reduce the Risk 

of Transmission of Mycobacterium 

Tuberculosis (Mtb) by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ to recommend 

implementation of the guidance 

recommendations on a longer 

timeframe, by May 4, 2025. The revised 

implementation date will permit FDA to 

consider the comments received thus far 

prior to the implementation date. 

Permitting the Agency additional time 

to further review and consider the 

guidances, including comments 

received, as well as seek additional 

comments is consistent with the 

President’s January 20, 2025, 

memorandum entitled, ‘‘Regulatory 

Freeze Pending Review.’’ See paragraph 

3 (directing agencies to consider 

postponing effective dates of certain 

rules ‘‘for the purpose of reviewing any 

questions of fact, law, and policy that 

the rules may raise’’; ‘‘where 

appropriate and consistent with 

applicable law, consider opening a 

comment period to allow interested 

parties to provide comments about 

issues of fact, law, and policy raised by 

the rules postponed under this 

memorandum’’; and consider further 

delaying such rules ‘‘where necessary to 

continue to review these questions of 

fact, law, and policy’’). 

FDA issued the guidance entitled 

‘‘Recommendations To Reduce the Risk 

of Transmission of Disease Agents 

Associated with Sepsis by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ to provide 

establishments making donor eligibility 

determinations with recommendations 

to reduce the risk of transmission of 

disease agents associated with sepsis for 

donors of human cells, tissues, and 

cellular and tissue-based products. 

FDA issued the guidance entitled 

‘‘Recommendations To Reduce the Risk 

of Transmission of Mycobacterium 

Tuberculosis (Mtb) by Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ to assist 

establishments that make donor 

eligibility determinations for donors of 

human cells, tissues, and cellular and 

tissue-based products, with 

recommendations for screening donors 

for evidence of, and risk factors for, 

infection with Mtb, the organism that 

causes tuberculosis. 

FDA is issuing these revised 

guidances consistent with our good 

guidance practices regulation (§ 10.115 

(21 CFR 10.115)). We are implementing 

these revisions without prior public 

comment because we have determined 

that prior public participation is not 

feasible or appropriate (see 

§ 10.115(g)(2) and section 701(h)(1)(C) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 371(h)(1)(C)). We made 

this determination because the revisions 

present a less burdensome policy that is 

consistent with public health. Although 

these guidance documents are being 

implemented immediately, you can 

comment on any guidance at any time 

(§ 10.115(g)(5)). FDA has already 

received comments on the guidances 

discussed above, and the Agency 


khammond on DSK9W7S144PROD with NOTICES
8804 Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 

intends to consider those comments. 

Please submit any additional comments 

regarding the guidances that you wish 

the Agency to consider, including 

whether it would be appropriate to 

reissue these guidances in draft form or 

consider a later implementation date. 

II. Paperwork Reduction Act of 1995 

While these guidance documents 

contain no collection of information, 

they do 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 1271 relating to HCT/Ps, 

including establishing and maintaining 

records, investigation and reporting of 

adverse actions and documentation of 

methods used in facilities related to 

HCT/Ps, which, includes but is not 

limited to donor screening, donor 

testing, and labeling have been 

approved under OMB control number 

0910–0543. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidances 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. 

Dorothy A. Fink, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2025–02167 Filed 1–31–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4146] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Biosimilars User 

Fee Program 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 5, 

2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0718. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Biosimilars User Fee Program 

OMB Control Number 0910–0718— 

Revision 

This information collection supports 

FDA’s Biosimilars User Fee Program 

and implementation of the Biologics 

Price Competition and Innovation Act of 

2009 (BPCI Act). The BPCI Act creates 

an abbreviated approval pathway for 

biological products shown to be 

biosimilar to or interchangeable with an 

FDA-licensed reference biological 

product. Section 351(k) of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

262(k)), added by the BPCI Act, allows 

a company to apply for licensure of a 

biosimilar or interchangeable biological 

product (351(k) application). The BPCI 

Act also amended section 735 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 379g) to include 

351(k) applications as a type of 

application under ‘‘human drug 

application’’ for the purposes of the 

prescription drug user fee provisions. 

The FD&C Act as amended by the 

Biosimilar User Fee Amendments of 

2022 (BsUFA III), reauthorizes FDA to 

assess and collect fees for biosimilar 

biological products from October 2022 

through September 2027 to facilitate the 

development of safe and effective 

biosimilar products for the American 

public. 

FDA maintains information on our 

website at https://www.fda.gov/ 

industry/fda-user-fee-programs/ 

biosimilar-user-fee-amendments 

regarding its BsUFA program. Also 

available on our website is the 

Biosimilars Action Plan (BAP), which 

discusses key actions the Agency is 

taking to encourage innovation and 

competition among biologics and the 

development of biosimilars. The BAP 

builds on progress in implementing the 

approval pathway for biosimilar and 

interchangeable products, and provides 

interested persons with updates on 

related deliverables and activities. 

We have revised the information 

collection to reflect the currently 

agreed-upon performance goals 

established and captured in the latest 

reauthorization document entitled, 

‘‘Biosimilar Biological Product 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2023 Through 

2027’’ (BsUFA Commitment Letter). The 

BsUFA Commitment Letter is available 

for download from our website at 

https://www.fda.gov/media/152279/ 

download?attachment. The BsUFA 

Commitment Letter outlines current 

program goals, including information 

technology goals, discusses program 

effectiveness considerations, and 

discusses user fee resource 

management. 

The information collection also 

includes Form FDA 3792, ‘‘Biosimilars 

User Fee Cover Sheet,’’ to be submitted 

by each new biological product 

development (BPD) entrant (identified 

via a new meeting request or 

investigational new drug submission) or 

new biologics license application (BLA) 

applicant. Form FDA 3792 requests the 

minimum information necessary to 

identify the request, to determine the 

amount of the fee to be assessed, and to 

account for and track user fees. Form 

FDA 3792 is completed electronically at 

https://userfees.fda.gov/OA_HTML/ 

bsufaCAcdLogin.jsp, and a notification 

is emailed to the respondent that 

includes information regarding annual 

program fees. We are discontinuing use 

of the associated annual survey at this 

time. 

Relatedly, Form FDA 3971 (Small 

Business Waiver and Refund Request), 

currently approved in OMB control 

number 0910–0297, may also be 

utilized. As instructed on our BsUFA 

web page, respondents should submit 

Form FDA 3971 by email to 

CDERCollections@fda.hhs.gov at least 4 

months prior to the submission of the 

application to see if they qualify for a 

small business waiver. Finally, user fee 

refund and transfer requests, currently 

approved in OMB control number 0910– 


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