Blood Products Advisory Committee; Notice of Meeting, 38351-38352 [2013-15239]
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38351
Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
application. Based on information
available to FDA, we estimate that
approximately 24 sponsors will prepare
approximately 1 breakthrough therapy
designation submission in accordance
with the draft guidance and that the
added burden for each submission will
be approximately 70 hours to prepare
and submit (totaling 1,680 hours).
Promotional Materials for Accelerated
Approval Under Part 314. The draft
guidance describes section 506(c)(2)(B)
of the FD&C Act and FDA’s accelerated
approval regulations (§§ 314.550 and
601.45). These provisions authorize
FDA to require sponsors to submit
copies of all promotional materials to
the Agency for consideration prior to
their dissemination. The regulations
provide that copies of all promotional
materials including promotional
labeling as well as advertisements
intended for dissemination or
publication within 120 days following
marketing approval must be submitted
to FDA during the preapproval period.
The regulations further provide that
after 120 days following marketing
approval, unless otherwise informed by
the Agency, the applicant must submit
promotional materials at least 30 days
prior to the intended time of initial
dissemination of the labeling or initial
publication of the advertisement.
Currently, FDA has OMB approval for
the submission of copies of all
promotional materials under part 601
(OMB control number 0910–0338) but
does not have approval for the
submission of copies of all promotional
materials under part 314.
Based on information from FDA’s
databases and information available to
FDA, we estimate that approximately 20
sponsors will submit promotional
materials for accelerated approval 7
times annually in accordance with
§ 314.550 and that the burden for each
submission will be approximately 120
hours (a total of 16,800 hours).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Draft guidance on expedited programs
Number of
responses per
respondent
Total annual
responses
Average
burden per response
Total hours
Priority Review Designation Request ..................................
Breakthrough Therapy Designation Request ......................
Promotional Materials for Accelerated Approval Under
§ 314.550 ..........................................................................
47
24
1
1
47
24
30
70
1,410
1,680
20
7
140
120
16,800
Total ..............................................................................
........................
........................
........................
........................
19,890
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
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.
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IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: June 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–15250 Filed 6–25–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Blood Products 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). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
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 August 2, 2013, from 10 a.m. to
approximately 1:30 p.m.
Location: National Institutes of
Health, Building 29, Conference Room
A/B, 9000 Rockville Pike, Bethesda, MD
20892. The public is welcome to attend
the meeting at the specified location
where a speakerphone will be provided.
Public participation in the meeting is
limited to the use of the speakerphone
in the conference room.
PO 00000
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Contact Person: Bryan Emery or
Pearline Muckelvene, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, HFM–71,
Rockville, MD 20852, 301–827–0314,
email: Bryan.Emery@fda.hhs.gov or
Pearline.Muckelvene@fda.hhs.gov or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). 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 advisory
committee information line, or visit our
Web site at https://www.fda.gov/
AdvisoryCommittees/default.htm to
learn about possible modifications
before coming to the meeting.
Agenda: On August 2, 2013, the
Committee will meet in open session to
hear updates on the research programs
of the Laboratory of Molecular Virology,
Division of Emerging and Transfusion
Transmitted Diseases, Office of Blood
Research and Review, Center for
Biologics Evaluation and Research,
FDA.
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
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38352
Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
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 meeting
link.
Procedure: On August 2, 2013, from
10 a.m. to approximately 1 p.m., the
meeting is open to the public. 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 July 26, 2013. Oral
presentations from the public will be
scheduled between approximately 12
noon and 1 p.m. 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 July 18,
2013. 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 July 19, 2013.
Closed Committee Deliberations: On
August 2, 2013, from approximately 1
p.m. to 1:30 p.m., the meeting will be
closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the site visit
report of the intramural research
programs and make recommendations
regarding personnel staffing decisions.
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 Bryan Emery
or Pearl Muckelvene at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
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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 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–15239 Filed 6–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Predicting Age of Onset of NiemannPick Disease
Description of Technology: NiemannPick disease (NPD) refers to a group of
fatal inherited metabolic disorders.
Children with type A or B NPD usually
die within the first few months or years
of life, while NPD type C progresses
more slowly, and affected individuals
may survive into their seventies. The
lifespan of patients with NPD is related
to the age of onset. At present, however,
PO 00000
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there is no effective diagnostic method
to predict the age of NPD disease onset.
The instant invention presents
diagnostic compositions and efficient
methods for predicting the age of onset
of a lysosomal storage disease (e.g.,
NPD) and of diseases associated with
lysosomal of autophagic defects (e.g.,
Parkinson’s disease and Alzheimer’s
disease) in patients. It can also be used
to screen for agents useful in treating
NPD patients.
Potential Commercial Applications:
• Predicting the age of disease onset
in patients with Niemann-Pick disease,
and other diseases associated with
lysosomal or autophagic defects.
• Identifying agents for treating NPD
patients.
Competitive Advantages: A new
method for predicting the age of NPD
disease onset.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vitro data available.
Inventors: William J. Pavan, et al.
(NHGRI).
Intellectual Property: HHS Reference
No. E–060–2013/0—U.S. Provisional
Application No. 61/781,807 filed 14 Mar
2013.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity:
The National Human Genome Research
Institute (NHGRI) is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize diagnostic methods for
predicting the age of onset of lysosomal
disorders, such as NPD and Parkinson’s.
For collaboration opportunities, please
contact Dr. William J. Pavan at
bpavan@nhgri.nih.gov.
Rat Model for Alzheimer’s Disease
Description of Technology: The
present invention is directed to a
transgenic rat model of Alzheimer’s
Disease (AD) termed TgF344–19+/¥.
The invention rat overexpresses two
human genes (APPswe and PS1DE9
genes), each of which are believed to be
independent dominant causes of earlyonset AD. The hemizygote exhibits
major features of AD pathology (i.e.,
dense and diffuse amyloid plaques,
neurofibrillary tangles, cerebral amyloid
angiopathy, hyperphosphorylated tau,
paired-helical filaments, Hirano bodies,
granulovacuolar degeneration, cognitive
impairment, and cortical neuronal loss).
The invention rat is superior to AD
mice models because the rat has a larger
sized brain to accommodate in vivo
imaging studies and complex behavioral
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]]>Agencies
[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38351-38352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Blood Products 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Blood Products 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 August 2, 2013, from 10
a.m. to approximately 1:30 p.m.
Location: National Institutes of Health, Building 29, Conference
Room A/B, 9000 Rockville Pike, Bethesda, MD 20892. The public is
welcome to attend the meeting at the specified location where a
speakerphone will be provided. Public participation in the meeting is
limited to the use of the speakerphone in the conference room.
Contact Person: Bryan Emery or Pearline Muckelvene, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, HFM-71, Rockville, MD 20852, 301-827-0314, email:
Bryan.Emery@fda.hhs.gov or Pearline.Muckelvene@fda.hhs.gov or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area). 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 advisory committee information line, or visit our Web site
at https://www.fda.gov/AdvisoryCommittees/default.htm to learn about
possible modifications before coming to the meeting.
Agenda: On August 2, 2013, the Committee will meet in open session
to hear updates on the research programs of the Laboratory of Molecular
Virology, Division of Emerging and Transfusion Transmitted Diseases,
Office of Blood Research and Review, Center for Biologics Evaluation
and Research, FDA.
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
[[Page 38352]]
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 meeting link.
Procedure: On August 2, 2013, from 10 a.m. to approximately 1 p.m.,
the meeting is open to the public. 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 July 26, 2013. Oral presentations from the public will be
scheduled between approximately 12 noon and 1 p.m. 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 July 18, 2013. 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 July 19, 2013.
Closed Committee Deliberations: On August 2, 2013, from
approximately 1 p.m. to 1:30 p.m., the meeting will be closed to permit
discussion where disclosure would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will
discuss the site visit report of the intramural research programs and
make recommendations regarding personnel staffing decisions.
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 Bryan Emery or Pearl
Muckelvene 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 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-15239 Filed 6-25-13; 8:45 am]
BILLING CODE 4160-01-P
