Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Membership Forms for Organ Procurement and Transplantation Network, OMB No. 0915-0184-Revision, 68713-68715 [2022-24926]
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Model DFL with Injector Placeholder
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38. Murphy, S.M., J.R. Morgan, P.J. Jeng and
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39. Han, J.K., L.G. Hill, M.E. Koenig and N.
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40. Katzman, J.G., M.Y. Takeda, S.R. Bhatt, et
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41. Katzman, J.G., N.H. Greenberg, M.Y.
Takeda and M. Moya Balasch, 2019,
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43. Oliva, E.M., M.L.D. Christopher, D. Wells,
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and P. Bellino, 2021, ‘‘Saving Lives: The
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Rapid Naloxone Initiative,’’ Joint
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45. Walley, A.Y., M. Doe-Simkins, E. Quinn,
et al., 2013, ‘‘Opioid Overdose
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46. Takeda, M.Y., J.G. Katzman, E. Dole, et
al., 2016, ‘‘Co-Prescription of Naloxone
as a Universal Precautions Model for
Patients on Chronic Opioid Therapy—
Observational Study,’’ Substance Abuse,
37(4):591–596.
47. *Legislative Analysis and Public Policy
Association, ‘‘Naloxone Access:
Summary of State Laws’’ (September
2020), available at https://
legislativeanalysis.org/wp-content/
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48. Brodrick, J.E., C.K. Brodrick, and B.
Adinoff, 2016, ‘‘Legal Regimes
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49. Smart, R., B. Pardo, and C.S. Davis, 2011,
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50. McClellan, C., B.H. Lambdin, M.M. Ali,
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51. Evoy, K.E., L.G. Hill, and C.S. Davis,
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of Over-the-Counter Naloxone,’’
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52. Graves, R.L., E. Andreyeva, J. Perrone, et
al., 2019, ‘‘Naloxone Availability and
Pharmacy Staff Knowledge of Standing
Order for Naloxone in Pennsylvania
Pharmacies,’’ Journal of Addiction
Medicine, 13(4):272–278.
53. Wu, C., T. Brown, and J.L. Moreno, 2020,
‘‘Access to Naloxone at Community
Pharmacies Under the Massachusetts
Statewide Standing Order,’’ Journal of
the American Pharmacists Association,
60:647–652.
54. Puzantian, T., J.J. Gasper, and C.M.
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PO 00000
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print May 13, 2020, doi: 10.1080/
15563650.2020.1758325.
Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24874 Filed 11–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Membership Forms for Organ
Procurement and Transplantation
Network, OMB No. 0915–0184—
Revision
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 has 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. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than December 16,
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 a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
SUMMARY:
E:\FR\FM\16NON1.SGM
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Federal Register / Vol. 87, No. 220 / Wednesday, November 16, 2022 / Notices
paperwork@hrsa.gov or call (301) 443–
9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Membership Forms for Organ
Procurement and Transplantation
Network, OMB No. 0915–0184—
Revision.
Abstract: Membership in the Organ
Procurement and Transplantation
Network (OPTN) is determined by
submission of application materials to
the OPTN (not to HRSA) demonstrating
that the applicant meets all required
criteria for membership and will agree
to comply with all applicable provisions
of the National Organ Transplant Act, as
amended, 42 U.S.C. 273 et seq.; the
OPTN final rule, 42 CFR part 121; OPTN
policies; and OPTN bylaws. Section
1138 of the Social Security Act, as
amended, 42 U.S.C. 1320b–8, requires
that hospitals in which transplants are
performed by members of, and abide by,
the rules and requirements of the OPTN
(that have been approved by the
Secretary of Health and Human
Services) as a condition of participation
in Medicare and Medicaid.
A 60-day notice was published in the
Federal Register, 87 FR 52389 (Aug. 25,
2022). There were no public comments.
Need and Proposed Use of the
Information: The application materials
are needed to ensure that all members
and prospective members of the OPTN
submit evidence that they meet the
required qualifications for membership.
These materials provide the OPTN with
information to permit the OPTN to
confirm and demonstrate that applicants
meet OPTN membership application
requirements, and to create a record of
the application review process and
resulting actions for consideration by
the Secretary of Health and Human
Services if an applicant subsequently
appeals a membership rejection by the
OPTN.
This is a request to revise the current
OPTN data collection associated with
transplant hospitals, organ procurement
organizations, transplant
histocompatibility laboratories,
medical/scientific and public
organizations, business organizations,
and individuals to meet or sustain
requirements for OPTN membership to
include data collection forms for OPTN
member hospitals requesting HIV Organ
Policy Equity (HOPE) Act variances as
well as the Kidney Paired Donation
Pilot Program (KPDPP) contact update
form. HRSA is submitting the following
changes to the membership forms to
clarify requirements and eliminate
redundancy while adding more
explanatory language and instruction to
the applications, which include:
(1) Adding two new data collection
forms for HOPE Act Variance Request
and KPDPP contact update form. The
HOPE Act Variance Request is for any
OPTN member transplant program that
wishes to start a variance to receive
HIV-positive organs for their HIVpositive patients. The KPDPP contact
update is a form that indicates contact
information for programs participating
in the KPDPP.
(2) Adding three standalone forms for
data collection: Primary Program
Administrator, Primary Data
Coordinator, and Additional Surgeon
and Physician. All three of these forms
include data previously collected on
other OMB-approved forms in this
package, but now will be standalone
forms for greater ease of use for the
applicant.
• The Primary Program Administrator
data collection form includes data
previously collected in each organspecific application form. Users will
only have to complete one form if the
proposed Primary Program
Administrator serves in that role for
multiple programs.
• The Primary Data Coordinator
collection form includes data previously
collected in each organ-specific
application form. This form will be used
for organ procurement organizations,
histocompatibility lab members, and
organ transplant programs so that one
standalone form will serve all three
member types.
• The Additional Surgeon and
Physician data collection form includes
data previously collected in the
Certificate of Assessment and Program
Coverage Plan (COA/PCP) Membership
Application form. Users will only have
to complete one form if the proposed
Surgeon and Physician serve in that role
for multiple programs.
The organ-specific application forms
have been revised to include the
information found in the COA/PCP,
which has been embedded into all of the
organ-specific application forms,
negating the need for an independent
data collection form.
Likely Respondents: New and existing
transplant hospitals, organ procurement
organizations, histocompatibility
laboratories, medical/scientific
organizations, public organizations,
businesses, and individual members.
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.
The total burden hours in the OMB
inventory increased by 944 hours from
the previously OMB-approved data
collection package from August 20,
2020. This increase is due in part to
including new membership forms.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents 1
khammond on DSKJM1Z7X2PROD with NOTICES
Form name
OPTN Membership Application for Transplant Hospitals
and Programs ...................................................................
OPTN Membership Application for Kidney Transplant Programs ................................................................................
OPTN Membership Application for Liver Transplant Programs ................................................................................
OPTN Membership Application for Pancreas Transplant
Programs ..........................................................................
OPTN Membership Application for Heart Transplant Programs ................................................................................
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Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
251
0.28
71
4.00
284
234
0.56
132
8.00
1,056
143
0.59
85
13.00
1,105
120
0.26
32
13.00
416
145
0.34
50
20.50
1,025
Sfmt 4703
E:\FR\FM\16NON1.SGM
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68715
Federal Register / Vol. 87, No. 220 / Wednesday, November 16, 2022 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Number of
respondents 1
Form name
OPTN Membership Application for Lung Transplant Programs ................................................................................
OPTN Membership Application for Islet Transplant Programs 2 .............................................................................
OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs ....................
OPTN Membership Application for Intestine Transplant
Programs ..........................................................................
OPTN Membership Application for Organ Procurement Organizations (OPOs) ..........................................................
OPTN Membership Application for Histocompatibility Laboratories ............................................................................
OPTN Representative Form ................................................
OPTN Medical/Scientific Membership Application ..............
OPTN Public Organization Membership Application ...........
OPTN Business Membership Application ............................
OPTN Individual Membership Application ...........................
OPTN Membership Application Surgeon or Physician
Log 3 .................................................................................
Primary Program Administrator Form ..................................
Primary Data Coordinator Form ..........................................
Additional Surgeon and Physician Request Form ...............
HOPE Act Variance Request Form 4 ...................................
Kidney Paired Donation Pilot Program (KPDPP) contact
update form ......................................................................
Total = 22 forms ...........................................................
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
72
0.64
47
9.00
423
19
0.00
0
5.00
0
43
0.98
43
15.50
667
21
0.19
4
11.00
44
57
0.14
8
40.00
320
141
1,760
10
7
11
8
0.21
0.02
0.30
0.57
0.55
0.88
30
36
3
4
7
8
2.50
0.25
0.75
0.50
0.88
0.25
75
9
3
2
7
2
0
1,562
1,760
1,562
68
0.00
0.05
0.03
0.08
0.00
0
79
53
125
0
0.00
0.25
0.13
1.17
1.33
0
20
7
147
0
159
0.33
53
1.63
87
8,153
........................
870
........................
5,699
1 The
numbers of respondents were updated with the data as of December 31, 2021, and reflect changes in members’ statuses.
were no Islet applications processed in 2021, hence no responses.
OPTN Membership Application Surgeon or Physician Log is an optional form. The information can also be submitted by the OPTN member using a different format. The burden to complete is built into the organ application data.
4 There were no HOPE Act Variance Request forms processed in 2021, hence no responses.
2 There
3 The
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.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Maria G. Button,
Director, Executive Secretariat.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Drug
Development.
Date: December 6, 2022.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maureen Shuh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 480–4097, maureen.shuh@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
[FR Doc. 2022–24926 Filed 11–15–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
17:27 Nov 15, 2022
Jkt 259001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 10, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24950 Filed 11–15–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68713-68715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24926]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Membership Forms for Organ
Procurement and Transplantation Network, OMB No. 0915-0184--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has 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. OMB may act on HRSA's ICR only after the
30-day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than December
16, 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 a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the HRSA
Information Collection Clearance Officer, at
[[Page 68714]]
[email protected] or call (301) 443-9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Membership Forms for Organ
Procurement and Transplantation Network, OMB No. 0915-0184--Revision.
Abstract: Membership in the Organ Procurement and Transplantation
Network (OPTN) is determined by submission of application materials to
the OPTN (not to HRSA) demonstrating that the applicant meets all
required criteria for membership and will agree to comply with all
applicable provisions of the National Organ Transplant Act, as amended,
42 U.S.C. 273 et seq.; the OPTN final rule, 42 CFR part 121; OPTN
policies; and OPTN bylaws. Section 1138 of the Social Security Act, as
amended, 42 U.S.C. 1320b-8, requires that hospitals in which
transplants are performed by members of, and abide by, the rules and
requirements of the OPTN (that have been approved by the Secretary of
Health and Human Services) as a condition of participation in Medicare
and Medicaid.
A 60-day notice was published in the Federal Register, 87 FR 52389
(Aug. 25, 2022). There were no public comments.
Need and Proposed Use of the Information: The application materials
are needed to ensure that all members and prospective members of the
OPTN submit evidence that they meet the required qualifications for
membership. These materials provide the OPTN with information to permit
the OPTN to confirm and demonstrate that applicants meet OPTN
membership application requirements, and to create a record of the
application review process and resulting actions for consideration by
the Secretary of Health and Human Services if an applicant subsequently
appeals a membership rejection by the OPTN.
This is a request to revise the current OPTN data collection
associated with transplant hospitals, organ procurement organizations,
transplant histocompatibility laboratories, medical/scientific and
public organizations, business organizations, and individuals to meet
or sustain requirements for OPTN membership to include data collection
forms for OPTN member hospitals requesting HIV Organ Policy Equity
(HOPE) Act variances as well as the Kidney Paired Donation Pilot
Program (KPDPP) contact update form. HRSA is submitting the following
changes to the membership forms to clarify requirements and eliminate
redundancy while adding more explanatory language and instruction to
the applications, which include:
(1) Adding two new data collection forms for HOPE Act Variance
Request and KPDPP contact update form. The HOPE Act Variance Request is
for any OPTN member transplant program that wishes to start a variance
to receive HIV-positive organs for their HIV-positive patients. The
KPDPP contact update is a form that indicates contact information for
programs participating in the KPDPP.
(2) Adding three standalone forms for data collection: Primary
Program Administrator, Primary Data Coordinator, and Additional Surgeon
and Physician. All three of these forms include data previously
collected on other OMB-approved forms in this package, but now will be
standalone forms for greater ease of use for the applicant.
The Primary Program Administrator data collection form
includes data previously collected in each organ-specific application
form. Users will only have to complete one form if the proposed Primary
Program Administrator serves in that role for multiple programs.
The Primary Data Coordinator collection form includes data
previously collected in each organ-specific application form. This form
will be used for organ procurement organizations, histocompatibility
lab members, and organ transplant programs so that one standalone form
will serve all three member types.
The Additional Surgeon and Physician data collection form
includes data previously collected in the Certificate of Assessment and
Program Coverage Plan (COA/PCP) Membership Application form. Users will
only have to complete one form if the proposed Surgeon and Physician
serve in that role for multiple programs.
The organ-specific application forms have been revised to include
the information found in the COA/PCP, which has been embedded into all
of the organ-specific application forms, negating the need for an
independent data collection form.
Likely Respondents: New and existing transplant hospitals, organ
procurement organizations, histocompatibility laboratories, medical/
scientific organizations, public organizations, businesses, and
individual members.
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.
The total burden hours in the OMB inventory increased by 944 hours
from the previously OMB-approved data collection package from August
20, 2020. This increase is due in part to including new membership
forms.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
\1\ respondent hours)
----------------------------------------------------------------------------------------------------------------
OPTN Membership Application for 251 0.28 71 4.00 284
Transplant Hospitals and
Programs.......................
OPTN Membership Application for 234 0.56 132 8.00 1,056
Kidney Transplant Programs.....
OPTN Membership Application for 143 0.59 85 13.00 1,105
Liver Transplant Programs......
OPTN Membership Application for 120 0.26 32 13.00 416
Pancreas Transplant Programs...
OPTN Membership Application for 145 0.34 50 20.50 1,025
Heart Transplant Programs......
[[Page 68715]]
OPTN Membership Application for 72 0.64 47 9.00 423
Lung Transplant Programs.......
OPTN Membership Application for 19 0.00 0 5.00 0
Islet Transplant Programs \2\..
OPTN Membership Application for 43 0.98 43 15.50 667
Vascularized Composite
Allograft (VCA) Transplant
Programs.......................
OPTN Membership Application for 21 0.19 4 11.00 44
Intestine Transplant Programs..
OPTN Membership Application for 57 0.14 8 40.00 320
Organ Procurement Organizations
(OPOs).........................
OPTN Membership Application for 141 0.21 30 2.50 75
Histocompatibility Laboratories
OPTN Representative Form........ 1,760 0.02 36 0.25 9
OPTN Medical/Scientific 10 0.30 3 0.75 3
Membership Application.........
OPTN Public Organization 7 0.57 4 0.50 2
Membership Application.........
OPTN Business Membership 11 0.55 7 0.88 7
Application....................
OPTN Individual Membership 8 0.88 8 0.25 2
Application....................
OPTN Membership Application 0 0.00 0 0.00 0
Surgeon or Physician Log \3\...
Primary Program Administrator 1,562 0.05 79 0.25 20
Form...........................
Primary Data Coordinator Form... 1,760 0.03 53 0.13 7
Additional Surgeon and Physician 1,562 0.08 125 1.17 147
Request Form...................
HOPE Act Variance Request Form 68 0.00 0 1.33 0
\4\............................
Kidney Paired Donation Pilot 159 0.33 53 1.63 87
Program (KPDPP) contact update
form...........................
-------------------------------------------------------------------------------
Total = 22 forms............ 8,153 .............. 870 .............. 5,699
----------------------------------------------------------------------------------------------------------------
\1\ The numbers of respondents were updated with the data as of December 31, 2021, and reflect changes in
members' statuses.
\2\ There were no Islet applications processed in 2021, hence no responses.
\3\ The OPTN Membership Application Surgeon or Physician Log is an optional form. The information can also be
submitted by the OPTN member using a different format. The burden to complete is built into the organ
application data.
\4\ There were no HOPE Act Variance Request forms processed in 2021, hence no responses.
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. 2022-24926 Filed 11-15-22; 8:45 am]
BILLING CODE 4165-15-P
