14890 Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices 

Dated: February 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–04234 Filed 2–28–24; 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; Proposed Collection; 

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 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 extension of an 

existing collection of information and to 

allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the extension of 

this information collection. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by April 

29, 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 

April 29, 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 the Docket No. FDA– 

2024–N–0022 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Device User Fee Cover Sheet, Form FDA 

3601 and Device Facility User Fee Cover 

Sheet, Form 3601a.’’ 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 

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: 

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: 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 extension 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices 14891 

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

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

2FDA and Industry Procedures for Section 513(g) 

Requests for Information under the Federal Food, 

Drug, and Cosmetic Act | FDA. 

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. 

Medical Device User Fee Cover Sheet, 

Form FDA 3601 and Device Facility 

User Fee Cover Sheet, Form FDA 3601a 

OMB Control Number 0910–0511— 

Extension 

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 

(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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
14892 Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

FDA form or activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

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 

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). 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 Accredited 

Persons to perform certain inspections. 

While all firms remain subject to 

inspection by FDA, eligible 

manufacturers have the option of 

requesting inspection by an Accredited 

Person. A device establishment is 

eligible for inspection by Accredited 

Persons 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 Accredited Person 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 Accredited Person 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 no 

adjustments to our burden estimate. 

Dated: February 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–04163 Filed 2–28–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–0920; FDA– 

2022–E–0921; FDA–2022–E–0923] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CAMCEVI 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for CAMCEVI and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by April 29, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 27, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 

April 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is 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 


khammond on DSKJM1Z7X2PROD with NOTICES