Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption, 41593-41594 [2020-14880]
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41593
Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
women and/or would benefit from sexand gender-related analyses.
Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14878 Filed 7–9–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1066]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Annual Reporting
for Custom Device Exemption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Submit written comments
(including recommendations) on the
collection of information by August 10,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
SUMMARY:
collection is 0910–0767. 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.
Annual Reporting for Custom Device
Exemption
OMB Control Number 0910–0767—
Extension
The custom device exemption is set
forth at section 520(b)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(b)(2)(B)). A
custom device is in a narrow category of
device that, by virtue of the rarity of the
patient’s medical condition or
physician’s special need the device is
designed to treat, it would be
impractical for the device to comply
with premarket review regulations and
performance standards.
The Food and Drug Administration
Safety and Innovation Act (FDASIA)
implemented changes to the custom
device exemption contained in section
520(b) of the FD&C Act. The new
provision amended the existing custom
device exemption and introduced new
concepts and procedures for custom
devices, such as:
• Devices created or modified to
comply with the order of an individual
physician or dentist;
• the potential for multiple units of a
device type (limited to no more than
five units per year) qualifying for the
custom device exemption; and
• annual reporting requirements by
the manufacturer to FDA about devices
manufactured and distributed under
section 520(b) of the FD&C Act.
Under FDASIA, ‘‘devices’’ that qualify
for the custom device exemption
contained in section 520(b) of the FD&C
Act were clarified to include no more
than ‘‘five units per year of a particular
device type’’ that otherwise meet all the
requirements necessary to qualify for
the custom device exemption.
In the Federal Register of September
24, 2014 (79 FR 57112), FDA announced
the availability of the guidance entitled
‘‘Custom Device Exemption.’’ FDA has
developed this document to provide
guidance to industry and FDA staff
about implementation of the custom
device exemption contained in the
FD&C Act. The intent of the guidance is
to define terms used in the custom
device exemption, explain how to
interpret the ‘‘five units per year of a
particular device type’’ language
contained in the FD&C Act, describe
information that FDA proposes
manufacturers should submit in the
custom device annual report, and
provide recommendations on how to
submit an annual report for devices
distributed under the custom device
exemption.
In the Federal Register of February
21, 2020 (85 FR 10175), we 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
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Annual reporting for custom devices ...................................
34
1
34
40
1,360
jbell on DSKJLSW7X2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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41594
Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
Our estimated burden for the
information collection reflects an
overall increase of 40 hours and a
corresponding increase of one response/
record. We attribute this adjustment to
an increase in the number of
submissions we received over the last
few years.
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0152. Also include
the FDA docket number found in
brackets in the heading of this
document.
Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2020–14880 Filed 7–9–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
[Docket No. FDA–2010–N–0601]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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: Submit written comments
(including recommendations) on the
collection of information by August 10,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
SUMMARY:
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.
Current Good Manufacturing Practice
Regulations for Medicated Feeds—21
CFR part 225
OMB Control Number 0910–0152—
Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351), FDA has the
statutory authority to issue current good
manufacturing practice (cGMP)
regulations for drugs, including
medicated feeds. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease, or growth
promotion and feed efficiency. Statutory
requirements for cGMPs have been
codified under part 225 (21 CFR part
225). Medicated feeds that are not
manufactured in accordance with these
regulations are considered adulterated
under section 501(a)(2)(B) of the FD&C
Act. Under part 225, a manufacturer is
required to establish, maintain, and
retain records for a medicated feed,
including records to document
procedures required during the
manufacturing process to assure that
proper quality control is maintained.
Such records would, for example,
contain information concerning receipt
and inventory of drug components,
batch production, laboratory assay
results (i.e., batch and stability testing),
labels, and product distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of medicated
feeds to investigate violative drug
residues in products from treated
animals and to investigate product
defects when a drug is recalled. In
addition, FDA will use the cGMP
criteria in part 225 to determine
whether or not the systems and
procedures used by manufacturers of
medicated feeds are adequate to assure
that their feeds meet the requirements of
the FD&C Act as to safety, and also that
they meet their claimed identity,
strength, quality, and purity, as required
by section 501(a)(2)(B) of the FD&C Act.
A license is required when the
manufacturer of a medicated feed
involves the use of a drug or drugs that
FDA has determined requires more
control because of the need for a
withdrawal period before slaughter or
because of carcinogenic concerns.
Conversely, a license is not required,
and the recordkeeping requirements are
less demanding for those medicated
feeds for which FDA has determined
that the drugs used in their manufacture
need less control. Respondents to this
collection of information are
commercial feed mills and mixer/
feeders.
In the Federal Register of March 4,
2020 (85 FR 12790), we published a 60day 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 RECORDKEEPING BURDEN (REGISTERED LICENSED COMMERCIAL FEED MILLS) 1
Number of
recordkeepers
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR section
225.42(b)(5) through (8) requires records of receipt,
storage, and inventory control of medicated feeds.
225.58(c) and (d) requires records of the results of
periodic assays for medicated feeds that are in accord with label specifications and also those medicated feeds not within documented permissible
assay limits.
225.80(b)(2) requires that verified medicated feed
label(s) be kept for 1 year.
225.102(b)(1) through (5), requires records of Master
Record Files and production records for medicated
feeds.
225.110(b)(1) and (2) requires maintenance of distribution records for medicated feeds.
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Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
825
260
214,500
1 ..........................
825
45
37,125
0.50 (30 minutes)
825
1,600
1,320,000
0.12 (7 minutes) ..
158,400
825
7,800
6,435,000
0.08 (5 minutes) ..
514,800
825
7,800
6,435,000
0.02 (1 minute) ....
128,700
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214,500
18,562.50
]]>Agencies
[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41593-41594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1066]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Annual Reporting for
Custom Device Exemption
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: Submit written comments (including recommendations) on the
collection of information by August 10, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0767. 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,
[email protected].
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.
Annual Reporting for Custom Device Exemption
OMB Control Number 0910-0767--Extension
The custom device exemption is set forth at section 520(b)(2)(B) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(b)(2)(B)). A custom device is in a narrow category of device that,
by virtue of the rarity of the patient's medical condition or
physician's special need the device is designed to treat, it would be
impractical for the device to comply with premarket review regulations
and performance standards.
The Food and Drug Administration Safety and Innovation Act (FDASIA)
implemented changes to the custom device exemption contained in section
520(b) of the FD&C Act. The new provision amended the existing custom
device exemption and introduced new concepts and procedures for custom
devices, such as:
Devices created or modified to comply with the order of an
individual physician or dentist;
the potential for multiple units of a device type (limited
to no more than five units per year) qualifying for the custom device
exemption; and
annual reporting requirements by the manufacturer to FDA
about devices manufactured and distributed under section 520(b) of the
FD&C Act.
Under FDASIA, ``devices'' that qualify for the custom device
exemption contained in section 520(b) of the FD&C Act were clarified to
include no more than ``five units per year of a particular device
type'' that otherwise meet all the requirements necessary to qualify
for the custom device exemption.
In the Federal Register of September 24, 2014 (79 FR 57112), FDA
announced the availability of the guidance entitled ``Custom Device
Exemption.'' FDA has developed this document to provide guidance to
industry and FDA staff about implementation of the custom device
exemption contained in the FD&C Act. The intent of the guidance is to
define terms used in the custom device exemption, explain how to
interpret the ``five units per year of a particular device type''
language contained in the FD&C Act, describe information that FDA
proposes manufacturers should submit in the custom device annual
report, and provide recommendations on how to submit an annual report
for devices distributed under the custom device exemption.
In the Federal Register of February 21, 2020 (85 FR 10175), we
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 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual reporting for custom devices................................ 34 1 34 40 1,360
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 41594]]
Our estimated burden for the information collection reflects an
overall increase of 40 hours and a corresponding increase of one
response/record. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.
Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14880 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P
