Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments, 18992 [2020-07016]
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
regulates under the Federal Food, Drug,
and Cosmetic Act or section 351 of the
Public Health Service Act (42 U.S.C.
262) requesting special protocol
assessment.
In the Federal Register of January 3,
2020 (85 FR 320) we published a 60-day
notice requesting public comment on
the proposed collection of information.
Although one comment was received, it
was not responsive to the information
collection topics solicited in the notice.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Total annual
responses
Average
burden per
response
Total hours
Notification for Carcinogenicity Protocols ............................
Requests for Special Protocol Assessment Reports ...........
106
113
1.78
1.03
189
116
8
15
1,510
1,740
Total ..............................................................................
........................
........................
305
........................
3,250
1
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
There are no capital costs or operating and maintenance costs associated with this collection of information.
Burden Estimate: Table 1 provides an
estimate of the annual reporting burden
for notifications for a carcinogenicity
protocol and requests for a special
protocol assessment.
Notification for a Carcinogenicity
Protocol: Based on the number of
notifications for carcinogenicity
protocols and the number of
carcinogenicity protocols currently
submitted to CDER and CBER, CDER
estimates that it will receive
approximately 188 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 105
sponsors. CBER estimates that it will
receive approximately one notification
of an intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately one
sponsor. The hours per response, which
is the estimated number of hours that a
sponsor would spend preparing the
notification and background
information to be submitted in
accordance with the guidance, is
estimated to be approximately 8 hours.
Requests for Special Protocol
Assessment: Based on the number of
requests for special protocol assessment
currently submitted to CDER and CBER,
CDER estimates that it will receive
approximately 108 requests for special
protocol assessment per year from
approximately 105 sponsors. CBER
estimates that it will receive
approximately eight requests from
approximately eight sponsors. The
hours per response is the estimated
number of hours that a respondent
would spend preparing the information
to be submitted with a request for
special protocol assessment, including
the time it takes to gather and copy
questions to be posed to the Agency
regarding the protocol and data,
assumptions, and information needed to
permit an adequate evaluation of the
protocol.
VerDate Sep<11>2014
17:45 Apr 02, 2020
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Based on our experience with these
submissions, we estimate approximately
15 hours on average would be needed
per response. The information
collection reflects an adjustment in
burden by 608 hours. We attribute this
adjustment to an increase in the number
of submissions we received over the last
few years.
Dated: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06983 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0907]
Medical Device User Fee Amendments
for Fiscal Years 2023 Through 2027;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments; postponement.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that the public meeting entitled
‘‘Medical Device User Fee Amendments
for Fiscal Years 2023 Through 2027;
Public Meeting; Request for Comments’’
that appeared in the Federal Register on
March 6, 2020, and was scheduled for
April 7, 2020, is postponed to May 5,
2020, and will take place by webcast
only.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Ellen Olson, Center for Devices and
Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 1664,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–4322,
ellen.olson@fda.hhs.gov or CDRHOPEQ-StrategicInitiatives@fda.hhs.gov.
The
public meeting entitled ‘‘Medical Device
User Fee Amendments for Fiscal Years
2023 Through 2027; Public Meeting;
Request for Comments’’ announced in
the Federal Register of March 6, 2020
(85 FR 13165), and scheduled for April
7, 2020, is postponed to May 5, 2020,
and will take place virtually due to
extenuating circumstances. There will
no longer be an in-person meeting and
instead the meeting will be held by
webcast only. The webcast link and
connection instructions will be
available on the registration web page
(https://www.fda.gov/medical-devices/
workshops-conferences-medicaldevices/2020-medical-device-meetingsand-workshops) after April 23, 2020.
Interested participants may continue to
register and, if applicable, to specify
whether they would like to present
during a particular session or the public
comment session.
SUPPLEMENTARY INFORMATION:
Dated: March 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–07016 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
The public meeting will take
place remotely on May 5, 2020,
beginning at 9 a.m. EST. Submit either
electronic or written comments on the
medical device user fee program and
suggestions regarding the commitments
FDA should propose for the next
reauthorized program by June 5, 2020.
DATES:
PO 00000
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]]>Agencies
[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Page 18992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07016]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0907]
Medical Device User Fee Amendments for Fiscal Years 2023 Through
2027; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments; postponement.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that the
public meeting entitled ``Medical Device User Fee Amendments for Fiscal
Years 2023 Through 2027; Public Meeting; Request for Comments'' that
appeared in the Federal Register on March 6, 2020, and was scheduled
for April 7, 2020, is postponed to May 5, 2020, and will take place by
webcast only.
DATES: The public meeting will take place remotely on May 5, 2020,
beginning at 9 a.m. EST. Submit either electronic or written comments
on the medical device user fee program and suggestions regarding the
commitments FDA should propose for the next reauthorized program by
June 5, 2020.
FOR FURTHER INFORMATION CONTACT: Ellen Olson, Center for Devices and
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1664,
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4322,
[email protected] or [email protected].
SUPPLEMENTARY INFORMATION: The public meeting entitled ``Medical Device
User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting;
Request for Comments'' announced in the Federal Register of March 6,
2020 (85 FR 13165), and scheduled for April 7, 2020, is postponed to
May 5, 2020, and will take place virtually due to extenuating
circumstances. There will no longer be an in-person meeting and instead
the meeting will be held by webcast only. The webcast link and
connection instructions will be available on the registration web page
(https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/2020-medical-device-meetings-and-workshops) after April 23,
2020. Interested participants may continue to register and, if
applicable, to specify whether they would like to present during a
particular session or the public comment session.
Dated: March 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07016 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P
