Federal Register / Vol. 90, No. 21 / Monday, February 3, 2025 / Notices 8801 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4167] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Labeling 

Requirements for Prescription Drugs 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 0910–0572. 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. 

Labeling Requirements for Prescription 

Drugs 

OMB Control Number 0910–0572— 

Revision 

This information collection helps 

implement statutory and regulatory 

requirements that govern the labeling of 

prescription drugs. FDA regulations 

codified in part 201 (21 CFR part 201), 

subpart B (§§ 201.50 through 201.58), 

apply to requisite labeling elements that 

include a statement of identity; a 

declaration of net quantity of contents; 

a statement of dosage; and specific 

content and formatting of information. 

The regulations also provide for 

requesting that FDA waive any 

requirement under §§ 201.56, 201.57, 

and 201.80. Since last approval of the 

information collection, FDA requested, 

and OMB approved, adding tasks 

provided for under § 201.25(d), 

requiring that manufacturers submit a 

written request for exemption from 

applicable barcode requirements, and 

tasks relating to exceptions or 

alternatives to the labeling requirements 

of products in the Strategic National 

Stockpile (SNS) as provided for in 

§ 201.26, to the scope of the activity. 

Under the Public Health Service Act 

(PHS Act), the Department of Health 

and Human Services stockpiles medical 

products that are essential to the 

security of the Nation (section 319F–2 of 

the PHS Act (42 U.S.C. 247d–6b). 

Information regarding the SNS is 

available at the following website: 

www.phe.gov/about/sns/Pages/ 

default.aspx. 

Relevant information regarding 

applicable statutory and regulatory 

requirements are also discussed in 

topic-specific guidance documents 

issued consistent with 21 CFR 314.445, 

21 CFR 601.29 (guidance documents), 

and Agency Good Guidance Practice 

regulations in 21 CFR 10.115, which 

provide for public comment at any time. 

The following guidance documents 

discuss activities included in the 

information collection: 

‘‘Safety Labeling Changes— 

Implementation of Section 505(o)(4) of 

the Federal Food, Drug, and Cosmetic 

Act’’ (FD&C Act) (78 FR 45930, July 30, 

2013). The guidance document includes 

instruction on communicating with 

FDA regarding labeling changes 

required under section 505(o)(4) 

(Section IV—Procedures) (21 U.S.C. 

355(o)(4)) and is available for download 

from our website at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/safetylabeling-changes-implementationsection-505o4-federal-food-drug-andcosmetic-act. 

‘‘Guidance for Industry on 

Hypertension Indication: Drug Labeling 

for Cardiovascular Outcome Claims’’ (76 

FR 14024, March 15, 2011). The 

guidance document is intended to help 

respondents with developing labeling 

for cardiovascular outcome claims for 

drugs that are indicated to treat 

hypertension. The guidance document 

is available for download from our 

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

regulatory-information/search-fdaguidance-documents/hypertensionindication-drug-labeling-cardiovascularoutcome-claims. 

Respondents to the information 

collection are sponsors of product 

labeling subject to the applicable 

labeling requirements. We characterize 

the information collection activities as 

recordkeeping, consistent with 5 CFR 

1320.3(m), noting that a recordkeeping 

requirement means a requirement to 

maintain specified records, including 

the requirement to retain and notify 

third parties, the Federal Government, 

or the public regarding such records. 

Regulations in part 201 govern the 

statement of ingredients and declaration 

of net quantity of contents regarding 

prescription drug product labeling. The 

regulations require that firms identify 

bulk or transport containers with the 

name of the product contained therein 

and that containers be accompanied by 

documentation that identifies the 

product as meeting applicable 

compendial standards. New drug 

product and biological product 

applicants must: (1) design and create 

prescription drug labeling containing 

‘‘Highlights,’’ ‘‘Contents,’’ and ‘‘Full 

Prescribing Information’’; (2) test the 

designed labeling (for example, to 

ensure that the designed labeling fits 

into carton-enclosed products); and (3) 

submit it to FDA for approval. 

In the Federal Register of September 

19, 2024 (89 FR 76853), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although two comments 

were received, they were not responsive 

to the four collection of information 

topics solicited. 

We estimate the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Labeling requirements for prescription drugs; §§ 201.56 and 201.57 ........... 414 1.326 549 3,349 ........................ 1,838,601 


khammond on DSK9W7S144PROD with NOTICES
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