Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption, 28860-28861 [2017-13245]
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28860
Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
530.22(b), Submission(s) of Analytical Method ...................
1 There
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13296 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
HHS.
ACTION:
2
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that Brineura
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets
the criteria for a priority review
voucher.
SUMMARY:
1
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that Brineura
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets
the criteria for a priority review
voucher. Brineura (cerliponase alfa) is
indicated to slow the progression of loss
of ambulation in symptomatic pediatric
patients 3 years of age and older with
late infantile neuronal ceroid
lipofuscinosis type 2 (CLN2), also
known as tripeptidyl peptidase 1 (TPP1)
deficiency.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsf
orRareDiseasesConditions/
RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about Brineura
(cerliponase alfa) go to the ‘‘Drugs@
FDA’’ Web site at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13236 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1066]
FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Total annual
responses
2
4,160
Total hours
8,320
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information
collection has not changed since the last
OMB approval.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR section
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6484, Silver Spring,
MD 20993–0002, 301–796–4061, FAX:
301–796–9858, email: althea.cuff@
fda.hhs.gov.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Annual Reporting
for Custom Device Exemption
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
ACTION:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:04 Jun 23, 2017
Jkt 241001
AGENCY:
Food and Drug Administration,
HHS.
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
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 26,
2017.
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 0910–0767. 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, 10A63, 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.
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;
E:\FR\FM\26JNN1.SGM
26JNN1
28861
Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
• 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 March 21,
2017 (82 FR 14518), 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
respondents
Activity
Annual reporting for custom devices ...................................
1 There
[FR Doc. 2017–13245 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3331]
Arthritis Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Arthritis Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The meeting will be held on
August 2, 2017, from 8 a.m. to 5 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Answers to commonly asked questions
including information regarding special
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
33
Total annual
responses
1
33
Average
burden per
response
40
Total hours
1,320
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
AGENCY:
Number of
responses per
respondent
VerDate Sep<11>2014
17:04 Jun 23, 2017
Jkt 241001
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–3331.
The docket will close on August 1,
2017. Submit either electronic or
written comments on this public
meeting by August 1, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 1,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 1, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before July
19, 2017, will be provided to the
committee.
Comments received after that date
will be taken into consideration by the
Agency.
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://
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–3331 for ‘‘Arthritis Advisory
Committee; Notice of Meeting;
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28860-28861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13245]
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by July
26, 2017.
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 0910-0767.
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, 10A63, 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.
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;
[[Page 28861]]
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 March 21, 2017 (82 FR 14518), 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 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Annual reporting for custom 33 1 33 40 1,320
devices........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13245 Filed 6-23-17; 8:45 am]
BILLING CODE 4164-01-P
