Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee, 38920-38921 [2014-16038]
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to www.standards@
cdrh.fda.gov. To be properly considered,
such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
sroberts on DSK5SPTVN1PROD with NOTICES
VI. Electronic Access
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page includes the guidance
as well as the current list of recognized
standards and other standards-related
documents. After publication in the
Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 036’’ will be available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. You may
access the CDRH home page at https://
www.fda.gov/MedicalDevices.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/Standards.
VII. Submission of Comments and
Effective Date
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov. FDA will consider
any comments received in determining
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whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
036. These modifications to the list of
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15989 Filed 7–8–14; 8:45 am]
BILLING CODE 4164–01–P
logging into the FDA Advisory
Committee Membership Nomination
Portal: https://www.accessdata.fda.gov/
scripts/FACTRSPortal/FACTRS/
index.cfm
Gail
Dapolito, Center for Biologics
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6124,
Silver Spring, MD 20993–0002, 240–
402–8046; gail.dapolito@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
Agency intends to add a nonvoting
industry representative to the following
advisory committee:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
I. Cellular, Tissue, and Gene Therapies
Advisory Committee
[Docket No. FDA–2014–N–0899]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for a Nonvoting Industry
Representative and Request for
Nominations for Nonvoting Industry
Representatives on the Cellular,
Tissue, and Gene Therapies Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Cellular, Tissue, and Gene
Therapies Advisory Committee for the
Center for Biologics Evaluation and
Research notify FDA in writing. FDA is
also requesting nominations for a
nonvoting industry representative to
serve on the Cellular, Tissue, and Gene
Therapies Advisory Committee. A
nominee may either be self-nominated
or nominated by an organization to
serve as a nonvoting industry
representative. Nominations will be
accepted for current or 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 by August 8, 2014, for the vacancy
listed in this notice. Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
August 8, 2014.
ADDRESSES: All letters of interest from
industry organizations should be
submitted in writing to Gail Dapolito
(see FOR FURTHER INFORMATION CONTACT).
All nominations should be submitted by
SUMMARY:
PO 00000
Frm 00071
Fmt 4703
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The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies and
xenotransplantation products which are
intended for transplantation,
implantation, infusion and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair or replacement of
tissues for various conditions. The
Committee also considers the quality
and relevance of FDA’s research
program which provides support for the
regulation of these products, and makes
appropriate recommendations to the
Commissioner of Food and Drugs (the
Commissioner).
II. 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 the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
E:\FR\FM\09JYN1.SGM
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
III. 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 provided within 30
days of publication of this document
(see DATES) by logging into the FDA
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
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).
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the cell, tissue, and
gene transfer products 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: July 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16038 Filed 7–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Evaluation of the NIH
Academic Research Enhancement
Award (NIH OD)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Michelle M.
Timmerman, Ph.D., Director, AREA
Program, Office of the Director, National
Institutes of Health, 6705 Rockledge
Drive, Bethesda, Maryland 20892; or
call non-toll-free number 301–402–
0672; or email your request, including
your address to michelle.timmerman@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Evaluation of the
NIH Academic Research Enhancement
Award, 0925-New, Office of the Director
(OD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The Academic Research
Enhancement Award (AREA) Program is
a grant mechanism spanning most of the
Institutes and Centers (ICs) of the
National Institutes of Health (NIH). The
AREA program was established by
Congress in 1985 to provide support to
scientists at public and private colleges
and universities that receive relatively
small amounts of NIH funding. The
purpose of the program is to support
meritorious research, expose
undergraduate and graduate students to
research, and strengthen the research
environment of the institutions
receiving the grants. In the past three
years alone, the federal government has
awarded approximately 78 million
dollars annually in AREA grants. The
evaluation will allow the NIH and
Congress to assess the extent to which
the AREA program is meeting its goals
and make recommendations so that this
significant investment of public funds
may be used as effectively as possible.
The evaluation will utilize the NIH’s
archived data on grants, institutions,
Principal Investigators (PIs), and
students funded with AREA monies.
The evaluation will collect new data
about (1) the quantity and quality of
student participation in AREA projects,
(2) records of PIs’ subsequent funding
histories, (3) applicants’ experiences
with the application process, (4) PIs’
experiences implementing AREA
Program objectives, and (5) the impact
of AREA Program research participation
on student career paths and outcomes.
The results of the evaluation will
indicate the extent to which the AREA
Program is meeting its goals of
supporting meritorious research,
strengthening the research environment
at institutions of higher education that
are not research intensive, and
recruiting and training subsequent
generations of the United States’
biomedical scientist workforce.
Intended audiences include the United
States Congress, staff at NIH ICs that
make AREA awards, and staff of the
NIHOD.
OMB approval is requested for one
year. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
629.
sroberts on DSK5SPTVN1PROD with NOTICES
ESTIMATES OF ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Principal Investigator Survey ...........................................................................
Awardee Semi-Structured Interview ................................................................
Student Survey ................................................................................................
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Number of
responses per
respondent
480
50
301
E:\FR\FM\09JYN1.SGM
1
1
1
09JYN1
Average
burden per
response
(in hours)
45/60
45/60
30/60
Total annual
burden hours
360
38
151
]]>Agencies
[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38920-38921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16038]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0899]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for a Nonvoting Industry
Representative and Request for Nominations for Nonvoting Industry
Representatives on the Cellular, Tissue, and Gene Therapies Advisory
Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting industry representative to serve on the Cellular, Tissue,
and Gene Therapies Advisory Committee for the Center for Biologics
Evaluation and Research notify FDA in writing. FDA is also requesting
nominations for a nonvoting industry representative to serve on the
Cellular, Tissue, and Gene Therapies Advisory Committee. A nominee may
either be self-nominated or nominated by an organization to serve as a
nonvoting industry representative. Nominations will be accepted for
current or 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 by August 8,
2014, for the vacancy listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by August 8,
2014.
ADDRESSES: All letters of interest from industry organizations should
be submitted in writing to Gail Dapolito (see FOR FURTHER INFORMATION
CONTACT). All nominations should be submitted by logging into the FDA
Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm
FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6124,
Silver Spring, MD 20993-0002, 240-402-8046; gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative to the following advisory committee:
I. Cellular, Tissue, and Gene Therapies Advisory Committee
The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies and xenotransplantation products which
are intended for transplantation, implantation, infusion and transfer
in the prevention and treatment of a broad spectrum of human diseases
and in the reconstruction, repair or replacement of tissues for various
conditions. The Committee also considers the quality and relevance of
FDA's research program which provides support for the regulation of
these products, and makes appropriate recommendations to the
Commissioner of Food and Drugs (the Commissioner).
II. 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 the committee. The interested organizations are not bound
by the list of nominees in selecting a candidate. However, if no
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent industry interests.
[[Page 38921]]
III. 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 provided within 30 days
of publication of this document (see DATES) by logging into the FDA
Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. 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).
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages nominations for appropriately qualified candidates from
these groups. Specifically, in this document, nominations for nonvoting
representatives of industry interests are encouraged from the cell,
tissue, and gene transfer products 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: July 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16038 Filed 7-8-14; 8:45 am]
BILLING CODE 4164-01-P
