Agency Information Collection Activities: Proposed Collection: Public Comment Request Bureau of Health Workforce Program Specific Form OMB No. 0915-XXXX-New, 58359-58360 [2022-20717]
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Federal Register / Vol. 87, No. 185 / Monday, September 26, 2022 / Notices
participating in a clinical investigation.
Such safeguards are an essential
requirement for the initiation and
conduct of pediatric investigations as
part of a medical product development
program.
This draft guidance describes the
ethical framework in FDA’s regulations,
including the principle of scientific
necessity, the risk categories for
interventions or procedures without the
prospect of direct benefit,
considerations regarding the prospect of
direct benefit, the assessment of risk for
interventions or procedures with a
prospect of direct benefit, evaluations
for the different components of a
clinical investigation using component
analysis of risk, the potential for review
of a protocol under 21 CFR 50.54, and
the necessity of obtaining parental/
guardian permission and child assent.
The draft guidance also describes the
application of 21 CFR part 50, subpart
D to pediatric clinical investigations,
including the data to support
conducting pediatric clinical
investigations, design considerations for
clinical investigations, and study
procedures in pediatric clinical
investigations.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Ethical Considerations for Clinical
Investigations of Medical Products
Involving Children.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130, the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014, and the collections
of information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078.
VerDate Sep<11>2014
16:43 Sep 23, 2022
Jkt 256001
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20720 Filed 9–23–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Bureau of Health
Workforce Program Specific Form
OMB No. 0915–XXXX–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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 October 26, 2022.
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 more information on the
proposed project or to obtain a copy of
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
58359
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer, at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Bureau of Health Workforce (BHW)
Program Specific Form OMB No. 0915–
XXXX–New.
Abstract: HRSA seeks to collect
disparity related data on two forms, the
BHW Program Specific Form and the
Scholarships for Disadvantaged
Students (SDS) Application Program
Specific Form. This clearance request is
for approval of both forms. The SDS
Application Program Specific Form is
currently approved under OMB
Approval No. 0915–0149 with the
expiration date of November 30, 2022.
For programmatic efficiency, HRSA is
consolidating this previous separate ICR
with this new ICR and will be
discontinuing OMB No. 0915–0149.
A 60-day notice published in the
Federal Register on May 25, 2022 (87
FR 31893). There were no public
comments.
Need and Proposed Use of the
Information: Historically, only the SDS
Program collects disparity related data
from applicants. In addition to the SDS
data, HRSA seeks to obtain general
demographic data for its other health
workforce programs to assess the
experience and performance of
applicants in strengthening the health
workforce and the populations in which
they serve. Examples of this data
include but are not limited to:
• Demographic Information:
Students/trainees gender, race, and
ethnicity;
• Class Enrollment Information:
Student/trainees from disadvantaged
backgrounds; and
• Graduate Service Information:
Graduates or program completers
serving in Medically Underserved
Communities, rural communities and in
primary care.
Collecting disparity related data from
BHW applicants would close a data gap
in program performance.
The Public Health Service (PHS) Act
authorizes the Secretary to collect data
for workforce information and analysis
activities for BHW’s Title VII and VIII
programs in sections 799(c) and 806(b)
and (f) (42 U.S.C. 295o–1(c); 42 U.S.C
296e(b) and (f)). PHS Act section 799(c)
specifically authorizes the Secretary to
ensure that such data collection takes
E:\FR\FM\26SEN1.SGM
26SEN1
58360
Federal Register / Vol. 87, No. 185 / Monday, September 26, 2022 / Notices
into account age, sex, race, and ethnicity
and sections 806(b) and (f) specifically
provide the Secretary with authority to
collect information and carry out
workforce analytical activities.
Collecting these data in the HRSA
Electronic Handbook will help grant
reviewers, policy makers and HRSA
staff make decisions that expand the
workforce and help increase access to
health care.
The SDS Application Program
Specific Form seeks to assist HRSA in
assessing applicants for the SDS
Program, which is to make grant awards
to eligible schools to provide
scholarships to full-time, financially
needy students from disadvantaged
backgrounds enrolled in health
professions programs. To qualify for
participation in the SDS program, a
school must be carrying out a program
for recruiting and retaining students
from disadvantaged backgrounds,
including students who are members of
racial and ethnic minority groups, as
required by section 737(d)(1)(B) of the
PHS Act (42 U.S.C 293a(d)(1)(B)). To
meet this requirement, a school must
provide data via the SDS Application
Program Specific Form that at least 20
percent of the school’s full-time
enrolled students and graduates are
from a disadvantaged background.
The SDS Application Program
Specific form previously approved
under OMB Control No. 0915–0149 does
not include substantive changes. Both
forms will be used to collect three years
of student and participant data from
BHW program applicants only.
Likely Respondents: Respondents vary
by the specific program and are
determined by each program’s
eligibility, to include but are not limited
to the following: Accredited schools of
nursing with advanced education
nursing programs; accredited allopathic
schools of medicine; accredited schools
of osteopathic medicine, dentistry,
pharmacy, and graduate programs in
behavioral or mental health; schools of
nursing; nurse managed health clinics/
centers; academic health centers; state
or local governments; public or private
nonprofit entities determined
appropriate by the Secretary; and
consortiums and partnerships of eligible
entities when applicable.
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
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
BHW Program Specific Form ..............................................
SDS Application Program Specific Form .............................
2,069
323
1
1
2,069
323
14
31
28,966
10,013
Total ..............................................................................
2,392
........................
2,392
........................
38,979
HRSA specifically requests comments
on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–20717 Filed 9–23–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier 0945–0002]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
VerDate Sep<11>2014
16:43 Sep 23, 2022
Jkt 256001
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 October 26, 2022.
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 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041. When submitting
comments or requesting information,
please include the document identifier
0945–0002–30D and project title for
reference.
SUMMARY:
Interested
persons are invited to send comments
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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: Complaint
Forms for Discrimination; Health
Information Privacy Complaints and
Civil Rights Discrimination.
Type of Collection: Extension.
OMB No.: 0945–0002.
Abstract: The Office for Civil Rights
(OCR) is requesting an extension of the
previously approved collection 0945–
0002 that is expiring in November 2022,
titled: Complaint Forms for
Discrimination; Health Information
Privacy Complaints and Civil Rights
Discrimination. This request revises the
OCR Civil Rights Discrimination
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 87, Number 185 (Monday, September 26, 2022)]
[Notices]
[Pages 58359-58360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20717]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Bureau of Health Workforce Program Specific Form
OMB No. 0915-XXXX-New
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 October
26, 2022.
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 more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Samantha Miller,
the acting HRSA Information Collection Clearance Officer, at (301) 443-
9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Bureau of Health Workforce
(BHW) Program Specific Form OMB No. 0915-XXXX-New.
Abstract: HRSA seeks to collect disparity related data on two
forms, the BHW Program Specific Form and the Scholarships for
Disadvantaged Students (SDS) Application Program Specific Form. This
clearance request is for approval of both forms. The SDS Application
Program Specific Form is currently approved under OMB Approval No.
0915-0149 with the expiration date of November 30, 2022. For
programmatic efficiency, HRSA is consolidating this previous separate
ICR with this new ICR and will be discontinuing OMB No. 0915-0149.
A 60-day notice published in the Federal Register on May 25, 2022
(87 FR 31893). There were no public comments.
Need and Proposed Use of the Information: Historically, only the
SDS Program collects disparity related data from applicants. In
addition to the SDS data, HRSA seeks to obtain general demographic data
for its other health workforce programs to assess the experience and
performance of applicants in strengthening the health workforce and the
populations in which they serve. Examples of this data include but are
not limited to:
Demographic Information: Students/trainees gender, race,
and ethnicity;
Class Enrollment Information: Student/trainees from
disadvantaged backgrounds; and
Graduate Service Information: Graduates or program
completers serving in Medically Underserved Communities, rural
communities and in primary care.
Collecting disparity related data from BHW applicants would close a
data gap in program performance.
The Public Health Service (PHS) Act authorizes the Secretary to
collect data for workforce information and analysis activities for
BHW's Title VII and VIII programs in sections 799(c) and 806(b) and (f)
(42 U.S.C. 295o-1(c); 42 U.S.C 296e(b) and (f)). PHS Act section 799(c)
specifically authorizes the Secretary to ensure that such data
collection takes
[[Page 58360]]
into account age, sex, race, and ethnicity and sections 806(b) and (f)
specifically provide the Secretary with authority to collect
information and carry out workforce analytical activities. Collecting
these data in the HRSA Electronic Handbook will help grant reviewers,
policy makers and HRSA staff make decisions that expand the workforce
and help increase access to health care.
The SDS Application Program Specific Form seeks to assist HRSA in
assessing applicants for the SDS Program, which is to make grant awards
to eligible schools to provide scholarships to full-time, financially
needy students from disadvantaged backgrounds enrolled in health
professions programs. To qualify for participation in the SDS program,
a school must be carrying out a program for recruiting and retaining
students from disadvantaged backgrounds, including students who are
members of racial and ethnic minority groups, as required by section
737(d)(1)(B) of the PHS Act (42 U.S.C 293a(d)(1)(B)). To meet this
requirement, a school must provide data via the SDS Application Program
Specific Form that at least 20 percent of the school's full-time
enrolled students and graduates are from a disadvantaged background.
The SDS Application Program Specific form previously approved under
OMB Control No. 0915-0149 does not include substantive changes. Both
forms will be used to collect three years of student and participant
data from BHW program applicants only.
Likely Respondents: Respondents vary by the specific program and
are determined by each program's eligibility, to include but are not
limited to the following: Accredited schools of nursing with advanced
education nursing programs; accredited allopathic schools of medicine;
accredited schools of osteopathic medicine, dentistry, pharmacy, and
graduate programs in behavioral or mental health; schools of nursing;
nurse managed health clinics/centers; academic health centers; state or
local governments; public or private nonprofit entities determined
appropriate by the Secretary; and consortiums and partnerships of
eligible entities when applicable.
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
BHW Program Specific Form....... 2,069 1 2,069 14 28,966
SDS Application Program Specific 323 1 323 31 10,013
Form...........................
-------------------------------------------------------------------------------
Total....................... 2,392 .............. 2,392 .............. 38,979
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-20717 Filed 9-23-22; 8:45 am]
BILLING CODE 4165-15-P
