Science Board to the Food and Drug Administration; Notice of Meeting, 21784-21785 [2012-8701]
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21784
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Validation of Aseptic Preparations for
Positron Emission Tomography (PET)
Drugs.’’ Most PET drugs are designed for
parenteral administration and are
produced by aseptic processing. The
goal of aseptic processing is to make a
product that is free of microorganisms
and toxic microbial byproducts, such as
bacterial endotoxins. The media fill is
the performance of an aseptic
manufacturing procedure using a sterile
microbiological growth medium in
place of the drug solution to test
whether the aseptic procedures are
adequate to prevent contamination
during actual drug production. This
guidance takes the form of questions
and answers written specifically to help
manufacturers comply with the
Agency’s current good manufacturing
practices for PET drugs (21 CFR part
212) regarding media fills.
A draft guidance of the same title was
announced in the Federal Register on
September 30, 2011 (76 FR 60847), and
Docket No. FDA 2011–D–0691 was open
for comments until December 29, 2011.
We received comments from industry
and professional societies. We have
carefully considered, and where
appropriate, we have made corrections,
added information, or clarified the
information in this guidance in response
to the comments or on our own
initiative.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on media fills and
process simulations for PET drugs. 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.
II. 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. 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.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
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Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 212 have been approved
under OMB control number 0910–0667.
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 or https://
www.regulations.gov.
Dated: April 6, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–8702 Filed 4–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2012–N–0001]
Science Board to the Food and Drug
Administration; 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: Science Board to
the Food and Drug Administration
(Science Board).
General Function of the Committee:
The Science Board provides advice
primarily to the Commissioner of Food
and Drugs and other appropriate
officials on specific complex and
technical issues, as well as emerging
issues within the scientific community
in industry and academia. Additionally,
the Science Board provides advice to
the Agency on keeping pace with
technical and scientific evolutions in
the fields of regulatory science, on
formulating an appropriate research
agenda, and on upgrading its scientific
and research facilities to keep pace with
these changes. It will also provide the
means for critical review of Agencysponsored intramural and extramural
scientific research programs.
Date and Time: The meeting will be
held on May 2, 2012, from 9 a.m. to 4
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993. For
those unable to attend in person, the
meeting will also be Web cast. The link
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for the Web cast is available at
https://collaboration.fda.gov/
scienceboard/. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
CONTACT PERSON FOR MORE INFORMATION:
Martha Monser, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4286, Silver Spring,
MD 20993, 301–796–4627, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC 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: The Science Board will be
provided with an overview of
Georgetown University’s proposed
programs under the Centers for
Excellence in Regulatory Science and
Innovation (CERSI) initiative. In
addition, the Board will also hear about
CERSI activities resulting from the
Memorandum of Understanding
between the National Center for
Toxicological Research and the state of
Arkansas. The Board will also be
provided with an overview of ongoing
genomic efforts at FDA as well as an
update on Foods activities and an
update regarding Scientific Computing
efforts.
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.
E:\FR\FM\11APN1.SGM
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Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices
wreier-aviles on DSK5TPTVN1PROD with NOTICES
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 April 25, 2012. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 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 April 17,
2012. 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 April 18, 2012.
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 Martha
Monser 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: April 5, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–8701 Filed 4–10–12; 8:45 am]
BILLING CODE 4160–01–P
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Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21785
Dated: April 6, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–8695 Filed 4–10–12; 8:45 am]
[Docket No. FDA–2012–N–0001]
BILLING CODE 4160–01–P
Medical Countermeasures Initiative
Regulatory Science Symposium
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
National Institutes of Health
Notice of meeting.
The Food and Drug Administration
(FDA) is announcing the following
meeting: Medical Countermeasures
Initiative Regulatory Science
Symposium. The symposium is
intended to provide a forum for the
exchange of ideas for medical
countermeasure development, highlight
work on regulatory science as it applies
to the development and advancement of
medical countermeasures, facilitate
innovative directions, and inform
stakeholders on medical
countermeasure-related scientific
progress and accomplishments.
Date and Time: This symposium will
be held on Tuesday, June 5 and
Wednesday, June 6, 2012, from 8 a.m. to
5:30 p.m. Persons interested in
attending the symposium in person or
viewing via Web cast must register by
Tuesday, May 29, 2012, at 5 p.m. EST.
Location: The symposium will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
rm. 1503, Silver Spring, MD 20993–
0002.
Contact: Rakesh Raghuwanshi, Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
rm. 4283, 301–796–4769, FAX: 301–
847–8615, email: Rakesh.Raghuwanshi
@fda.hhs.gov.
Registration: If you wish to attend the
symposium or view via Web cast, you
must register at https://www.fda.gov/
medicalcountermeasures by Tuesday,
May 29, 2012, at 5 p.m. EST. When
registering, you must provide the
following information: (1) Your name,
(2) title, (3) company or organization (if
applicable), (4) mailing address, (5)
phone number, and (6) email address.
There is no fee to register for the
symposium and registration will be on
a first-come, first-served basis. Early
registration is recommended because
seating is limited. If you need special
accommodations due to a disability,
please enter pertinent information in the
‘‘Notes’’ section of the electronic
registration form when you register.
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Submission for OMB Review;
Comment Request: Prevalence,
Incidence, Epidemiology and
Molecular Variants of HIV in Blood
Donors in Brazil
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) 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 January 13, 2012, page 2072,
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 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:
Prevalence, Incidence, Epidemiology
and Molecular Variants of HIV in Blood
Donors in Brazil. Type of Information
Collection Request: Reinstatement
(OMB No. 0925–0597). Need and Use of
Information Collection: Establishing and
monitoring viral prevalence and
incidence rates, and identifying
behavioral risk behaviors for HIV
infection among donors are critical steps
to assessing and reducing risk of HIV
transmission through blood transfusion.
Detecting donors with recently acquired
HIV infection is particularly critical as
it enables characterization of the viral
subtypes currently transmitted within
the screened population. In addition to
characterizing genotypes of recently
infected donors for purposes of blood
safety, molecular surveillance of
incident HIV infections in blood donors
serves important public health roles by
identifying new HIV infections for antiretroviral treatment, and enabling
documentation of the rates of primary
E:\FR\FM\11APN1.SGM
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Agencies
[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21784-21785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8701]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No FDA-2012-N-0001]
Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug
Administration (Science Board).
General Function of the Committee: The Science Board provides
advice primarily to the Commissioner of Food and Drugs and other
appropriate officials on specific complex and technical issues, as well
as emerging issues within the scientific community in industry and
academia. Additionally, the Science Board provides advice to the Agency
on keeping pace with technical and scientific evolutions in the fields
of regulatory science, on formulating an appropriate research agenda,
and on upgrading its scientific and research facilities to keep pace
with these changes. It will also provide the means for critical review
of Agency-sponsored intramural and extramural scientific research
programs.
Date and Time: The meeting will be held on May 2, 2012, from 9 a.m.
to 4 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993.
For those unable to attend in person, the meeting will also be Web
cast. The link for the Web cast is available at https://collaboration.fda.gov/scienceboard/. Information regarding special
accommodations due to a disability, visitor parking, and transportation
may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm;
under the heading ``Resources for You,'' click on ``Public Meetings at
the FDA White Oak Campus.'' Please note that visitors to the White Oak
Campus must enter through Building 1.
CONTACT PERSON FOR MORE INFORMATION: Martha Monser, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301-796-4627, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC 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: The Science Board will be provided with an overview of
Georgetown University's proposed programs under the Centers for
Excellence in Regulatory Science and Innovation (CERSI) initiative. In
addition, the Board will also hear about CERSI activities resulting
from the Memorandum of Understanding between the National Center for
Toxicological Research and the state of Arkansas. The Board will also
be provided with an overview of ongoing genomic efforts at FDA as well
as an update on Foods activities and an update regarding Scientific
Computing efforts.
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.
[[Page 21785]]
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
April 25, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 April 17, 2012. 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 April 18, 2012.
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 Martha Monser 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: April 5, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8701 Filed 4-10-12; 8:45 am]
BILLING CODE 4160-01-P