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Agency issued the draft guidance 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 The draft guidance also 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preparing the draft guidance, FDA 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Agency issued the draft guidance for 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 


lotter on DSK11XQN23PROD with NOTICES1
72086 Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices 

the information to identify 

opportunities for strengthening its 

dissemination channels and resources to 

improve care and health outcomes for 

program participants. A 60-day notice 

was published in the Federal Register 

on July 12, 2023, Vol. 88, No. 132, pp. 

44371–44373 (88 FR 44371). HRSA 

received no comments. 

Need and Proposed Use of the 

Information: Currently, HRSA does not 

systematically gather information about 

the resources accessed by RWHAP 

providers, RWHAP recipients, or AIDS 

Education and Training Center (AETC) 

staff and the extent to which they use 

those resources to inform 

implementation of interventions. 

The mixed-methods RUDI evaluation 

will help HRSA systematically assess 

and understand (1) how, where, and 

why recipients of RWHAP funding 

access and use its disseminated 

resources and products; and (2) the 

utility and effectiveness of the 

disseminated resources and products in 

caring for and treating people with HIV. 

HRSA will use the findings from the 

RUDI evaluation to develop strategies to 

maximize the uptake and impact of its 

disseminated resources and products, 

contributing to ending the HIV epidemic 

in the United States. 

Likely Respondents: The mixedmethods RUDI evaluation includes a 

web-based survey of all RWHAP 

recipients and subrecipients nationally, 

individual and small group interviews 

with a sample of RWHAP recipients, 

virtual site visits with a sample of 

RWHAP providers, and individual 

interviews with all AETCs. The RUDI 

web-based survey design includes two 

versions of the survey that will be 

administered to non-overlapping 

respondents—the RUDI Recipients 

Survey for RWHAP Part A and B 

recipient administrative entities—and 

the RUDI Providers Survey for Part A 

and B subrecipients and Part C, D, and 

F recipients who provide direct care. 

Both versions ask about respondents’ 

use of HRSA-disseminated resources, 

how they were helpful, what could be 

improved, and reasons for non-use 

where applicable. In addition, the RUDI 

Recipients Survey asks about the 

recipients’ role in guiding their 

subrecipients to needed resources, and 

the RUDI Providers Survey asks about 

the providers’ experience implementing 

interventions for which they used the 

resources. Both surveys are designed to 

be followed up with additional sets of 

interviews with a sample of the survey 

respondents to provide deeper 

understanding of their experience to 

support development of actionable 

recommendations pertaining to 

dissemination. Virtual site visits to 

RWHAP providers include interviews 

with an average of three staff within 

each provider organization that were 

part of an intervention implementation 

with assistance from HRSA resources. 

Individual interviews for Part A and B 

recipient administrative entities and 

AETCs will generate a complete picture 

of how those organizations use HRSA 

resources and how the resources or their 

dissemination could be improved for 

the future, especially when considered 

together with the survey responses and 

virtual site visit data from the RWHAP 

providers. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Respondent Data collection 

Number of 

respondents 

(RWHAP 

sites) 

Number of 

responses 

per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

RWHAP recipients .............. RUDI—Recipient Survey .... 56 1 56 0.33 18.48 

RWHAP provider ................. RUDI—Provider Survey ..... 1,066 1 1,066 0.33 351.78 

RWHAP recipients .............. Interviews ........................... 20 3 60 0.75 45.00 

RWHAP provider ................. Virtual site visit interviews .. 40 3 120 1.00 120.00 

AETC providers ................... Interviews ........................... 8 1 8 1.00 8.00 

1,190 1,310 543.26 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–23108 Filed 10–18–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Bureau of 

Health Workforce Performance Data 

Collection, OMB No. 0915–0061— 

Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than December 18, 

2023. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 


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