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is hereby withdrawn as of November 20, 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application is withdrawn, including any 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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72084 Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices 

1The virus has been named ‘‘SARS–CoV–2’’ and 

the disease it causes has been named ‘‘Coronavirus 

Disease 2019’’ (COVID–19). 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Focus groups and individual in-depth interviews ................ 12,000 1 12,000 1.75 21,000 

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

The estimated burden for the 

information collection reflects an 

overall increase of 5,600 hours and a 

corresponding increase of 3,200 

responses. We have added individual 

in-depth interviews as a method of 

information gathering. In addition, we 

are consolidating ICR 0910–0677, 

‘‘Focus Groups About Drug Products as 

Used by the Food and Drug 

Administration’’ into this request for 

extension. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23011 Filed 10–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1057 and FDA– 

2020–D–1136] 

Food and Drug Administration; Center 

of Drug Evaluation and Research 

Guidance Documents Related to 

Coronavirus Disease 2019, Expiration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the withdrawal of 

guidances for industry entitled 

‘‘Notifying FDA of a Permanent 

Discontinuance or Interruption in 

Manufacturing Under Section 506C of 

the FD&C Act,’’ which posted March 

2020 to communicate recommendations 

for notifying the Agency about the 

permanent discontinuance or 

interruption in manufacturing of certain 

drug products; and ‘‘COVID–19: Potency 

Assay Consideration for Monoclonal 

Antibodies and Other Therapeutic 

Proteins Targeting SARS–CoV–2 

Infectivity’’ which posted January 2021 

to communicate information on the 

development of monoclonal antibodies 

(mAbs) and other therapeutic proteins 

for use as COVID–19 therapeutics. FDA 

is withdrawing these two guidance 

documents because new draft guidances 

are available that reflect comments 

received on the COVID–19 guidances, 

and many of the recommendations set 

forth in the COVID–19 guidances are 

applicable outside the context of the 

public health emergency (PHE) and 

included in the draft guidances. 

DATES: The expiration date is November 

7, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Thomas, Office of Regulatory 

Policy, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–2357. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As part of FDA’s commitment to 

providing timely guidance to support 

response efforts to the Coronavirus 

Disease 2019 (COVID–19) 1 pandemic, 

the Agency published on the FDA 

website the guidance for industry 

entitled ‘‘Notifying FDA of Permanent 

Discontinuance or Interruption in 

Manufacturing Under Section 506C of 

the FD&C Act’’ in March 2020, and 

announced its availability in the 

Federal Register on April 6, 2020 (85 FR 

18247), (Notifying FDA Guidance); and 

in January 2021, the Agency published 

on the FDA website the guidance for 

industry entitled ‘‘COVID–19: Potency 

Assay Considerations for Monoclonal 

Antibodies and Other Therapeutic 

Proteins Targeting SARS–CoV–2 

Infectivity’’ and announced its 

availability in the Federal Register 

February 19, 2021 (86 FR 10285), 

(Potency Assay Guidance). The 

Notifying FDA Guidance explained that 

during the COVID–19 pandemic FDA 

had been closely monitoring the 

medical supply chain with the 

expectation that it may be impacted by 

the COVID–19 outbreak, potentially 

leading to supply disruptions or 

shortages of drug and biological 

products in the United States. The 

Notifying FDA Guidance, therefore, 

communicated the Agency’s 

recommendations for providing timely, 

informative notifications about changes 

in the production of certain drugs and 

biological products to help the Agency 

in its efforts to prevent or mitigate 

shortages of such products. The Potency 

Assay Guidance communicated 

information to assist sponsors in the 

development of mAbs and other 

therapeutic proteins for use as COVID– 

19 therapeutics and described how 

potency assay methods required for 

release and stability testing can be 

shown to assess known or potential 

mechanism(s) of action of the product. 

The guidance also described methods 

that applicants should use to ensure the 

potency of mAbs and other therapeutic 

proteins proposed for use in as antiinfective agents for COVID–19. FDA 

issued both guidances to communicate 

its recommendations for the duration of 

the COVID–19 PHE declared by the 

Secretary of Health and Human Services 

(HHS) on January 31, 2020, including 

any renewals made by the HHS 

Secretary in accordance with section 

319(a)(2) of the Public Health Service 

Act (42 U.S.C. 247d(a)(2)). We also said 

in both guidances that we expected their 

recommendations would continue to 

apply in circumstances outside the 

context of the PHE and that following 

the end of the COVID–19 PHE, FDA 

intended to revise and replace the 

guidances with updated guidances that 

incorporated any appropriate changes 

based on comments received and the 

Agency’s experience with 

implementation. Furthermore, in the 

Federal Register of March 13, 2023 (88 

FR 15417), FDA listed the COVID–19- 

related guidance documents that will no 

longer be in effect with the expiration of 

the COVID–19 PHE declaration on May 

11, 2023, guidances that FDA revised to 

continue in effect for 180 days after the 

expiration of the COVID–19 PHE 

declaration to provide a period for 

stakeholder transition and then would 

no longer be in effect, and guidances 

that FDA revised to continue in effect 

for 180 days after the expiration of the 

PHE declaration during which time FDA 

planned to further revise the guidances. 

The Notifying FDA Guidance and the 

Potency Assay Guidance were included 

in the latter category and were revised 

to remain in effect for 180 days post 

expiration of the PHE declaration. 

FDA also stated in the Federal 

Register of March 13, 2023, that the 


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