Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Panels, 3390-3391 [2014-01003]
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Federal Register / Vol. 79, No. 13 / Tuesday, January 21, 2014 / Notices
letter. The interested organizations are
not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within the 60
days, the Commissioner of Food and
Drugs will select the nonvoting member
to represent industry interests.
IV. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. The nominee’s
contact information, a current
curriculum vitae, and the name of the
committee of interest should be sent to
the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within
30 days of publication of this document
(see DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 14, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–00964 Filed 1–17–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1633]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on Public Advisory
Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organization interested in
participating in the selection of
nonvoting industry representatives to
serve on the Medical Devices Advisory
Committee (MDAC) in the Center for
Devices and Radiological Health (CDRH)
notify FDA in writing. FDA is also
requesting nominations for nonvoting
industry representatives to serve on
certain device panels of the MDAC in
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SUMMARY:
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the CDRH. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for upcoming vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA (see ADDRESSES) by February 20,
2014, for the vacancies listed in this
notice. Concurrently, nomination
materials for prospective candidates
should be sent to FDA (see ADDRESSES)
by February 20, 2014.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Margaret Ames (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5234, Silver Spring,
MD 20993. Telephone: 301–796–5960,
Fax: 301–847–8505, email:
margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
520(f)(3) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360j(f)(3)), as amended by the Medical
Device Amendments of 1976, provides
that each medical device panel include
one nonvoting member to represent the
interests of the medical device
manufacturing industry. The Agency is
requesting nominations for nonvoting
industry representatives to certain
panels identified in the following
paragraphs.
I. Functions of MDAC
(1) Review and evaluate data on the
safety and effectiveness of marketed and
investigational devices and make
recommendations for their regulation;
(2) advise the Commissioner of Food
and Drugs (the Commissioner) regarding
recommended classification or
reclassification of these devices into one
of three regulatory categories; (3) advise
on any possible risks to health
associated with the use of devices; (4)
advise on formulation of product
development protocols; (5) review
premarket approval applications for
medical devices; (6) review guidelines
and guidance documents; (7)
recommend exemption to certain
devices from the application of portions
of the FD&C Act; (8) advise on the
necessity to ban a device; (9) respond to
requests from the Agency to review and
make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices; and (10)
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Fmt 4703
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make recommendations on the quality
in the design of clinical studies
regarding the safety and effectiveness of
marketed and investigational devices.
A. Dental Products Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational
products for use in dentistry,
endodontics, or bone physiology
relative to the oral and maxillofacial
area and makes appropriate
recommendations to the Commissioner.
B. Hematology and Pathology Devices
Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational in vitro
devices for use in clinical laboratory
medicine including pathology,
hematology, histopathology,
cytotechnology, and molecular biology
and makes appropriate
recommendations to the Commissioner.
C. Immunology Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational in vitro
devices for use in clinical laboratory
medicine including oncology,
immunology, and allergy and makes
appropriate recommendations to the
Commissioner.
II. Qualifications
Persons nominated for the device
panels should be full-time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
´
´
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular device panel.
The interested organizations are not
E:\FR\FM\21JAN1.SGM
21JAN1
Federal Register / Vol. 79, No. 13 / Tuesday, January 21, 2014 / Notices
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within the 60
days, the Commissioner will select the
nonvoting member to represent industry
interests.
IV. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the panel.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees, and therefore encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from the device
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. App. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 13, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–01003 Filed 1–17–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission For OMB Review; 30-Day
Comment Request: Gulf Long-Term
Follow-Up Study (GuLF STUDY)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Environmental Health
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SUMMARY:
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16:42 Jan 17, 2014
Jkt 232001
Sciences (NIEHS), the National
Institutes of Health, has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on November 7,
2013 on pages 66945–66946 and
allowed 60-days for public comment.
No public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institute of Environmental
Health Sciences (NIEHS), 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Dr. Dale P. Sandler, Chief,
Epidemiology Branch, NIEHS, Rall
Building A3–05, P.O. Box 12233,
Research Triangle Park, NC 27709 or
call non-toll-free number 919–541–4668
or Email your request, including your
address to: Sandler@niehs.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Gulf Long-Term
Follow-Up Study (GuLF STUDY), 0925–
0626, Expiration Date 01/31/2014—
REVISION, National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
Need and Use of Information
Collection:
FOR FURTHER INFORMATION CONTACT:
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3391
The purpose of the GuLF STUDY is to
investigate potential short- and longterm health effects associated with oil
spill clean-up activities and exposures
related to the Deepwater Horizon
disaster, and to create a resource for
additional collaborative research on
focused hypotheses or subgroups.
Exposures range from negligible to
potentially significant; however,
potential long-term human health
consequences are largely unknown due
to insufficient research in this area.
The study has enrolled 32,762
participants with a range of jobs/
exposures, including participants who
performed various types of clean-uprelated work (‘‘exposed’’) and other who
did not (‘‘unexposed’’ controls). Of the
32,762 enrolled into the Full Cohort,
20,000 have been assigned to the Active
Follow-up Sub-cohort, and 6,000 of
these have been assigned to the
Biomedical Surveillance Sub-cohort.
In order to minimize loss to followup, updated contact information will be
collected yearly for the Full Cohort.
Follow-up questionnaires will be
administered biennially to the Active
Follow-up Sub-Cohort to assess changes
in health status and factors that could
confound associations between
exposures and outcomes. A
supplemental mental health
questionnaire will be administered
repeatedly over a 2-year period to a
subset of 4,600 participants in the
Active Follow-up Sub-cohort to assess
mental health trajectories among those
affected by the oil spill and utilization
of mental health services in the Gulf
region. Participants in the Biomedical
Surveillance Sub-cohort will be invited
to take part in a comprehensive
research-based clinical examination.
The clinical exam provides an
opportunity to carry out more
comprehensive clinical testing and
mental health evaluations than could be
completed during the baseline home
visit. The exams will allow for a much
more in-depth assessment of
pulmonary, neurological, and mental
health outcomes that may be associated
with the Deepwater Horizon oil spill
exposures and experiences.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
21,724.
E:\FR\FM\21JAN1.SGM
21JAN1
]]>Agencies
[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3390-3391]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01003]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1633]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on Public Advisory Panels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organization interested in participating in the selection of
nonvoting industry representatives to serve on the Medical Devices
Advisory Committee (MDAC) in the Center for Devices and Radiological
Health (CDRH) notify FDA in writing. FDA is also requesting nominations
for nonvoting industry representatives to serve on certain device
panels of the MDAC in the CDRH. A nominee may either be self-nominated
or nominated by an organization to serve as a nonvoting industry
representative. Nominations will be accepted for upcoming vacancies
effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA (see
ADDRESSES) by February 20, 2014, for the vacancies listed in this
notice. Concurrently, nomination materials for prospective candidates
should be sent to FDA (see ADDRESSES) by February 20, 2014.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret Ames (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993. Telephone: 301-796-
5960, Fax: 301-847-8505, email: margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section 520(f)(3) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(f)(3)), as amended by
the Medical Device Amendments of 1976, provides that each medical
device panel include one nonvoting member to represent the interests of
the medical device manufacturing industry. The Agency is requesting
nominations for nonvoting industry representatives to certain panels
identified in the following paragraphs.
I. Functions of MDAC
(1) Review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation; (2) advise the Commissioner of Food and Drugs (the
Commissioner) regarding recommended classification or reclassification
of these devices into one of three regulatory categories; (3) advise on
any possible risks to health associated with the use of devices; (4)
advise on formulation of product development protocols; (5) review
premarket approval applications for medical devices; (6) review
guidelines and guidance documents; (7) recommend exemption to certain
devices from the application of portions of the FD&C Act; (8) advise on
the necessity to ban a device; (9) respond to requests from the Agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices; and (10) make
recommendations on the quality in the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
A. Dental Products Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational products for use in dentistry,
endodontics, or bone physiology relative to the oral and maxillofacial
area and makes appropriate recommendations to the Commissioner.
B. Hematology and Pathology Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational in vitro devices for use in clinical
laboratory medicine including pathology, hematology, histopathology,
cytotechnology, and molecular biology and makes appropriate
recommendations to the Commissioner.
C. Immunology Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational in vitro devices for use in clinical
laboratory medicine including oncology, immunology, and allergy and
makes appropriate recommendations to the Commissioner.
II. Qualifications
Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations, and a list of all nominees
along with their current r[eacute]sum[eacute]s. The letter will also
state that it is the responsibility of the interested organizations to
confer with one another and to select a candidate, within 60 days after
the receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for a particular device panel. The
interested organizations are not
[[Page 3391]]
bound by the list of nominees in selecting a candidate. However, if no
individual is selected within the 60 days, the Commissioner will select
the nonvoting member to represent industry interests.
IV. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the panel. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from the device manufacturing industry.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. App. 2) and 21 CFR part 14, relating to advisory committees.
Dated: January 13, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-01003 Filed 1-17-14; 8:45 am]
BILLING CODE 4160-01-P
