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. 


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Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices 72083 

Application No. Drug Applicant 

ANDA 202784 .................................................... Esomeprazole Magnesium Capsule, Delayed 

Release Pellets, EQ 20 mg base and EQ 40 

mg base.

Hetero USA, Inc., U.S. Agent for Hetero Labs 

Ltd., Unit-III, 1035 Centennial Ave., 

Piscataway, NJ 08854. 

ANDA 208413 .................................................... Choline C–11 Injectable, 4–33.1 millicurie/mL Washington University School of Medicine, 

510 South Kingshighway Blvd., St. Louis, 

MO 63110. 

ANDA 208939 .................................................... Esomeprazole Magnesium Capsule, Delayed 

Release, EQ 20 mg base.

Hetero USA, Inc., U.S. Agent for Hetero Labs 

Ltd. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of November 20, 

2023. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in the table without an approved 

new drug application or abbreviated 

new drug application violates sections 

505(a) and 301(d) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

355(a) and 331(d)). Drug products that 

are listed in the table that are in 

inventory on November 20, 2023 may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23064 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–1005] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Focus Groups and 

Interviews as Used by the Food and 

Drug Administration 

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 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by November 

20, 2023. 

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 0910–0497. 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. 

Focus Groups and Interviews as Used 

by the Food and Drug Administration 

OMB Control No. 0910–0497—Extension 

FDA conducts focus groups and indepth individual interviews on a variety 

of topics involving FDA-regulated 

products, including drugs, biologics, 

devices, food, tobacco products, and 

veterinary medicine. 

Focus groups are an important role in 

gathering information because they 

allow for a better understanding of 

consumers’ attitudes, beliefs, 

motivations, and feelings than do 

quantitative studies and encourages 

interaction between participants. 

Individual interviews allow for a 

more comprehensive, in-depth 

information exchange where more 

insights are likely to be collected. 

Both focus groups and in-depth 

individual interviews serve the 

narrowly defined need for direct and 

informal opinion on a specific topic 

and, as a qualitative research tool, have 

three major purposes: 

• To obtain consumer information 

that is useful for developing variables 

and measures for quantitative studies, 

• To better understand consumers’ 

attitudes and emotions in response to 

topics and concepts, and 

• To further explore findings 

obtained from quantitative studies. 

FDA will use findings to test and 

refine ideas but will generally conduct 

further research before making 

important decisions, such as adopting 

new policies and allocating or 

redirecting significant resources to 

support these policies. 

Respondents to this collection of 

information will include members of the 

general public, healthcare professionals, 

the industry, and other stakeholders 

who are related to a product under 

FDA’s jurisdiction. Inclusion and 

exclusion criteria will vary depending 

on the research topic. 

In the Federal Register of April 11, 

2023 (88 FR 21680), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Three comments were 

received, two in support of the 

information collection, and one that did 

not address the elements of the PRA. 

FDA estimates the burden of this 

collection of information as follows: 


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