81_FR_89352 81 FR 89115 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Organ Procurement and Transplantation Network

81 FR 89115 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Organ Procurement and Transplantation Network

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 237 (December 9, 2016)

Page Range89115-89117
FR Document2016-29504

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.

Federal Register, Volume 81 Issue 237 (Friday, December 9, 2016)
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89115-89117]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected] 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 [email protected] 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



                                                                                         Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices                                                                               89115

                                                  HRSA to submit assessed data on the                                        requested. This includes the time                                personnel and to be able to respond to
                                                  number of FTE residents trained by the                                     needed to review instructions; to                                a collection of information; to search
                                                  children’s hospitals participating in the                                  develop, acquire, install, and utilize                           data sources; to complete and review
                                                  CHGME Payment Program in an FTE                                            technology and systems for the purpose                           the collection of information; and to
                                                  resident assessment summary.                                               of collecting, validating, and verifying                         transmit or otherwise disclose the
                                                    Burden Statement: Burden in this                                         information, processing and                                      information. The total annual burden
                                                  context means the time expended by                                         maintaining information, and disclosing                          hours estimated for this ICR are
                                                  persons to generate, maintain, retain,                                     and providing information; to train                              summarized in the table below.
                                                  disclose, or provide the information

                                                                                                                     TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                     Average
                                                                                                                                                                     Number of
                                                                                                                                                Number of                                        Total             burden per              Total burden
                                                                                     Form name                                                                     responses per
                                                                                                                                               respondents                                    responses             response                  hours
                                                                                                                                                                     respondent                                     (in hours)

                                                  Application Cover Letter (Initial and Reconciliation) ............                                         60                         2              120                     0.33                39.6
                                                  HRSA 99 (Initial and Reconciliation) ...................................                                   60                         2              120                     0.33                39.6
                                                  HRSA 99–1 (Initial) ..............................................................                         60                         1               60                     26.5               1,590
                                                  HRSA 99–1 (Reconciliation) ................................................                                60                         1               60                      6.5                 390
                                                  HRSA 99–1 (Supplemental) (FTE Resident Assessment) ..                                                      30                         2               60                     3.67               220.2
                                                  HRSA 99–2 (Initial) ..............................................................                         60                         1               60                    11.33               679.8
                                                  HRSA 99–2 (Reconciliation) ................................................                                60                         1               60                     3.67               220.2
                                                  HRSA 99–4 (Reconciliation) ................................................                                60                         1               60                     12.5                 750
                                                  HRSA 99–5 (Initial and Reconciliation) ...............................                                     60                         2              120                     1.55                 186
                                                  CFO Form Letter (Initial and Reconciliation) .......................                                       60                         2              120                     0.33                39.6
                                                  Exhibit 2 (Initial and Reconciliation) ....................................                                60                         2              120                     0.33                39.6
                                                  Exhibit 3 (Initial and Reconciliation) ....................................                                60                         2              120                     0.33                39.6
                                                  Exhibit 4 (Initial and Reconciliation) ....................................                                60                         2              120                     0.33                39.6
                                                  FTE Resident Assessment Cover Letter (FTE Resident
                                                    Assessment) .....................................................................                        30                         2               60                      0.33               19.8
                                                  Conversation Record (FTE Resident Assessment) .............                                                30                         2               60                      3.67              220.2
                                                  Exhibit C (FTE Resident Assessment) ................................                                       30                         2               60                      3.67              220.2
                                                  Exhibit F (FTE Resident Assessment) ................................                                       30                         2               60                      3.67              220.2
                                                  Exhibit N (FTE Resident Assessment) ................................                                       30                         2               60                      3.67              220.2
                                                  Exhibit O(1) (FTE Resident Assessment) ...........................                                         30                         2               60                      3.67              220.2
                                                  Exhibit O(2) (FTE Resident Assessment) ...........................                                         30                         2               60                      26.5               1590
                                                  Exhibit P (FTE Resident Assessment) ................................                                       30                         2               60                      3.67              220.2
                                                  Exhibit P(2) (FTE Resident Assessment) ............................                                        30                         2               60                      3.67              220.2
                                                  Exhibit S (FTE Resident Assessment) ................................                                       30                         2               60                      3.67              220.2
                                                  Exhibit T (FTE Resident Assessment) ................................                                       30                         2               60                      3.67              220.2
                                                  Exhibit T(1) (FTE Resident Assessment) ............................                                        30                         2               60                      3.67              220.2
                                                  Exhibit 1 (FTE Resident Assessment) .................................                                      30                         2               60                      0.33               19.8
                                                  Exhibit 2 (FTE Resident Assessment) .................................                                      30                         2               60                      0.33               19.8
                                                  Exhibit 3 (FTE Resident Assessment) .................................                                      30                         2               60                      0.33               19.8
                                                  Exhibit 4 (FTE Resident Assessment) .................................                                      30                         2               60                      0.33               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                                      DEPARTMENT OF HEALTH AND                                         described below, to the Office of
                                                  on (1) the necessity and utility of the                                    HUMAN SERVICES                                                   Management and Budget (OMB). Prior
                                                  proposed information collection for the                                                                                                     to submitting the ICR to OMB, HRSA
                                                  proper performance of the agency’s                                         Health Resources and Services                                    seeks comments from the public
                                                  functions, (2) the accuracy of the                                         Administration                                                   regarding the burden estimate, below, or
                                                  estimated burden, (3) ways to enhance                                                                                                       any other aspect of the ICR.
                                                                                                                             Agency Information Collection
                                                  the quality, utility, and clarity of the
                                                                                                                             Activities: Proposed Collection: Public                          DATES:  Comments on this Information
                                                  information to be collected, and (4) the                                   Comment Request; Organ                                           Collection Request must be received no
                                                  use of automated collection techniques                                     Procurement and Transplantation                                  later than February 7, 2017.
                                                  or other forms of information                                              Network
                                                  technology to minimize the information                                                                                                      ADDRESSES:   Submit your comments to
                                                  collection burden.                                                         AGENCY: Health Resources and Services                            paperwork@hrsa.gov or by mail to the
                                                                                                                             Administration (HRSA), Department of                             HRSA Information Collection Clearance
                                                  Jason E. Bennett,
                                                                                                                             Health and Human Services (HHS).                                 Officer, at 5600 Fishers Lane, Room
                                                  Director, Division of the Executive Secretariat.                                                                                            14N39, Rockville, MD 20857.
                                                                                                                             ACTION: Notice.
                                                  [FR Doc. 2016–29503 Filed 12–8–16; 8:45 am]
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                                              FOR FURTHER INFORMATION CONTACT:    To
                                                  BILLING CODE 4165–15–P                                                     SUMMARY:   In compliance with the                                request more information on the
                                                                                                                             requirement for opportunity for public
                                                                                                                                                                                              proposed project or to obtain copies of
                                                                                                                             comment on proposed data collection
                                                                                                                                                                                              the data collection plans and draft
                                                                                                                             projects (Section 3506(c)(2)(A) of the
                                                                                                                             Paperwork Reduction Act of 1995),                                instruments, email paperwork@hrsa.gov
                                                                                                                             HRSA announces plans to submit an                                or call the HRSA Information Collection
                                                                                                                             Information Collection Request (ICR),                            Clearance Officer at (301) 443–1984.



                                             VerDate Sep<11>2014        19:08 Dec 08, 2016          Jkt 241001       PO 00000       Frm 00074    Fmt 4703     Sfmt 4703     E:\FR\FM\09DEN1.SGM        09DEN1


                                                  89116                        Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices

                                                  SUPPLEMENTARY INFORMATION:     When                     requirements, including those relating                 VCA abdominal wall pancreas, VCA
                                                  submitting comments or requesting                       to data collection, mandatory for all                  abdominal wall intestine, and VCA
                                                  information, please include the                         OPOs. The membership application                       other.
                                                  information request collection title for                forms listed below enable prospective                     • Intestine program applications,
                                                  reference.                                              OPTN members to submit the                             based on an existing organ-specific
                                                     Information Collection Request Title:                information necessary for OPTN to                      application form.
                                                  Organ Procurement and Transplantation                   make membership decisions. Likewise,                      • Cover pages, based on existing
                                                  Network OMB No. 0915–0184—                              the designated transplant program                      cover pages for other organ types, have
                                                  Revision.                                               application forms listed below enable                  been created for VCA new transplant
                                                     Abstract: HRSA is proposing                          OPTN members to submit the                             program, VCA key personnel change,
                                                  additions and revisions to the following                information necessary for OPTN to                      VCA other new transplant program, and
                                                  documents used to collect information                   make designation decisions.                            VCA other key personnel change.
                                                  from existing or potential members of                      New membership forms have been
                                                  the Organ Procurement and                                                                                         • Questions and tables reflecting new
                                                                                                          created for transplant centers seeking to              ordering and numbering for improved
                                                  Transplantation Network (OPTN). The                     perform Vascularized Composite
                                                  documents under revision include: (1)                                                                          flow on various forms.
                                                                                                          Allograft (VCA) transplants, a new and
                                                  Application forms for individuals or                                                                              The burden of completing the new
                                                                                                          emerging field. VCAs were added to the
                                                  organizations interested in membership                                                                         and revised forms is expected to be
                                                                                                          set of organs covered by NOTA and the
                                                  in OPTN, (2) application forms for                                                                             minimal, as these forms are based on
                                                                                                          OPTN final rule via regulation, effective
                                                  OPTN members applying to have organ-                                                                           OPTN membership applications that
                                                                                                          July 3, 2014. The OPTN Board approved
                                                  specific transplant programs designated                                                                        organizations have completed in the
                                                                                                          OPTN membership requirements for
                                                  within their institutions, and (3) forms                                                                       past.
                                                                                                          VCA programs in late 2015. Because a
                                                  submitted by OPTN members to report                     transplant center applying to be an                       Likely Respondents: Likely
                                                  certain personnel changes.                              OPTN-approved VCA transplant                           respondents to this notice include the
                                                     Need and Proposed Use of the                         program must already have current                      following: Hospitals performing or
                                                  Information: Membership in the OPTN                     OPTN approval as a designated                          seeking to perform organ transplants,
                                                  is determined by submission of                          transplant program for at least one other              organ procurement organizations, and
                                                  application materials to the OPTN (not                  organ, the VCA membership forms were                   medical laboratories seeking to become
                                                  to HRSA) demonstrating that the                         developed based on existing                            OPTN-approved histocompatibility
                                                  applicant meets all required criteria for               membership forms.                                      laboratories.
                                                  membership and will agree to comply                        To keep pace with scientific and                       Burden Statement: Burden in this
                                                  with all applicable provisions of the                   clinical advances in the field of                      context means the time expended by
                                                  National Organ Transplant Act, as                       transplantation, HRSA plans to submit a                persons to generate, maintain, retain,
                                                  amended, 42 U.S.C. 273, et seq. (NOTA),                 clearance package to OMB after                         disclose, or provide the information
                                                  OPTN Final Rule, 42 CFR part 121,                       reviewing comments to this notice. New                 requested, including the time needed to
                                                  OPTN bylaws, and OPTN policies.                         forms and revisions to the current OPTN                (1) review instructions; (2) develop,
                                                  Section 1138 of the Social Security Act,                forms include the following:                           acquire, install, and utilize technology
                                                  as amended, 42 U.S.C. 1320b–8 (section                     • Organ-specific program and                        and systems for the purpose of
                                                  1138) requires that hospitals in which                  histocompatibility laboratory                          collecting, validating, and verifying
                                                  transplants are performed be members                    applications reflecting key personnel                  information, processing and
                                                  of, and abide by, the rules and                         requirement revisions made to the                      maintaining information, and
                                                  requirements (as approved by the                        OPTN bylaws (the bylaws revisions will                 transmitting, disclosing, or providing
                                                  Secretary of HHS) of the OPTN,                          be implemented upon approval of these                  information; (3) train personnel to
                                                  including those relating to data                        forms).                                                respond to a collection of information;
                                                  collection, as a condition of                              • Program applications based on                     (4) search data sources; (5) complete and
                                                  participation in Medicare and Medicaid                  existing organ-specific application                    review the information collected; (6)
                                                  for the hospital. Section 1138 contains                 forms, for programs seeking intestinal                 and transmit or otherwise disclose the
                                                  a similar provision for organ                           and VCA transplantation approval                       information. The total annual burden
                                                  procurement organizations (OPOs) and                    OPTN-defined VCAs: VCA head and                        hours estimated for this Information
                                                  makes membership in the OPTN and                        neck, VCA upper limb, VCA abdominal                    Collection Request are summarized in
                                                  compliance with its operating rules and                 wall kidney, VCA abdominal wall liver,                 the table below.

                                                                                                     TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                     Average
                                                                                                                                               Number of
                                                                                                                         Number of                                  Total          burden per        Total burden
                                                                            Form name                                                        responses per
                                                                                                                        respondents                              responses          response            hours
                                                                                                                                               respondent                           (in hours)

                                                  A. New Transplant Member Application—General ..............                            2                 1                2                    8             16
                                                  B Kidney (KI) Designated Program Application ..................                      118                 2              236                    4            944
                                                  B Liver (LI) Designated Program Application ......................                    59                 2              118                    4            472
mstockstill on DSK3G9T082PROD with NOTICES




                                                  B Pancreas (PA) Designated Program Application .............                          60                 2              120                    4            480
                                                  B Heart (HR) Designated Program Application ...................                       92                 2              184                    4            736
                                                  B Lung (LU) Designated Program Application ....................                       30                 2               60                    4            240
                                                  B Islet (PI) Designated Program Application .......................                    2                 2                4                    3             12
                                                  B Living Donor (LD) Recovery Program Application ...........                          42                 2               84                    3            252
                                                  B VCA Head and Neck Designated Program Application ...                                14                 2               28                    3             84
                                                  B VCA Upper Limb Designated Program Application .........                             17                 2               34                    3            102
                                                  B VCA Abdominal Wall * Designated Program Application                                 13                 2               26                    3             78



                                             VerDate Sep<11>2014   18:13 Dec 08, 2016   Jkt 241001   PO 00000   Frm 00075   Fmt 4703    Sfmt 4703   E:\FR\FM\09DEN1.SGM   09DEN1


                                                                                      Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices                                                                       89117

                                                                                                    TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                                          Average
                                                                                                                                                            Number of
                                                                                                                                        Number of                                       Total           burden per              Total burden
                                                                                  Form name                                                               responses per
                                                                                                                                       respondents                                   responses           response                  hours
                                                                                                                                                            respondent                                   (in hours)

                                                       VCA Abdominal Wall—Kidney
                                                       VCA Abdominal Wall—Liver
                                                       VCA Abdominal Wall—Pancreas
                                                       VCA Abdominal Wall—Intestine
                                                  B VCA Other ** Designated Program Application ...............                                       9                        2              18                          2               36
                                                  B Intestine Designated Program Application .......................                                 40                        2              80                          3              240
                                                  C OPO New Application ......................................................                        0                        1               0                          4                0
                                                  D Histocompatibility Lab Application ...................................                            3                        2               6                          4               24
                                                  E Change in Transplant Program Key Personnel ...............                                      395                        2             790                          4            3,160
                                                  F Change in Histocompatibility Lab Director .......................                                25                        2              50                          2              100
                                                  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
                                                    * VCA Abdominal Wall Designated Program qualification requirements require documentation on VCA Head and Neck, VCA Upper Limb, Kid-
                                                  ney, 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                               to submit a new Information Collection                         and reliable scale in research settings
                                                  on (1) the necessity and utility of the                             Request (ICR), described below, to the                         but its use as a performance measure
                                                  proposed information collection for the                             Office of Management and Budget                                hasn’t yet been evaluated. Family
                                                  proper performance of the agency’s                                  (OMB). Prior to submitting the ICR to                          planning providers will also complete a
                                                  functions; (2) the accuracy of the                                  OMB, OS seeks comments from the                                short survey about provider
                                                  estimated burden; (3) ways to enhance                               public regarding the burden estimate                           characteristics (approximately 80
                                                  the quality, utility, and clarity of the                            below or any other aspect of the ICR.                          providers) and clinic demographics
                                                  information to be collected; and (4) the                            DATES: Comments on the ICR must be                             (approximately 10 clinics).
                                                  use of automated collection techniques                              received on or before February 7, 2017.                           Need and Proposed Use of the
                                                  or other forms of information                                       ADDRESSES: Submit your comments to                             Information: The proposed use of the
                                                  technology to minimize the information                              Information.CollectionClearance@                               information to be collected is to develop
                                                  collection burden.                                                  hhs.gov or by calling (202) 690–5683.                          a patient-reported outcome performance
                                                  Jason E. Bennett,                                                   SUPPLEMENTARY INFORMATION: When                                measure (PRO–PM) on contraceptive
                                                  Director, Division of the Executive Secretariat.                    submitting comments or requesting                              counseling and assess its validity,
                                                  [FR Doc. 2016–29504 Filed 12–8–16; 8:45 am]
                                                                                                                      information, please include the                                reliability, feasibility, usability, and use.
                                                                                                                      document identifier OS–0990–New–60D                            If we find that this measure has
                                                  BILLING CODE 4165–15–P
                                                                                                                      for reference.                                                 adequately met these criteria, UCSF and
                                                                                                                        Information Collection Request Title:                        the Office of Population Affairs (OPA)
                                                                                                                      A Client-Centered Performance Measure                          will prepare it for submission to the
                                                  DEPARTMENT OF HEALTH AND
                                                                                                                      for Contraceptive Services.                                    National Quality Forum (NQF) for use
                                                  HUMAN SERVICES                                                        Abstract: The Office of the Assistant
                                                                                                                                                                                     in a variety of clinical settings where
                                                  Office of the Secretary                                             Secretary for Health/Office of
                                                                                                                                                                                     family planning care is provided.
                                                                                                                      Population Affairs is seeking an
                                                  [Document Identifier: OS–0990–New–60D]                                                                                             Measurement of the quality of
                                                                                                                      approval by the Office of Management
                                                                                                                                                                                     contraceptive counseling can be used as
                                                                                                                      and Budget on a new information
                                                  Agency Information Collection                                       collection. We propose to evaluate a                           part of quality improvement activities to
                                                  Activities; Proposed Collection; Public                             scale previously developed by our                              increase awareness and use of client-
                                                  Comment Request                                                     collaborators at the University of                             centered counseling approaches. By
                                                                                                                      California San Francisco (UCSF)—the                            improving client-centered services,
                                                  AGENCY:     Office of the Secretary, HHS.                                                                                          women can choose the contraceptive
                                                  ACTION:     Notice.                                                 11-item Interpersonal Quality of Family
                                                                                                                      Planning Care (IQFP) scale—among                               method that works best for them, which
                                                  SUMMARY:   In compliance with section                               3,000 female family planning clients.                          can lead to reductions in rates of
                                                  3506(c)(2)(A) of the Paperwork                                      Initially informed by qualitative work                         unintended pregnancy and other
                                                  Reduction Act of 1995, the Office of the                            around women’s preferences for                                 adverse reproductive outcomes.
mstockstill on DSK3G9T082PROD with NOTICES




                                                  Secretary (OS), Department of Health                                contraceptive counseling, the IQFP scale                          Likely Respondents: Family planning
                                                  and Human Services, announces plans                                 has already been shown to be a valid                           providers and their patients.




                                             VerDate Sep<11>2014       18:13 Dec 08, 2016       Jkt 241001     PO 00000      Frm 00076   Fmt 4703    Sfmt 4703     E:\FR\FM\09DEN1.SGM      09DEN1



Document Created: 2018-02-14 09:03:51
Document Modified: 2018-02-14 09:03:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this Information Collection Request must be received no later than February 7, 2017.
ContactTo request more information on the proposed project or to obtain copies of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984.
FR Citation81 FR 89115 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR