Agency Information Collection Activities: Submission for OMB Review; Comment Request, 16217-16218 [E9-8141]
Download as PDF
Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices
dwashington3 on PROD1PC60 with NOTICES
only upon valid scientific evidence to
determine whether there is reasonable
assurance of the safety and effectiveness
of the device, if regulated by general
controls alone (class I) or by general
controls and special controls (class II).
Valid scientific evidence consists of
evidence from well-controlled
investigations, partially controlled
studies, studies and objective trials
without matched controls, welldocumented case histories conducted by
qualified experts, and reports of
significant human experience with a
marketed device, from which it can
fairly and responsibly be concluded by
qualified experts that there is reasonable
assurance of the safety and effectiveness
of a device under its conditions of use.
The evidence required may vary
according to the characteristics of the
device, its conditions of use, the
existence and adequacy of warnings and
other restrictions, and the extent of
experience with its use. Isolated case
reports, random experience, reports
lacking sufficient details to permit
scientific evaluation, and
unsubstantiated opinions are not
regarded as valid scientific evidence to
show safety or effectiveness (see
§ 860.7(c)(2)).
According to § 860.7(d)(1), there is
reasonable assurance that a device is
safe when it can be determined, based
upon valid scientific evidence, that the
probable benefits to health from use of
the device for its intended uses and
conditions of use, when accompanied
by adequate directions and warnings
against unsafe use, outweigh any
probable risks. The valid scientific
evidence used to determine the safety of
a device shall adequately demonstrate
the absence of unreasonable risk of
illness or injury associated with the use
of the device for its intended uses and
conditions for use. Moreover, under
§ 860.7(e)(1), there is reasonable
assurance that a device is effective when
it can be determined, based upon valid
scientific evidence, that in a significant
portion of the target population, the use
of the device for its intended uses and
conditions of use, when accompanied
by adequate directions for use and
warnings against unsafe use, will
provide clinically significant results.
IV. Submission of Required Information
The summary of, and citation to, any
information required by the act must be
submitted by the dates listed in the
DATES section of this document to the
Division of Dockets Management (see
ADDRESSES).
VerDate Nov<24>2008
15:28 Apr 08, 2009
Jkt 217001
V. Paperwork Reduction Act of 1995
This order refers to collections of
information necessary to comply with
the requirements found in sections
510(k) of the act (21 U.S.C. 360(k)) and
21 CFR part 807, subpart E or the
requirements of 515(b) of the act (21
U.S.C. 360e(b)), 21 CFR part 860, and 21
CFR part 814. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
860.123 have been approved under
OMB control number 0910–0138; the
collections of information in 21 CFR
part 814, have been approved under
OMB control number 0910–0231; and
the collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120.
Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8022 Filed 4–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
The 12th Annual Food and Drug
Administration-Orange County
Regulatory Affairs Educational
Conference; ‘‘Regulatory Affairs: The
Challenges of Ensuring Product
Safety’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA) is announcing the following
conference: 12th Annual Educational
Conference co-sponsored with the
Orange County Regulatory Affairs
Discussion Group (OCRA). The
conference is intended to provide the
Drug, Device, and Biologics industries
with an opportunity to interact with
FDA reviewers and compliance officers
from the Centers and District Offices, as
well as other industry experts. The main
focus of this interactive conference will
be product approval, compliance, and
risk management in the three medical
product areas. Industry speakers,
interactive questions and answers, and
workshop sessions will also be included
to assure open exchange and dialogue
on the relevant regulatory issues.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
16217
Date and Time: The conference will
be held on June 9 and 10, 2009, from
7:30 a.m. to 5 p.m.
Location: The conference will be held
at the Irvine Marriott Hotel, 18000 Von
Karman Ave., Irvine, CA 92612.
Contact: Linda Hartley, Food and
Drug Administration, 19701 Fairchild,
Irvine, CA 92612, 949–608–4413, FAX:
949–608–4417, or OCRA, Attention to
Detail, 5319 University Dr., suite 641,
Irvine, CA 92612, 949–387–9046, FAX:
949–387–9047, Web site: https://
www.ocra-dg.org.
Registration and Meeting Information:
See OCRA Web site, https://www.ocradg.org. Contact Attention to Detail at
949–387–9046.
Before May 8, 2009, registration fees
are as follows: $675.00 for members,
$725.00 for nonmembers and $475.00
for FDA/Govt/Students.1 After May 8,
2009, $725.00 for members, $775.00 for
nonmembers, and $475.00 for FDA/
Govt/Students.1
The registration fee will cover actual
expenses including refreshments, lunch,
materials, parking, and speaker
expenses.
If you need special accommodations
due to a disability, please contact Linda
Hartley at least 10 days in advance.
Dated: April 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8135 Filed 4–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
1 OCRA Student Rate applies to those individuals
enrolled in a Regulatory or Quality related
academic program at an accredited institution.
Proof of enrollment required.
E:\FR\FM\09APN1.SGM
09APN1
16218
Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Uncompensated
Services Assurance Report (OMB No.
0915–0077)—[Extension]
Under the Hill-Burton Act, the
government provides grants and loans
for construction or renovation of health
care facilities. As a condition of
receiving this construction assistance,
facilities are required to provide
services to persons unable to pay. A
condition of receiving this assistance
requires facilities to provide assurances
periodically that the required level of
Responses
per
respondent
Number of
respondents
Instrument
uncompensated care is being provided,
and that certain notification and record
keeping procedures are being followed.
These requirements are referred to as
the uncompensated services assurance.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Disclosure Burden (42 CFR)
Published Notices (124.504(c)) ...........................................
Individual Notices (124.504(c)) ............................................
Determinations of Eligibility (124.507) .................................
86
86
86
1
1
99
86
86
8,514
0.75
43.6
0.75
64.5
3,749.6
6,385.50
Subtotal disclosure burden ...........................................
........................
........................
........................
........................
10,199.60
10
1
10
11.0
110
4
0
2
1
........................
1
4
........................
2
6.0
........................
6.0
24
........................
12
37
14
0
1
1
1
37
14
0
0.5
0.5
0.5
18.5
7
0
10
10
........................
1
1
........................
10
10
........................
0.25
0.5
........................
2.5
5
179
Number of
recordkeepers
Hours per year
Non-alternative Facilities (124.510(a)) ........................................................................................
86
50
4,300
Subtotal recordkeeping burden ............................................................................................
........................
........................
4,300
Reporting
Uncompensated Services Report—HRSA–710 Form
(124.509(a)) ......................................................................
Application for Compliance Alternatives:
Public Facilities (124.513) ............................................
Small Obligation Facilities (124.514(c)) ........................
Charitable Facilities (124.516(c)) ..................................
Annual Certification for Compliance Alternatives:
Public Facilities (124.509(b)) ........................................
Charitable Facilities (124.509(b)) .................................
Small Obligation Facilities (124.509(c)) ........................
Complaint Information (124.511(a)):
Individuals .....................................................................
Facilities ........................................................................
Subtotal reporting burden .............................................
Recordkeeping
The total burden for this project is
estimated to be 14,678.60 hours. Written
comments and recommendations
concerning the proposed information
collection should be sent within 30 days
of this notice to the desk officer for
HRSA, either by e-mail to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: April 3, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–8141 Filed 4–8–09; 8:45 am]
dwashington3 on PROD1PC60 with NOTICES
BILLING CODE 4165–15–P
VerDate Nov<24>2008
15:28 Apr 08, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders in Newborns and Children
(ACHDNC); Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Heritable
Disorders in Newborns and Children.
Date and Time: May 12, 2009, 1 p.m.–5
p.m. EST.
Place: Web cast.
The ACHDNC will meet on Tuesday, May
12, 2009 from 1 p.m. to 5 p.m. EST. The
general public can join the meeting via
Webcast by logging onto https://
altarum.na3.acrobat.com/achdnc/; next
select ‘‘enter as a guest,’’ type in your full
name, and click ‘‘enter room.’’ Participants
must also dial the toll free phone number for
audio (listen only). The dial-in number is 1
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Total hour
burden
(877) 551–8166; when prompted say the
password ‘‘HRSA Genetics’’. Participants
should call no later than 12:50 p.m. EST in
order for the logistics to be established for
participation in the call. If there are technical
problems gaining access to the call, please
contact Alison Gary, Web Meetings
Coordinator, Altarum Institute, telephone
(202) 828–5100, or e-mail
webmeeting@altarum.org.
Meeting Registration: General public
participants are asked to register for the
conference by going to the meeting Web site
at https://events.SignUp4.com/achdnc0509.
The registration deadline is Monday, May 11,
2009.
Special Accommodations: Attendees
requiring special needs such as large print
materials or additional special needs may
make comments when registering at the
Online Web site. Or you may wish to contact
Tamar R. Shealy, Senior Meetings Manager,
Conference and Meetings Management,
Conference, Web and Communication
Services, Altarum Institute; telephone (202)
828–5100, or e-mail Tamar Shealy at
conferences@altarum.org.
Agenda: The meeting will include (1) A
presentation of the external review
E:\FR\FM\09APN1.SGM
09APN1
Agencies
[Federal Register Volume 74, Number 67 (Thursday, April 9, 2009)]
[Notices]
[Pages 16217-16218]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8141]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management
[[Page 16218]]
and Budget for review under the Paperwork Reduction Act of 1995:
Proposed Project: Uncompensated Services Assurance Report (OMB No.
0915-0077)--[Extension]
Under the Hill-Burton Act, the government provides grants and loans
for construction or renovation of health care facilities. As a
condition of receiving this construction assistance, facilities are
required to provide services to persons unable to pay. A condition of
receiving this assistance requires facilities to provide assurances
periodically that the required level of uncompensated care is being
provided, and that certain notification and record keeping procedures
are being followed. These requirements are referred to as the
uncompensated services assurance.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Disclosure Burden (42 CFR)
----------------------------------------------------------------------------------------------------------------
Published Notices (124.504(c)).. 86 1 86 0.75 64.5
Individual Notices (124.504(c)). 86 1 86 43.6 3,749.6
Determinations of Eligibility 86 99 8,514 0.75 6,385.50
(124.507)......................
-------------------------------------------------------------------------------
Subtotal disclosure burden.. .............. .............. .............. .............. 10,199.60
----------------------------------------------------------------------------------------------------------------
Reporting
----------------------------------------------------------------------------------------------------------------
Uncompensated Services Report-- 10 1 10 11.0 110
HRSA-710 Form (124.509(a)).....
Application for Compliance
Alternatives:
Public Facilities (124.513). 4 1 4 6.0 24
Small Obligation Facilities 0 .............. .............. .............. ..............
(124.514(c))...............
Charitable Facilities 2 1 2 6.0 12
(124.516(c))...............
Annual Certification for
Compliance Alternatives:
Public Facilities 37 1 37 0.5 18.5
(124.509(b))...............
Charitable Facilities 14 1 14 0.5 7
(124.509(b))...............
Small Obligation Facilities 0 1 0 0.5 0
(124.509(c))...............
Complaint Information
(124.511(a)):
Individuals................. 10 1 10 0.25 2.5
Facilities.................. 10 1 10 0.5 5
Subtotal reporting burden... .............. .............. .............. .............. 179
----------------------------------------------------------------------------------------------------------------
Number of Total hour
Recordkeeping recordkeepers Hours per year burden
----------------------------------------------------------------------------------------------------------------
Non-alternative Facilities (124.510(a))......................... 86 50 4,300
-----------------------------------------------
Subtotal recordkeeping burden............................... .............. .............. 4,300
----------------------------------------------------------------------------------------------------------------
The total burden for this project is estimated to be 14,678.60
hours. Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to (202) 395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: April 3, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-8141 Filed 4-8-09; 8:45 am]
BILLING CODE 4165-15-P