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, 1264-1265 [2018-00253]

Download as PDF 1264 Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices account the probable risks and benefits of currently available devices or alternative forms of treatment. Respondents may submit a humanitarian device exemption (HDE) application seeking exemption from the effectiveness requirements of sections 514 and 515 of the FD&C Act as authorized by section 520(m)(2). The information collected will assist FDA in making determinations on the following: (1) Whether to grant HUD designation of a medical device; (2) whether to exempt an HUD from the effectiveness requirements under sections 514 and 515 of the FD&C Act, provided that the device meets requirements set forth under section 520(m) of the FD&C Act; and (3) whether to grant marketing approval(s) for the HUD. Failure to collect this information would prevent FDA from making a determination on the factors listed previously in this document. Further, the collected information would also enable FDA to determine whether the holder of an HUD is in compliance with the HUD provisions under section 520(m) of the FD&C Act. In the Federal Register of October 16, 2017 (82 FR 48096), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours Request for HUD designation—814.102 ............................. HDE Application—814.104 .................................................. HDE Amendments and resubmitted HDEs—814.106 ......... HDE Supplements—814.108 ............................................... Notification of withdrawal of an HDE—814.116(e)(3) ......... Notification of withdrawal of Institutional Review Board approval—814.124(b) ........................................................... Periodic reports—814.126(b)(1) .......................................... 19 3 6 110 1 1 1 5 1 1 19 3 30 110 1 40 320 50 80 1 760 960 1,500 8,800 1 1 35 1 1 1 35 2 120 2 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 Activity/21 CFR section Number of recordkeepers Number of records per recordkeeping Total annual records Average burden per recordkeeping Total hours 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 Activity/21 CFR section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Notification of emergency use—814.124(a) ........................ 22 1 22 1 22 daltland on DSKBBV9HB2PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The number of respondents in tables 1, 2, and 3 of this document are an average based on data for the previous 3 years, i.e., fiscal years 2014 through 2016. The number of annual reports submitted under § 814.126(b)(1) in table 1 reflects 35 respondents with approved HUD applications. Under § 814.126(b)(2) in table 2, the estimated number of recordkeepers is 247. The number of respondents has been adjusted to reflect updated respondent data. This has resulted in an overall decrease of 2,971 hours to the total estimated annual reporting burden. There have been no program changes and the estimated Average Burden per Response has not changed for any of the VerDate Sep<11>2014 18:23 Jan 09, 2018 Jkt 244001 information collections since the last OMB approval. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: January 4, 2018. Leslie Kux, Associate Commissioner for Policy. Health Resources and Services Administration [FR Doc. 2018–00241 Filed 1–9–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\10JAN1.SGM 10JAN1 1265 Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 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 paperwork@hrsa.gov 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 paperwork@hrsa.gov 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 SUMMARY: 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 respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Performance Improvement Measurement System (PIMS) .. 21 1 21 7 147 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] daltland on DSKBBV9HB2PROD with NOTICES BILLING CODE 4165–15–P VerDate Sep<11>2014 18:23 Jan 09, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Environmental Health Sciences Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Environmental Health Sciences Council. Date: February 12–13, 2018. Closed: February 12, 2018, 8:30 a.m. to 10:15 a.m. Agenda: To review and evaluate grant applications. Place: Nat. Inst. of Environmental Health Sciences, Building 101, Rodbell Auditorium, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709. Open: February 12, 2018, 10:30 a.m. to 4:45 p.m. Agenda: Discussion of program and issues. Place: Nat. Inst. of Environmental Health Sciences, Building 101, Rodbell Auditorium, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709. Open: February 13, 2018, 8:30 a.m. to 10:30 a.m. E:\FR\FM\10JAN1.SGM 10JAN1

Agencies

[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1264-1265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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