81 FR 13378 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 49 (March 14, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 49 (March 14, 2016)
| Page Range | 13378-13380 | |
| FR Document | 2016-05684 |
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)] [Notices] [Pages 13378-13380] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05684] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY: Health Resources and Services Administration, 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), the Health Resources and Services Administration (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 within 60 days of this notice. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N39, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. 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 and Scientific Registry of Transplant Recipients Data System OMB No. 0915-0157--Revision. Abstract: Section 372 of the Public Health Service (PHS) Act, as amended, requires that the Secretary, by contract, provide for the establishment and operation of an Organ Procurement and Transplantation Network (OPTN). This is a request for revisions to current OPTN data collection forms associated with an individual's clinical characteristics at the time of registration, transplant, and follow-up after the transplant. These specific data elements of the OPTN data system are collected from transplant hospitals. The information is used to indicate the disease severity of transplant candidates, to monitor compliance of member organizations with OPTN rules and requirements, to report periodically on the clinical and scientific status of organ donation and transplantation and other purposes consistent with the law. Data are used to: (1) Facilitate organ placement and match donor organs with recipients; (2) monitor compliance of member organizations with federal laws and regulations and with OPTN requirements; (3) review and report periodically to the public on the status of organ donation and transplantation in the United States; (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation; and (5) perform transplantation-related public health surveillance including possible transmission of donor disease. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of Health and Human Services, and members of the public for evaluation, research, patient information, and other important purposes. Likely Respondents: Transplant programs, medical and scientific organizations, and public organizations. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to: (1) Review instructions; 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; (2) train personnel to respond to a request for collection of information; (3) search data sources; (4) complete and review the collection of information; and (5) to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. [[Page 13379]] Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Average Number of number of Total number burden per Total burden Section/activity respondents responses per of responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Deceased Donor Registration..... 58 158.2 9175.6 1.1 10093.2 Living Donor Registration....... 307 20.6 6324.2 1.8 11383.6 Living Donor Follow-up.......... 307 60.7 18634.9 1.3 24225.4 Donor Histocompatibility........ 154 96.7 14891.8 0.2 2978.4 Recipient Histocompatibility.... 154 173.5 26719 0.4 10687.6 Heart Candidate Registration.... 132 30.5 4026 0.9 3623.4 Heart Recipient Registration.... 132 19.9 2626.8 1.2 3152.2 Heart Follow Up (6 Month)....... 132 17 2244 0.4 897.6 Heart Follow Up (1-5 Year)...... 132 73.9 9754.8 0.9 8779.3 Heart Follow Up (Post 5 Year)... 132 115.2 15206.4 0.5 7603.2 Heart Post-Transplant Malignancy 132 11 1452 0.9 1306.8 Form........................... Lung Candidate Registration..... 70 39.6 2772 0.9 2494.8 Lung Recipient Registration..... 70 28.3 1981 1.2 2377.2 Lung Follow Up (6 Month)........ 70 26.2 1834 0.5 917.0 Lung Follow Up (1-5 Year)....... 70 99.4 6958 1.1 7653.8 Lung Follow Up (Post 5 Year).... 70 65.6 4592 0.6 2755.2 Lung Post-Transplant Malignancy 70 1.5 105 0.4 42.0 Form........................... Heart/Lung Candidate 69 0.7 48.3 1.1 53.1 Registration................... Heart/Lung Recipient 69 0.4 27.6 1.3 35.9 Registration................... Heart/Lung Follow Up (6 Month).. 69 0.3 20.7 0.8 16.6 Heart/Lung Follow Up (1-5 Year). 69 1.5 103.5 1.1 113.9 Heart/Lung Follow Up (Post 5 69 3.1 213.9 0.6 128.3 Year).......................... Heart/Lung Post-Transplant 69 0.2 13.8 0.4 5.5 Malignancy Form................ Liver Candidate Registration.... 141 89.2 12577.2 0.8 10061.8 Liver Recipient Registration.... 141 48.8 6880.8 1.2 8257.0 Liver Follow-up (6 Month--5 141 231.1 32585.1 1 32585.1 Year).......................... Liver Follow-up (Post 5 Year)... 141 256.5 36166.5 0.5 18083.3 Liver Recipient Explant 141 12.3 1734.3 0.6 1040.6 Pathology Form................. Liver Post-Transplant Malignancy 141 13.2 1861.2 0.8 1489.0 Intestine Candidate Registration 40 4.4 176 1.3 228.8 Intestine Recipient Registration 40 3.4 136 1.8 244.8 Intestine Follow Up (6 Month--5 40 13.3 532 1.5 798.0 Year).......................... Intestine Follow Up (Post 5 40 13.5 540 0.4 216.0 Year).......................... Intestine Post-Transplant 40 0.6 24 1 24.0 Malignancy Form................ Kidney Candidate Registration... 238 162.6 38698.8 0.8 30959.0 Kidney Recipient Registration... 238 71.8 17088.4 1.2 20506.1 Kidney Follow-Up (6 Month--5 238 379.5 90321 0.9 81288.9 Year).......................... Kidney Follow-up (Post 5 Year).. 238 346.7 82514.6 0.5 41257.3 Kidney Post-Transplant 238 18.1 4307.8 0.8 3446.2 Malignancy Form................ Pancreas Candidate Registration. 141 3.4 479.4 0.6 287.6 Pancreas Recipient Registration. 141 1.8 253.8 1.2 304.6 Pancreas Follow-up (6 Month--5 141 8.2 1156.2 0.5 578.1 Year).......................... Pancreas Follow-up (Post 5 Year) 141 13.5 1903.5 0.5 951.8 Pancreas Post-Transplant 141 0.8 112.8 0.6 67.7 Malignancy Form................ Kidney/Pancreas Candidate 141 9.6 1353.6 0.6 812.2 Registration................... Kidney/Pancreas Recipient 141 5.2 733.2 1.2 879.8 Registration................... Kidney/Pancreas Follow-up (6 141 26.9 3792.9 0.5 1896.5 Month--5 Year)................. Kidney/Pancreas Follow-up (Post 141 48.2 6796.2 0.6 4077.7 5 Year)........................ Kidney/Pancreas Post-Transplant 141 1.6 225.6 0.4 90.2 Malignancy Form................ VCA Candidate Registration...... 23 1.7 39.1 0.4 15.6 VCA Recipient Registration...... 23 1.7 39.1 1.3 50.8 VCA Recipient Follow Up......... 23 1.7 39.1 1 39.1 ------------------------------------------------------------------------------- Total....................... * 457 .............. 471411.4 .............. 359889.5 ---------------------------------------------------------------------------------------------------------------- * Total number of OPTN transplant hospitals as of October 23, 2015. Number of respondents for transplant candidate or recipient forms is based on number of organ specific programs associated with each form. ** Bold entries represent those forms being modified during this submission. [[Page 13380]] 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. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2016-05684 Filed 3-11-16; 8:45 am] BILLING CODE 4165-15-P
![13378 Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
technology and systems for the purpose personnel and to be able to respond to information. The total annual burden
of collecting, validating and verifying a collection of information; to search hours estimated for this ICR are
information, processing and data sources; to complete and review summarized in the table below.
maintaining information, and disclosing the collection of information; and to
and providing information; to train transmit or otherwise disclose the
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of Average
Number of responses Total burden per Total burden
Form name respondents per responses response hours
respondent (in hours)
Direct Financial Support Program ....................................... 618 1 618 3.117 1,926
Infrastructure Program ......................................................... 149 1 149 4.57 681
Multipurpose or Hybrid Program .......................................... 790 1 790 4.285 3,385
Total .............................................................................. 1,557 ........................ 1,557 ........................ 5,992
Jackie Painter, FOR FURTHER INFORMATION CONTACT: To periodically to the public on the status
Director, Division of the Executive Secretariat. request more information on the of organ donation and transplantation in
[FR Doc. 2016–05602 Filed 3–11–16; 8:45 am] proposed project or to obtain a copy of the United States; (4) provide data to
BILLING CODE 4165–15–P the data collection plans and draft researchers and government agencies to
instruments, email paperwork@hrsa.gov study the scientific and clinical status of
or call the HRSA Information Collection organ transplantation; and (5) perform
DEPARTMENT OF HEALTH AND Clearance Officer at (301) 443–1984. transplantation-related public health
HUMAN SERVICES SUPPLEMENTARY INFORMATION: When surveillance including possible
submitting comments or requesting transmission of donor disease. The
Health Resources and Services information, please include the practical utility of the data collection is
Administration information request collection title for further enhanced by requirements that
reference. the OPTN data must be made available,
Agency Information Collection Information Collection Request Title: consistent with applicable laws, for use
Activities: Proposed Collection: Public Organ Procurement and Transplantation by OPTN members, the Scientific
Comment Request Network and Scientific Registry of Registry of Transplant Recipients, the
Transplant Recipients Data System Department of Health and Human
AGENCY:Health Resources and Services OMB No. 0915–0157—Revision. Services, and members of the public for
Administration, HHS. Abstract: Section 372 of the Public evaluation, research, patient
ACTION: Notice. Health Service (PHS) Act, as amended, information, and other important
requires that the Secretary, by contract, purposes.
SUMMARY: In compliance with the provide for the establishment and
Likely Respondents: Transplant
requirement for opportunity for public operation of an Organ Procurement and
programs, medical and scientific
comment on proposed data collection Transplantation Network (OPTN). This
organizations, and public organizations.
projects (Section 3506(c)(2)(A) of the is a request for revisions to current
Paperwork Reduction Act of 1995), the OPTN data collection forms associated Burden Statement: Burden in this
Health Resources and Services with an individual’s clinical context means the time expended by
Administration (HRSA) announces characteristics at the time of persons to generate, maintain, retain,
plans to submit an Information registration, transplant, and follow-up disclose, or provide the information
Collection Request (ICR), described after the transplant. These specific data requested. This includes the time
below, to the Office of Management and elements of the OPTN data system are needed to: (1) Review instructions;
Budget (OMB). Prior to submitting the collected from transplant hospitals. The develop, acquire, install and utilize
ICR to OMB, HRSA seeks comments information is used to indicate the technology and systems for the purpose
from the public regarding the burden disease severity of transplant of collecting, validating and verifying
estimate, below, or any other aspect of candidates, to monitor compliance of information, processing and
the ICR. member organizations with OPTN rules maintaining information, and disclosing
and requirements, to report periodically and providing information; (2) train
DATES: Comments on this Information on the clinical and scientific status of personnel to respond to a request for
Collection Request must be received organ donation and transplantation and collection of information; (3) search data
within 60 days of this notice. other purposes consistent with the law. sources; (4) complete and review the
ADDRESSES: Submit your comments to Data are used to: (1) Facilitate organ collection of information; and (5) to
paperwork@hrsa.gov or mail the HRSA placement and match donor organs with transmit or otherwise disclose the
Information Collection Clearance recipients; (2) monitor compliance of information. The total annual burden
jstallworth on DSK7TPTVN1PROD with NOTICES
Officer, Room 14N39, Parklawn member organizations with federal laws hours estimated for this Information
Building, 5600 Fishers Lane, Rockville, and regulations and with OPTN Collection Request are summarized in
MD 20857. requirements; (3) review and report the table below.
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![13380 Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
HRSA specifically requests comments Request (ICR), described below, to the through OAH and the Centers for
on (1) the necessity and utility of the Office of Management and Budget Disease Control (CDC).
proposed information collection for the (OMB). Prior to submitting the ICR to The proposed information request
proper performance of the agency’s OMB, OS seeks comments from the includes instruments that will collect
functions; (2) the accuracy of the public regarding the burden estimate, data on: (1) Whether and how federally-
estimated burden; (3) ways to enhance below, or any other aspect of the ICR. funded programs have been sustained;
the quality, utility, and clarity of the DATES: Comments on the ICR must be (2) factors affecting program
information to be collected; and (4) the received on or before May 13, 2016. sustainability; (3) methods and
use of automated collection techniques ADDRESSES: Submit your comments to strategies employed by grantees to
or other forms of information Information.CollectionClearance@ sustain programs; (4) support and
technology to minimize the information hhs.gov or by calling (202) 690–6162. technical assistance that grantees
collection burden. FOR FURTHER INFORMATION CONTACT: received related to sustaining the
Jackie Painter, Information Collection Clearance staff, programs; and (5) key lessons learned
Director, Division of the Executive Secretariat. Information.CollectionClearance@ based on the outcomes of these efforts.
[FR Doc. 2016–05684 Filed 3–11–16; 8:45 am]
hhs.gov or (202) 690–6162. The data will be analyzed and
SUPPLEMENTARY INFORMATION: When incorporated into study deliverables
BILLING CODE 4165–15–P
submitting comments or requesting that clearly describe grantees’
information, please include the sustainability efforts for all audiences
DEPARTMENT OF HEALTH AND document identifier HHS–OS–0990– and highlight key challenges, successes,
HUMAN SERVICES new–60D for reference. and lessons learned for future funding
Information Collection Request Title: and program implementation.
Office of the Secretary Sustainability study of federally-funded
The data will be used for the study
programs designed to prevent or delay
[Document Identifier: HHS–OS–0990–new– team to identify key factors in program
teen pregnancy (TPP Sustainability
60D] sustainability, the strategies that either
Study).
Abstract: The Office of Adolescent worked or did not work in sustaining
Agency Information Collection programs over time, and the types of
Health (OAH), U.S. Department of
Activities; Proposed Collection; Public support and assistance grantees required
Health and Human Services (HHS) is
Comment Request in order to sustain programs. Collecting
requesting approval by OMB on a new
AGENCY: Office of the Secretary, HHS. collection. The TPP Sustainability this data is crucial to closing an existing
Study is a key piece of OAH’s broad and gap in OAH knowledge about how to
ACTION: Notice. support the sustainability efforts of
ongoing effort to comprehensively
SUMMARY: In compliance with section evaluate all of its teen pregnancy current and future grantees, including
3506(c)(2)(A) of the Paperwork prevention funding efforts which the 2015–2020 TPP grantee cohort and
Reduction Act of 1995, the Office of the consist of: (1) The Teen Pregnancy the 2013–2016 PAF cohort.
Secretary (OS), Department of Health Prevention Program (TPP); the (2) Likely Respondents: Program
and Human Services, announces plans Pregnancy Assistance Fund (PAF); and administrators at 117 grantee
to submit a new Information Collection the Communitywide program funded organizations.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)
Grantee Survey .............................................................................................. 39 1 0.41 16.0
In-Depth Interview Master Topic Guide ......................................................... 17 2 1.5 51.0
Total ........................................................................................................ 56 ........................ .......................... 66.0
OS specifically requests comments on DEPARTMENT OF HEALTH AND Earliest Anticipated Start Date: June
(1) the necessity and utility of the HUMAN SERVICES 1, 2016.
proposed information collection for the
Indian Health Service I. Funding Opportunity Description
proper performance of the agency’s
functions, (2) the accuracy of the Statutory Authority
Office of Urban Indian Health
estimated burden, (3) ways to enhance
Programs; 4-in-1 Grant Programs; The Indian Health Service (IHS) is
the quality, utility, and clarity of the Announcement Type: New and
information to be collected, and (4) the accepting competitive grant applications
Competing Continuation Funding for the FY 2016 4-in-1 Title V Programs.
use of automated collection techniques Announcement Number: HHS–2016–
or other forms of information This program is authorized under the
jstallworth on DSK7TPTVN1PROD with NOTICES
IHS–UIHP2–0001; Catalogue of Federal
technology to minimize the information Snyder Act, 25 U.S.C. 13, Public Law
Domestic Assistance Number: 93.193
collection burden. 67–85, and Title V of the Indian Health
Key Dates Care Improvement Act (IHCIA), Public
Terry S. Clark, Law 94–437, as amended, specifically
Application Deadline Date: May 15,
Asst Collection Clearance Officer. 2016. the provisions codified at 25 U.S.C.
[FR Doc. 2016–05603 Filed 3–11–16; 8:45 am] Review Period: May 23, 2016–May 27, 1652, 1653, and 1660a. This program is
BILLING CODE 4168–11–P 2016. described in the Catalog of Federal
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Document Created: 2016-03-12 01:00:40
Document Modified: 2016-03-12 01:00:40
| 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 Information Collection Request must be received within 60 days of this notice. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 81 FR 13378 |
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