83 FR 1263 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		1263-1264
FR Document		2018-00241

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.

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

[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1263-1264]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-00241]

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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

[[Page 1264]]

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
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation-- 19 1 19 40 760
814.102........................
HDE Application--814.104........ 3 1 3 320 960
HDE Amendments and resubmitted 6 5 30 50 1,500
HDEs--814.106..................
HDE Supplements--814.108........ 110 1 110 80 8,800
Notification of withdrawal of an 1 1 1 1 1
HDE--814.116(e)(3).............
Notification of withdrawal of 1 1 1 2 2
Institutional Review Board
approval--814.124(b)...........
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 burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeping records 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
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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
Sec. 814.126(b)(1) in table 1 reflects 35 respondents with approved
HUD applications. Under Sec. 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

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

OMB, Attn: FDA Desk Officer, Fax: 202– Extralabel Drug Use in Animals—21 be instances when analytical
395–7285, or emailed to oira_ CFR Part 530 methodology will be required. We are,
submission@omb.eop.gov. All therefore, estimating the reporting
OMB Control Number 0910–0325—
comments should be identified with the burden based on two methods being
Extension
OMB control number 0910–0325. Also required annually. The requirement to
include the FDA docket number found The Animal Medicinal Drug Use establish an analytical method may be
Clarification Act of 1994 (Pub. L. 103– fulfilled by any interested person. We
in brackets in the heading of this
396) allows a veterinarian to prescribe believe that the sponsor of the drug will
document.
the extralabel use of approved new be willing to develop the method in
FOR FURTHER INFORMATION CONTACT: Ila animal drugs. Also, it permits FDA, if it most cases. Alternatively, FDA, the
S. Mizrachi, Office of Operations, Food finds that there is a reasonable sponsor, and perhaps a third party may
and Drug Administration, Three White probability that the extralabel use of an cooperatively arrange for method
Flint North, 10A–12M, 11601 animal drug may present a risk to the development. The respondents may be
public health, to establish a safe level sponsors of new animal drugs, State, or
Landsdown St., North Bethesda, MD
for a residue from the extralabel use of Federal and/or State Agencies,
20852, 301–796–7726, PRAStaff@
the drug, and to require the academia, or individuals.
fda.hhs.gov. development of an analytical method for
the detection of residues above that In the Federal Register of June 26,
SUPPLEMENTARY INFORMATION: In 2017 (82 FR 28858), FDA published a
compliance with 44 U.S.C. 3507, FDA established safe level (21 CFR
530.22(b)). Although, to date, we have 60-day notice requesting public
has submitted the following proposed comment on the proposed collection of
not established a safe level for a residue
collection of information to OMB for information. No comments were
from the extralabel use of any new
review and clearance. received.
animal drug and, therefore, have not
required the development of analytical FDA estimates the burden of this
methodology, we believe that there may collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
21 CFR section responses per burden per
respondents responses hours
respondent response

530.22(b), Submission(s) of Analytical Method ................... 2 1 2 4,160 8,320
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimate has not changed, DATES: Fax written comments on the Medical Devices; Humanitarian Use
and remains the same. collection of information by February 9, Devices—21 CFR Part 814
Dated: January 4, 2018. 2018.
OMB Control Number 0910–0332—
Leslie Kux, ADDRESSES: To ensure that comments on Extension
Associate Commissioner for Policy. the information collection are received,
[FR Doc. 2018–00237 Filed 1–9–18; 8:45 am] OMB recommends that written This collection of information
BILLING CODE 4164–01–P comments be faxed to the Office of implements the humanitarian use
Information and Regulatory Affairs, devices (HUDs) provision of section
520(m) of the Federal Food, Drug, and
OMB, Attn: FDA Desk Officer, Fax: 202–
DEPARTMENT OF HEALTH AND Cosmetic Act (FD&C Act) (21 U.S.C.
395–7285, or emailed to oira_
HUMAN SERVICES 360j(m)) and part 814, subpart H (21
submission@omb.eop.gov. All CFR part 814, subpart H). Under section
Food and Drug Administration comments should be identified with the 520(m) of the FD&C Act, FDA is
OMB control number 0910–0332. Also authorized to exempt an HUD from the
include the FDA docket number found effectiveness requirements of sections
[Docket No. FDA 2017–N–4951]
in brackets in the heading of this 514 and 515 of the FD&C Act (21 U.S.C.
Agency Information Collection document. 360d and 360e) provided that the
Activities; Submission for Office of device: (1) Is designed to treat or
FOR FURTHER INFORMATION CONTACT:
Management and Budget Review; diagnose a disease or condition that
Amber Sanford, Office of Operations,
Comment Request; Medical Devices; affects no more than 8,000 individuals
Food and Drug Administration, Three in the United States; (2) would not be
Humanitarian Use Devices
White Flint North, 10A–12M, 11601 available to a person with a disease or
AGENCY: Food and Drug Administration, Landsdown St., North Bethesda, MD condition unless an exemption is
HHS. 20852, 301–796–8867, PRAStaff@ granted and there is no comparable
ACTION: Notice. fda.hhs.gov. device other than another HUD
SUPPLEMENTARY INFORMATION: In approved under this exemption that is
daltland on DSKBBV9HB2PROD with NOTICES

SUMMARY: The Food and Drug available to treat or diagnose such
compliance with 44 U.S.C. 3507, FDA
Administration (FDA) is announcing disease or condition; and (3) will not
has submitted the following proposed
that a proposed collection of expose patients to an unreasonable or
information has been submitted to the collection of information to OMB for significant risk of illness or injury and
Office of Management and Budget review and clearance. the probable benefit to health from the
(OMB) for review and clearance under use of the device outweighs the risk of
the Paperwork Reduction Act of 1995. injury or illness from its use, taking into

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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

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Document Created: 2018-10-26 09:34:01
Document Modified: 2018-10-26 09:34:01

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		Fax written comments on the collection of information by February 9, 2018.
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, [email protected]
FR Citation		83 FR 1263

83 FR 1263 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration