Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Formerly Known as the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology), Renewal, 3805-3806 [2016-01181]
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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This draft guidance refers to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Cybersecurity in Medical Devices’’ draft
guidance, in general, and on the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• In the draft guidance, the FDA is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?
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• 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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22JAN1
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3806
Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Notices
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, ACPS–
CP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee. The
committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Pharmaceutical Science and
Clinical Pharmacology Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
scientific, clinical, and technical issues
related to the safety and effectiveness of
drug products for use in the treatment
of a broad spectrum of human diseases;
the quality characteristics which such
drugs purport or are represented to
have, and as required, any other product
for which the Food and Drug
Administration has regulatory
responsibility; and makes appropriate
recommendations to the Commissioner
of Food and Drugs. The Committee may
also review Agency sponsored
intramural and extramural biomedical
research programs in support of FDA’s
drug regulatory responsibilities and its
critical path initiatives related to
improving the efficacy and safety of
drugs and improving the efficiency of
drug development.
The Committee shall consist of a core
of 14 voting members including two
Chairpersons. Members and
Chairpersons are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of pharmaceutical sciences
(pharmaceutical manufacturing,
bioequivalence research, laboratory
analytical techniques, pharmaceutical
chemistry, physiochemistry,
biochemistry, molecular biology,
immunology, microbiology); clinical
pharmacology (dose-response,
pharmacokinetics-pharmacodynamics,
modeling and simulation,
pharmacogenomics, clinical trial design,
pediatrics and special populations and
innovative methods in drug
development); biostatistics, related
biomedical and pharmacological
specialties, current good manufacturing
VerDate Sep<11>2014
16:59 Jan 21, 2016
Jkt 238001
practices, and quality systems
implementation. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
up to three non-voting members who are
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at: https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
AdvisoryCommitteeforPharmaceutical
ScienceandClinicalPharmacology/ucm
107524.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). Due to
a change in the committee name, FDA
will publish a final rule will in the
Federal Register amending 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: January 15, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special
Programs.
[FR Doc. 2016–01181 Filed 1–21–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60 Day
Information Collection: Indian Health
Service Forms To Implement the
Privacy Rule
Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
general public to comment on the
information collection titled, ‘‘IHS
Forms to Implement the Privacy Rule
(45 CFR parts 160 and 164),’’ Office of
Management and Budget (OMB) Control
Number 0917–0030.
DATES: Comment Due Date: March 22,
2016. Your comments regarding this
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
information collection are best assured
of having full effect if received within
60 days of the date of this publication.
ADDRESSES: Send your written
comments, requests for more
information on the collection, or
requests to obtain a copy of the data
collection instrument and instructions
to Tamara Clay by one of the following
methods:
• Mail: Tamara Clay, Information
Collection Clearance Officer, Indian
Health Service, Office of Management
Services, Division of Regulatory Affairs,
5600 Fishers Lane, Mail Stop 09E70,
Rockville, MD 20857.
• Phone: 301–443–4750.
• Email: tamara.clay@ihs.gov.
• Fax: 301–443–2316.
SUPPLEMENTARY INFORMATION: This
previously approved information
collection project was last published in
the Federal Register (78 FR 2412) on
January 11, 2013, and allowed 30 days
for public comment. No public
comment was received in response to
the notice. This notice announces our
intent to submit the collection, which
expires April 30, 2016, to OMB for
approval of an extension, and to solicit
comments on specific aspects of the
information collection. A copy of the
supporting statement is available at
www.regulations.gov (see Docket ID
IHS–2016–1).
Title of Collection: 0917–0030, IHS
Forms to Implement the Privacy Rule
(45 CFR parts 160 and 164). Type of
Information Collection Request:
Extension of the currently approved
information collection, 0917–0030, IHS
Forms to Implement the Privacy Rule
(45 CFR parts 160 and 164). Form(s):
IHS–810, IHS–912–1, IHS–912–2, IHS–
913, and IHS–917. Need and Use of
Information Collection: This collection
of information is made necessary by the
Department of Health and Human
Services Rule entitled ‘‘Standards for
Privacy of Individually Identifiable
Health Information’’ (Privacy Rule) (45
CFR parts 160 and 164). The Privacy
Rule implements the privacy
requirements of the Administrative
Simplification subtitle of the Health
Insurance Portability and
Accountability Act of 1996, creates
national standards to protect
individual’s personal health
information, and gives patients
increased access to their medical
records. 45 CFR 164.508, 164.522,
164.526 and 164.528 of the Rule require
the collection of information to
implement these protection standards
and access requirements. The IHS will
continue to use the following data
collection instruments to meet the
E:\FR\FM\22JAN1.SGM
22JAN1
]]>Agencies
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Notices]
[Pages 3805-3806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01181]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
[[Page 3806]]
Drug Administration, 10903 New Hampshire Avenue, Bldg. 31, Rm. 2417,
Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, ACPS-CP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Pharmaceutical Science and Clinical Pharmacology
Advisory Committee. The committee is a discretionary Federal advisory
committee established to provide advice to the Commissioner. The
Pharmaceutical Science and Clinical Pharmacology Advisory Committee
advises the Commissioner or designee in discharging responsibilities as
they relate to helping to ensure safe and effective drugs for human use
and, as required, any other product for which the Food and Drug
Administration has regulatory responsibility.
The Committee reviews and evaluates scientific, clinical, and
technical issues related to the safety and effectiveness of drug
products for use in the treatment of a broad spectrum of human
diseases; the quality characteristics which such drugs purport or are
represented to have, and as required, any other product for which the
Food and Drug Administration has regulatory responsibility; and makes
appropriate recommendations to the Commissioner of Food and Drugs. The
Committee may also review Agency sponsored intramural and extramural
biomedical research programs in support of FDA's drug regulatory
responsibilities and its critical path initiatives related to improving
the efficacy and safety of drugs and improving the efficiency of drug
development.
The Committee shall consist of a core of 14 voting members
including two Chairpersons. Members and Chairpersons are selected by
the Commissioner or designee from among authorities knowledgeable in
the fields of pharmaceutical sciences (pharmaceutical manufacturing,
bioequivalence research, laboratory analytical techniques,
pharmaceutical chemistry, physiochemistry, biochemistry, molecular
biology, immunology, microbiology); clinical pharmacology (dose-
response, pharmacokinetics-pharmacodynamics, modeling and simulation,
pharmacogenomics, clinical trial design, pediatrics and special
populations and innovative methods in drug development); biostatistics,
related biomedical and pharmacological specialties, current good
manufacturing practices, and quality systems implementation. Almost all
non-Federal members of this committee serve as Special Government
Employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
up to three non-voting members who are identified with industry
interests.
Further information regarding the most recent charter and other
information can be found at: https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/ucm107524.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). Due to a change in the committee name,
FDA will publish a final rule will in the Federal Register amending 21
CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: January 15, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Programs.
[FR Doc. 2016-01181 Filed 1-21-16; 8:45 am]
BILLING CODE 4164-01-P
