National Institute on Drug Abuse; Notice of Meeting, 44273 [E8-17259]
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Federal Register / Vol. 73, No. 147 / Wednesday, July 30, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Nucleic Acid Testing (NAT) to
Reduce the Possible Risk of Parvovirus
B19 Transmission by Plasma-Derived
Products’’ dated July 2008. Parvovirus
B19 is a small, non-enveloped single
strand DNA virus that is highly resistant
to all commonly used inactivation
methods. The parvovirus B19 can be
transmitted by blood components and
certain plasma derivatives and may
cause morbidity to susceptible
recipients such as pregnant women,
persons with underlying hemolytic
disorders, and immune compromised
individuals. The disease transmission
from transfusion of blood components is
rare; however, extremely high levels of
parvovirus B19 in plasma of acutely
infected but asymptomatic donors may
present a greater risk in plasma
derivatives due to pooling of large
numbers of plasma units in the
manufacture of these products.
The draft guidance provides
recommendations for performing
parvovirus B19 NAT as an in-process
test for Source Plasma and recovered
plasma used in the further
manufacturing of plasma-derived
products to identify and help to prevent
the use of plasma units containing high
levels of parvovirus B19. The draft
guidance also recommends how to
report to the FDA implementation of
parvovirus B19 NAT.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. 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. Paperwork Reduction Act of 1995
This draft guidance refers to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 Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 211.165 and
211.194 have been approved under
0910–0139; the collections of
information in 21 CFR 600.12 have been
approved under 0910–0308.
III. Comments
The draft guidance is being
distributed for comment purposes only
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and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.regulations.gov.
Dated: July 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17431 Filed 7–29–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Advisory Council on Drug
Abuse.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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44273
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Drug Abuse.
Date: September 9–10, 2008.
Closed: September 9, 2008, 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Open: September 10, 2008, 8:30 a.m. to 1
p.m.
Agenda: This portion of the meeting will
be open to the public for announcements and
reports of administrative, legislative and
program developments in the drug abuse
field.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Teresa Levitin, PhD,
Director, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 220, MSC 8401, 6101 Executive
Boulevard, Bethesda, MD 20892–8401, (301)
443–2755.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.drugabuse.gov/NACDA/
NACDAHome.html, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: July 22, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–17259 Filed 7–29–08; 8:45 am]
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[Federal Register Volume 73, Number 147 (Wednesday, July 30, 2008)]
[Notices]
[Page 44273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17259]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of
the National Advisory Council on Drug Abuse.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Advisory Council on Drug Abuse.
Date: September 9-10, 2008.
Closed: September 9, 2008, 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852.
Open: September 10, 2008, 8:30 a.m. to 1 p.m.
Agenda: This portion of the meeting will be open to the public
for announcements and reports of administrative, legislative and
program developments in the drug abuse field.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852.
Contact Person: Teresa Levitin, PhD, Director, Office of
Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS,
Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892-
8401, (301) 443-2755.
Any member of the public interested in presenting oral comments
to the committee may notify the Contact Person listed on this notice
at least 10 days in advance of the meeting. Interested individuals
and representatives of organizations may submit a letter of intent,
a brief description of the organization represented, and a short
description of the oral presentation. Only one representative of an
organization may be allowed to present oral comments and if accepted
by the committee, presentations may be limited to five minutes. Both
printed and electronic copies are requested for the record. In
addition, any interested person may file written comments with the
committee by forwarding their statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
Information is also available on the Institute's/Center's home
page: https://www.drugabuse.gov/NACDA/NACDAHome.html, where an agenda
and any additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: July 22, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-17259 Filed 7-29-08; 8:45 am]
BILLING CODE 4140-01-M
