Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices 1263 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0325. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Extralabel Drug Use in Animals—21 

CFR Part 530 

OMB Control Number 0910–0325— 

Extension 

The Animal Medicinal Drug Use 

Clarification Act of 1994 (Pub. L. 103– 

396) allows a veterinarian to prescribe 

the extralabel use of approved new 

animal drugs. Also, it permits FDA, if it 

finds that there is a reasonable 

probability that the extralabel use of an 

animal drug may present a risk to the 

public health, to establish a safe level 

for a residue from the extralabel use of 

the drug, and to require the 

development of an analytical method for 

the detection of residues above that 

established safe level (21 CFR 

530.22(b)). Although, to date, we have 

not established a safe level for a residue 

from the extralabel use of any new 

animal drug and, therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are, 

therefore, estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal and/or State Agencies, 

academia, or individuals. 

In the Federal Register of June 26, 

2017 (82 FR 28858), 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

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

530.22(b), Submission(s) of Analytical Method ................... 2 1 2 4,160 8,320 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimate has not changed, 

and remains the same. 

Dated: January 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00237 Filed 1–9–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2017–N–4951] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 9, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0332. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Devices; Humanitarian Use 

Devices—21 CFR Part 814 

OMB Control Number 0910–0332— 

Extension 

This collection of information 

implements the humanitarian use 

devices (HUDs) provision of section 

520(m) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360j(m)) and part 814, subpart H (21 

CFR part 814, subpart H). Under section 

520(m) of the FD&C Act, FDA is 

authorized to exempt an HUD from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act (21 U.S.C. 

360d and 360e) provided that the 

device: (1) Is designed to treat or 

diagnose a disease or condition that 

affects no more than 8,000 individuals 

in the United States; (2) would not be 

available to a person with a disease or 

condition unless an exemption is 

granted and there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose such 

disease or condition; and (3) will not 

expose patients to an unreasonable or 

significant risk of illness or injury and 

the probable benefit to health from the 

use of the device outweighs the risk of 

injury or illness from its use, taking into 


daltland on DSKBBV9HB2PROD with NOTICES
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