Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request for Comments, 62072-62073 [2011-25597]
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62072
Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
Dated: September 30, 2011.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 2011–25853 Filed 10–5–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Personal Responsibility
Education Program (PREP) MultiComponent Evaluation—Design Survey.
OMB No.: New collection.
Description: The Family and Youth
Services Bureau. (HHS/ACF/ACYF/
FYSB) and the Office of Planning,
Research, and Evaluation(HHS/ACF/
OPRE) in the Administration for
Children and Families (ACF) propose a
data collection activity as part of the
Personal Responsibility Education
Program (PREP) Multi-Component
Evaluation.
In addition to other activities, the
PREP Evaluation will document the
design of the PREP State grant programs
via data gathered from States and
selected sub-awardees funded by PREP.
The findings will be of interest to the
general public, federal and state policymakers, PREP sub-awardees,
community-based organizations, and
other organizations interested in teen
pregnancy prevention programming.
The proposed activity involves the
collection of information through
telephone conversations or in-person
interviews held with administrators and
program staff at the State and subawardee level. The data collection
instrument will focus on information
related to program context,
administration, and design. This
includes, but is not limited to: Program
goals and strategy/approach, program
setting, population characteristics, statelevel requirements and processes,
program monitoring, and training and
technical assistance.
Respondents: State Level
Coordinators; Program Directors;
Program Staff; General Staff; Schools
and Organizations; and CommunityBased Organizations.
ANNUAL BURDEN ESTIMATES
Design survey
Instrument
Annual
number of
eespondents
Number of responses per
respondent
Average burden hours per
response
Total burden
hours
Discussion Guide for use with State Level Coordinators and State-Level
Staff ..............................................................................................................
Discussion Guide for use with Program Staff; Schools and Organizations;
and Community-Based Organizations .........................................................
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Estimated Annual Burden Total for Design Survey .................................
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research, and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov. In
compliance with the requirements of
Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. E-mail address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
OMB Comment: OMB is required to
make a decision concerning the
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16:07 Oct 05, 2011
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collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Fax: 202–
395–6974, Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–25849 Filed 10–5–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0648]
Center for Devices and Radiological
Health; Standard Operating
Procedures for Network of Experts;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
availability of draft standard operating
procedures (SOPs) for a new ‘‘Network
of Experts.’’ The draft SOPs describe a
new process for staff at the Center for
Devices and Radiological Health (CDRH,
the center) to gain access to scientific,
engineering, and medical expertise
when it is needed to supplement
existing knowledge and expertise within
the Center.
DATES: Submit either electronic or
written comments on the report by
November 7, 2011.
ADDRESSES: See the SUPPLEMENTARY
INFORMATION section for electronic
SUMMARY:
E:\FR\FM\06OCN1.SGM
06OCN1
Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
access to the document. Submit
electronic comments on the preliminary
report to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Nada O. Hanafi, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5422, Silver Spring,
MD 20993–0002, 301–796–5427.
SUPPLEMENTARY INFORMATION:
I. Background
In September 2009, the Task Force on
the Utilization of Science in Regulatory
Decision Making (Task Force) and the
510(k) Working Group were established
to address critical challenges facing the
Center and our external constituents.
The 510(k) Working Group was charged
with evaluating the premarket
notification (510(k)) program and
exploring actions CDRH can take to
enhance our 510(k) decision making.
The Task Force was charged with
making recommendations on how the
Center can quickly incorporate new
science—including evolving
information, novel technologies, and
new scientific methods—into its
decision making in as predictable a
manner as is practical. The 510(k)
Working Group and Task Force made
recommendations and then developed a
plan of action for implementation of
these 510(k) and Science
Recommendations. This plan identified
internal and administrative matters to
be addressed and included an action
item of leveraging external expertise.
mstockstill on DSK4VPTVN1PROD with NOTICES
II. The Draft SOPs
FDA is announcing the availability of
two draft SOPs, one entitled, ‘‘Network
of Experts—Expert Utilization Standard
Operating Procedure’’ and one entitled,
‘‘Network of Experts—Expert
Enrollment Standard Operating
Procedure.’’ The purpose of the draft
SOPs is to develop a network of external
experts to appropriately and efficiently
leverage external scientific expertise,
and to describe the process for staff
engagement with external experts. The
network will be built on a series of
agreements with external organizations
including professional, scientific, and
medical organizations and academic
institutions. The draft SOPs describe
CDRH processes for providing CDRH
staff with access to scientific,
engineering, and medical expertise
VerDate Mar<15>2010
16:07 Oct 05, 2011
Jkt 226001
when it is needed to supplement
existing knowledge and expertise within
CDRH. The network of experts is
designed to broaden CDRH’s exposure
to scientific viewpoints, but not to
provide external policy advice or
opinions.
CDRH has a knowledgeable,
professional internal cadre of scientific
expertise, including over 800 scientists,
engineers, and clinicians. Despite this
internal resource, it is unrealistic to
expect CDRH staff to encompass all of
the applicable expertise and experience
necessary to fulfill our mission given
the rapidly growing variety and
complexity of medical devices. This is
particularly true when it comes to new
and emerging fields of science and
pioneering technologies. In these areas,
it is often necessary for our experts to
gain further scientific understanding
from external sources. The Network of
Experts will facilitate this exchange.
In developing the draft SOPs, CDRH
assessed best practices. CDRH is also
beginning a pilot project to use these
draft SOPs on a trial basis. Experience
from the pilot, along with comments on
this notice, will further assist the agency
in determining whether the draft SOPs
should be improved going forward.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons interested in obtaining a copy
of the draft SOPs may do so by using the
Internet. The draft SOP entitled:
‘‘Network of Experts—Expert Utilization
Standard Operating Procedure’’ can be
obtained from FDA’s Web site at
https://www.fda.gov/AboutFDA/
CentersOffices/CDRH/CDRHReports/
ucm271521.htm. The draft SOP entitled:
‘‘Network of Experts—Expert
Enrollment Standard Operating
Procedure’’ can be obtained from FDA’s
Web Site at https://www.fda.gov/
AboutFDA/CentersOffices/CDRH/
CDRHReports/ucm271523.htm. The
draft SOPs are also available from
https://www.regulations.gov and can be
located using the docket number found
in brackets in the heading of this
document.
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62073
Dated: September 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–25597 Filed 10–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0721]
Guidance for Industry on
Implementation of the Fee Provisions
of the FDA Food Safety Modernization
Act; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Implementation of the Fee
Provisions of Section 107 of the FDA
Food Safety Modernization Act.’’ FDA is
issuing this guidance to provide
answers to common questions that
might arise about the new fee provisions
and FDA’s plans for their
implementation in fiscal year (FY) 2012.
DATES: Submit either electronic or
written comments on the guidance at
any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Regulatory Affairs, Office of
Resource Management, 12420 Parklawn
Dr., Rm. 2012, Rockville, MD 20857.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amy Waltrip, Office of Regulatory
Affairs, Office of Resource Management,
12420 Parklawn Dr., Rm. 2012,
Rockville, MD 20857, 301–796–8811.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Implementation of the Fee Provisions
of Section 107 of the FDA Food Safety
Modernization Act.’’ The purpose of the
guidance document is to provide
E:\FR\FM\06OCN1.SGM
06OCN1
]]>Agencies
[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62072-62073]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25597]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0648]
Center for Devices and Radiological Health; Standard Operating
Procedures for Network of Experts; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft standard operating procedures (SOPs) for a new
``Network of Experts.'' The draft SOPs describe a new process for staff
at the Center for Devices and Radiological Health (CDRH, the center) to
gain access to scientific, engineering, and medical expertise when it
is needed to supplement existing knowledge and expertise within the
Center.
DATES: Submit either electronic or written comments on the report by
November 7, 2011.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
[[Page 62073]]
access to the document. Submit electronic comments on the preliminary
report to https://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Nada O. Hanafi, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-796-5427.
SUPPLEMENTARY INFORMATION:
I. Background
In September 2009, the Task Force on the Utilization of Science in
Regulatory Decision Making (Task Force) and the 510(k) Working Group
were established to address critical challenges facing the Center and
our external constituents. The 510(k) Working Group was charged with
evaluating the premarket notification (510(k)) program and exploring
actions CDRH can take to enhance our 510(k) decision making. The Task
Force was charged with making recommendations on how the Center can
quickly incorporate new science--including evolving information, novel
technologies, and new scientific methods--into its decision making in
as predictable a manner as is practical. The 510(k) Working Group and
Task Force made recommendations and then developed a plan of action for
implementation of these 510(k) and Science Recommendations. This plan
identified internal and administrative matters to be addressed and
included an action item of leveraging external expertise.
II. The Draft SOPs
FDA is announcing the availability of two draft SOPs, one entitled,
``Network of Experts--Expert Utilization Standard Operating Procedure''
and one entitled, ``Network of Experts--Expert Enrollment Standard
Operating Procedure.'' The purpose of the draft SOPs is to develop a
network of external experts to appropriately and efficiently leverage
external scientific expertise, and to describe the process for staff
engagement with external experts. The network will be built on a series
of agreements with external organizations including professional,
scientific, and medical organizations and academic institutions. The
draft SOPs describe CDRH processes for providing CDRH staff with access
to scientific, engineering, and medical expertise when it is needed to
supplement existing knowledge and expertise within CDRH. The network of
experts is designed to broaden CDRH's exposure to scientific
viewpoints, but not to provide external policy advice or opinions.
CDRH has a knowledgeable, professional internal cadre of scientific
expertise, including over 800 scientists, engineers, and clinicians.
Despite this internal resource, it is unrealistic to expect CDRH staff
to encompass all of the applicable expertise and experience necessary
to fulfill our mission given the rapidly growing variety and complexity
of medical devices. This is particularly true when it comes to new and
emerging fields of science and pioneering technologies. In these areas,
it is often necessary for our experts to gain further scientific
understanding from external sources. The Network of Experts will
facilitate this exchange.
In developing the draft SOPs, CDRH assessed best practices. CDRH is
also beginning a pilot project to use these draft SOPs on a trial
basis. Experience from the pilot, along with comments on this notice,
will further assist the agency in determining whether the draft SOPs
should be improved going forward.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons interested in obtaining a copy of the draft SOPs may do so
by using the Internet. The draft SOP entitled: ``Network of Experts--
Expert Utilization Standard Operating Procedure'' can be obtained from
FDA's Web site at https://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm271521.htm. The draft SOP entitled: ``Network of
Experts--Expert Enrollment Standard Operating Procedure'' can be
obtained from FDA's Web Site at https://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm271523.htm. The draft SOPs are also
available from https://www.regulations.gov and can be located using the
docket number found in brackets in the heading of this document.
Dated: September 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-25597 Filed 10-5-11; 8:45 am]
BILLING CODE 4160-01-P
