Statement of Organization, Functions, and Delegations of Authority, 229-230 [2021-28463]
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229
Federal Register / Vol. 87, No. 2 / Tuesday, January 4, 2022 / Notices
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
1 There
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
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).
[FR Doc. 2021–28465 Filed 1–3–22; 8:45 am]
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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
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
SUMMARY:
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.
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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.
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[Federal Register Volume 87, Number 2 (Tuesday, January 4, 2022)]
[Notices]
[Pages 229-230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28463]
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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
[[Page 230]]
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 (Sec. 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 HIV-related program
policies.
Section RVA.30 Delegation of Authority
All delegations of authority and re-delegations 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]
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