83_FR_1271 83 FR 1264 - Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Office for the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311-Revision

83 FR 1264 - Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Office for the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311-Revision

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 7 (January 10, 2018)

Page Range1264-1265
FR Document2018-00253

In compliance with the requirement for opportunity for public comment on proposed data collection projects 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 83 Issue 7 (Wednesday, January 10, 2018) 
[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1264-1265]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: Office for 
the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311--
Revision

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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[[Page 1265]]

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects 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 ICR should be received no later than March 12, 
2018.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N39, 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 Lisa Wright-
Solomon, 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: Office for the Advancement of 
Telehealth Outcome Measures, OMB No. 0915-0311--Revision.
    Abstract: In order to help carry out its mission, the Office for 
the Advancement of Telehealth (OAT) created a set of performance 
measures that grantees can use to evaluate the effectiveness of their 
services programs and monitor their progress through the use of 
performance reporting data.
    Need and Proposed Use of the Information: As required by the 
Government Performance and Review Act of 1993 (GPRA), all federal 
agencies must develop strategic plans describing their overall goal and 
objectives. OAT has worked with its grantees to develop performance 
measures used to evaluate and monitor the progress of the grantees. 
Grantee goals are to improve access to needed services, reduce rural 
practitioner isolation, improve health system productivity and 
efficiency, and improve patient outcomes.
    In each of these categories, specific indicators were designed to 
be reported through a performance monitoring website. New measures are 
being added to the Telehealth Network Grant Program and all measures 
speak to OAT's progress toward meeting the goals, specifically 
telehealth services delivered through rural schools.
    Likely Respondents: Telehealth Network Grantees.
    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 review 
instructions; to 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; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Performance Improvement                       21               1              21               7             147
 Measurement System (PIMS)......
                                 -------------------------------------------------------------------------------
    Total.......................              21  ..............              21  ..............             147
----------------------------------------------------------------------------------------------------------------

    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.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-00253 Filed 1-9-18; 8:45 am]
BILLING CODE 4165-15-P

1264 Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices account the probable risks and benefits whether to exempt an HUD from the whether the holder of an HUD is in of currently available devices or effectiveness requirements under compliance with the HUD provisions alternative forms of treatment. sections 514 and 515 of the FD&C Act, under section 520(m) of the FD&C Act. Respondents may submit a provided that the device meets In the Federal Register of October 16, humanitarian device exemption (HDE) requirements set forth under section 2017 (82 FR 48096), FDA published a application seeking exemption from the 520(m) of the FD&C Act; and (3) effectiveness requirements of sections 60-day notice requesting public whether to grant marketing approval(s) 514 and 515 of the FD&C Act as for the HUD. Failure to collect this comment on the proposed collection of authorized by section 520(m)(2). The information would prevent FDA from information. No comments were information collected will assist FDA in making a determination on the factors received. making determinations on the listed previously in this document. FDA estimates the burden of this following: (1) Whether to grant HUD Further, the collected information collection of information as follows: designation of a medical device; (2) would also enable FDA to determine TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of responses Total annual Total Activity/21 CFR section burden per respondents per responses hours response respondent Request for HUD designation—814.102 ............................. 19 1 19 40 760 HDE Application—814.104 .................................................. 3 1 3 320 960 HDE Amendments and resubmitted HDEs—814.106 ......... 6 5 30 50 1,500 HDE Supplements—814.108 ............................................... 110 1 110 80 8,800 Notification of withdrawal of an HDE—814.116(e)(3) ......... 1 1 1 1 1 Notification of withdrawal of Institutional Review Board ap- proval—814.124(b) ........................................................... 1 1 1 2 2 Periodic reports—814.126(b)(1) .......................................... 35 1 35 120 4,200 Total .............................................................................. ........................ ........................ ........................ ........................ 16,223 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Average Number of Total annual Total Activity/21 CFR section records per burden per recordkeepers records hours recordkeeping recordkeeping HDE Records—814.126(b)(2) .............................................. 247 1 247 2 494 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual Total Activity/21 CFR section burden per respondents per disclosures hours disclosure respondent Notification of emergency use—814.124(a) ........................ 22 1 22 1 22 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The number of respondents in tables information collections since the last DEPARTMENT OF HEALTH AND 1, 2, and 3 of this document are an OMB approval. HUMAN SERVICES average based on data for the previous Dated: January 4, 2018. 3 years, i.e., fiscal years 2014 through Health Resources and Services 2016. The number of annual reports Leslie Kux, Administration submitted under § 814.126(b)(1) in table Associate Commissioner for Policy. 1 reflects 35 respondents with approved [FR Doc. 2018–00241 Filed 1–9–18; 8:45 am] Agency Information Collection HUD applications. Under BILLING CODE 4164–01–P Activities: Proposed Collection: Public § 814.126(b)(2) in table 2, the estimated Comment Request Information number of recordkeepers is 247. Collection Request Title: Office for the The number of respondents has been Advancement of Telehealth Outcome daltland on DSKBBV9HB2PROD with NOTICES adjusted to reflect updated respondent Measures, OMB No. 0915–0311— data. This has resulted in an overall Revision decrease of 2,971 hours to the total AGENCY: Health Resources and Services estimated annual reporting burden. Administration (HRSA), Department of There have been no program changes Health and Human Services. and the estimated Average Burden per ACTION: Notice. Response has not changed for any of the VerDate Sep<11>2014 18:23 Jan 09, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\10JAN1.SGM 10JAN1

Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 1265 SUMMARY: In compliance with the information request collection title for through a performance monitoring requirement for opportunity for public reference. website. New measures are being added comment on proposed data collection Information Collection Request Title: to the Telehealth Network Grant projects of the Paperwork Reduction Act Office for the Advancement of Program and all measures speak to of 1995, HRSA announces plans to Telehealth Outcome Measures, OMB OAT’s progress toward meeting the submit an Information Collection No. 0915–0311—Revision. goals, specifically telehealth services Request (ICR), described below, to the Abstract: In order to help carry out its delivered through rural schools. Office of Management and Budget mission, the Office for the Advancement (OMB). Prior to submitting the ICR to Likely Respondents: Telehealth of Telehealth (OAT) created a set of Network Grantees. OMB, HRSA seeks comments from the performance measures that grantees can public regarding the burden estimate, use to evaluate the effectiveness of their Burden Statement: Burden in this below, or any other aspect of the ICR. services programs and monitor their context means the time expended by DATES: Comments on this ICR should be progress through the use of performance persons to generate, maintain, retain, received no later than March 12, 2018. reporting data. disclose, or provide the information ADDRESSES: Submit your comments to Need and Proposed Use of the requested. This includes the time paperwork@hrsa.gov or mail the HRSA Information: As required by the needed to review instructions; to Information Collection Clearance Government Performance and Review develop, acquire, install, and utilize Officer, Room 14N39, 5600 Fishers Act of 1993 (GPRA), all federal agencies technology and systems for the purpose Lane, Rockville, MD 20857. must develop strategic plans describing of collecting, validating, and verifying FOR FURTHER INFORMATION CONTACT: To their overall goal and objectives. OAT information, processing and request more information on the has worked with its grantees to develop maintaining information, and disclosing proposed project or to obtain a copy of performance measures used to evaluate and providing information; to train the data collection plans and draft and monitor the progress of the personnel and to be able to respond to instruments, email paperwork@hrsa.gov grantees. Grantee goals are to improve a collection of information; to search or call Lisa Wright-Solomon, the HRSA access to needed services, reduce rural data sources; to complete and review Information Collection Clearance practitioner isolation, improve health the collection of information; and to Officer, at (301) 443–1984. system productivity and efficiency, and transmit or otherwise disclose the SUPPLEMENTARY INFORMATION: When improve patient outcomes. information. The total annual burden submitting comments or requesting In each of these categories, specific hours estimated for this ICR are information, please include the indicators were designed to be reported summarized in 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) Performance Improvement Measurement System (PIMS) .. 21 1 21 7 147 Total .............................................................................. 21 ........................ 21 ........................ 147 HRSA specifically requests comments DEPARTMENT OF HEALTH AND the discussions could disclose on: (1) The necessity and utility of the HUMAN SERVICES confidential trade secrets or commercial proposed information collection for the property such as patentable material, proper performance of the agency’s National Institutes of Health and personal information concerning functions; (2) the accuracy of the individuals associated with the grant National Institute of Environmental applications, the disclosure of which estimated burden; (3) ways to enhance Health Sciences; Notice of Meeting would constitute a clearly unwarranted the quality, utility, and clarity of the information to be collected; and (4) the Pursuant to section 10(d) of the invasion of personal privacy. use of automated collection techniques Federal Advisory Committee Act, as Name of Committee: National Advisory or other forms of information amended, notice is hereby given of a Environmental Health Sciences Council. technology to minimize the information meeting of the National Advisory Date: February 12–13, 2018. Environmental Health Sciences Council. Closed: February 12, 2018, 8:30 a.m. to collection burden. 10:15 a.m. The meeting will be open to the Amy McNulty, Agenda: To review and evaluate grant public as indicated below, with applications. Acting Director, Division of the Executive attendance limited to space available. Place: Nat. Inst. of Environmental Health Secretariat. Individuals who plan to attend and Sciences, Building 101, Rodbell Auditorium, [FR Doc. 2018–00253 Filed 1–9–18; 8:45 am] need special assistance, such as sign 111 T. W. Alexander Drive, Research BILLING CODE 4165–15–P language interpretation or other Triangle Park, NC 27709. reasonable accommodations, should Open: February 12, 2018, 10:30 a.m. to 4:45 daltland on DSKBBV9HB2PROD with NOTICES notify the Contact Person listed below p.m. Agenda: Discussion of program and issues. in advance of the meeting. Place: Nat. Inst. of Environmental Health The meeting will be closed to the Sciences, Building 101, Rodbell Auditorium, public in accordance with the 111 T. W. Alexander Drive, Research provisions set forth in sections Triangle Park, NC 27709. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Open: February 13, 2018, 8:30 a.m. to 10:30 as amended. The grant applications and a.m. VerDate Sep<11>2014 18:23 Jan 09, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\10JAN1.SGM 10JAN1


Document Created: 2018-10-26 09:32:59
Document Modified: 2018-10-26 09:32:59
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 ICR should be received no later than March 12, 2018.
ContactTo 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 Lisa Wright- Solomon, the HRSA Information Collection Clearance Officer, at (301) 443-1984.
FR Citation83 FR 1264 
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