83554 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 

Dated: November 27, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26306 Filed 11–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2459] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Product 

Jurisdiction and Combination 

Products 

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 January 2, 

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 0910–0523. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Product Jurisdiction and Combination 

Products—21 CFR Parts 3 and 4 

OMB Control Number 0910–0523— 

Extension 

This information collection helps 

support implementation of statutory 

requirements that govern product 

jurisdiction and combination products. 

Congress expressly directed FDA to 

assign combination products to the 

appropriate Agency component for 

regulation as set forth in section 503(g) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 353(g)). 

Congress also expressly directed FDA to 

determine the classification of a product 

as a drug, biological product, device, or 

combination product, or the component 

of the Agency that will regulate the 

product, as applicable, in response to a 

request submitted under section 563 of 

the FD&C Act (21 U.S.C. 360bbb–2). 

Regulations in 21 CFR part 3 provide 

for product classification 

determinations and FDA designation on 

which Agency component will have 

primary jurisdiction for any drug, 

device, biological, or combination 

product, where such jurisdiction is 

unclear or in dispute. These 

determinations are made by our Office 

of Combination Products (OCP) upon 

receiving Requests for Designation 

(RFDs). We maintain a web page that 

includes contact and resource 

information pertaining to the RFDs 

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

combination-products/jurisdictionalinformation. As communicated on our 

web page, FDA welcomes comments 

from interested stakeholders on issues 

pertaining to OCP and encourages 

medical product developers to contact 

us if they are uncertain about the 

classification or assignment of their 

products and with questions regarding 

premarket or postmarket considerations 

for combination products. A dedicated 

mailbox is established at combination@

fda.hhs.gov. 

Similar to the RFD process, we have 

established the Pre-RFD process for 

sponsors to obtain preliminary, 

nonbinding feedback regarding medical 

product classification and assignment. 

Although Forms FDA 5003, 5004, and 

5005 (pre-request and request for 

designation forms) were previously 

developed to facilitate information 

collection for Pre-RFDs and RFDs, we 

have more recently issued the following 

Agency guidance documents to provide 

instruction and recommendations to 

respondents regarding the submission of 

RFDs and Pre-RFDs. 

• The guidance document entitled, 

‘‘How to Write a Request for 

Designation’’ (April 2011), provides 

instruction regarding the information 

that needs to be submitted to OCP in an 

RFD as described in 21 CFR 3.7. The 

guidance is available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/howwrite-request-designation-rfd. 

• The guidance document entitled 

‘‘How to Prepare a Pre-Request for 

Designation,’’ (February 2018) was 

developed to assist sponsors in 

obtaining a preliminary, non-binding 

assessment regarding the classification 

and assignment of products from OCP 

through the Pre-RFD process. The 

guidance explains the Pre-RFD process 

and helps a sponsor understand the type 

of information to provide in a Pre-RFD 

submission. The guidance is available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/how-prepare-pre-requestdesignation-pre-rfd. 

• This information collection also 

includes burden associated with 

Combination Product Agreement 

Meetings (CPAM) requests. The 

guidance document entitled, 

‘‘Requesting FDA Feedback on 

Combination Products,’’ (December 

2020) was developed to discuss ways in 

which combination product sponsors 

can obtain feedback from FDA on 

scientific and regulatory questions and 

to describe best practices for FDA and 

sponsors when interacting on these 

topics. The guidance is available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/requesting-fda-feedbackcombination-products. 

The guidance documents were issued 

consistent with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

The information collection also 

includes regulations in 21 CFR part 4 

that govern current good manufacturing 

practice requirements and 

postmarketing safety requirements for 

combination products. We expect, 

however, that burden attendant to the 

associated recordkeeping, reporting, 

and/or disclosure activities is already 

accounted for in approved information 

collections that apply to drug, device, 

and/or biologic products specifically 

and respectively. Therefore, we do not 

ascribe separate burden in this 

information collection request for the 

activities generated by these 

requirements. 

Respondents to the information 

collection are sponsors of medical 

products, including combination 

products. Based on submissions 

received by OCP during fiscal years 

2020, 2021, and 2022, we account for 

135 respondents annually. 

In the Federal Register of July 31, 

2023 (88 FR 49467), we published a 60- 

day notice soliciting comment on the 

proposed collection of information. One 

comment was received expressing 

interest in combination product 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 83555 

submissions, but was not responsive to 

the four information collection topics 

solicited in our notice and therefore we 

do not discuss the comment here. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

3.7; request for designation (RFD) ...................................... 55 1 55 24 1,320 

Pre-RFD submissions .......................................................... 77 1 77 24 1,848 

CPAM requests .................................................................... 3 1 3 25 75 

Total .............................................................................. ........................ ........................ ........................ ........................ 3,243 

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

Our estimated burden reflects a 

decrease in the number of respondents 

(four respondents) and a corresponding 

decrease in total hours (96 hours). Based 

on a recent evaluation of CPAM requests 

received from each product center in 

fiscal years 2020, 2021, and 2022, our 

estimated annual burden for CPAM 

requests remains unchanged. 

Dated: November 24, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26262 Filed 11–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–2198; FDA– 

2022–E–2202; FDA–2022–E–2203; and FDA– 

2022–E–2204] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Ukoniq 

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 Ukoniq and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of 

applications 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 must submit either electronic 

or written comments and ask for a 

redetermination by January 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 

May 28, 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 

January 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 Nos. FDA– 

2022–E–2198; FDA–2022–E–2202; 

FDA–2022–E–2203; and FDA–2022–E– 

2204 for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; UKONIQ.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES