Advisory Committee on Organ Transplantation; Cancellation of Meeting, 26768 [2014-10739]
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Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices
If an applicant does not have a PSUR
waiver in place for an approved
application, the applicant may submit a
waiver request under § 314.90(a) or
§ 600.90(a) to submit a PBRER instead of
the PADER/PAER. The applicant should
submit a request to FDA for each
approved application for which a
waiver is requested, and a single waiver
request letter can include multiple
applications. Waiver requests should be
submitted to each of the application(s)
in the request, and may be submitted
electronically or by mail as described in
the April 8, 2013, draft guidance. Each
PBRER waiver request should include
the following information:
1. The product name(s) and
application number(s);
2. A brief description of the
justification for the request;
3. The U.S. approval date for the
product(s) and current reporting interval
used;
4. The reporting interval of the last
PADER/PAER submitted for the
product(s);
5. The data lock point that will be
used for each PBRER. If a data lock
point other than one aligned to the U.S.
approval date is proposed, the applicant
should describe how he/she will ensure
that there are no gaps in reporting
intervals (e.g., by submitting
overlapping reports; submitting a onetime PADER/PAER to cover the gap
period; or, if the gap is less than 2
months, extending the reporting interval
of the final PADER/PAER to close the
gap).
6. The frequency for submitting the
PBRER, as described in section IV.C of
the April 8, 2013, draft guidance.
7. The email address and telephone
number for the individual who can
provide additional information
regarding the waiver request.
As explained earlier, existing
regulations at §§ 314.90(a) or 600.90(a)
permit applicants to request waivers of
any postmarketing safety reporting
requirement, and the information
collections associated with such waiver
requests generally are approved under
OMB control numbers 0910–0001and
0910–0308. FDA believes that the
information submitted under numbers 1
to 4 and number 7 in the list in the
previous paragraph is information that
is typical of any waiver request
regarding postmarketing safety reporting
and is accounted for in the existing
approved collections of information for
waiver requests and reports. Concerning
numbers 5 and 6, FDA expects
approximately 67 waiver requests to
include the additional information for
using a different data lock point and/or
for using a different reporting frequency
when submitting a PBRER. FDA expects
approximately 29 applicants to make
these submissions, and we estimate that
the time for submitting the additional
information described in the previous
paragraph would be on average
approximately 2 hours for each waiver
request.
In the Federal Register of December
10, 2013 (78 FR 74151), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the additional burden
of this collection of information as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Additional information and/or notifications for using
a different data lock point and/or a different
reporting frequency
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Applicants that have a PSUR waiver for an approved application ............................................................................
Applicants that do not have a PSUR waiver for an approved application ............................................................
55
3.4
187
1
187
29
2.3
67
2
134
Total ..............................................................................
........................
........................
........................
........................
321
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
all sessions of the meeting. The meeting
was announced in the Federal Register
on April 22, 2014 (79 FR 22507).
For Further Information Contact:
Patricia Stroup, MBA, MPA, Office of
the Associate Administrator, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 17W43, Rockville,
Maryland 20857; telephone (301) 443–
1127.
[FR Doc. 2014–10658 Filed 5–8–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
ehiers on DSK2VPTVN1PROD with NOTICES
Advisory Committee on Organ
Transplantation; Cancellation of
Meeting
Name: Advisory Committee on Organ
Transplantation.
Dates and Times: May 15, 2014, 10:00
a.m. to 4:00 p.m., Eastern Time.
Status: The meeting of the Advisory
Committee on Organ Transplantation
scheduled for May 15, 2014, is
cancelled. This cancellation applies to
Dated: May 5, 2014.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2014–10739 Filed 5–8–14; 8:45 am]
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SECURITY
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[Docket No. DHS–2014–0022]
Privacy Act of 1974; Computer
Matching Program
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: Notice.
AGENCY:
Privacy Act of
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Unemployment Assistance.
SUMMARY: This document provides
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[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Notices]
[Page 26768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10739]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Organ Transplantation; Cancellation of
Meeting
Name: Advisory Committee on Organ Transplantation.
Dates and Times: May 15, 2014, 10:00 a.m. to 4:00 p.m., Eastern
Time.
Status: The meeting of the Advisory Committee on Organ
Transplantation scheduled for May 15, 2014, is cancelled. This
cancellation applies to all sessions of the meeting. The meeting was
announced in the Federal Register on April 22, 2014 (79 FR 22507).
For Further Information Contact:
Patricia Stroup, MBA, MPA, Office of the Associate Administrator,
Healthcare Systems Bureau, Health Resources and Services
Administration, 5600 Fishers Lane, Room 17W43, Rockville, Maryland
20857; telephone (301) 443-1127.
Dated: May 5, 2014.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2014-10739 Filed 5-8-14; 8:45 am]
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