Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Safety Assurance Case, 32964 [2014-13291]
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32964
Federal Register / Vol. 79, No. 110 / Monday, June 9, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
21 U.S.C. Section 393(d)(2)(D)
(various data collection methods)
Number of
responses per
respondent
Number of
respondents
Individual Indepth Interviews ............
General Public Focus Group Interviews.
Intercept Interviews: Central Location.
Intercept Interviews: Telephone ........
Self-Administered Surveys ................
Gatekeeper Reviews .........................
Omnibus Surveys ..............................
Total annual
responses
Average burden per response
Total hours
360
288
1
1
360
288
0.75 (45 minutes) .............................
1.50 (90 minutes) .............................
270
432
200
1
200
0.25 (15 minutes) .............................
50
4,000
2,400
400
1,200
1
1
1
1
4,000
2,400
400
1,200
0.08
0.25
0.50
0.17
(5 minutes) ...............................
(15 minutes) .............................
(30 minutes) .............................
(10 minutes) .............................
320
600
200
204
Total (General Public) ................
Physician Focus Group Interviews ...
8,848
432
1
1
8,848
432
...........................................................
1.50 (90 minutes) .............................
2,076
648
Total (Physician) ........................
Total (Overall) ............................
432
9,280
........................
1
........................
9,280
...........................................................
0.29 (17 minutes) .............................
648
2,724
Dated: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
control number 0910–0766. The
approval expires on May 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
[FR Doc. 2014–13292 Filed 6–6–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2014–13291 Filed 6–6–14; 8:45 am]
BILLING CODE 4160–01–P
[Docket No. FDA–2010–D–0194]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Safety Assurance Case
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Safety Assurance Case’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
On April
10, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Safety Assurance Case’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
ehiers on DSK2VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:08 Jun 06, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0736]
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Obstetrics and
Gynecology Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 10 and 11, 2014, from 8
a.m. to 6 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Shanika Craig, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 301–796–6639, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On July 10 and 11, 2014, the
committee will discuss the safety of
laparoscopic power morcellator devices
as it pertains to their potential to
disseminate and upstage a confined, but
undetected (occult) uterine malignancy
during laparoscopic hysterectomy or
myomectomy. FDA is convening this
committee to seek expert scientific and
clinical opinion on the risks and
benefits of these types of devices when
used for these procedures, based on
available scientific data. The committee
will make recommendations regarding
the appropriate use, premarket testing,
labeling, and other risk mitigations
E:\FR\FM\09JNN1.SGM
09JNN1
]]>Agencies
[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Page 32964]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13291]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0194]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Safety Assurance Case
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Safety Assurance Case'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On April 10, 2014, the Agency submitted a
proposed collection of information entitled ``Safety Assurance Case''
to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. OMB has now approved the information collection and has
assigned OMB control number 0910-0766. The approval expires on May 31,
2017. A copy of the supporting statement for this information
collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13291 Filed 6-6-14; 8:45 am]
BILLING CODE 4160-01-P
