Ophthalmic Devices Panel of the Medical Devices Advisory Committee: Notice of Meeting; Postponement, 23970-23971 [2020-09232]
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Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
516.119; requires a foreign drug company to submit and
update the name and address of a permanent U.S. resident agent ........................................................................
516.121; written request for a meeting with FDA to discuss the requirements for indexing a new animal drug ...
516.123; written request for an informal conference and a
requestor’s written response to an FDA initial decision
denying a request .............................................................
516.125; correspondence and information associated with
investigational use of new animal drugs intended for indexing ...............................................................................
516.129; content and format of a request for determination
of eligibility for indexing ....................................................
516.141; information to be submitted to FDA by a requestor seeking to establish a qualified expert panel .....
516.143; content and format of the written report of the
qualified expert panel .......................................................
516.145; content and format of a request for addition to
the index ...........................................................................
516.161; content and format of a request for modification
of an indexed drug ...........................................................
516.163; information to be contained in a request to FDA
to transfer ownership of a drug’s index file to another
person ...............................................................................
516.165; requires drug experience reports and distributor
statements to be submitted to FDA .................................
Total ..............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
5
1
5
1
5
30
2
60
4
240
3
1
3
8
24
2
3
6
20
120
30
2
60
20
1,200
20
1
20
16
320
20
1
20
120
2,400
20
1
20
20
400
3
1
3
4
12
1
1
1
2
2
10
10
100
5
500
........................
........................
........................
........................
5,223
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Total annual
records
Average burden per
recordkeeping
Total hours
516.141, requires the qualified expert panel leader to
maintain a copy of the written report and all notes
or minutes relating to panel deliberations that are
submitted to the requestor for 2 years after the report is submitted.
516.165, requires the holder of an indexed drug to
maintain records of all information pertinent to the
safety or effectiveness of the indexed drug, from
foreign and domestic sources.
30
2
60
0.5 ..........................
(30 minutes) ...........
30
10
2
20
1 .............................
20
Total ......................................................................
........................
........................
........................
................................
50
1
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Number of
records per
recordkeeper
There are no capital costs or operating and maintenance costs associated with this collection of information.
We based our estimates in tables 1
and 2 on our experience with the
MUMS indexing program and the
requests for eligibility for indexing and
for addition to the index, as well as the
periodic drug experience reports
submitted during the past 3 years.
Our estimated burden for the
information collection reflects an
overall increase of 351 reporting hours
and a corresponding increase of 85
responses. We attribute this adjustment,
generally, to an increase in the number
of submissions we received over the last
few years. We also reduced our burden
hour estimate for drug experience
VerDate Sep<11>2014
18:56 Apr 29, 2020
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reports and distributor statements under
§ 516.165 from 8 hours per submission
to 5 hours per submission based on our
experience with this type of reporting.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[Docket No. FDA–2020–N–0008]
[FR Doc. 2020–09170 Filed 4–29–20; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee:
Notice of Meeting; Postponement
AGENCY:
Food and Drug Administration,
HHS.
Notice of meeting;
postponement.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is postponing the
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Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
meeting of the Ophthalmic Devices
Panel of the Medical Devices Advisory
Committee scheduled for June 9, 2020.
The meeting was announced in the
Federal Register of April 1, 2020. FDA,
like other government agencies, is
taking the necessary steps to ensure the
Agency is prepared to continue our vital
public health mission in the event that
our day-to-day operations are impacted
by the COVID–19 public health
emergency. Therefore, we are
postponing this meeting and will
reassess on an ongoing basis for future
months. A future meeting date will be
announced in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, Aden.Asefa@
fda.hhs.gov, 301–796–0400, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area) and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: The
meeting of the Ophthalmic Devices
Panel of the Medical Devices Advisory
Committee was originally announced in
the Federal Register of April 1, 2020 (85
FR 18249), and was initially scheduled
for June 9, 2020. FDA continues to
evaluate whether and how to proceed
with upcoming scheduled meetings
while our day-to-day operations are
impacted by the COVID–19 public
health emergency, and we have decided
to postpone this public meeting until
further notice.
Dated: April 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09232 Filed 4–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jbell on DSKJLSW7X2PROD with NOTICES
[Docket No. FDA–2008–N–0424]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Safety Information Sharing by
Constituent Part Applicants for
Combination Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:56 Apr 29, 2020
Jkt 250001
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 the requirements
under the Postmarketing Safety
Reporting Rule for Combination Product
for Constituent Part Applicants to share
specified adverse event information
with one another.
DATES: Submit either electronic or
written comments on the collection of
information by June 29, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 29, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 29, 2020. 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.
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
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
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23971
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–
2008–N–0424 for ‘‘Postmarketing Safety
Information Sharing by Constituent Part
Applicants for Combination Products.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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 Dockets Management
Staff. 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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]]>Agencies
[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23970-23971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09232]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Ophthalmic Devices Panel of the Medical Devices Advisory
Committee: Notice of Meeting; Postponement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting; postponement.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is postponing the
[[Page 23971]]
meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory
Committee scheduled for June 9, 2020. The meeting was announced in the
Federal Register of April 1, 2020. FDA, like other government agencies,
is taking the necessary steps to ensure the Agency is prepared to
continue our vital public health mission in the event that our day-to-
day operations are impacted by the COVID-19 public health emergency.
Therefore, we are postponing this meeting and will reassess on an
ongoing basis for future months. A future meeting date will be
announced in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
[email protected], 301-796-0400, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area) and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting.
SUPPLEMENTARY INFORMATION: The meeting of the Ophthalmic Devices Panel
of the Medical Devices Advisory Committee was originally announced in
the Federal Register of April 1, 2020 (85 FR 18249), and was initially
scheduled for June 9, 2020. FDA continues to evaluate whether and how
to proceed with upcoming scheduled meetings while our day-to-day
operations are impacted by the COVID-19 public health emergency, and we
have decided to postpone this public meeting until further notice.
Dated: April 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09232 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P
