Agency Information Collection Activities: Proposed Collection: Public Comment Request; Organ Procurement and Transplantation Network, 89115-89117 [2016-29504]
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89115
Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
HRSA to submit assessed data on the
number of FTE residents trained by the
children’s hospitals participating in the
CHGME Payment Program in an FTE
resident assessment summary.
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
Application Cover Letter (Initial and Reconciliation) ............
HRSA 99 (Initial and Reconciliation) ...................................
HRSA 99–1 (Initial) ..............................................................
HRSA 99–1 (Reconciliation) ................................................
HRSA 99–1 (Supplemental) (FTE Resident Assessment) ..
HRSA 99–2 (Initial) ..............................................................
HRSA 99–2 (Reconciliation) ................................................
HRSA 99–4 (Reconciliation) ................................................
HRSA 99–5 (Initial and Reconciliation) ...............................
CFO Form Letter (Initial and Reconciliation) .......................
Exhibit 2 (Initial and Reconciliation) ....................................
Exhibit 3 (Initial and Reconciliation) ....................................
Exhibit 4 (Initial and Reconciliation) ....................................
FTE Resident Assessment Cover Letter (FTE Resident
Assessment) .....................................................................
Conversation Record (FTE Resident Assessment) .............
Exhibit C (FTE Resident Assessment) ................................
Exhibit F (FTE Resident Assessment) ................................
Exhibit N (FTE Resident Assessment) ................................
Exhibit O(1) (FTE Resident Assessment) ...........................
Exhibit O(2) (FTE Resident Assessment) ...........................
Exhibit P (FTE Resident Assessment) ................................
Exhibit P(2) (FTE Resident Assessment) ............................
Exhibit S (FTE Resident Assessment) ................................
Exhibit T (FTE Resident Assessment) ................................
Exhibit T(1) (FTE Resident Assessment) ............................
Exhibit 1 (FTE Resident Assessment) .................................
Exhibit 2 (FTE Resident Assessment) .................................
Exhibit 3 (FTE Resident Assessment) .................................
Exhibit 4 (FTE Resident Assessment) .................................
60
60
60
60
30
60
60
60
60
60
60
60
60
2
2
1
1
2
1
1
1
2
2
2
2
2
120
120
60
60
60
60
60
60
120
120
120
120
120
0.33
0.33
26.5
6.5
3.67
11.33
3.67
12.5
1.55
0.33
0.33
0.33
0.33
39.6
39.6
1,590
390
220.2
679.8
220.2
750
186
39.6
39.6
39.6
39.6
30
30
30
30
30
30
30
30
30
30
30
30
30
30
30
30
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
60
60
60
60
60
60
60
60
60
60
60
60
60
60
60
60
0.33
3.67
3.67
3.67
3.67
3.67
26.5
3.67
3.67
3.67
3.67
3.67
0.33
0.33
0.33
0.33
19.8
220.2
220.2
220.2
220.2
220.2
1590
220.2
220.2
220.2
220.2
220.2
19.8
19.8
19.8
19.8
Total ..............................................................................
* 90
........................
* 90
........................
8,164.80
* The total is 90 because the same hospitals and auditors are completing the forms.
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.
mstockstill on DSK3G9T082PROD with NOTICES
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–29503 Filed 12–8–16; 8:45 am]
19:08 Dec 08, 2016
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Organ
Procurement and Transplantation
Network
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995),
HRSA announces plans to submit an
Information Collection Request (ICR),
SUMMARY:
BILLING CODE 4165–15–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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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.
Comments on this Information
Collection Request must be received no
later than February 7, 2017.
DATES:
Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, at 5600 Fishers Lane, Room
14N39, Rockville, MD 20857.
ADDRESSES:
To
request more information on the
proposed project or to obtain copies of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\09DEN1.SGM
09DEN1
89116
Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Organ Procurement and Transplantation
Network OMB No. 0915–0184—
Revision.
Abstract: HRSA is proposing
additions and revisions to the following
documents used to collect information
from existing or potential members of
the Organ Procurement and
Transplantation Network (OPTN). The
documents under revision include: (1)
Application forms for individuals or
organizations interested in membership
in OPTN, (2) application forms for
OPTN members applying to have organspecific transplant programs designated
within their institutions, and (3) forms
submitted by OPTN members to report
certain personnel changes.
Need and Proposed Use of the
Information: Membership in the 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. (NOTA),
OPTN Final Rule, 42 CFR part 121,
OPTN bylaws, and OPTN policies.
Section 1138 of the Social Security Act,
as amended, 42 U.S.C. 1320b–8 (section
1138) requires that hospitals in which
transplants are performed be members
of, and abide by, the rules and
requirements (as approved by the
Secretary of HHS) of the OPTN,
including those relating to data
collection, as a condition of
participation in Medicare and Medicaid
for the hospital. Section 1138 contains
a similar provision for organ
procurement organizations (OPOs) and
makes membership in the OPTN and
compliance with its operating rules and
SUPPLEMENTARY INFORMATION:
requirements, including those relating
to data collection, mandatory for all
OPOs. The membership application
forms listed below enable prospective
OPTN members to submit the
information necessary for OPTN to
make membership decisions. Likewise,
the designated transplant program
application forms listed below enable
OPTN members to submit the
information necessary for OPTN to
make designation decisions.
New membership forms have been
created for transplant centers seeking to
perform Vascularized Composite
Allograft (VCA) transplants, a new and
emerging field. VCAs were added to the
set of organs covered by NOTA and the
OPTN final rule via regulation, effective
July 3, 2014. The OPTN Board approved
OPTN membership requirements for
VCA programs in late 2015. Because a
transplant center applying to be an
OPTN-approved VCA transplant
program must already have current
OPTN approval as a designated
transplant program for at least one other
organ, the VCA membership forms were
developed based on existing
membership forms.
To keep pace with scientific and
clinical advances in the field of
transplantation, HRSA plans to submit a
clearance package to OMB after
reviewing comments to this notice. New
forms and revisions to the current OPTN
forms include the following:
• Organ-specific program and
histocompatibility laboratory
applications reflecting key personnel
requirement revisions made to the
OPTN bylaws (the bylaws revisions will
be implemented upon approval of these
forms).
• Program applications based on
existing organ-specific application
forms, for programs seeking intestinal
and VCA transplantation approval
OPTN-defined VCAs: VCA head and
neck, VCA upper limb, VCA abdominal
wall kidney, VCA abdominal wall liver,
VCA abdominal wall pancreas, VCA
abdominal wall intestine, and VCA
other.
• Intestine program applications,
based on an existing organ-specific
application form.
• Cover pages, based on existing
cover pages for other organ types, have
been created for VCA new transplant
program, VCA key personnel change,
VCA other new transplant program, and
VCA other key personnel change.
• Questions and tables reflecting new
ordering and numbering for improved
flow on various forms.
The burden of completing the new
and revised forms is expected to be
minimal, as these forms are based on
OPTN membership applications that
organizations have completed in the
past.
Likely Respondents: Likely
respondents to this notice include the
following: Hospitals performing or
seeking to perform organ transplants,
organ procurement organizations, and
medical laboratories seeking to become
OPTN-approved histocompatibility
laboratories.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested, including the time needed to
(1) review instructions; (2) develop,
acquire, install, and utilize technology
and systems for the purpose of
collecting, validating, and verifying
information, processing and
maintaining information, and
transmitting, disclosing, or providing
information; (3) train personnel to
respond to a collection of information;
(4) search data sources; (5) complete and
review the information collected; (6)
and transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
mstockstill on DSK3G9T082PROD with NOTICES
Form name
A. New Transplant Member Application—General ..............
B Kidney (KI) Designated Program Application ..................
B Liver (LI) Designated Program Application ......................
B Pancreas (PA) Designated Program Application .............
B Heart (HR) Designated Program Application ...................
B Lung (LU) Designated Program Application ....................
B Islet (PI) Designated Program Application .......................
B Living Donor (LD) Recovery Program Application ...........
B VCA Head and Neck Designated Program Application ...
B VCA Upper Limb Designated Program Application .........
B VCA Abdominal Wall * Designated Program Application
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Frm 00075
Number of
responses per
respondent
2
118
59
60
92
30
2
42
14
17
13
Fmt 4703
Sfmt 4703
Total
responses
1
2
2
2
2
2
2
2
2
2
2
E:\FR\FM\09DEN1.SGM
2
236
118
120
184
60
4
84
28
34
26
09DEN1
Average
burden per
response
(in hours)
Total burden
hours
8
4
4
4
4
4
3
3
3
3
3
16
944
472
480
736
240
12
252
84
102
78
89117
Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
VCA Abdominal Wall—Kidney
VCA Abdominal Wall—Liver
VCA Abdominal Wall—Pancreas
VCA Abdominal Wall—Intestine
B VCA Other ** Designated Program Application ...............
B Intestine Designated Program Application .......................
C OPO New Application ......................................................
D Histocompatibility Lab Application ...................................
E Change in Transplant Program Key Personnel ...............
F Change in Histocompatibility Lab Director .......................
G Change in OPO Key Personnel .......................................
H Medical Scientific Org Application ...................................
I Public Org Application .......................................................
J Business Member Application ..........................................
K Individual Member Application .........................................
9
40
0
3
395
25
10
7
4
2
4
2
2
1
2
2
2
1
1
1
1
1
18
80
0
6
790
50
10
7
4
2
4
2
3
4
4
4
2
1
2
2
2
1
36
240
0
24
3,160
100
10
14
8
4
4
Total = 25 forms ...........................................................
948
........................
1,867
........................
7,016
* VCA Abdominal Wall Designated Program qualification requirements require documentation on VCA Head and Neck, VCA Upper Limb, Kidney, Liver, Intestine, or Pancreas program requirements.
** VCA Other Designated Program Application data based on four categories of ‘‘others’’ including genitourinary and lower limb as defined by
the OPTN bylaws.
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.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–29504 Filed 12–8–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–0990–New–60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:13 Dec 08, 2016
Jkt 241001
to submit a new Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate
below or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before February 7, 2017.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–5683.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier OS–0990–New–60D
for reference.
Information Collection Request Title:
A Client-Centered Performance Measure
for Contraceptive Services.
Abstract: The Office of the Assistant
Secretary for Health/Office of
Population Affairs is seeking an
approval by the Office of Management
and Budget on a new information
collection. We propose to evaluate a
scale previously developed by our
collaborators at the University of
California San Francisco (UCSF)—the
11-item Interpersonal Quality of Family
Planning Care (IQFP) scale—among
3,000 female family planning clients.
Initially informed by qualitative work
around women’s preferences for
contraceptive counseling, the IQFP scale
has already been shown to be a valid
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
and reliable scale in research settings
but its use as a performance measure
hasn’t yet been evaluated. Family
planning providers will also complete a
short survey about provider
characteristics (approximately 80
providers) and clinic demographics
(approximately 10 clinics).
Need and Proposed Use of the
Information: The proposed use of the
information to be collected is to develop
a patient-reported outcome performance
measure (PRO–PM) on contraceptive
counseling and assess its validity,
reliability, feasibility, usability, and use.
If we find that this measure has
adequately met these criteria, UCSF and
the Office of Population Affairs (OPA)
will prepare it for submission to the
National Quality Forum (NQF) for use
in a variety of clinical settings where
family planning care is provided.
Measurement of the quality of
contraceptive counseling can be used as
part of quality improvement activities to
increase awareness and use of clientcentered counseling approaches. By
improving client-centered services,
women can choose the contraceptive
method that works best for them, which
can lead to reductions in rates of
unintended pregnancy and other
adverse reproductive outcomes.
Likely Respondents: Family planning
providers and their patients.
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89115-89117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29504]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Organ Procurement and Transplantation Network
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) 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 Information Collection Request must be received
no later than February 7, 2017.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance Officer, at 5600 Fishers Lane,
Room 14N39, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain copies of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
[[Page 89116]]
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Organ Procurement and
Transplantation Network OMB No. 0915-0184--Revision.
Abstract: HRSA is proposing additions and revisions to the
following documents used to collect information from existing or
potential members of the Organ Procurement and Transplantation Network
(OPTN). The documents under revision include: (1) Application forms for
individuals or organizations interested in membership in OPTN, (2)
application forms for OPTN members applying to have organ-specific
transplant programs designated within their institutions, and (3) forms
submitted by OPTN members to report certain personnel changes.
Need and Proposed Use of the Information: Membership in the 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.
(NOTA), OPTN Final Rule, 42 CFR part 121, OPTN bylaws, and OPTN
policies. Section 1138 of the Social Security Act, as amended, 42
U.S.C. 1320b-8 (section 1138) requires that hospitals in which
transplants are performed be members of, and abide by, the rules and
requirements (as approved by the Secretary of HHS) of the OPTN,
including those relating to data collection, as a condition of
participation in Medicare and Medicaid for the hospital. Section 1138
contains a similar provision for organ procurement organizations (OPOs)
and makes membership in the OPTN and compliance with its operating
rules and requirements, including those relating to data collection,
mandatory for all OPOs. The membership application forms listed below
enable prospective OPTN members to submit the information necessary for
OPTN to make membership decisions. Likewise, the designated transplant
program application forms listed below enable OPTN members to submit
the information necessary for OPTN to make designation decisions.
New membership forms have been created for transplant centers
seeking to perform Vascularized Composite Allograft (VCA) transplants,
a new and emerging field. VCAs were added to the set of organs covered
by NOTA and the OPTN final rule via regulation, effective July 3, 2014.
The OPTN Board approved OPTN membership requirements for VCA programs
in late 2015. Because a transplant center applying to be an OPTN-
approved VCA transplant program must already have current OPTN approval
as a designated transplant program for at least one other organ, the
VCA membership forms were developed based on existing membership forms.
To keep pace with scientific and clinical advances in the field of
transplantation, HRSA plans to submit a clearance package to OMB after
reviewing comments to this notice. New forms and revisions to the
current OPTN forms include the following:
Organ-specific program and histocompatibility laboratory
applications reflecting key personnel requirement revisions made to the
OPTN bylaws (the bylaws revisions will be implemented upon approval of
these forms).
Program applications based on existing organ-specific
application forms, for programs seeking intestinal and VCA
transplantation approval OPTN-defined VCAs: VCA head and neck, VCA
upper limb, VCA abdominal wall kidney, VCA abdominal wall liver, VCA
abdominal wall pancreas, VCA abdominal wall intestine, and VCA other.
Intestine program applications, based on an existing
organ-specific application form.
Cover pages, based on existing cover pages for other organ
types, have been created for VCA new transplant program, VCA key
personnel change, VCA other new transplant program, and VCA other key
personnel change.
Questions and tables reflecting new ordering and numbering
for improved flow on various forms.
The burden of completing the new and revised forms is expected to
be minimal, as these forms are based on OPTN membership applications
that organizations have completed in the past.
Likely Respondents: Likely respondents to this notice include the
following: Hospitals performing or seeking to perform organ
transplants, organ procurement organizations, and medical laboratories
seeking to become OPTN-approved histocompatibility laboratories.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested, including the time needed to (1) review
instructions; (2) develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and transmitting,
disclosing, or providing information; (3) train personnel to respond to
a collection of information; (4) search data sources; (5) complete and
review the information collected; (6) and transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
A. New Transplant Member 2 1 2 8 16
Application--General...........
B Kidney (KI) Designated Program 118 2 236 4 944
Application....................
B Liver (LI) Designated Program 59 2 118 4 472
Application....................
B Pancreas (PA) Designated 60 2 120 4 480
Program Application............
B Heart (HR) Designated Program 92 2 184 4 736
Application....................
B Lung (LU) Designated Program 30 2 60 4 240
Application....................
B Islet (PI) Designated Program 2 2 4 3 12
Application....................
B Living Donor (LD) Recovery 42 2 84 3 252
Program Application............
B VCA Head and Neck Designated 14 2 28 3 84
Program Application............
B VCA Upper Limb Designated 17 2 34 3 102
Program Application............
B VCA Abdominal Wall * 13 2 26 3 78
Designated Program Application.
[[Page 89117]]
VCA Abdominal Wall--Kidney
VCA Abdominal Wall--Liver
VCA Abdominal Wall--Pancreas
VCA Abdominal Wall--
Intestine
B VCA Other ** Designated 9 2 18 2 36
Program Application............
B Intestine Designated Program 40 2 80 3 240
Application....................
C OPO New Application........... 0 1 0 4 0
D Histocompatibility Lab 3 2 6 4 24
Application....................
E Change in Transplant Program 395 2 790 4 3,160
Key Personnel..................
F Change in Histocompatibility 25 2 50 2 100
Lab Director...................
G Change in OPO Key Personnel... 10 1 10 1 10
H Medical Scientific Org 7 1 7 2 14
Application....................
I Public Org Application........ 4 1 4 2 8
J Business Member Application... 2 1 2 2 4
K Individual Member Application. 4 1 4 1 4
-------------------------------------------------------------------------------
Total = 25 forms............ 948 .............. 1,867 .............. 7,016
----------------------------------------------------------------------------------------------------------------
* VCA Abdominal Wall Designated Program qualification requirements require documentation on VCA Head and Neck,
VCA Upper Limb, Kidney, Liver, Intestine, or Pancreas program requirements.
** VCA Other Designated Program Application data based on four categories of ``others'' including genitourinary
and lower limb as defined by the OPTN bylaws.
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.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-29504 Filed 12-8-16; 8:45 am]
BILLING CODE 4165-15-P
