Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 41507-41508 [2011-17695]
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Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
the increased risk of a serious side
effect. Another reason for this increasing
interest is the emergence of new
technologies that are improving our
ability to individualize, or personalize,
medical therapy by identifying patients
who are more likely to respond
positively or negatively to treatment, or
who are at lower risk for a particular
side effect.
When an appropriate scientific
rationale supports such an approach,
FDA encourages the development and
use of therapeutic products that depend
on the use of approved or cleared
companion diagnostic devices, and the
Agency has already approved/cleared
several companion diagnostics for use
with corresponding therapeutic
products. FDA believes that use of a
companion diagnostic with a
therapeutic product raises important
concerns about the safety and
effectiveness of both the test and the
therapeutic product. An erroneous test
result could lead to withholding an
appropriate therapy or to administering
an inappropriate therapy. Healthcare
professionals must be able to rely on
information from companion diagnostic
devices to help make critical treatment
decisions. FDA oversight of companion
diagnostics will protect patients from
treatment risks that could arise from in
vitro companion diagnostic devices that
have inadequate performance
characteristics. To facilitate the
development and clearance or approval
of therapeutic products that are
intended for use with companion
diagnostic devices, as well as the
development of the companion
diagnostics themselves, FDA is
clarifying relevant policies related to
these devices and products.
wreier-aviles on DSKGBLS3C1PROD with NOTICES
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on companion diagnostic devices. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationsGuidance/
GuidanceDocuments/_default.htm.
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Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘In Vitro Companion Diagnostic
Devices’’, you may either send an e-mail
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1737 to
identify the guidance you are
requesting.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance documents. 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 Part 807 Subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR Part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR Part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR Part 601 have
been approved under OMB control
number 0910–0338; the collections of
information in 21 CFR Part 814,
subparts B and E, have been approved
under OMB Control No. 0910–0231; the
collections of information in 21 CFR
Part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
Part 801 and 21 CFR 809.10 have been
approved under OMB Control No. 0910–
0485; and the collections of information
in 21 CFR 201.56 and 21 CR 201.57 have
been approved under OMB control
number 0910–572.
ACTION:
V. 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.
Dated: July 8, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–17671 Filed 7–12–11; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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 September 8 and 9, 2011, from
8 a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, 2
Montgomery Village Ave., Gaithersburg,
MD 20879.
Contact Person: Shanika Craig, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1613,
301–796–6639, 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.
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 and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On September 8 and 9, 2011,
the committee will discuss and make
recommendations regarding the safety
and effectiveness of transvaginal
surgical mesh used for repair of pelvic
organ prolapse. FDA is convening this
meeting to seek expert opinion on the
risks and benefits of these devices in
light of adverse events, e.g., vaginal
erosion leading to pelvic pain and
dyspareunia, and available information
on clinical benefit. The committee will
be asked to provide scientific and
clinical input on the Agency’s proposed
premarket and postmarket regulatory
strategies for these devices, including
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41508
Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
reclassification into Class III (premarket
approval), labeling improvements and
postmarket surveillance studies. The
committee will also consider surgical
mesh used to treat stress urinary
incontinence.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 30, 2011.
Oral presentations from the public will
be scheduled between approximately 10
a.m. and 11 a.m. on September 8 and 9,
2011. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 22, 2011. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 23, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Committee Management Staff,
301–796–5966 at least 7 days in advance
of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
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AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–17695 Filed 7–13–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Formative
Research Methodology Studies for the
National Children’s Study
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for reinstatement of
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 27, 2011,
pages 23608–23609, and allowed 60
days for public comment. Two written
comments and two verbal comments
were received. The verbal comments
expressed support for the broad scope of
the study. The written comments were
identical and questioned the cost and
utility of the study. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection: Title: Formative
Research Studies for the National
Children’s Study (NCS) Need and Use of
Information Collection: The Children’s
Health Act of 2000 (Pub. L. 106–310)
states:
(a) Purpose.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) In General.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
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appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) Plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) Investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) Requirement.—The study under
subsection (b) shall—
(1) Incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) Gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) Consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research and pilot tests will
be used to maximize the efficiency of
NCS procedures, materials, and
methods for outreach, engagement of
stakeholders, recruitment and retention
of Study subjects, and to ensure
scientifically robust data collection
methodologies for the National
Children’s Study (NCS) Vanguard and
Main Studies. With this submission, the
NCS seeks to obtain OMB’s generic
approval to conduct survey and
instrument design and administration,
focus groups, cognitive interviews, and
health and social service provider
information collection surrounding
outreach, engagement, recruitment,
consent and questionnaire design, and
retention activities.
The results from formative research
and pilot tests proposed will inform the
feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study recruitment,
retention, study visit measures and
study logistics. Type of Review:
Reinstatement of OMB #0925–0590,
Expiration June 30, 2011. Frequency of
Response: Annual [As needed on an ongoing and concurrent basis]. Affected
Public: Members of the public,
researchers, practitioners, and other
health professionals. Type of
Respondents: Women of child-bearing
age, fathers, community leaders,
members, and organizations, health care
facilities and professionals, public
health, environmental, social and
cognitive science professional
organizations and practitioners, hospital
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[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41507-41508]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17695]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 September 8 and 9, 2011,
from 8 a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879.
Contact Person: Shanika Craig, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 1613, 301-796-6639, 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. 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
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On September 8 and 9, 2011, the committee will discuss and
make recommendations regarding the safety and effectiveness of
transvaginal surgical mesh used for repair of pelvic organ prolapse.
FDA is convening this meeting to seek expert opinion on the risks and
benefits of these devices in light of adverse events, e.g., vaginal
erosion leading to pelvic pain and dyspareunia, and available
information on clinical benefit. The committee will be asked to provide
scientific and clinical input on the Agency's proposed premarket and
postmarket regulatory strategies for these devices, including
[[Page 41508]]
reclassification into Class III (premarket approval), labeling
improvements and postmarket surveillance studies. The committee will
also consider surgical mesh used to treat stress urinary incontinence.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 30, 2011. Oral presentations from the public will be scheduled
between approximately 10 a.m. and 11 a.m. on September 8 and 9, 2011.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
August 22, 2011. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by August 23, 2011.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Committee Management Staff, 301-796-5966 at least 7 days in advance of
the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-17695 Filed 7-13-11; 8:45 am]
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