Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices 229 

compliance with Federal policies and 

good quality drug production, and (3) 

barriers and opportunities related to 

outsourcing facility interactions with 

FDA. 

FDA used previous research results 

under this information collection to 

develop an understanding of the 

outsourcing facility sector, the sector’s 

challenges, and opportunities for 

advancement. The information collected 

was an essential tool to help FDA 

identify knowledge and information 

gaps, operational barriers, and views on 

interactions with FDA. FDA has 

presented this information in public 

settings, such as stakeholder meetings. 

Continuing this collection will enable 

FDA to deepen our understanding of the 

outsourcing facility sector and increase 

our efficacy in developing a Center of 

Excellence that is responsive to 

outsourcing facilities’ needs. The 

research results will inform FDA’s 

future activities for the Center of 

Excellence in the areas of 

communication, education, training, 

and other engagement with outsourcing 

facilities to address challenges and 

support advancement. 

Researchers engage with pharmacists, 

staff, management from outsourcing 

facilities, similar compounding 

businesses, and related stakeholders and 

may use surveys, interviews, and focus 

groups to obtain information about 

outsourcing facilities’ challenges and 

opportunities. Within this context, we 

may pose the following questions or 

similar, related questions: 

1. What financial and operational 

considerations inform outsourcing 

facility operational and business model 

decisions? 

2. What factors impact developing a 

sustainable outsourcing facility 

business? 

3. What financial and operational 

considerations inform outsourcing 

facility product decisions? 

4. Do outsourcing facilities 

understand the Federal laws and 

policies that apply to them? What, if 

any, knowledge gaps do we need to 

address? 

5. What are outsourcing facilities’ 

challenges when implementing Federal 

CGMP requirements? 

6. How do outsourcing facilities 

implement quality practices at their 

facilities? 

7. How do outsourcing facilities 

develop CGMP and quality expertise? 

How do they obtain this knowledge, and 

what training do they need? 

8. What are the economic 

consequences of CGMP noncompliance 

and product failures for outsourcing 

facilities? 

9. What are outsourcing facility 

management and staff views on current 

interactions with FDA? How do they 

want the interactions to change? 

10. What are outsourcing facilities’ 

understanding of how to engage with 

FDA during and following an 

inspection? 

In the Federal Register of October 1, 

2021 (86 FR 54450), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment from an industry association 

relating to the quality of questions 

previously posed to industry 

stakeholders concerning outsourcing 

facilities. Specifically, the commenter 

stated that the proposed questions 

included in the 60-day notice were 

insufficient to fully acquire information 

relating to the challenges and 

opportunities outsourcing facilities face. 

Accordingly, the commenter provided a 

number of additional questions for FDA 

to use, which the commenter believes 

will better solicit relevant information. 

FDA has considered the commenter’s 

additional questions and will take them 

under advisement for possible inclusion 

in future studies. However, at this time 

FDA will not include the commenter’s 

questions in this particular study 

because we believe the proposed 

questions listed in the 60-day notice 

will sufficiently solicit the specific 

information we are currently seeking. 

FDA estimates the burden of this 

collection of information as follows: 

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 

Surveys, focus groups, and interviews ................................ 300 2 600 1 600 

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

Our original request for the 

information collection was approved 

January 21, 2020; however, the 

subsequent public health emergency 

inhibited our ability to administer the 

requested survey. We have therefore 

made no adjustments to our current 

burden estimate. 

Dated: December 28, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–28465 Filed 1–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Recourses and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 86 FR 48737–48743 

dated August 31, 2021). 

This reorganization updates the 

functions of the HIV/AIDS Bureau’s 

Division Policy and Data (RVA). 

Chapter RVA—Division of Policy and 

Data 

Section RVA.20 Function 

Delete the functional statement for the 

Division of Policy and Data (RVA) in its 

entirety and replace with the following: 

Division of Policy and Data (RVA) 

The Division of Policy and Data 

serves as the Bureau’s focal point for 

program data collection and analysis, 

development of policy guidance, 

advancement of implementation 

science, and analyses of data for reports 

for dissemination, coordination of 

program and clinical performance 

activities, and technical assistance and 

training internally and externally. The 

division directs and manages the 

portfolio of recipients and programs 

funded under Special Projects of 


tkelley on DSK125TN23PROD with NOTICE 
230 Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices 

National Significance of title XXVI of 

the Public Health Service Act as 

amended by the Ryan White HIV/AIDS 

Treatment Extension Act of 2009, Public 

Law 111–87 (the Ryan White HIV/AIDS 

Program), 42 U.S.C. 300ff–101 (§ 2691 of 

the Public Health Service Act). The 

Division advises the Bureau’s associate 

administrator and collaborates with 

division directors to develop policy, 

evaluation, data, and clinical proposals 

to support the Bureau’s mission. The 

Division also coordinates and develops 

efforts with other HHS components and 

all HRSA Bureaus and Offices, 

including HRSA’s Office of Planning, 

Analysis and Evaluation and Office of 

Legislation, in the preparation of HIVrelated program policies. 

Section RVA.30 Delegation of Authority 

All delegations of authority and redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegation, if allowed, 

provided they are consistent with this 

reorganization. 

This reorganization is effective upon 

date of signature. 

(Authority: 44 U.S.C. 3101) 

Diana Espinosa, 

Acting Administrator. 

[FR Doc. 2021–28463 Filed 1–3–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before March 7, 2022. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990-New-60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Understanding 

Economic Risk for Low Income 

Families: Economic Security, Program 

Benefits, and Decisions about Work. 

Type of Collection: New. 

OMB No.: 0990–XXXX. 

Abstract: The primary purpose of this 

study is to identify the risks that federal 

program benefit recipients weigh when 

faced with an opportunity to increase 

earnings, including benefit reductions, 

earnings instability and the ease of 

regaining lost benefits if needed. 

The study will use a discrete choice 

experiment to explore the importance of 

these considerations when low-income 

individuals are presented with a 

hypothetical opportunity to increase 

earnings. Statistical analysis will 

explore interactions between factors and 

threshold effects. The focus population 

will be persons currently receiving 

benefits from at least one of the 

following programs: Supplemental 

Nutrition Assistance Program (SNAP), 

Medicaid/Children’s Health Insurance 

Program (CHIP), housing assistance, 

Child Care Development Fund (CCDF) 

subsidies, and/or Temporary Assistance 

for Needy Families (TANF). The study 

will explore whether different 

preferences are exhibited by parents 

with children and by persons of 

different races and ethnicities. 

The results of this study will provide 

HHS with a better understanding of the 

economic risks that people weigh when 

they make decisions about increasing 

earnings, which will inform HHS policy 

and programs at large, and further lines 

of research around benefit programs and 

employment decisions. 

The length of the request for data 

collection is one year. The data will be 

collected once, using primarily a webbased survey, from a sample of lowincome persons receiving one or more 

federal benefit programs. The survey 

consists of five vignettes presenting 

different combinations of experimental 

conditions surrounding a hypothetical 

earnings increase. In each vignette, 

respondents will be presented with a 

scenario where a hypothetical 

individual is presented with an 

opportunity to increase their earnings 

(by accepting a higher hourly wage); 

consequences of the earnings increase 

for his or her receipt of benefits; the risk 

of going back down to the lower, 

original hourly wage at a later time; and 

the prospect of re-applying for lost 

benefits. Respondents will be asked to 

review the vignette and choose whether 

they think the hypothetical individual 

should accept the earnings increase. In 

addition, the questionnaire includes 

follow-up questions for each vignette/ 

experimental condition, and a set of 

demographic questions. 

ANNUALIZED BURDEN HOUR TABLE

Number of respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total 

burden 

hours 

Approximately 2,000 .................................................................................................................... 1 20/60 667 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–28466 Filed 1–3–22; 8:45 am] 

BILLING CODE 4150–05–P 


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