Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Patient Survey, 16452-16453 [2023-05482]
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Federal Register / Vol. 88, No. 52 / Friday, March 17, 2023 / Notices
high performance in its regulatory
project management staff. CDER seeks to
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
Firms that want to learn more about this
training opportunity or that are
interested in offering a site tour should
respond by sending a proposed agenda
by email directly to Dan Brum (see
DATES and FOR FURTHER INFORMATION
CONTACT).
II. The Site Tours Program
Health Resources and Services
Administration
In this program, which generally lasts
a few days, small groups of CDER
regulatory project managers, often
including a senior level regulatory
project manager, can observe operations
of pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, nonclinical
and clinical evaluation, postmarketing
activities, and regulatory submission
operations. The overall benefit to
regulatory project managers will be
exposure to project management, team
techniques, and processes employed by
the pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
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III. Site Selection
All travel expenses associated with
the Site Tours Program will be the
responsibility of CDER; therefore,
selection will be based on the
availability of funds and resources for
each fiscal year. Selection will also be
based on firms having a favorable
facility status as determined by FDA’s
Office of Regulatory Affairs District
Offices in the firms’ respective regions.
VerDate Sep<11>2014
17:04 Mar 16, 2023
Jkt 259001
Dated: March 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05509 Filed 3–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[OMB No. 0915–0368—Extension]
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Health Center Patient Survey
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.
DATES: Comments on this ICR should be
received no later than April 17, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 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 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
information request collection title for
reference.
Information Collection Request Title:
Health Center Patient Survey.
OMB No. 0915–0368—Extension.
Abstract: HRSA-supported health
centers (those entities funded under
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
section 330 of the Public Health Service
Act) deliver comprehensive, affordable,
quality primary health care to over 30
million patients nationwide, regardless
of their ability to pay. Nearly 1,400
health centers operate over 14,000
service delivery sites in every U.S. state,
the District of Columbia, Puerto Rico,
the U.S. Virgin Islands, and the Pacific
Basin. In the past, HRSA conducted the
Health Center Patient Survey (HCPS),
which surveys patients of HRSA-funded
health centers. The HCPS collects
information about sociodemographic
characteristics, health conditions, health
behaviors, access to and utilization of
health care services, and satisfaction
with health care received at HRSAfunded health centers. The renewal of
the HCPS will use the same modules
from the 2022 HCPS (OMB #0915–
0368). There is no change to the current
survey instruments. Survey results come
from in-person, one-on-one interviews
with patients who are selected as
representative of the Health Center
Program patient population nationally.
A 60-day notice was published in the
Federal Register on January 4, 2023,
vol. 88, No. 2; pp. 361–362. There were
no public comments.
Need and Proposed Use of the
Information: The HCPS is unique
because it focuses on comprehensive,
nationally representative, individual
level data from the perspective of health
center patients. By investigating how
well HRSA-funded health centers meet
health care needs of the medically
underserved and how patients perceive
their quality of care, the HCPS serves as
an empirically-based resource to inform
HRSA policy, funding, and planning
decisions.
Likely Respondents: Staff and patients
at HRSA-supported health centers.
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.
E:\FR\FM\17MRN1.SGM
17MRN1
16453
Federal Register / Vol. 88, No. 52 / Friday, March 17, 2023 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total
burden hours
Awardee Recruitment ..........................................................
Site Recruitment and Training .............................................
Patient Screening .................................................................
Patient Screening: Short Blessed Scale 1 ...........................
Patient Survey ......................................................................
220
700
13,120
18
9,000
1
1
1
1
1
220
700
13,120
18
9,000
2.00
3.15
.17
.05
1.00
440.00
2,205.00
2,230.40
0.90
9,000.00
Total National Study .....................................................
23,058
........................
23,058
........................
13,876.30
1 The
Short Blessed Scale Form will be administered to respondents when a field interviewer believes that a person might be too cognitively
impaired to participate in the survey. According to 2022 survey experience, only three eligible participants in the main survey were screened with
this form.
Maria G. Button,
Director, Executive Secretariat.
Public Comments’’ or by using the
search function.
[FR Doc. 2023–05482 Filed 3–16–23; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0322—Extension]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Data
Collection Tool for State Offices of
Rural Health Grant Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of 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.
DATES: Comments on this ICR should be
received no later than April 17, 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:04 Mar 16, 2023
Jkt 259001
To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 594–
4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Data Collection Tool for State Offices of
Rural Health Grant Program, OMB No.
0915–0322—Extension.
Abstract: HRSA is requesting OMB
approval to continue use of a Technical
Assistance (TA) Data Form for the State
Offices of Rural Health (SORH) Grant
program established by section 338J of
the Public Health Service Act (42 U.S.C.
254r). In its authorizing language (sec.
711 of the Social Security Act [42 U.S.C.
912]), Congress charged HRSA’s Federal
Office of Rural Health Policy (FORHP)
with administering grants, cooperative
agreements, and contracts to provide TA
and other activities as necessary to
support activities related to improving
health care in rural areas. The mission
of FORHP is to sustain and improve
access to quality health care services for
rural communities. This electronic form
is used collect information from SORH
grantees on the amount of direct
technical assistance they provide to
clients within their state.
A 60-day notice published in the
Federal Register on December 28, 2022,
vol. 87, No. 248; pp. 79891–79892.
There were no public comments.
Need and Proposed Use of the
Information: FORHP seeks to continue
gathering information from grantees on
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
their efforts to provide TA to clients
within their state. SORH grantees
submit a TA Report that includes: (1)
the total number of TA encounters
provided directly by the grantee; and (2)
the total number of unduplicated clients
that received direct TA from the grantee.
These measures will continue in these
three categories: (1) information
disseminated, (2) information created,
and (3) collaborative efforts by topic
area and type of audience. These
measures are used to obtain an accurate
depiction of the breadth of SORH work,
based on recommendations from the
grantees. Submission of the TA Report
is submitted via the HRSA Electronic
Handbook no later than 60 days after the
end of each 12-month budget period.
Grant dollars are awarded annually;
therefore, this information is needed
annually by the program in order to
measure effective use of grant dollars
consistently among all the grantees.
Likely Respondents: 50 State Offices
of Rural Health award recipients.
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.
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Notices]
[Pages 16452-16453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05482]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0915-0368--Extension]
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Health Center Patient
Survey
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.
DATES: Comments on this ICR should be received no later than April 17,
2023.
ADDRESSES: Submit your comments to [email protected] or by mail to the
HRSA Information Collection Clearance Officer, Room 14N136B, 5600
Fishers Lane, Rockville, MD 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 information request collection title
for reference.
Information Collection Request Title: Health Center Patient Survey.
OMB No. 0915-0368--Extension.
Abstract: HRSA-supported health centers (those entities funded
under section 330 of the Public Health Service Act) deliver
comprehensive, affordable, quality primary health care to over 30
million patients nationwide, regardless of their ability to pay. Nearly
1,400 health centers operate over 14,000 service delivery sites in
every U.S. state, the District of Columbia, Puerto Rico, the U.S.
Virgin Islands, and the Pacific Basin. In the past, HRSA conducted the
Health Center Patient Survey (HCPS), which surveys patients of HRSA-
funded health centers. The HCPS collects information about
sociodemographic characteristics, health conditions, health behaviors,
access to and utilization of health care services, and satisfaction
with health care received at HRSA-funded health centers. The renewal of
the HCPS will use the same modules from the 2022 HCPS (OMB #0915-0368).
There is no change to the current survey instruments. Survey results
come from in-person, one-on-one interviews with patients who are
selected as representative of the Health Center Program patient
population nationally.
A 60-day notice was published in the Federal Register on January 4,
2023, vol. 88, No. 2; pp. 361-362. There were no public comments.
Need and Proposed Use of the Information: The HCPS is unique
because it focuses on comprehensive, nationally representative,
individual level data from the perspective of health center patients.
By investigating how well HRSA-funded health centers meet health care
needs of the medically underserved and how patients perceive their
quality of care, the HCPS serves as an empirically-based resource to
inform HRSA policy, funding, and planning decisions.
Likely Respondents: Staff and patients at HRSA-supported health
centers.
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.
[[Page 16453]]
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
----------------------------------------------------------------------------------------------------------------
Awardee Recruitment............. 220 1 220 2.00 440.00
Site Recruitment and Training... 700 1 700 3.15 2,205.00
Patient Screening............... 13,120 1 13,120 .17 2,230.40
Patient Screening: Short Blessed 18 1 18 .05 0.90
Scale \1\......................
Patient Survey.................. 9,000 1 9,000 1.00 9,000.00
-------------------------------------------------------------------------------
Total National Study........ 23,058 .............. 23,058 .............. 13,876.30
----------------------------------------------------------------------------------------------------------------
\1\ The Short Blessed Scale Form will be administered to respondents when a field interviewer believes that a
person might be too cognitively impaired to participate in the survey. According to 2022 survey experience,
only three eligible participants in the main survey were screened with this form.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-05482 Filed 3-16-23; 8:45 am]
BILLING CODE 4165-15-P
