Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration, 22459-22461 [2023-07774]
Download as PDF
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
(R) TDS products using an appropriately
designed skin I/S study with human
subjects to demonstrate that the
potential for a skin irritation or
sensitization reaction with the T TDS is
no worse than the reaction observed
with the R TDS.
This revised draft guidance provides
the following updates to the original
draft guidance:
(1) Clarifies recommendations for the
design and conduct of studies to
evaluate the in vivo skin I/S potential of
a proposed TDS.
(2) Clarifies when an in vivo study to
assess the sensitization potential of a
TDS product may not be needed.
(3) Provides guidance to applicants
intending to utilize alternative scoring
scales or alternative approaches to
compare irritation and sensitization
between the T and R TDS.
The recommendations in this revised
draft guidance relate to studies
submitted in support of an ANDA. The
Agency is seeking comments on the
recommendations reflected in the
revised draft guidance announced in
this notice. In addition, FDA invites
comments on the scoring scales and any
alternative approaches, including those
recommended by international
regulatory agencies, that may have been
used for the comparative assessment of
the I/S potential for proposed generic
TDS products. FDA also specifically
invites comments regarding the
comparative assessment of sensitization
itself, i.e., whether there are clinical
scenarios where a comparative
sensitization assessment may be
uninformative when conducted in
addition to a comparative irritation
assessment.
This revised draft guidance is being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 The draft guidance, when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 ‘‘Assessing the
Irritation and Sensitization Potential of
Transdermal and Topical Delivery
Systems for ANDAs.’’ 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While this revised draft guidance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
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17:56 Apr 12, 2023
Jkt 259001
collections of information are subject to
review by OMB under the PRA. The
collections of information in 21 CFR
part 314 relating to the submission of
abbreviated new drug applications have
been approved under OMB control
number 0910–0001. The collections of
information relating to good clinical
practice have been approved under
OMB control number 0910–0843.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07769 Filed 4–12–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0379
Revision]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title:
Questionnaire and Data Collection
Testing, Evaluation, and Research for
the Health Resources and Services
Administration
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 June 12, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
SUMMARY:
PO 00000
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22459
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer, at (301) 594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Questionnaire and Data Collection
Testing, Evaluation, and Research for
HRSA—OMB No. 0915–0379—Revision
Abstract: The purpose of information
collections under this generic umbrella
ICR package is to allow HRSA to
continue collecting feedback from
members of the public for HRSA to use
when developing new questions,
questionnaires, and tools; pilot/pre-test
instruments to be deployed by HRSA;
and to identify problems in instruments
currently in use.
This generic clearance is limited to
data collection for the development or
revision of HRSA tools and data
collection instruments, as well as
reports for internal decision-making and
development purposes. Information
collected under this generic clearance
will not be used for data collection,
reports, or policy documents to be
released to the public. It is anticipated
that data collection approved under this
generic clearance will rely heavily on
qualitative techniques and not the
collection of numerical data. In general,
these activities are not designed to yield
results that meet generally accepted
standards of statistical rigor but
designed to obtain information to
develop clearer and more effective and
efficient data collection tools that will
yield more accurate results and decrease
public non-response. The forms
submitted under this generic clearance
will be voluntary, low-burden, and
uncontroversial.
HRSA originally developed this
generic umbrella ICR to support similar
needs across HRSA’s bureaus and
offices as reflected in their specific
activities informed by their specific
authorizing statutes. The purpose is to
collect qualitative data from small
groups of people in response to short
questionnaires, using questions posed
on HRSA’s website, through focus
groups and individual interviews of
HRSA staff and members of the public.
The abbreviated clearance process of the
generic clearance helps ensure timely
data gathering on current issues HRSA
is addressing (e.g., allows program
offices to gather a suitable pool of
FOR FURTHER INFORMATION CONTACT:
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13APN1
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Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices
candidates for piloting future
instruments).
HRSA seeks to extend OMB approval
of this ICR and existing ICRs that fall
under it while including a slight
increase in the burden estimate to
account for HRSA’s implementation of
Executive Order 13985, which calls on
agencies to advance racial equity and
support for underserved communities
through identifying and addressing
barriers to equal opportunity that
underserved communities may face;
HRSA will likely conduct additional
information collection requests so that
HRSA may effectively implement this
Executive Order.
Need and Proposed Use of the
Information: HRSA conducts
interviews, focus groups, usability tests,
and field tests/pilot interviews for data
collection instrument development and
evaluation (including assessment of
response errors in data collection
instruments). HRSA staff use various
techniques to evaluate intervieweradministered, self-administered,
telephone, Computer Assisted Personal
Interviewing, Computer Assisted SelfInterviewing, Audio Computer-Assisted
Self-Interviewing, and web-based
questionnaires.
Each information collection under
this generic clearance will specify the
specific testing and evaluation
procedures to be used. Participation will
be fully voluntary, and nonparticipation will not affect eligibility
for, or receipt of, future HRSA health
services research activities or grant
awards, recruitment, or participation.
Appropriate consent procedures will be
customized and used for each
information collection activity and any
collection of personal, privacy-protected
information will be handled in
accordance with all applicable federal
requirements. If HRSA wishes to record
the encounter, the respondent’s
permission to record will be obtained
before beginning the interview. If
consent is not provided, the interview
either will not be recorded or not be
conducted. When screening is used
(e.g., quota sampling), the screening will
be as brief as possible, and the screening
questionnaire will be provided to OMB
for review.
Collection methods—The particular
information collection methods used
will vary, but may include the
following:
• Individual in-depth interviews—Indepth interviews will commonly be
used to ensure that the respondent
understands the meaning of a
questionnaire or strategy. When indepth interviewing is used, the
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17:56 Apr 12, 2023
Jkt 259001
interview guide will be provided to
OMB for review.
• Focus groups—Focus groups will be
used to obtain insights into beliefs and
understandings of the target audience
early in the development of a
questionnaire or tool. When focus
groups are used, the focus group
discussion guide will be provided to
OMB for review.
• Expert/Gatekeeper review of tools—
In some instances, medical providers or
other gatekeepers may review tools to
provide feedback on the acceptability
and usability of a particular tool. This
will usually be in addition to an
individual user pretesting the tool.
• Record abstractions—On occasion,
the development of a tool or other
information collection requires review
and interaction with records, rather than
individuals.
• ‘‘Dress rehearsal’’ of a specific
protocol—In some instances, the
proposed pre-testing will constitute a
walkthrough of the intended data
collection procedure. In these cases, the
request will mirror what is expected to
occur for the larger scale data collection.
Professionally recognized procedures
are followed in each information
collection activity to ensure collection
of high-quality information. Examples of
these procedures could include the
following:
• Monitoring by supervisory staff of
some telephone interviews;
• Conducting interviews using
methods including ‘‘think-aloud’’
techniques and debriefings;
• Computerizing data-entry from mail
or paper-and-pencil surveys using
scannable forms or double-key entry
(i.e., two people input the data from
mail or paper-and-pencil surveys into
an electronic format, and then
comparing the two sets of entries for
anomalies);
• Monitoring by observers of focus
groups and recording (e.g., video
recording, audio recording) of focus
group proceedings (subject to
participant consent); and
• Employing commonly used
statistical validation techniques to
ensure accuracy (such as disallowing
out-of-range values) of data submitted
through on-line surveys.
HRSA is requesting approval for
generic information collections
previously approved by OMB. These
include:
• Health Center Workforce WellBeing Survey: Listening Sessions
• Health Center Workforce WellBeing Survey: Cognitive Sessions
• Health Center Workforce WellBeing Survey: Pilot Testing
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Fmt 4703
Sfmt 4703
• Health Center Workforce Survey
Evaluation and Technical Assistance:
Pilot Survey
• Fast Track Interviews with National
Hypertension Control Initiative Group 2
Participants.
HRSA notes that the previously
approved collections are mostly
unchanged, except that they may have
updates to include any advances in
burden estimation or information
collection protocols. HRSA also
anticipates conducting additional
collections as the agency implements
Executive Order 13985. To identify
areas for improvement, HRSA
anticipates collecting and aggregating
data by race, ethnicity, gender,
disability, income, veteran status, or
other key demographic variables, while
protecting individual privacy, so that
HRSA can use the information to help
increase equity in its programs for
people from a robust range of
demographic groups.
Likely Respondents: Participation in
any collections under this clearance will
be entirely voluntary, and the privacy of
respondents will be preserved to the
extent requested by participants and as
permitted by law.
Respondents will be recruited by
means of advertisements in public
venues or through techniques that
replicate prospective data collection
activities that are the focus of the
project. For instance, a survey on
physician communication, designed to
be administered following an office
visit, might be pretested using the same
procedure. Each ICR will specify the
recruitment procedure to be used.
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. HRSA anticipates that the
total burden of collections under this
generic package will be slightly greater
than under the prior approval, due to
HRSA’s efforts to comply with
Executive Order 13985. HRSA also
reduced the number of hours for inperson testing as it has become a less
popular option among prospective
survey participants. The total annual
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Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices
burden hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of information collection
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Mail/email 1 ...........................................................................
Telephone ............................................................................
Web-based ...........................................................................
Focus Groups ......................................................................
In-person ..............................................................................
Automated 2 ..........................................................................
Cognitive Testing .................................................................
1,000
1,000
1,200
925
250
500
700
1
1
1
1
1
1
1
1,000
1,000
1,200
925
250
500
700
0.26
0.26
0.25
1.00
1.00
1.00
1.41
260
260
300
925
250
500
987
Total ..............................................................................
5,575
........................
5,575
........................
3482
1 May
2 May
include telephone non-response follow-up in which case the burden will not change.
include testing of database software, Computer Assisted Personal Interviewing software, or other automated technologies.
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. 2023–07774 Filed 4–12–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
Carlo Spirli, Ph.D. (Respondent), who
was an Assistant Professor of Medicine,
Department of Digestive Diseases, Yale
University (YU). Respondent engaged in
research misconduct in research
supported by U.S. Public Health Service
(PHS) funds, specifically National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), National
Institutes of Health (NIH), grants R01
DK079005 and P30 DK034989. The
administrative actions, including
debarment for a period of four (4) years,
were implemented beginning on March
28, 2023, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Sheila Garrity, JD, MPH, MBA, Director,
Office of Research Integrity, 1101
SUMMARY:
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Number of
responses per
respondent
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17:56 Apr 12, 2023
Jkt 259001
Wootton Parkway, Suite 240, Rockville,
MD 20852, (240) 453–8200.
Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Carlo Spirli, Ph.D., Yale University:
Based on the report of an investigation
conducted by YU and additional
analysis conducted by ORI in its
oversight review, ORI found that Carlo
Spirli, Ph.D., former Assistant Professor
of Medicine, Department of Digestive
Diseases, YU, engaged in research
misconduct in research supported by
PHS funds, specifically NIDDK, NIH,
grants R01 DK079005 and P30
DK034989.
ORI found that Respondent engaged
in research misconduct by knowingly,
intentionally, or recklessly falsifying
and/or fabricating data included in the
following four (4) published papers, two
(2) presentations, and three (3) grant
applications submitted for PHS funds:
• Cyclic AMP/PKA-dependent
Paradoxical Activation of Raf/MEK/ERK
Signaling in Polycystin-2 Defective Mice
Treated with Sorafenib. Hepatology.
2012 Dec;56(6):2363–74. doi: 10.1002/
hep.25872 (hereafter referred to as
‘‘Hepatology 2012a’’).
• Altered Store Operated Calcium
Entry Increases Cyclic 3′,5′-Adenosine
Monophosphate Production and
Extracellular Signal-Regulated Kinases 1
and 2 Phosphorylation in Polycystin-2Defective Cholangiocytes. Hepatology.
2012 Mar;55(3):856–68. doi: 10.1002/
hep.24723 (hereafter referred to as
‘‘Hepatology 2012b’’).
• Protein Kinase A-Dependent
pSer(675)-b-catenin, a Novel Signaling
Defect in a Mouse Model of Congenital
Hepatic Fibrosis. Hepatology. 2013
Nov;58(5):1713–23. doi:10.1002/
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
hep.26554 (hereafter referred to as
‘‘Hepatology 2013’’).
• Posttranslational Regulation of
Polycystin-2 Protein Expression as a
Novel Mechanism of Cholangiocyte
Reaction and Repair from Biliary
Damage. Hepatology. 2015 Dec;
62(6):1828–39. doi: 10.1002/hep.28138
(hereafter referred to as ‘‘Hepatology
2015’’). Retraction in: Hepatology. 2022
Dec;76(6):1904. doi: 10.1002/hep.32595.
• PKA-Dependent p-SER675-bCatenin Phosphorylation Increases
Cholangiocyte Motility in Pkhd1del4/
del4 Mouse, a Model of Fibropolycystic
Liver Diseases Caused by Defective
Fibrocystin Function. Presented at the
European Association for the Study of
the Liver (EASL) (hereafter referred to as
‘‘EASL Presentation 2011’’).
• Cyclic-AMP-Dependent, Rac1Mediated Nuclear Translocation Of PSer-675b-Catenin, A Novel Signaling
Defect in Congenital Hepatic Fibrosis
(CHF) and Caroli’s Disease (CD).
Presented at the American Association
for the Study of Liver Diseases (AASLD)
Annual Meeting, Boston, MA, in
November 2012 (hereafter referred to as
‘‘AASLD Presentation 2011’’).
• R01 DK079005–11A1, ‘‘Epithelial
Angiogenic Signaling in Biliary
Pathophysiology and in Polycystic
Disease,’’ submitted to NIDDK, NIH, on
December 13, 2018. Administratively
withdrawn by the funding agency on
March 1, 2021.
• R01 DK090021–01 ‘‘Mechanisms of
fibrosis in fibrocystin-deficiency
associated cholangiopathies’’ submitted
to NIDDK, NIH, on February 2, 2010.
Administratively withdrawn by the
funding agency on July 1, 2012.
• R01 DK090021–01A1 ‘‘Mechanisms
of fibrosis in fibrocystin-deficiency
associated cholangiopathies’’ submitted
to NIDDK, NIH, on November 11, 2010.
E:\FR\FM\13APN1.SGM
13APN1
Agencies
[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22459-22461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07774]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0915-0379 Revision]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title:
Questionnaire and Data Collection Testing, Evaluation, and Research for
the Health Resources and Services Administration
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 June 12,
2023.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
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) 594-
4394.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Questionnaire and Data
Collection Testing, Evaluation, and Research for HRSA--OMB No. 0915-
0379--Revision
Abstract: The purpose of information collections under this generic
umbrella ICR package is to allow HRSA to continue collecting feedback
from members of the public for HRSA to use when developing new
questions, questionnaires, and tools; pilot/pre-test instruments to be
deployed by HRSA; and to identify problems in instruments currently in
use.
This generic clearance is limited to data collection for the
development or revision of HRSA tools and data collection instruments,
as well as reports for internal decision-making and development
purposes. Information collected under this generic clearance will not
be used for data collection, reports, or policy documents to be
released to the public. It is anticipated that data collection approved
under this generic clearance will rely heavily on qualitative
techniques and not the collection of numerical data. In general, these
activities are not designed to yield results that meet generally
accepted standards of statistical rigor but designed to obtain
information to develop clearer and more effective and efficient data
collection tools that will yield more accurate results and decrease
public non-response. The forms submitted under this generic clearance
will be voluntary, low-burden, and uncontroversial.
HRSA originally developed this generic umbrella ICR to support
similar needs across HRSA's bureaus and offices as reflected in their
specific activities informed by their specific authorizing statutes.
The purpose is to collect qualitative data from small groups of people
in response to short questionnaires, using questions posed on HRSA's
website, through focus groups and individual interviews of HRSA staff
and members of the public. The abbreviated clearance process of the
generic clearance helps ensure timely data gathering on current issues
HRSA is addressing (e.g., allows program offices to gather a suitable
pool of
[[Page 22460]]
candidates for piloting future instruments).
HRSA seeks to extend OMB approval of this ICR and existing ICRs
that fall under it while including a slight increase in the burden
estimate to account for HRSA's implementation of Executive Order 13985,
which calls on agencies to advance racial equity and support for
underserved communities through identifying and addressing barriers to
equal opportunity that underserved communities may face; HRSA will
likely conduct additional information collection requests so that HRSA
may effectively implement this Executive Order.
Need and Proposed Use of the Information: HRSA conducts interviews,
focus groups, usability tests, and field tests/pilot interviews for
data collection instrument development and evaluation (including
assessment of response errors in data collection instruments). HRSA
staff use various techniques to evaluate interviewer-administered,
self-administered, telephone, Computer Assisted Personal Interviewing,
Computer Assisted Self-Interviewing, Audio Computer-Assisted Self-
Interviewing, and web-based questionnaires.
Each information collection under this generic clearance will
specify the specific testing and evaluation procedures to be used.
Participation will be fully voluntary, and non-participation will not
affect eligibility for, or receipt of, future HRSA health services
research activities or grant awards, recruitment, or participation.
Appropriate consent procedures will be customized and used for each
information collection activity and any collection of personal,
privacy-protected information will be handled in accordance with all
applicable federal requirements. If HRSA wishes to record the
encounter, the respondent's permission to record will be obtained
before beginning the interview. If consent is not provided, the
interview either will not be recorded or not be conducted. When
screening is used (e.g., quota sampling), the screening will be as
brief as possible, and the screening questionnaire will be provided to
OMB for review.
Collection methods--The particular information collection methods
used will vary, but may include the following:
Individual in-depth interviews--In-depth interviews will
commonly be used to ensure that the respondent understands the meaning
of a questionnaire or strategy. When in-depth interviewing is used, the
interview guide will be provided to OMB for review.
Focus groups--Focus groups will be used to obtain insights
into beliefs and understandings of the target audience early in the
development of a questionnaire or tool. When focus groups are used, the
focus group discussion guide will be provided to OMB for review.
Expert/Gatekeeper review of tools--In some instances,
medical providers or other gatekeepers may review tools to provide
feedback on the acceptability and usability of a particular tool. This
will usually be in addition to an individual user pretesting the tool.
Record abstractions--On occasion, the development of a
tool or other information collection requires review and interaction
with records, rather than individuals.
``Dress rehearsal'' of a specific protocol--In some
instances, the proposed pre-testing will constitute a walkthrough of
the intended data collection procedure. In these cases, the request
will mirror what is expected to occur for the larger scale data
collection.
Professionally recognized procedures are followed in each
information collection activity to ensure collection of high-quality
information. Examples of these procedures could include the following:
Monitoring by supervisory staff of some telephone
interviews;
Conducting interviews using methods including ``think-
aloud'' techniques and debriefings;
Computerizing data-entry from mail or paper-and-pencil
surveys using scannable forms or double-key entry (i.e., two people
input the data from mail or paper-and-pencil surveys into an electronic
format, and then comparing the two sets of entries for anomalies);
Monitoring by observers of focus groups and recording
(e.g., video recording, audio recording) of focus group proceedings
(subject to participant consent); and
Employing commonly used statistical validation techniques
to ensure accuracy (such as disallowing out-of-range values) of data
submitted through on-line surveys.
HRSA is requesting approval for generic information collections
previously approved by OMB. These include:
Health Center Workforce Well-Being Survey: Listening
Sessions
Health Center Workforce Well-Being Survey: Cognitive
Sessions
Health Center Workforce Well-Being Survey: Pilot Testing
Health Center Workforce Survey Evaluation and Technical
Assistance: Pilot Survey
Fast Track Interviews with National Hypertension Control
Initiative Group 2 Participants.
HRSA notes that the previously approved collections are mostly
unchanged, except that they may have updates to include any advances in
burden estimation or information collection protocols. HRSA also
anticipates conducting additional collections as the agency implements
Executive Order 13985. To identify areas for improvement, HRSA
anticipates collecting and aggregating data by race, ethnicity, gender,
disability, income, veteran status, or other key demographic variables,
while protecting individual privacy, so that HRSA can use the
information to help increase equity in its programs for people from a
robust range of demographic groups.
Likely Respondents: Participation in any collections under this
clearance will be entirely voluntary, and the privacy of respondents
will be preserved to the extent requested by participants and as
permitted by law.
Respondents will be recruited by means of advertisements in public
venues or through techniques that replicate prospective data collection
activities that are the focus of the project. For instance, a survey on
physician communication, designed to be administered following an
office visit, might be pretested using the same procedure. Each ICR
will specify the recruitment procedure to be used.
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. HRSA anticipates that the total burden of
collections under this generic package will be slightly greater than
under the prior approval, due to HRSA's efforts to comply with
Executive Order 13985. HRSA also reduced the number of hours for in-
person testing as it has become a less popular option among prospective
survey participants. The total annual
[[Page 22461]]
burden hours estimated for this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Type of information collection respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Mail/email \1\.................. 1,000 1 1,000 0.26 260
Telephone....................... 1,000 1 1,000 0.26 260
Web-based....................... 1,200 1 1,200 0.25 300
Focus Groups.................... 925 1 925 1.00 925
In-person....................... 250 1 250 1.00 250
Automated \2\................... 500 1 500 1.00 500
Cognitive Testing............... 700 1 700 1.41 987
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Total....................... 5,575 .............. 5,575 .............. 3482
----------------------------------------------------------------------------------------------------------------
\1\ May include telephone non-response follow-up in which case the burden will not change.
\2\ May include testing of database software, Computer Assisted Personal Interviewing software, or other
automated technologies.
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. 2023-07774 Filed 4-12-23; 8:45 am]
BILLING CODE 4165-15-P