Arthritis Advisory Committee; Notice of Meeting; Correction, 3805 [2016-01248]
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Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Notices
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of
‘‘Postmarket Management of
Cybersecurity in Medical Devices’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400044 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This draft guidance refers to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 803
(medical device reporting) have been
approved under OMB control number
0910–0437; the collections of
information in 21 CFR part 806 (reports
of corrections and removals) have been
approved under OMB control number
0910–0359; the collections of
information in 21 CFR part 810 (medical
device recall authority) have been
approved under OMB control number
0910–0432; the collections of
information in 21 CFR part 814
(premarket approval) have been
approved under OMB control number
0910–0231; the collections of
information in 21 CFR part 820 (quality
system regulations) have been approved
under OMB control number 0910–0073;
and the collections of information in 21
CFR part 822 (postmarket surveillance
of medical devices) have been approved
under OMB control number 0910–0449.
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V. Other Issues for Consideration
The Agency invites comments on the
‘‘Postmarket Management of
Cybersecurity in Medical Devices’’ draft
guidance, in general, and on the
following questions, in particular:
• What factors contribute to a
manufacturer’s decision whether or not
to participate in an ISAO?
• In the draft guidance, the FDA is
proposing its intention to not enforce
certain regulatory requirements for
manufacturer’s that are ‘‘participating
members ’’ of an ISAO. Should FDA
define what it means to be a
‘‘participating member’’ of an ISAO and
if so, how should such participation be
verified?
VerDate Sep<11>2014
16:59 Jan 21, 2016
Jkt 238001
• What are the characteristics
(participation, expertise, policies, and
practices) of an ISAO that would make
it qualified to participate in the sharing
and analysis of medical device
cybersecurity vulnerabilities? What are
the benefits and disadvantages of FDA
‘‘recognizing’’ specific ISAOs as
possessing specialized expertise
relevant to sharing and analysis of
medical device vulnerabilities and what
should such recognition entail?
• When cybersecurity vulnerability
information is not reported to FDA,
what information should be reported to
the ISAO, and when?
• How should the FDA interact with
ISAOs, manufacturers, HDOs, security
researchers and other stakeholders to
maximize the sharing of information
concerning cybersecurity threats while
maintaining confidentiality and
protecting commercial confidential
information?
Dated: January 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01172 Filed 1–21–16; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Arthritis Advisory Committee; Notice
of Meeting; Correction
Food and Drug Administration,
HHS.
ACTION:
Dated: January 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01248 Filed 1–21–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2016–N–0001]
Advisory Committee; Pharmaceutical
Science and Clinical Pharmacology
Advisory Committee (Formerly Known
as the Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology), Renewal
AGENCY:
Fmt 4703
Sfmt 4703
Notice.
The Food and Drug
Administration (FDA) is announcing the
renewal of the Pharmaceutical Science
and Clinical Pharmacology Advisory
Committee (formerly known as the
Advisory Committee for Pharmaceutical
Science and Clinical Pharmacology) by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Pharmaceutical
Science and Clinical Pharmacology
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until the January 22, 2018.
DATES: Authority for the Pharmaceutical
Science and Clinical Pharmacology
Advisory Committee will expire on
January 22, 2018, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
SUMMARY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on January 19, 2016 (81 FR
2873). The document announced an
‘‘Arthritis Advisory Committee’’
meeting and contained an incorrect date
for individuals requesting oral
presentations, and for FDA notifying
individuals regarding their request to
speak at the meeting. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533.
SUPPLEMENTARY INFORMATION: In FR Doc.
2016–00823, appearing on page 2873 in
the Federal Register of Tuesday,
January 19, 2016, the following
corrections are made:
Frm 00030
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY:
PO 00000
1. On page 2873, in the third column,
in the ‘‘Procedure’’ paragraph, the
fourth sentence is corrected to read
‘‘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 January 28, 2016.’’
2. On page 2873, in the third column,
in the ‘‘Procedure’’ paragraph, the last
sentence is corrected to read ‘‘The
contact person will notify interested
persons regarding their request to speak
by January 29, 2016.’’
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
3805
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[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Notices]
[Page 3805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Arthritis Advisory Committee; Notice of Meeting; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on January 19, 2016 (81 FR 2873).
The document announced an ``Arthritis Advisory Committee'' meeting and
contained an incorrect date for individuals requesting oral
presentations, and for FDA notifying individuals regarding their
request to speak at the meeting. This document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533.
SUPPLEMENTARY INFORMATION: In FR Doc. 2016-00823, appearing on page
2873 in the Federal Register of Tuesday, January 19, 2016, the
following corrections are made:
1. On page 2873, in the third column, in the ``Procedure''
paragraph, the fourth sentence is corrected to read ``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 January 28, 2016.''
2. On page 2873, in the third column, in the ``Procedure''
paragraph, the last sentence is corrected to read ``The contact person
will notify interested persons regarding their request to speak by
January 29, 2016.''
Dated: January 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01248 Filed 1-21-16; 8:45 am]
BILLING CODE 4164-01-P
