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

Activity/21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

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 approval—814.124(b) ........................................................... 1 1 1 2 2 

Periodic reports—814.126(b)(1) .......................................... 35 1 35 120 4,200 

Total .............................................................................. ........................ ........................ ........................ ........................ 16,223 

1There 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 

1There 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 

1There 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 

information collections since the last 

OMB approval. 

Dated: January 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00241 Filed 1–9–18; 8:45 am] 

BILLING CODE 4164–01–P 

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. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 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 

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 

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

Form name Number of 

respondents 

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] 

BILLING CODE 4165–15–P 

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 

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. 


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