Saccharomyces boulardii Eligibility for Consideration To Be Added to the Over-the-Counter Drug Monograph for Antidiarrheal Drug Products; Request for Safety and Effectiveness Data; Withdrawal, 55245-55246 [E9-25803]
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Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices
(arthropod-borne viruses), by
transfusion, infusion, implantation, or
transplantation in the United States.
The public workshop will feature
presentations and roundtable
discussions led by experts from
academic institutions, government, and
industry.
Date and Time: The public workshop
will be held on December 14, 2009, from
8:30 a.m. to 5:30 p.m. and December 15,
2009, from 8:30 a.m. to 5:30 p.m.
Location: The public workshop will
be held at the Natcher Conference
Center, Main Auditorium, Bldg. 45,
National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 550N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
Contact Person by November 20, 2009.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
Requests for Presentations of Data:
Interested persons are invited to present
data related to technologies for the
detection or inactivation of arboviruses
in blood products, organs, or tissues. If
you are interested in presenting, submit
a brief statement of the general nature of
the presentation to the Contact Person
by November 20, 2009 (see section II of
this document for additional
information).
SUPPLEMENTARY INFORMATION:
pwalker on DSK8KYBLC1PROD with NOTICES
I. Background
Arboviruses are a large group of
viruses that are spread by certain
invertebrate animals, most commonly
blood-sucking insects. Arboviruses are
found throughout the world, including
the United States. Arboviruses, such as
Dengue virus, Japanese Encephalitis
virus (JE), tick-borne encephalitis virus
(TBE), and West Nile virus (WNV), are
becoming increasingly widespread.
Transmission of WNV and Dengue virus
through blood transfusion has been well
documented. Transfusion transmission
of the Colorado tick fever (CTF) virus,
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a tick-borne agent present in the United
States, also has been reported. Other
arboviruses, including JE, TBE, and St.
Louis Encephalitis are of concern to
blood, cell, tissue, and organ safety
because of the possibility of viremia in
asymptomatic human infections.
Dengue outbreaks have recently
occurred in Texas, Hawaii, Puerto Rico,
and the U.S. Virgin Islands. Dengue
virus, as well as TBE, and JE, have the
potential to become endemic in certain
regions of the United States. Therefore,
proactive discussions among the
Department of Health and Human
Services public health agencies,
including the FDA, National Institutes
of Health, and the Centers for Disease
Control and Prevention, academia,
industry, blood establishments, cell and
tissue establishments, and other
stakeholders are necessary to address
blood, cell, tissue, and organ safety in
response to the emerging arboviruses.
The public workshop will facilitate a
scientific discussion on approaches to
reduce the risk of transmission of
arboviruses by transfusion, infusion,
implantation, or transplantation in the
United States. Topics to be discussed
include: (1) Biology and pathogenesis of
arboviruses; (2) epidemiology and
prevention of arbovirus vectors and
hosts in the United States; (3) laboratory
detection and prevention of arbovirus
infection in humans; (4) transfusion,
infusion, implantation or
transplantation transmission of
arboviruses in the United States; and (5)
potential approaches, including donor
testing and pathogen inactivation, to
reduce the risk of transfusion
transmission of arboviruses.
II. Requests for Presentations of Data
Interested persons are invited to
present data related to technologies for
the detection or inactivation of
arboviruses in blood products, organs,
or tissues. Those desiring to make
presentations at the workshop should
notify the Contact Person and submit a
brief statement of the general nature of
the presentation before November 20,
2009. Presentations will be scheduled
on the afternoon of December 15, 2009.
Time allotted for each presentation will
be limited depending on the number of
individuals requesting to speak.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
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55245
Internet at https://www.fda.gov/Biologics
BloodVaccines/NewsEvents/Workshops
MeetingsConferences/Transcripts
Minutes/default.htm.
Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25802 Filed 10–26–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0063] (formerly
Docket No. 2004N–0346)
Saccharomyces boulardii Eligibility for
Consideration To Be Added to the
Over-the-Counter Drug Monograph for
Antidiarrheal Drug Products; Request
for Safety and Effectiveness Data;
Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Withdrawal of notice of
eligibility and request for data and
information.
SUMMARY: We (Food and Drug
Administration (FDA)) are withdrawing
a notice of eligibility and call-for-data
for safety and effectiveness information.
The original notice published in the
Federal Register of August 23, 2004 (69
FR 51852). In that notice, we announced
that Saccharomyces boulardii (S.
boulardii) was eligible for consideration
to be added to the over-the-counter
(OTC) monograph for antidiarrheal drug
products.
FOR FURTHER INFORMATION CONTACT:
Michael L. Koenig, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION: In 2004,
we published a notice of eligibility for
consideration of the yeast S. boulardii in
the OTC drug monograph system. We
announced our intention to evaluate S.
boulardii for inclusion in the
monograph for OTC antidiarrheal drug
products (21 CFR part 335). The notice
also requested submission of data and
information on the safety and
effectiveness of S. boulardii for us to
determine whether it could be generally
recognized as safe and effective (GRAS/
E) and not misbranded for its proposed
OTC drug use.
S. boulardii for antidiarrheal use
meets the definition of a drug in the
Federal Food, Drug, and Cosmetic Act.
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55246
Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices
(See section 201(g)(1) (21 U.S.C.
321(g)(1).) S. boulardii is a yeast or
unicellular fungus and, therefore, also
meets the definition of a biological
product in the Public Health Service Act
for this use. (See section 351(i) (42
U.S.C. 262(i) and 21 CFR 600.3(h)(1).)
We have determined that this yeast is
more appropriately regulated as a
biological product under the biologics
license application system than as an
OTC drug product under the monograph
system. Because we have decided to
regulate S. boulardii as a biological
product, S. boulardii is not eligible for
consideration to be included in an OTC
drug monograph. Therefore, this
document withdraws the 2004 notice of
eligibility permitting consideration of S.
boulardii for addition to the monograph
for OTC antidiarrheal drug products.
This document also withdraws our 2004
request for submission of safety and
effectiveness data and information on S.
boulardii for OTC antidiarrheal use.
Any further consideration of the
potential therapeutic use(s) of this yeast
should be addressed under regulations
and procedures governing biological
products.
Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25803 Filed 10–26–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2009–0091]
Notice of Availability of Proposed
Guidance for Protecting Responders’
Health During the First Week Following
a Wide-Area Anthrax Attack
Office of Health Affairs, DHS.
ACTION: Notice of availability; request
for comments.
pwalker on DSK8KYBLC1PROD with NOTICES
AGENCY:
SUMMARY: The Department of Homeland
Security (DHS) is accepting comments
on ‘‘Proposed Guidance for Protecting
Responders’ Health During the First
Week Following a Wide-Area Anthrax
Attack.’’
DATES: Comments must be received by
November 27, 2009.
ADDRESSES: Comments must be
identified by docket number DHS–
2009–0091 and may be submitted by
one of the following methods:
• Mail: David V. Adams, U.S.
Department of Homeland Security,
Office of Health Affairs, Mail Stop 0315,
Washington, DC 20528; and
• Federal Rulemaking Portal: https://
www.regulations.gov. Follow the
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instructions for submitting comments.
Please note the Proposed Guidance is
not a rulemaking and the Federal
Rulemaking Portal is being utilized only
as a mechanism for receiving comments.
FOR FURTHER INFORMATION CONTACT:
David V. Adams, Director, Contingency
Planning & Policy, Office of Health
Affairs, Mail Stop 0315, Washington, DC
20528, e-mail address
david.v.adams@dhs.gov, telephone
number (202) 254–5756.
SUPPLEMENTARY INFORMATION:
I. Public Participation
DHS invites interested persons to
contribute suggestions and comments
on the document entitled ‘‘Proposed
Guidance for Protecting Responders’
Health During the First Week Following
a Wide-Area Anthrax Attack’’ (Proposed
Guidance) by submitting written data or
views. Comments that will provide the
most assistance to DHS will explain the
reason for any recommended changes to
the Proposed Guidance and include
data, information, or authority that
supports such recommended changes.
DHS requests that commenters identify
any recommended changes by page and
line number, and/or by Figure or Table
number. The Proposed Guidance can be
viewed or downloaded at https://
www.regulations.gov.
Instructions: All submissions received
must include the agency/organization
name and docket number for this action.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to read the
Privacy Act notice that is available on
the Privacy and Use Notice link on the
Administration Navigation Bar of
www.regulations.gov.
You may submit your comments and
material by the methods specified in the
ADDRESSES section above. Please submit
your comments and any supporting
material by only one means to avoid the
receipt and review of duplicate
submissions. If you submit comments
by mail, your submission should be an
unbound document and no larger than
8.5 by 11 inches to enable copying and
electronic document management.
Docket: The Guidance and any
comments received can be viewed at
https://www.regulations.gov by searching
the docket number referenced above.
II. Background
This document provides policy
recommendations for protection of the
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health of personnel responding to a
wide-area anthrax attack. At the request
of the Homeland Security Council (HSC)
a Federal interagency working group,
consisting of subject matter experts in
biodefense, infectious diseases, and
occupational health and safety, has
developed this consensus proposed
guidance regarding appropriate
protective measures for responders in
the immediate post-attack environment
of an aerosolized anthrax attack. This
proposed guidance statement reflects
the most current understanding of the
unique environment that will exist after
a wide-area anthrax release. These
recommendations will evolve with
stakeholder input, scientific
developments, and availability of new
environmental monitoring techniques.
The Proposed Guidance does not have
the force or effect of law.
DHS seeks comment on the Proposed
Guidance document, which is available
online at https://www.regulations.gov.
Based on the comments received, DHS
may make appropriate revisions to the
Proposed Guidance or may leave the
Proposed Guidance as is. In any event,
DHS will make available the Final
Guidance at https://www.regulations.gov.
The Final Guidance will not have the
force or effect of law.
Dated: October 21, 2009.
Alex Garza,
Assistant Secretary and Chief Medical Officer,
Office of Health Affairs.
[FR Doc. E9–25770 Filed 10–26–09; 8:45 am]
BILLING CODE 9110–9K–P
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
[Docket No. TSA–2004–19147]
Intent To Request Renewal From OMB
of One Current Public Collection of
Information: Flight Training for Aliens
and Other Designated Individuals;
Security Awareness Training for Flight
School Employees
AGENCY: Transportation Security
Administration, DHS.
ACTION: 60-day notice.
SUMMARY: The Transportation Security
Administration (TSA) invites public
comment on an existing information
collection requirement abstracted below
that will be submitted to the Office of
Management and Budget (OMB) for
renewal in compliance with the
Paperwork Reduction Act. The
collection involves conducting
background checks for all aliens and
other designated individuals seeking
E:\FR\FM\27OCN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Pages 55245-55246]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25803]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0063] (formerly Docket No. 2004N-0346)
Saccharomyces boulardii Eligibility for Consideration To Be Added
to the Over-the-Counter Drug Monograph for Antidiarrheal Drug Products;
Request for Safety and Effectiveness Data; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Withdrawal of notice of eligibility and request for data and
information.
-----------------------------------------------------------------------
SUMMARY: We (Food and Drug Administration (FDA)) are withdrawing a
notice of eligibility and call-for-data for safety and effectiveness
information. The original notice published in the Federal Register of
August 23, 2004 (69 FR 51852). In that notice, we announced that
Saccharomyces boulardii (S. boulardii) was eligible for consideration
to be added to the over-the-counter (OTC) monograph for antidiarrheal
drug products.
FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.
SUPPLEMENTARY INFORMATION: In 2004, we published a notice of
eligibility for consideration of the yeast S. boulardii in the OTC drug
monograph system. We announced our intention to evaluate S. boulardii
for inclusion in the monograph for OTC antidiarrheal drug products (21
CFR part 335). The notice also requested submission of data and
information on the safety and effectiveness of S. boulardii for us to
determine whether it could be generally recognized as safe and
effective (GRAS/E) and not misbranded for its proposed OTC drug use.
S. boulardii for antidiarrheal use meets the definition of a drug
in the Federal Food, Drug, and Cosmetic Act.
[[Page 55246]]
(See section 201(g)(1) (21 U.S.C. 321(g)(1).) S. boulardii is a yeast
or unicellular fungus and, therefore, also meets the definition of a
biological product in the Public Health Service Act for this use. (See
section 351(i) (42 U.S.C. 262(i) and 21 CFR 600.3(h)(1).) We have
determined that this yeast is more appropriately regulated as a
biological product under the biologics license application system than
as an OTC drug product under the monograph system. Because we have
decided to regulate S. boulardii as a biological product, S. boulardii
is not eligible for consideration to be included in an OTC drug
monograph. Therefore, this document withdraws the 2004 notice of
eligibility permitting consideration of S. boulardii for addition to
the monograph for OTC antidiarrheal drug products. This document also
withdraws our 2004 request for submission of safety and effectiveness
data and information on S. boulardii for OTC antidiarrheal use. Any
further consideration of the potential therapeutic use(s) of this yeast
should be addressed under regulations and procedures governing
biological products.
Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25803 Filed 10-26-09; 8:45 am]
BILLING CODE 4160-01-S
