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 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