Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Organ Procurement and Transplantation Network, OMB No. 0915-0184-Revision, 22145-22147 [2017-09621]
Download as PDF
<![CDATA[
22145
Federal Register / Vol. 82, No. 91 / Friday, May 12, 2017 / Notices
involved in the delivery or care of
infants and who referred such infants
born with and identified as being
affected by illegal substance abuse or
withdrawal symptoms resulting from
prenatal drug exposure, or a Fetal
Alcohol Spectrum Disorder.
The Children’s Bureau proposes to
modify the Child File by adding two
new fields.
• Field 151, Has A Safe Care Plan:
The Safe Care Plan field will establish
a flag as to whether a child has a safe
care plan.
• Field 152, Referral to CARA-Related
Services: The Referral to CARA-related
Services field will establish a flag as to
whether a referral was made for
appropriate services, including services
for the affected family or caregiver.
Respondents: State governments, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Detailed Case Data Component (Child File and Agency File) ........................
mstockstill on DSK30JT082PROD with NOTICES
Estimated Total Annual Burden
Hours: 7,717.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information may be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–09684 Filed 5–11–17; 8:45 am]
BILLING CODE 4184–01–P
VerDate Sep<11>2014
17:41 May 11, 2017
Jkt 241001
52
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; Information Collection
Request Title: 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 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.
DATES: Comments on this ICR should be
received no later than June 12, 2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
Average
burden hours
per response
149
Total burden
hours
7,717
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 the 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 Health and Human
Services) of the OPTN, including those
related to data collection, as a condition
of participation in Medicare and
Medicaid for the hospital. Section 1138
contains a similar provision for the
organ procurement organizations
(OPOs) and makes membership in the
OPTN and compliance with its
operating rules and requirements (as
approved by the Secretary of Health and
Human Services), including those
relating to data collection, mandatory
E:\FR\FM\12MYN1.SGM
12MYN1
22146
Federal Register / Vol. 82, No. 91 / Friday, May 12, 2017 / Notices
for all OPOs. The membership
application forms listed below enable
prospective OPTN members to submit
the information necessary for the OPTN
to make membership decisions.
Likewise, the designated transplant
program application forms listed below
enable OPTN members to submit the
information necessary for the 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
definition of organs covered by the rules
governing the operation of the OPTN,
effective July 3, 2014. The OPTN Board
approved OPTN membership
requirements for VCA programs during
late 2015. Because a transplant hospital
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.
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 program
application forms, for programs seeking
VCA transplantation approval. The
OPTN Board of Directors has approved
language modifying OPTN Policy 1.2
(definitions) to provide that VCAs,
for programs seeking designation as an
intestine transplant program.
• Cover pages, based on existing
cover pages for other organ types, for
VCA new transplant program, VCA key
personnel change, VCA other new
transplant program, and VCA other key
personnel change forms.
• Questions and tables reflecting new
ordering and numbering for improved
flow on various forms.
These forms are based on OPTN
membership applications that
organizations have completed in the
past; the burden of completing the new
and revised forms is minimized.
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 disclosing
and providing information; (3) train
personnel to respond to a collection of
information; (4) search data sources; (5)
complete and review the information
collected; and (6) to transmit or
otherwise disclose the information. The
total annual burden hours estimated for
this ICR are summarized in the table
below.
defined generally in OPTN Policy 1.2
include the following:
• Upper limb (including, but not
limited to, any group of body parts from
the upper limb or radial forearm flap);
• Head and neck (including, but not
limited to, face including underlying
skeleton and muscle, larynx,
parathyroid gland, scalp, trachea, or
thyroid);
• Abdominal wall (including, but not
limited to, symphysis pubis or other
vascularized skeletal elements of the
pelvis);
• Genitourinary organs (including,
but not limited to, uterus, internal/
external male and female genitalia, or
urinary bladder);
• Glands (including, but not limited
to adrenal or thymus);
• Lower limb (including, but not
limited to, pelvic structures that are
attached to the lower limb and
transplanted intact, gluteal region,
vascularized bone transfers from the
lower extremity, anterior lateral thigh
flaps, or toe transfers);
• Musculoskeletal composite graft
segment (including, but not limited to,
latissimus dorsi, spine axis, or any other
vascularized muscle, bone, nerve, or
skin flap); and
• Spleen.
Some of the program application
forms for programs seeking VCA
transplantation approval are specific to
these body parts (e.g., VCA Upper Limb
Transplant Program Application), and
others are classified as VCA Other
Program Applications with a checklist
to indicate which of the listed body
parts the program seeks designation to
transplant.
• Program applications based on an
existing organ-specific application form
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
mstockstill on DSK30JT082PROD with NOTICES
Number of
responses per
respondent
2
118
59
60
92
30
2
42
14
17
13
1
2
2
2
2
2
2
2
2
2
2
2
236
118
120
184
60
4
84
28
34
26
8
4
4
4
4
4
3
3
3
3
3
16
944
472
480
736
240
12
252
84
102
78
9
40
0
2
2
1
18
80
0
2
3
4
36
240
0
A
B
B
B
B
B
B
B
B
B
B
New Transplant Member/Program Application—General .........
Kidney (KI) Designated Program Application ............................
Liver (LI) Designated Program Application ................................
Pancreas (PA) Designated Program Application ......................
Heart (HR) Designated Program Application ............................
Lung (LU) Designated Program Application ..............................
Islet (PI) Designated Program Application ................................
Living Donor (LD) Recovery Program Application ....................
VCA Head and Neck Designated Program Application ............
VCA Upper Limb Designated Program Application ...................
VCA Abdominal Wall * Designated Program Application ..........
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 ................................................................
VerDate Sep<11>2014
17:41 May 11, 2017
Jkt 241001
Average
burden per
response
(in hours)
Number of
respondents
Form name
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Total
responses
E:\FR\FM\12MYN1.SGM
12MYN1
Total burden
hours
22147
Federal Register / Vol. 82, No. 91 / Friday, May 12, 2017 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Average
burden per
response
(in hours)
Number of
respondents
Number of
responses per
respondent
Histocompatibility Lab Application .............................................
Change in Transplant Program Key Personnel .........................
Change in Histocompatibility Lab Director .................................
Change in OPO Key Personnel ................................................
Medical Scientific Org Application .............................................
Public Org Application .................................................................
Business Member Application ....................................................
Individual Member Application ...................................................
3
395
25
10
7
4
2
4
2
2
2
1
1
1
1
1
6
790
50
10
7
4
2
4
4
4
2
1
2
2
2
1
24
3,160
100
10
14
8
4
4
Total = 25 forms .......................................................................
948
........................
1,867
....................
7,016
Form name
D
E
F
G
H
I
J
K
Total
responses
Total burden
hours
* There are 4 types of forms that can be used to apply for designation as a VCA Abdominal Wall Program.
** VCA Other Designated Program Application data based on four categories of ‘‘others’’ including genitourinary and lower limb as defined by
the OPTN bylaws.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017–09621 Filed 5–11–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–0990–New–30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, has
submitted an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB) for review and approval. The ICR
SUMMARY:
is for a new collection. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before June 12, 2017.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn,
Sherrette.funncoleman@hhs.gov or (202)
795–7714.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
Information Collection Request Title
and document identifier 0990–New–
30D for reference.
Information Collection Request Title:
Pregnancy Assistance Fund (PAF)
Performance Measures Collection,
FY2017–FY2019 cohort.
Abstract: The Office of Adolescent
Health (OAH), U.S. Department of
Health and Human Services (HHS), is
requesting approval by OMB of a new
information collection request. In
FY2017, OAH expects to award a new,
3-year cohort of Pregnancy Assistance
Fund (PAF) grants. Performance
measure data collection is a requirement
of PAF grants and is included in the
funding announcement.
Need and Proposed Use of the
Information: The data collection will
provide OAH with performance data to
inform planning and resource allocation
decisions; identify technical assistance
needs for grantees; facilitate grantees’
continuous quality improvement in
program implementation; and provide
HHS, Congress, OMB, and the general
public with information about the
individuals who participate in PAFfunded activities and the services they
receive.
Likely Respondents: 20 PAF grantees
(States and Tribes).
The total annual burden hours
estimated for this ICR are summarized
in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
mstockstill on DSK30JT082PROD with NOTICES
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Training ............................................................................................................
Partnerships and Sustainability .......................................................................
Dissemination ..................................................................................................
Reach and Demographics ...............................................................................
Core Services ..................................................................................................
Education .........................................................................................................
Birth Outcomes ................................................................................................
Self-Sufficiency Outcomes ...............................................................................
20
20
20
20
20
20
20
20
1
1
1
1
1
1
1
1
15/60
3
30/60
645/60
750/60
7
270/60
90/60
5
60
10
215
250
140
90
30
Total ..........................................................................................................
20
1
40
800
VerDate Sep<11>2014
17:41 May 11, 2017
Jkt 241001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 82, Number 91 (Friday, May 12, 2017)]
[Notices]
[Pages 22145-22147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09621]
-----------------------------------------------------------------------
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; Information Collection
Request Title: 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 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.
DATES: Comments on this ICR should be received no later than June 12,
2017.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by
fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference, in compliance with Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995.
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 the 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 Health and Human
Services) of the OPTN, including those related to data collection, as a
condition of participation in Medicare and Medicaid for the hospital.
Section 1138 contains a similar provision for the organ procurement
organizations (OPOs) and makes membership in the OPTN and compliance
with its operating rules and requirements (as approved by the Secretary
of Health and Human Services), including those relating to data
collection, mandatory
[[Page 22146]]
for all OPOs. The membership application forms listed below enable
prospective OPTN members to submit the information necessary for the
OPTN to make membership decisions. Likewise, the designated transplant
program application forms listed below enable OPTN members to submit
the information necessary for the 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 definition of organs
covered by the rules governing the operation of the OPTN, effective
July 3, 2014. The OPTN Board approved OPTN membership requirements for
VCA programs during late 2015. Because a transplant hospital 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.
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
program application forms, for programs seeking VCA transplantation
approval. The OPTN Board of Directors has approved language modifying
OPTN Policy 1.2 (definitions) to provide that VCAs, defined generally
in OPTN Policy 1.2 include the following:
Upper limb (including, but not limited to, any group of
body parts from the upper limb or radial forearm flap);
Head and neck (including, but not limited to, face
including underlying skeleton and muscle, larynx, parathyroid gland,
scalp, trachea, or thyroid);
Abdominal wall (including, but not limited to, symphysis
pubis or other vascularized skeletal elements of the pelvis);
Genitourinary organs (including, but not limited to,
uterus, internal/external male and female genitalia, or urinary
bladder);
Glands (including, but not limited to adrenal or thymus);
Lower limb (including, but not limited to, pelvic
structures that are attached to the lower limb and transplanted intact,
gluteal region, vascularized bone transfers from the lower extremity,
anterior lateral thigh flaps, or toe transfers);
Musculoskeletal composite graft segment (including, but
not limited to, latissimus dorsi, spine axis, or any other vascularized
muscle, bone, nerve, or skin flap); and
Spleen.
Some of the program application forms for programs seeking VCA
transplantation approval are specific to these body parts (e.g., VCA
Upper Limb Transplant Program Application), and others are classified
as VCA Other Program Applications with a checklist to indicate which of
the listed body parts the program seeks designation to transplant.
Program applications based on an existing organ-specific
application form for programs seeking designation as an intestine
transplant program.
Cover pages, based on existing cover pages for other organ
types, for VCA new transplant program, VCA key personnel change, VCA
other new transplant program, and VCA other key personnel change forms.
Questions and tables reflecting new ordering and numbering
for improved flow on various forms.
These forms are based on OPTN membership applications that
organizations have completed in the past; the burden of completing the
new and revised forms is minimized.
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 disclosing and
providing information; (3) train personnel to respond to a collection
of information; (4) search data sources; (5) complete and review the
information collected; and (6) 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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response hours
respondent (in hours)
----------------------------------------------------------------------------------------------------------------
A New Transplant Member/Program 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 Program 60 2 120 4 480
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 Program 42 2 84 3 252
Application.............................
B VCA Head and Neck Designated Program 14 2 28 3 84
Application.............................
B VCA Upper Limb Designated Program 17 2 34 3 102
Application.............................
B VCA Abdominal Wall * Designated Program 13 2 26 3 78
Application.............................
VCA Abdominal Wall--Kidney
VCA Abdominal Wall--Liver
VCA Abdominal Wall--Pancreas
VCA Abdominal Wall--Intestine
B VCA Other ** Designated Program 9 2 18 2 36
Application.............................
B Intestine Designated Program 40 2 80 3 240
Application.............................
C OPO New Application.................... 0 1 0 4 0
[[Page 22147]]
D Histocompatibility Lab Application..... 3 2 6 4 24
E Change in Transplant Program Key 395 2 790 4 3,160
Personnel...............................
F Change in Histocompatibility Lab 25 2 50 2 100
Director................................
G Change in OPO Key Personnel............ 10 1 10 1 10
H Medical Scientific Org Application..... 7 1 7 2 14
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
----------------------------------------------------------------------------------------------------------------
* There are 4 types of forms that can be used to apply for designation as a VCA Abdominal Wall Program.
** VCA Other Designated Program Application data based on four categories of ``others'' including genitourinary
and lower limb as defined by the OPTN bylaws.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017-09621 Filed 5-11-17; 8:45 am]
BILLING CODE 4165-15-P
