82 FR 22145 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 91 (May 12, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 91 (May 12, 2017)
| Page Range | 22145-22147 | |
| FR Document | 2017-09621 |
[Federal Register Volume 82, Number 91 (Friday, May 12, 2017)] [Notices] [Pages 22145-22147] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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 [email protected] 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
![Federal Register / Vol. 82, No. 91 / Friday, May 12, 2017 / Notices 22145
involved in the delivery or care of The Children’s Bureau proposes to Services field will establish a flag as to
infants and who referred such infants modify the Child File by adding two whether a referral was made for
born with and identified as being new fields. appropriate services, including services
affected by illegal substance abuse or • Field 151, Has A Safe Care Plan: for the affected family or caregiver.
withdrawal symptoms resulting from The Safe Care Plan field will establish
Respondents: State governments, the
prenatal drug exposure, or a Fetal a flag as to whether a child has a safe
care plan. District of Columbia, and the
Alcohol Spectrum Disorder. Commonwealth of Puerto Rico.
• Field 152, Referral to CARA-Related
Services: The Referral to CARA-related
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Detailed Case Data Component (Child File and Agency File) ........................ 52 1 149 7,717
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Information Collection Request Title:
Hours: 7,717. HUMAN SERVICES Organ Procurement and Transplantation
In compliance with the requirements Network OMB No. 0915–0184—
Health Resources and Services Revision.
of the Paperwork Reduction Act of 1995
Administration Abstract: HRSA is proposing
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
additions and revisions to the following
Administration for Children and Agency Information Collection documents used to collect information
Families is soliciting public comment Activities: Submission to OMB for from existing or potential members of
on the specific aspects of the Review and Approval; Public Comment the Organ Procurement and
information collection described above. Request; Information Collection Transplantation Network (OPTN). The
Copies of the proposed collection of Request Title: Organ Procurement and documents under revision include: (1)
information may be obtained and Transplantation Network, OMB No. Application forms for individuals or
comments may be forwarded by writing 0915–0184—Revision organizations interested in membership
to the Administration for Children and in the OPTN; (2) application forms for
AGENCY: Health Resources and Services
Families, Office of Planning, Research OPTN members applying to have organ-
Administration (HRSA), Department of
and Evaluation, 330 C Street SW., specific transplant programs designated
Health and Human Services.
Washington DC 20201. Attn: ACF within their institutions; and (3) forms
ACTION: Notice.
Reports Clearance Officer. Email submitted by OPTN members to report
address: infocollection@acf.hhs.gov. All SUMMARY: In compliance with the certain personnel changes.
requests should be identified by the title Paperwork Reduction Act of 1995, Need and Proposed Use of the
of the information collection. HRSA has submitted an Information Information: Membership in the OPTN
The Department specifically requests Collection Request (ICR) to the Office of is determined by submission of
comments on: (a) Whether the proposed Management and Budget (OMB) for application materials to the OPTN (not
collection of information is necessary review and approval. Comments to HRSA) demonstrating that the
for the proper performance of the submitted during the first public review applicant meets all required criteria for
of this ICR will be provided to OMB. membership and will agree to comply
functions of the agency, including
OMB will accept further comments from with all applicable provisions of the
whether the information shall have
the public during the review and National Organ Transplant Act, as
practical utility; (b) the accuracy of the amended, 42 U.S.C. 273, et seq. (NOTA),
agency’s estimate of the burden of the approval period.
DATES: Comments on this ICR should be
OPTN Final Rule, 42 CFR part 121,
proposed collection of information; (c) OPTN bylaws, and OPTN policies.
the quality, utility, and clarity of the received no later than June 12, 2017.
Section 1138 of the Social Security Act,
information to be collected; and (d) ADDRESSES: Submit your comments,
as amended, 42 U.S.C. 1320b–8 (section
ways to minimize the burden of the including the ICR Title, to the desk 1138) requires that hospitals in which
collection of information on officer for HRSA, either by email to transplants are performed be members
respondents, including through the use OIRA_submission@omb.eop.gov or by of, and abide by, the rules and
of automated collection techniques or fax to 202–395–5806. requirements (as approved by the
other forms of information technology. FOR FURTHER INFORMATION CONTACT: To Secretary of Health and Human
Consideration will be given to request a copy of the clearance requests Services) of the OPTN, including those
comments and suggestions submitted submitted to OMB for review, email the related to data collection, as a condition
within 60 days of this publication. HRSA Information Collection Clearance of participation in Medicare and
Officer at paperwork@hrsa.gov or call Medicaid for the hospital. Section 1138
Robert Sargis, (301) 443–1984. contains a similar provision for the
mstockstill on DSK30JT082PROD with NOTICES
Reports Clearance Officer. SUPPLEMENTARY INFORMATION: When organ procurement organizations
[FR Doc. 2017–09684 Filed 5–11–17; 8:45 am] submitting comments or requesting (OPOs) and makes membership in the
BILLING CODE 4184–01–P information, please include the OPTN and compliance with its
information request collection title for operating rules and requirements (as
reference, in compliance with Section approved by the Secretary of Health and
3506(c)(2)(A) of the Paperwork Human Services), including those
Reduction Act of 1995. relating to data collection, mandatory
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![Federal Register / Vol. 82, No. 91 / Friday, May 12, 2017 / Notices 22147
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)
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
* 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, is for a new collection. Comments Health and Human Services (HHS), is
Director, Division of the Executive Secretariat. submitted during the first public review requesting approval by OMB of a new
[FR Doc. 2017–09621 Filed 5–11–17; 8:45 am] of this ICR will be provided to OMB. information collection request. In
BILLING CODE 4165–15–P OMB will accept further comments from FY2017, OAH expects to award a new,
the public on this ICR during the review 3-year cohort of Pregnancy Assistance
and approval period. Fund (PAF) grants. Performance
DEPARTMENT OF HEALTH AND DATES: Comments on the ICR must be measure data collection is a requirement
HUMAN SERVICES received on or before June 12, 2017. of PAF grants and is included in the
ADDRESSES: Submit your comments to funding announcement.
Office of the Secretary Need and Proposed Use of the
OIRA_submission@omb.eop.gov or via
[Document Identifier: OS–0990–New–30D] facsimile to (202) 395–5806. Information: The data collection will
FOR FURTHER INFORMATION CONTACT: provide OAH with performance data to
Agency Information Collection Sherrette Funn, inform planning and resource allocation
Activities; Submission to OMB for Sherrette.funncoleman@hhs.gov or (202) decisions; identify technical assistance
Review and Approval; Public Comment 795–7714. needs for grantees; facilitate grantees’
Request continuous quality improvement in
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting program implementation; and provide
AGENCY: Office of the Secretary, HHS.
information, please include the HHS, Congress, OMB, and the general
ACTION: Notice. public with information about the
Information Collection Request Title
SUMMARY: In compliance with the and document identifier 0990–New– individuals who participate in PAF-
Paperwork Reduction Act of 1995, the 30D for reference. funded activities and the services they
Office of the Secretary (OS), Department Information Collection Request Title: receive.
of Health and Human Services, has Pregnancy Assistance Fund (PAF) Likely Respondents: 20 PAF grantees
submitted an Information Collection Performance Measures Collection, (States and Tribes).
Request (ICR), described below, to the FY2017–FY2019 cohort. The total annual burden hours
Office of Management and Budget Abstract: The Office of Adolescent estimated for this ICR are summarized
(OMB) for review and approval. The ICR Health (OAH), U.S. Department of in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)
Training ............................................................................................................ 20 1 15/60 5
Partnerships and Sustainability ....................................................................... 20 1 3 60
Dissemination .................................................................................................. 20 1 30/60 10
Reach and Demographics ............................................................................... 20 1 645/60 215
Core Services .................................................................................................. 20 1 750/60 250
Education ......................................................................................................... 20 1 7 140
Birth Outcomes ................................................................................................ 20 1 270/60 90
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Self-Sufficiency Outcomes ............................................................................... 20 1 90/60 30
Total .......................................................................................................... 20 1 40 800
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Document Created: 2017-05-12 01:09:11
Document Modified: 2017-05-12 01:09:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than June 12, 2017. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 82 FR 22145 |
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