Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption, 14518-14520 [2017-05349]
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14518
Federal Register / Vol. 82, No. 53 / Tuesday, March 21, 2017 / Notices
individual during an interview. The
CMS–43 application follows the
questions and requirements used by
SSA to determine Title II eligibility.
This is done not only for consistency
purposes, but because certain Title II
and Title XVIII insured status and
relationship requirements must be met
in order to qualify for Medicare under
the end stage renal disease provisions.
Form Number: CMS–43 (OMB control
number: 0938–0800); Frequency: Once;
Affected Public: Individuals or
households; Number of Respondents:
25,000; Total Annual Responses:
25,000; Total Annual Hours: 10,400.
(For policy questions regarding this
collection contact Carla Patterson at
410–786–8911.)
3. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Request for
Termination of Premium Hospital and
Supplementary Medical Insurance; Use:
The CMS–1763 form provides us and
the Social Security Administration
(SSA) with the enrollee’s request for
termination of Part B, Part A or both
Part B and A premium coverage. The
form is completed by an SSA claims or
field representative using information
provided by the Medicare enrollee
during an interview. The purpose of the
form is to provide to the enrollee with
a standardized format to request
termination of Part B, Part A premium
coverage or both, explain why the
enrollee wishes to terminate such
coverage, and to acknowledge that the
ramifications of the decision are
understood. Form Number: CMS–1763
(OMB control number: 0938–0025);
Frequency: Once; Affected Public:
Individuals or households; Number of
Respondents: 101,000; Total Annual
Responses: 101,000; Total Annual
Hours: 16,867. (For policy questions
regarding this collection contact Carla
Patterson at 410–786–8911.)
4. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Collection of
Prescription Drug Event Data from
Contracted Part D Providers for
Payment; Use: The collected
information is used primarily for
payment, but is also used for claim
validation as well as for other legislated
functions such as quality monitoring,
program integrity, and oversight. Form
Number: CMS–10174 (OMB control
number: 0938–0982); Frequency:
Monthly; Affected Public: Business or
other for-profits and Not-for-profit
institutions; Number of Respondents:
779; Total Annual Responses:
1,409,828,464; Total Annual Hours:
VerDate Sep<11>2014
16:47 Mar 20, 2017
Jkt 241001
2,820. (For policy questions regarding
this collection contact Ivan Iveljic at
410–786–3312.)
5. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicaid
Payment for Prescription Drugs—
Physicians and Hospital Outpatient
Departments Collecting and Submitting
Drug Identifying Information to State
Medicaid Programs; Use: States are
required to provide for the collection
and submission of utilization data for
certain physician-administered drugs in
order to receive federal financial
participation for these drugs.
Physicians, serving as respondents to
states, submit National Drug Code
numbers and utilization information for
‘‘J’’ code physician-administered drugs
so that the states will have sufficient
information to collect drug rebate
dollars. Form Number: CMS–10215
(OMB control number: 0938–1026);
Frequency: Weekly; Affected Public:
Business or other for-profits and Notfor-profit institutions); Number of
Respondents: 20,000; Total Annual
Responses: 3,910,000; Total Annual
Hours: 16,227. (For policy questions
regarding this collection contact Lisa
Ferrandi at 410–786–5445.)
6. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Request for
Retirement Benefit Information; Use:
Section 1818(d)(5) of the Social Security
Act provides that former state and local
government employees (who are age 65
or older, have been entitled to Premium
Part A for at least 7 years, and did not
have the premium paid for by a state, a
political subdivision of a state, or an
agency or instrumentality of one or
more states or political subdivisions)
may have the Part A premium reduced
to zero. These individuals must also
have 10 years of employment with the
state or local government employer or a
combination of 10 years of employment
with a state or local government
employer and a non-government
employer. The CMS–R–285 form is an
essential part of the process of
determining whether an individual
qualifies for the premium reduction.
The Social Security Administration will
use this information to help determine
whether a beneficiary meets the
requirements for reduction of the Part A
premium. Form Number: CMS–R–285
(OMB control number: 0938–0769);
Frequency: Once; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 500; Total Annual
Responses: 500; Total Annual Hours:
125. (For policy questions regarding this
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collection contact Carla Patterson at
410–786–8911.)
Dated: March 16, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–05535 Filed 3–20–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1066]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Annual Reporting
for Custom Device Exemption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection associated with
the annual reporting for custom devices.
DATES: Submit either electronic or
written comments on the collection of
information by May 22, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
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Federal Register / Vol. 82, No. 53 / Tuesday, March 21, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–1066 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Annual
Reporting for Custom Device
Exemption.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
VerDate Sep<11>2014
16:47 Mar 20, 2017
Jkt 241001
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
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14519
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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
(the 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 in
order 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
Food, Drug, and Cosmetic Act (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
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Federal Register / Vol. 82, No. 53 / Tuesday, March 21, 2017 / Notices
submit an annual report for devices
distributed under the custom device
exemption.
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 ...................................
33
1
33
40
1,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 15, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–05349 Filed 3–20–17; 8:45 am]
BILLING CODE 4164–01–P
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
[FR Doc. 2017–05487 Filed 3–20–17; 8:45 am]
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
Dated: March 15, 2017.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK3G9T082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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 Institute of
Mental Health Special Emphasis Panel,
Mental Health Services Research Conflicts.
Date: April 7, 2017.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Karen Gavin-Evans, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center,
6001 Executive Boulevard, Room 6153, MSC
9606, Bethesda, MD 20892, 301–451–2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
16:47 Mar 20, 2017
Jkt 241001
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
VerDate Sep<11>2014
[FR Doc. 2017–05486 Filed 3–20–17; 8:45 am]
Eunice Kennedy Shrive National
Institute of Child Health and Human
Development; Notice of Committee
Establishment
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
App.), the Director, National Institutes
of Health (NIH), announces the
establishment of the Task Force on
Research Specific to Pregnant Women
and Lactating Women (Task Force) as
required by section 2041 of the 21st
Century Cures Act, Public Law 114–255.
The Task Force will provide advice
and guidance to the Secretary,
Department of Health and Human
Services (Secretary), regarding Federal
activities related to identifying and
addressing gaps in knowledge and
research regarding safe and effective
therapies for pregnant women and
lactating women, including the
development of such therapies and the
collaboration on and coordination of
such activities. The Task Force will, not
later than 18 months after the
establishment, prepare and submit a
report to the Secretary, the Committee
on Health, Education, Labor and
Pensions of the Senate, and the
Committee on Energy and Commerce of
the House of Representatives.
It is determined that the Task Force is
in the public interest in connection with
the performance of duties imposed on
the NIH by statute, and that these duties
can best be performed through the
advice and counsel of this group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Notice of Diabetes Mellitus Interagency
Coordinating Committee Meeting
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
National Institutes of Health
The Diabetes Mellitus
Interagency Coordinating Committee
(DMICC) will hold a meeting on April
26–27, 2017. The topic for this meeting
will be ‘‘Opportunities for Research
Supported by the Special Statutory
Funding Program for Type 1 Diabetes
Research.’’ The meeting is open to the
public. Non-federal individuals
planning to attend the workshop should
register by email to Charlemae Clarke,
The Scientific Consulting Group, Inc.
(cclarke@scgcorp.com; please put
‘‘Registration DMICC T1D Meeting’’ in
the subject line) at least 7 days prior to
the workshop.
DATES: The meeting will be held on
April 26, 2017 from 8:00 a.m. to 5:45
p.m. and on April 27, 2017 from 8:00
a.m. to 3:00 p.m.
ADDRESSES: The meeting will be held in
the Conference Room (terrace level) at
5635 Fishers Ln., Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: An
agenda for the DMICC meeting will be
available by contacting Charlemae
Clarke, The Scientific Consulting Group,
Inc. (cclarke@scgcorp.com; please put
‘‘Agenda Request for DMICC T1D
Meeting’’ in the subject line). For further
information concerning this meeting,
contact Dr. B. Tibor Roberts, Executive
Secretary of the Diabetes Mellitus
Interagency Coordinating Committee,
National Institute of Diabetes and
SUMMARY:
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]]>Agencies
[Federal Register Volume 82, Number 53 (Tuesday, March 21, 2017)]
[Notices]
[Pages 14518-14520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05349]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1066]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with the annual reporting for custom devices.
DATES: Submit either electronic or written comments on the collection
of information by May 22, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact
[[Page 14519]]
information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-1066 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Annual Reporting for Custom
Device Exemption.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 (the 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 in order 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 Food, Drug, and Cosmetic Act (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
[[Page 14520]]
submit an annual report for devices distributed under the custom device
exemption.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Annual reporting for custom devices................................ 33 1 33 40 1,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05349 Filed 3-20-17; 8:45 am]
BILLING CODE 4164-01-P
