81 FR 3805 - Arthritis Advisory Committee; Notice of Meeting; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 14 (January 22, 2016)

Page Range		3805-3805
FR Document		2016-01248

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.

Federal Register, Volume 81 Issue 14 (Friday, January 22, 2016)

[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Notices]
[Page 3805]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Notices 3805

GuidanceDocuments/default.htm. • What are the characteristics 1. On page 2873, in the third column,
Guidance documents are also available (participation, expertise, policies, and in the ‘‘Procedure’’ paragraph, the
at http://www.fda.gov/BiologicsBlood practices) of an ISAO that would make fourth sentence is corrected to read
Vaccines/GuidanceCompliance it qualified to participate in the sharing ‘‘Those individuals interested in making
RegulatoryInformation/Guidances/ and analysis of medical device formal oral presentations should notify
default.htm or http:// cybersecurity vulnerabilities? What are the contact person and submit a brief
www.regulations.gov. Persons unable to the benefits and disadvantages of FDA statement of the general nature of the
download an electronic copy of ‘‘recognizing’’ specific ISAOs as evidence or arguments they wish to
‘‘Postmarket Management of possessing specialized expertise present, the names and addresses of
Cybersecurity in Medical Devices’’ may relevant to sharing and analysis of proposed participants, and an
send an email request to CDRH- medical device vulnerabilities and what indication of the approximate time
Guidance@fda.hhs.gov to receive an should such recognition entail? requested to make their presentation on
electronic copy of the document. Please • When cybersecurity vulnerability or before January 28, 2016.’’
use the document number 1400044 to information is not reported to FDA, 2. On page 2873, in the third column,
identify the guidance you are what information should be reported to in the ‘‘Procedure’’ paragraph, the last
requesting. the ISAO, and when? sentence is corrected to read ‘‘The
• How should the FDA interact with contact person will notify interested
IV. Paperwork Reduction Act of 1995 ISAOs, manufacturers, HDOs, security persons regarding their request to speak
This draft guidance refers to researchers and other stakeholders to by January 29, 2016.’’
previously approved collections of maximize the sharing of information Dated: January 19, 2016.
information found in FDA regulations. concerning cybersecurity threats while
Leslie Kux,
These collections of information are maintaining confidentiality and
Associate Commissioner for Policy.
subject to review by the Office of protecting commercial confidential
information? [FR Doc. 2016–01248 Filed 1–21–16; 8:45 am]
Management and Budget (OMB) under
BILLING CODE 4164–01–P
the Paperwork Reduction Act of 1995 Dated: January 15, 2016.
(44 U.S.C. 3501–3520). The collections Leslie Kux,
of information in 21 CFR part 803 Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND
(medical device reporting) have been
[FR Doc. 2016–01172 Filed 1–21–16; 8:45 am] HUMAN SERVICES
approved under OMB control number
BILLING CODE 4164–01–P
0910–0437; the collections of Food and Drug Administration
information in 21 CFR part 806 (reports
of corrections and removals) have been [Docket No. FDA–2016–N–0001]
DEPARTMENT OF HEALTH AND
approved under OMB control number HUMAN SERVICES Advisory Committee; Pharmaceutical
0910–0359; the collections of
Science and Clinical Pharmacology
information in 21 CFR part 810 (medical Food and Drug Administration Advisory Committee (Formerly Known
device recall authority) have been
[Docket No. FDA–2016–N–0001] as the Advisory Committee for
approved under OMB control number
Pharmaceutical Science and Clinical
0910–0432; the collections of
Arthritis Advisory Committee; Notice Pharmacology), Renewal
information in 21 CFR part 814
of Meeting; Correction
(premarket approval) have been AGENCY: Food and Drug Administration,
approved under OMB control number AGENCY: Food and Drug Administration, HHS.
0910–0231; the collections of HHS. ACTION: Notice.
information in 21 CFR part 820 (quality ACTION: Notice; correction.
system regulations) have been approved SUMMARY: The Food and Drug
under OMB control number 0910–0073; SUMMARY: The Food and Drug Administration (FDA) is announcing the
and the collections of information in 21 Administration (FDA) is correcting a renewal of the Pharmaceutical Science
CFR part 822 (postmarket surveillance notice that appeared in the Federal and Clinical Pharmacology Advisory
of medical devices) have been approved Register on January 19, 2016 (81 FR Committee (formerly known as the
under OMB control number 0910–0449. 2873). The document announced an Advisory Committee for Pharmaceutical
‘‘Arthritis Advisory Committee’’ Science and Clinical Pharmacology) by
V. Other Issues for Consideration meeting and contained an incorrect date the Commissioner of Food and Drugs
The Agency invites comments on the for individuals requesting oral (the Commissioner). The Commissioner
‘‘Postmarket Management of presentations, and for FDA notifying has determined that it is in the public
Cybersecurity in Medical Devices’’ draft individuals regarding their request to interest to renew the Pharmaceutical
guidance, in general, and on the speak at the meeting. This document Science and Clinical Pharmacology
following questions, in particular: corrects those errors. Advisory Committee for an additional 2
• What factors contribute to a FOR FURTHER INFORMATION CONTACT: years beyond the charter expiration
manufacturer’s decision whether or not Stephanie L. Begansky, Center for Drug date. The new charter will be in effect
to participate in an ISAO? Evaluation and Research, Food and until the January 22, 2018.
• In the draft guidance, the FDA is Drug Administration, 10903 New DATES: Authority for the Pharmaceutical
Hampshire Ave., Bldg. 31, Rm. 2417, Science and Clinical Pharmacology
mstockstill on DSK4VPTVN1PROD with NOTICES

proposing its intention to not enforce
certain regulatory requirements for Silver Spring, MD 20993–0002, 301– Advisory Committee will expire on
manufacturer’s that are ‘‘participating 796–9001, FAX: 301–847–8533. January 22, 2018, unless the
members ’’ of an ISAO. Should FDA SUPPLEMENTARY INFORMATION: In FR Doc. Commissioner formally determines that
define what it means to be a 2016–00823, appearing on page 2873 in renewal is in the public interest.
‘‘participating member’’ of an ISAO and the Federal Register of Tuesday, FOR FURTHER INFORMATION CONTACT:
if so, how should such participation be January 19, 2016, the following Jennifer Shepherd, Center for Drug
verified? corrections are made: Evaluation and Research, Food and

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Document Created: 2016-01-22 01:16:43
Document Modified: 2016-01-22 01:16:43

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; correction.
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.
FR Citation		81 FR 3805

81 FR 3805 - Arthritis Advisory Committee; Notice of Meeting; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 14 (January 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration