72080 Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices 

4See 88 FR 53484 (Aug. 8, 2023). 

2. Activity-Based Stock Purchase 

Requirement Submissions 

FHFA estimates that the average 

number of daily transactions between 

Banks and members that will require the 

exchange of information to confirm the 

member’s activity-based stock purchase 

requirement will be 300, and that there 

will be an average of 261 working days 

per year, resulting in an estimated 

78,300 submissions annually. The 

estimate for the average preparation 

time per submission is 0.2 hours. 

Accordingly, the estimate for the annual 

hour burden associated with activitybased stock purchase requirement 

submissions is (78,300 submissions × 

0.2 hours per submission) = 15,660 

hours. 

E. Comment Request 

In accordance with the requirements 

of 5 CFR 1320.8(d), FHFA published an 

initial notice and request for public 

comments regarding this information 

collection in the Federal Register on 

August 8, 2023.4 The 60-day comment 

period closed on October 10, 2023. 

FHFA received no substantive 

comments. 

FHFA requests written comments on 

the following: (1) whether the collection 

of information is necessary for the 

proper performance of FHFA functions, 

including whether the information has 

practical utility; (2) the accuracy of 

FHFA’s estimates of the burdens of the 

collection of information; (3) ways to 

enhance the quality, utility, and clarity 

of the information collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Shawn Bucholtz, 

Chief Data Officer, Federal Housing Finance 

Agency. 

[FR Doc. 2023–23067 Filed 10–18–23; 8:45 am] 

BILLING CODE 8070–01–P 

FEDERAL RESERVE SYSTEM 

Sunshine Meeting Notice 

AGENCY HOLDING THE MEETING: Board of 

Governors of the Federal Reserve 

System. 

TIME AND DATE: 1:00 p.m. on Wednesday, 

October 25, 2023. 

PLACE: Martin Federal Reserve Board 

Building, C Street entrance between 

20th and 21st Streets NW, Washington, 

DC 20551. 

STATUS: Open. 

On the day of the meeting, you will 

be able to view the meeting via webcast 

from a link available on the Board’s 

website. You do not need to register to 

view the webcast of the meeting. A link 

to the meeting documentation will also 

be available approximately 20 minutes 

before the start of the meeting. Both 

links may be accessed from the Board’s 

website at www.federalreserve.gov. 

If you plan to attend the open meeting 

in person, we ask that you notify us in 

advance and provide your name, date of 

birth, and social security number (SSN) 

or passport number. You may provide 

this information by calling 202–452– 

2474 or you may register online 

www.federalreserve.gov. You may preregister until close of business on 

October 24, 2023. You also will be asked 

to provide identifying information, 

including a photo ID, before being 

admitted to the Board meeting. The 

Public Affairs Office must approve the 

use of cameras; please email media@

frb.gov for further information. If you 

need an accommodation for a disability, 

please contact Penelope Beattie on 202– 

452–3982. For users of telephone 

systems via text telephone (TTY) or any 

TTY-based Telecommunications Relay 

Services (TRS), please call 202–263– 

4869 or dial 7–1–1 from any telephone, 

anywhere in the United States. 

Privacy Act Notice: The information 

you provide will be used to assist us in 

prescreening you to ensure the security 

of the Board’s premises and personnel. 

In order to do this, we may disclose 

your information consistent with the 

routine uses listed in the Privacy Act 

Notice for BGFRS–32, including to 

appropriate federal, state, local, or 

foreign agencies where disclosure is 

reasonably necessary to determine 

whether you pose a security risk or 

where the security or confidentiality of 

your information has been 

compromised. We are authorized to 

collect your information by 12 U.S.C. 

243 and 248, and Executive Order 9397. 

In accordance with Executive Order 

9397, we collect your SSN so that we 

can keep accurate records, because other 

people may have the same name and 

birth date. In addition, we use your SSN 

when we make requests for information 

about you from law enforcement and 

other regulatory agency databases. 

Furnishing the information requested is 

voluntary; however, your failure to 

provide any of the information 

requested may result in disapproval of 

your request for access to the Board’s 

premises. You may be subject to a fine 

or imprisonment under 18 U.S.C. 1001 

for any false statements you make in 

your request to enter the Board’s 

premises. 

MATTERS TO BE CONSIDERED: 

Discussion Agenda 

1. Proposed revisions to the Board’s 

debit interchange fee cap. 

Notes: 1. For those attending in 

person, the staff memo will be available 

to attendees on the day of the meeting 

in paper. Meeting documentation will 

be available on the Board’s website 

about 20 minutes before the start of the 

meeting. 

2. This meeting will be recorded for 

the benefit of those unable to attend. 

The webcast recording and a transcript 

of the meeting will be available after the 

meeting on the Board’s website http://

www.federalreserve.gov/aboutthefed/ 

boardmeetings/. 

For questions please contact: Public 

Affairs Office at media@frb.gov. 

SUPPLEMENTARY INFORMATION: You may 

access the Board’s website at 

www.federalreserve.gov for an electronic 

announcement. (The website also 

includes procedural and other 

information about the open meeting.) 

Dated: October 16, 2023. 

Ann E. Misback, 

Secretary of the Board. 

[FR Doc. 2023–23116 Filed 10–18–23; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4356] 

Enforcement Policy for Non-Invasive 

Remote Monitoring Devices Used To 

Support Patient Monitoring; Guidance 

for Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Enforcement Policy 

for Non-Invasive Remote Monitoring 

Devices Used to Support Patient 

Monitoring.’’ The enforcement policy 

described in this guidance applies to 

modified devices where the original 

device was a legally marketed, noninvasive remote monitoring device 

listed in the guidance that measures or 

detects common physiological 

parameters and that is used to support 

patient monitoring. The guidance is 

intended to describe the enforcement 

policy for limited modifications to the 

indications, functionality, or hardware 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices 72081 

or software of device types in the scope 

of the guidance without prior 

submission of a 510(k) where such 

submission would be required. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 19, 2023. 

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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–4356 for ‘‘Enforcement Policy 

for Non-Invasive Remote Monitoring 

Devices Used to Support Patient 

Monitoring.’’ Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Enforcement Policy 

for Non-Invasive Remote Monitoring 

Devices Used to Support Patient 

Monitoring’’ to the Office of Policy, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Paulsen, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2108, Silver Spring, 

MD 20993–0002, 301–796–6883. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The enforcement policy described in 

this guidance applies to modified 

devices where the original device was a 

legally marketed, noninvasive remote 

monitoring device listed in the guidance 

that measures or detects common 

physiological parameters and that is 

used to support patient monitoring. The 

guidance is intended to describe the 

enforcement policy for limited 

modifications to the indications, 

functionality, or hardware or software of 

device types in the scope of the 

guidance without prior submission of a 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) (see 21 CFR 807.81) where such 

submission would be required. This 

guidance supersedes ‘‘Enforcement 

Policy for Non-Invasive Remote 

Monitoring Devices Used to Support 

Patient Monitoring During the 

Coronavirus Disease 2019 (COVID–19) 

Public Health Emergency’’ issued in 

March 2020 and updated in June 2020, 

October 2020, and March 2023. 

In the Federal Register of March 13, 

2023 (88 FR 15417), FDA announced 

that that guidance was being revised to 

continue in effect for 180 days after the 

expiration of the COVID–19 public 

health emergency (PHE) declaration 

issued under section 319 of the Public 

Health Service Act, during which time, 

FDA intended to further revise the 

guidance. Consistent with what we said 

in the Federal Register of March 13, 

2023, FDA is therefore issuing this 

revised final guidance. 

Leveraging the perspective gained 

during the COVID–19 pandemic, FDA is 

updating the policy reflected in the 

‘‘Enforcement Policy for Non-Invasive 

Remote Monitoring Devices Used to 

Support Patient Monitoring During the 

Coronavirus Disease 2019 (COVID–19) 

Public Health Emergency’’ guidance to 

exercise certain enforcement policies for 

certain devices beyond the expiration of 

the COVID–19 PHE (which expired on 

May 11, 2023) and the 180-day period 

announced in the March 13, 2023 

Federal Register notice, including by 

removing clinical thermometers and 

pulse oximeters from the scope of the 

guidance, revising the policy with 


lotter on DSK11XQN23PROD with NOTICES1
72082 Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices 

respect to certain device types subject to 

special controls, and removing use of 

the term ‘‘claims.’’ 

This guidance is being implemented 

without prior public comment because 

FDA has determined that prior public 

participation for this guidance is not 

feasible or appropriate (see section 

701(h)(1)(C) of the FD&C Act (21 U.S.C. 

371(h)(1)(C)) and § 10.115(g)(2) (21 CFR 

10.115(g)(2)). FDA has determined that 

this guidance document presents a less 

burdensome policy that is consistent 

with public health. Although this policy 

is being implemented immediately 

without prior comment, it remains 

subject to comment in accordance with 

FDA’s good guidance practices 

regulation (§ 10.115(g)(3)(i)(D)). FDA 

will consider all comments received and 

revise the guidance document as 

appropriate. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the current thinking 

of FDA on ‘‘Enforcement Policy for NonInvasive Remote Monitoring Devices 

Used to Support Patient Monitoring.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Enforcement Policy 

for Non-Invasive Remote Monitoring 

Devices Used to Support Patient 

Monitoring’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number GUI00007017 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information in 

the following FDA regulations, 

guidance, and forms have been 

approved by OMB as listed in the 

following table: 

21 CFR Part Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket Notification ................................................................ 0910–0120 

800, 801, and 809 ...................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 

Dated: October 16, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23110 Filed 10–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4414] 

American Regent, Inc., et al.; 

Withdrawal of Approval of Eight 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of eight 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

applicants notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

November 20, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived the 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 040515 .................................................... Promethazine Hydrochloride Injectable, 25 

milligrams (mg)/milliliter (mL).

American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967. 

ANDA 080028 .................................................... Sulfacetamide Sodium Solution/Drops, 10% 

and 30%.

Allergan Sales, LLC, 2525 Dupont Dr., Irvine, 

CA 92612. 

ANDA 091300 .................................................... Riluzole Tablet, 50 mg ..................................... Apotex Corp., U.S. Agent for Apotex Inc., 

2400 North Commerce Parkway, Suite 400, 

Weston, FL 33326. 

ANDA 200271 .................................................... Hydroxyprogesterone Caproate Solution, 

1,250 mg/5 mL (250 mg/mL).

Lachman Consultant Services, Inc., U.S. 

Agent for Aspen Global Inc., 1600 Stewart 

Ave., Suite 604, Westbury, NY 11590. 

ANDA 201570 .................................................... Abacavir Sulfate Tablet, Equivalent to (EQ) 

300 mg base.

Apotex Corp., U.S. Agent for Apotex Inc. 


lotter on DSK11XQN23PROD with NOTICES1