Notice of Charter Renewal, 21778 [2014-08677]
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21778
Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
to mitigate future outbreaks of TASS.
This draft guidance is not final nor is it
in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 16, 2014.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for
single copies of the draft guidance
document entitled ‘‘Endotoxin Testing
Recommendations for Single-Use
Intraocular Ophthalmic Devices’’ to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Michelle Tarver, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2504, Silver Spring,
MD 20993–0002, 301–796–5620.
SUPPLEMENTARY INFORMATION:
I. Background
TASS has been increasing in
frequency. Some cases of TASS are
severe enough to require secondary
surgical interventions including
glaucoma surgery and corneal
transplantation. It is estimated that
clusters of 3 to 20 cases of TASS occur
several times each year, translating to an
estimated incidence of more than 1 in
1,000. The use of inadequately or
improperly processed ophthalmic
surgical instruments is one of many
factors suggested as a potential cause of
TASS. In many TASS cases, bacterial
endotoxin from medical devices is
believed to cause the inflammation.
This guidance document was
developed to notify manufacturers and
other entities involved in submitting
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PMAs or 510(k)s for different categories
of IODs of the recommended endotoxin
limit for the release of IODs and singleuse intraocular ophthalmic surgical
instruments/accessories in an effort to
mitigate future TASS outbreaks.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on endotoxin testing and limits for
single-use IODs. 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 statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov.
To receive ‘‘Endotoxin Testing
Recommendations for Single-Use
Intraocular Ophthalmic Devices,’’ you
may either send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document or
send a fax request to 301–847–8149 to
receive a hard copy. Please use the
document number 1836 to identify the
guidance you are requesting.
IV. 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 part 814 have
been approved under OMB control
number 0910–0231.
V. 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
PO 00000
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will be posted to the docket at https://
www.regulations.gov.
Dated: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08711 Filed 4–16–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Charter Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations, 102–
3.65(a), notice is hereby given that the
Charter for the National Science
Advisory Board for Biosecurity
(NSABB) was renewed for an additional
two-year period on April 7, 2014.
It is determined that the NSABB is in
the public interest and consistent with
the performance of duties imposed on
the Department of Health and Human
Services by law, and that these duties
can best be performed with the advice
and counsel of this group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: April 11, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–08677 Filed 4–16–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Vaccine
Research Center Board of Scientific
Counselors, NIAID.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Allergy and
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[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Page 21778]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08677]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Charter Renewal
In accordance with Title 41 of the U.S. Code of Federal
Regulations, 102-3.65(a), notice is hereby given that the Charter for
the National Science Advisory Board for Biosecurity (NSABB) was renewed
for an additional two-year period on April 7, 2014.
It is determined that the NSABB is in the public interest and
consistent with the performance of duties imposed on the Department of
Health and Human Services by law, and that these duties can best be
performed with the advice and counsel of this group.
Inquiries may be directed to Jennifer Spaeth, Director, Office of
Federal Advisory Committee Policy, Office of the Director, National
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda,
Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or
spaethj@od.nih.gov.
Dated: April 11, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-08677 Filed 4-16-14; 8:45 am]
BILLING CODE 4140-01-P
