Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76853 

response are based on past FDA 

experience with the various cover sheet 

submissions and range from 5 to 30 

minutes. The hours per response are 

based on the average of these estimates 

(18 minutes). The total hours are 

rounded to the nearest whole number. 

Inspection by Accredited Persons 

Program Under Section 704 of the FD&C 

Act 

Section 704(g) of the FD&C Act 

provides for accreditation of persons for 

the purpose of conducting inspections 

and provides the minimum 

requirements a person must meet to be 

accredited to conduct inspections (an 

Accredited Person (AP)). The burden 

estimate for requests for accreditation is 

based on the number of applications 

we’ve received. Once an organization is 

accredited, it will not be required to 

reapply. 

The AP Program permits eligible 

manufacturers to use APs to perform 

certain inspections. While all firms 

remain subject to inspection by FDA, 

eligible manufacturers have the option 

of requesting inspection by an AP. A 

device establishment is eligible for 

inspection by APs if the establishment 

meets certain conditions of section 

704(g)(6) of the FD&C Act, including 

that they provide notice of their 

intention to use an AP to conduct 

inspections of the establishment. 

We estimate there are 4,000 domestic 

manufacturers and 4,000 foreign 

manufacturers that are eligible for 

inclusion under the AP program. Based 

on informal communications with 

industry, approximately 10 of these 

manufacturers may submit a request to 

use an AP in any given year. 

Request for Information Under Section 

513(g) of the FD&C Act 

Respondents may elect to prepare 

their 513(g) request for information 

using CDRH’s electronic Submission 

Template and Resource (eSTAR) 

voluntary guided submission 

preparation tool, which was developed 

to improve submission consistency and 

enhance efficiency in the review 

process. The total number of annual 

responses is based on the average 

number of 513(g) requests received each 

year by CDRH and CBER respectively. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made 

modifications to our burden estimate. In 

our March 2023 change request 

submission, we erroneously excluded 

the information collection entitled, 

‘‘Notification of the intent to use an 

Accredited Person.’’ We have included 

the information collection activity to 

this renewal. The information 

collection, therefore, reflects a 

cumulative increase in burden by 10 

annual responses and 150 burden hours. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21435 Filed 9–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4167] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Labeling 

Requirements for Prescription Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed revision of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with labeling 

requirements for prescription drugs. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 18, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 18, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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 Docket No. FDA–2024–N– 

4167 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Labeling 

Requirements for Prescription Drugs.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 


lotter on DSK11XQN23PROD with NOTICES1
76854 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

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. 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed revision of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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 to § 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 bar code 

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,’’ (July 2013). The guidance 

document includes instruction on 

communicating with FDA regarding 

labeling changes required under section 

505(o)(4) (Section IV—Procedures) and 

is available for download from our 

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

regulatory-information/search-fdaguidance-documents/safety-labelingchanges-implementation-section-505o4- 

federal-food-drug-and-cosmetic-act. 

‘‘Guidance for Industry on 

Hypertension Indication: Drug Labeling 

for Cardiovascular Outcome Claims,’’ 

(March 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-fda-guidance-documents/ 

hypertension-indication-drug-labelingcardiovascular-outcome-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, 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 with regard 

to 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. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76855 

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 

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 Federal Food, Drug, and Cosmetic Act (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 a final rule 

published 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 

section505(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 drug 

products that include a hypertension 

indication as discussed in the 

applicable guidance, reducing the 

overall estimate for this element by 4 

hours annually. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21436 Filed 9–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Supplemental Funding, 

Poison Control Centers Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: HRSA is awarding 

supplemental funds in fiscal year 2024 

to provide coverage for calls to the tollfree Poison Help line that originate from 

Puerto Rico. The current program period 

of performance ends on August 31, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Maureen Perkins, MPH; Team Lead; 

Poison Control Program; Division of 

Child, Adolescent and Family Health; 

Maternal and Child Health Bureau; 

HRSA, at mperkins@hrsa.gov and 301– 

443–9163. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient(s) of the Award: 

New York City Health & Hospitals 

Corporation. 

Amount of Non-Competitive 

Award(s): One award of $265,188. 

Project Period: September 1, 2024, to 

August 31, 2025. 

Assistance Listing (CFDA) Number: 

93.253. 

Award Instrument: Supplement for 

Poison Control Services. 

Authority: 42 U.S.C. 300d–73 (title 

XII, 1273 of the Public Health Service 

Act). 

TABLE 1—RECIPIENT AND AWARD AMOUNT

Grant No. Award recipient name State Award amount 

H4BHS15477 ................................................... New York City Health & Hospitals Corporation .................................. NY $265,188 


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