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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices 72085 

2The CARES Act (Pub. L. 116–136) was enacted 

on March 27, 2020. The CARES Act amendments 

to section 506C of the FD&C Act took effect on 

September 23, 2020. See section 3112(g) of the 

CARES Act. 

Agency ‘‘continues to assess the needs 

and circumstances related to the 

policies in our COVID–19-related 

guidances, and we may alter our 

approach for individual guidances listed 

in this notice.’’ (88 FR 15417 at 15418). 

Following the expiration of the COVID– 

19 PHE declaration on May 11, 2023, 

FDA has reviewed the Notifying FDA 

Guidance and the Potency Assay 

Guidance and determined that these two 

guidances are no longer needed because 

new draft guidances are available. 

In March 2023 (88 FR 13126), the 

Agency issued the draft guidance 

document entitled ‘‘Potency Assay 

Considerations for Monoclonal 

Antibodies and Other Therapeutic 

Proteins Targeting Viral Pathogens,’’ 

which provides information to assist in 

the development of mAbs and other 

therapeutic proteins directly targeting 

viral proteins or host cell proteins 

mediating pathogenic mechanisms of 

infection. The draft guidance also 

provides detailed recommendations for 

drug developers with the goal of helping 

to ensure that drug developers provide 

adequate information to assess potency 

at each stage of a product’s life cycle. 

FDA believes that many of the 

recommendations set forth in the 2021 

Potency Assay Guidance are applicable 

outside the context of the COVID–19 

PHE and are applicable to mAbs and 

other therapeutic protein directly 

targeting any viral surfaces (glycol) 

proteins mediating pathogenic 

mechanisms of infection, not just those 

that directly target SARS–CoV–2. In 

preparing the draft guidance, FDA 

considered comments received 

regarding the 2021 Potency Assay 

Guidance as well as the Agency’s 

experience with SARS–CoV–2 and other 

viruses. 

In April 2023 (88 FR 20526), the 

Agency issued the draft guidance for 

industry entitled ‘‘Notification of a 

Permanent Discontinuance or 

Interruption in Manufacturing Under 

Section 506C of the FD&C Act’’ to assist 

applicants and manufacturers in 

providing FDA timely, informative 

notifications about changes in the 

production of certain finished drugs and 

biological products as well as certain 

active pharmaceutical ingredients (API) 

that may, in turn, help the Agency in its 

effort to prevent and mitigate shortages. 

The draft guidance discusses the 

notification requirements under section 

506C of the Federal Food, Drug and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

356c), including requirements added by 

the Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act) 2

related to notifying FDA about finished 

product and API manufacturing 

discontinuances and interruptions. The 

draft guidance provides 

recommendations for applicants and 

manufacturers to provide additional 

details and follow additional procedures 

to ensure FDA has the specific 

information it needs to help prevent or 

mitigate shortages. In addition, the draft 

guidance explains how FDA 

communicates information about 

products in shortage to the public. In 

preparing the draft guidance, FDA 

considered comments received on the 

2020 Notifying FDA Guidance. 

For the reasons discussed above, FDA 

is announcing the guidance entitled 

‘‘Notifying FDA of Permanent 

Discontinuance or Interruption in 

Manufacturing Under Section 506C of 

the FD&C Act’’ (March 2020) and the 

guidance entitled ‘‘COVID–19: Potency 

Assay Consideration for Monoclonal 

Antibodies and Other Therapeutic 

Proteins Targeting SARS–CoV–2 

Infectivity’’ (January 2021) will expire 

on November 7, 2023. 

II. Expiration Date 

The expiration date for the guidance 

documents in this document is 

November 7, 2023. 

Dated: October 16, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23071 Filed 10–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Rapid Uptake of 

Disseminated Interventions Evaluation, 

OMB No. 0906-xxxx 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than November 20, 

2023. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to 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. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Rapid Uptake of Disseminated 

Interventions (RUDI) Evaluation, OMB 

No. 0906-xxxx—New. 

Abstract: HRSA dedicated significant 

resources and effort to developing novel 

intervention strategies aimed at 

eliminating disparities and improving 

HIV-related health outcomes for people 

with HIV. HRSA encourages and 

supports Ryan White HIV/AIDS 

Program (RWHAP) providers to 

implement interventions developed 

through its RWHAP Part F Special 

Projects of National Significance 

program and technical assistance 

initiatives that have been found to be 

effective, with adaptations for priority 

populations served as applicable. HRSA 

disseminates its RWHAP Part F Special 

Projects of National Significance and 

technical assistance initiative resources 

and products across a variety of 

dissemination channels, hoping to reach 

a maximum number of RWHAP 

recipients and subrecipients for whom 

these resources may meet an important 

need. This mixed-methods RUDI 

evaluation will use a web-based survey 

and virtual site visits to collect 

information from RWHAP recipients 

and subrecipients on the uptake, utility, 

and efficacy of the resources and 

products HRSA disseminates; the 

effectiveness of its dissemination 

processes; and the reach of its 

dissemination channels. HRSA will use 


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