Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76851 

including considerations for vaccine 

composition for (H5) vaccines. Under 

Topic III, the Committee will hear an 

overview of the research programs in 

the Laboratory of Pediatric & 

Respiratory Viral Diseases and the 

Laboratory of DNA Viruses in the 

Division of Viral Products, Office of 

Vaccines Research and Review, CBER. 

After the open session, the meeting will 

be closed to the public for committee 

deliberations. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at: https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: On October 10, 2024, from 

8 a.m. to 11:15 a.m. Eastern Time for 

Topic I, from 11:45 a.m. to 2:30 p.m. 

Eastern Time for Topic II, and from 2:40 

p.m. to 4:20 p.m. Eastern Time for Topic 

III, the meeting is open to the public. 

Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

Committee. All electronic and written 

submissions to the Docket (see 

ADDRESSES) on or before October 2, 

2024, will be provided to the 

Committee. Comments received on or 

after October 2, 2024, and by October 9, 

2024, will be taken into consideration 

by FDA. Oral presentations from the 

public will be scheduled between 

approximately 9:55 a.m. to 10:15 a.m. 

Eastern Time for Topic I, 1:10 p.m. to 

1:30 p.m. Eastern Time for Topic II, and 

4 p.m. to 4:20 p.m. Eastern Time for 

Topic III. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, along with their 

names, email addresses, and direct 

contact phone numbers of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 12 p.m. 

Eastern Time on September 24, 2024. 

Time allotted for each presentation may 

be limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 27, 2024. 

Closed Committee Deliberations: On 

October 10, 2024, the meeting will be 

closed from 4:30 p.m. to 5:30 p.m. to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The recommendations of the 

advisory committee regarding the 

progress of the individual investigators’ 

research programs, along with other 

information, will be discussed during 

this session. We believe that public 

discussion of these discussions and 

committee recommendations on 

individual scientists would constitute 

an unwarranted invasion of personal 

privacy. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Kathleen 

Hayes or Sussan Paydar (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

The conditions for issuance of a waiver 

under 21 CFR 10.19 are met. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21431 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–0022] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

User Fee Cover Sheet, Form FDA 3601 

and Device Facility User Fee Cover 

Sheet, Form 3601a 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 October 21, 

2024. 

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 0910–0511. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Medical Device User Fee Cover Sheet, 

Form FDA 3601 and Device Facility 

User Fee Cover Sheet, Form FDA 3601a 

OMB Control Number 0910–0511— 

Revision 

This information collection supports 

the FDA medical device and device user 

fee programs. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the Medical Device User 

Fee and Modernization Act of 2002 


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76852 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

1https://www.fda.gov/medical-devices/ 

postmarket-requirements-devices/third-partyinspection-devices. 

2https://www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/fda-and-industryprocedures-section-513g-requests-informationunder-federal-food-drug-and-cosmetic. 

(MDUFMA) (Pub. L. 107–250), and the 

Medical Device User Fee Amendments 

of 2007 (Title II of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Pub. L. 110–85)), 

authorizes FDA to collect user fees for 

certain medical device applications. 

Under this authority, companies pay a 

fee for certain new medical device 

applications or supplements submitted 

to the Agency for review. Because the 

submission of user fees concurrently 

with applications and supplements is 

required, the review of an application 

cannot begin until the fee is submitted. 

Form FDA 3601, the ‘‘Medical Device 

User Fee Cover Sheet,’’ is designed to 

provide the minimum necessary 

information to determine whether a fee 

is required for review of an application, 

to determine the amount of the fee 

required, and to account for and track 

user fees. Form FDA 3601 and 

instructions are available online for 

registered users. The form provides a 

cross-reference between the fees 

submitted for an application with the 

actual submitted application by using a 

unique number tracking system. The 

information collected is used by FDA’s 

Center for Devices and Radiological 

Health (CDRH) and FDA’s Center for 

Biologics Evaluation and Research 

(CBER) to initiate the administrative 

screening of new medical device 

applications and supplemental 

applications. 

Owners or operators of places of 

business (also called establishments or 

facilities) that are involved in the 

production and distribution of medical 

devices intended for use in the United 

States are required to register annually 

with FDA, a process known as 

establishment registration (21 CFR part 

807, subparts A through D). (The 

information collection for medical 

device establishment registration and 

listing is approved under OMB control 

number 0910–0625.) All establishments 

required to register must pay a user fee. 

Form FDA 3601a, the ‘‘Device Facility 

User Fee Cover Sheet,’’ is designed to 

collect payments for the annual 

establishment registration fee for 

medical device establishments. 

Under section 704(g) of the FD&C Act 

(21 U.S.C. 374(g)), FDA may accredit 

persons to inspect qualified 

manufacturers of class II and class III 

devices. An eligible establishment is 

permitted to select any FDA-accredited 

person to conduct an inspection in lieu 

of an FDA inspection, but the eligible 

establishment must submit notice to 

FDA for selection approval (see 21 

U.S.C. 374(g)(1) and (g)(6)(B)). Referred 

to as the ‘‘Accredited Persons Inspection 

Program,’’ FDA publishes a complete 

list of accredited persons and the 

activities for which they are accredited 

on our website at Third Party Device 

Inspection,1 along with additional 

information about the program. 

The guidance document entitled 

‘‘FDA and Industry Procedures for 

Section 513(g) Requests for Information 

under the Federal Food, Drug, and 

Cosmetic Act’’ (December 2019) 2

provides FDA’s recommendations 

regarding provision of user fees for 

513(g) requests for information under 

section 738(a)(2)(A)(ix) of the FD&C Act 

(21 U.S.C. 379j(a)(2)(A)(ix)). Instructions 

for submission and specific content 

elements are discussed in the guidance 

document in sections IV and V, 

respectively. 

In the Federal Register of February 

29, 2024 (89 FR 14890), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form or activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average burden per 

response 

Total 

hours 

User Fee Cover Sheet 

Form FDA 3601 (Medical Device User Fee Cover Sheet) ........... 6,182 1 6,182 0.30 (18 minutes) .... 1,855 

Form FDA 3601a (Device Facility User Fee Cover Sheet) .......... 24,086 1 24,086 0.17 (10 minutes) .... 4,095 

Subtotal ................................................................................... .................... ........................ 30,268 .................................. 5,950 

Inspection by Accredited Persons Program Under Section 704 of the FD&C Act 

Request for accreditation ............................................................... 1 1 1 80 ............................. 80

Notification of the intent to use an Accredited Person .................. 10 1 10 15 ............................. 150 

Subtotal ................................................................................... .................... ........................ 11 .................................. 230 

Request for Information Under Section 513(g) of the FD&C Act 

Sections IV and V of Guidance; CDRH 513(g) requests .............. 114 1 114 12 ............................. 1,368 

Sections IV and V of Guidance; CBER 513(g) requests .............. 4 1 4 12 ............................. 48 

Subtotal ................................................................................... .................... ........................ 118 .................................. 1,416 

Total ................................................................................. .................... ........................ .................... .................................. 7,596 

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

User Fee Cover Sheet 

According to FDA’s database system, 

manufacturers of products subject to 

MDUFMA submit an average of 6,182 

applications annually and submit an 

average of 24,086 Device Facility User 

Fee applications. However, not all 

manufacturers will have any cover sheet 

submissions in a given year and some 

may have multiple cover sheet 

submissions. The estimated hours per 


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I I 

I I I I 

I I I I 
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 


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