Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal, 71106-71107 [2016-24810]
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Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests.
FOR FURTHER INFORMATION CONTACT:
Regarding the draft guidance: Bakul
Patel, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5458, Silver Spring,
MD 20993–0002, 301–796–5528.
Regarding the IMDRF: Melissa A.
Torres, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5432, Silver Spring,
MD 20993–0002, 301–796–5576.
SUPPLEMENTARY INFORMATION:
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I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. One of the goals of global
harmonization is to identify and then
reduce differences in regulatory policies
among regulatory agencies. IMDRF
seeks to advance international
harmonization or convergence of
medical device regulation.
IMDRF was organized to provide an
opportunity for global harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. The current members of
the Management Committee of the
IMDRF are regulatory officials from
Australia (Therapeutic Goods
Administration), Brazil (National Health
Surveillance Agency), Canada (Health
Canada), China (China Food and Drug
Administration), European Union
(European Commission DirectorateGeneral for Internal Market, Industry,
Entrepreneurship and Small and
Medium-sized Enterprises), Japan
(Pharmaceuticals and Medical Devices
Agency and the Ministry of Health,
Labour and Welfare), Russia (Ministry of
Healthcare), and the United States (U.S.
FDA). The World Health Organization
and the Asia-Pacific Economic
Cooperation Life Sciences Innovation
Forum Regulatory Harmonization
Steering Committee are Official
Observers. The Asian Harmonization
Working Party and the Pan American
Health Organization are IMDRF Affiliate
Organizations.
In September 2016, the IMDRF
Management Committee endorsed the
draft guidance entitled ‘‘Software as a
Medical Device (SaMD): Clinical
Evaluation’’ and agreed that the
guidance should be made available for
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public comment. The IMDRF SaMD
Working Group (WG) includes
representatives from the IMDRF
members, as well as members from the
Medical Device Regulatory Authorities
and Regional Harmonization Initiatives
from around the world. The draft
guidance is the product of the IMDRF
SaMD WG. Comments about this draft
will be considered by FDA and the
IMDRF SaMD WG.
We welcome comments on all aspects
of the draft guidance as well as the
following specific issues:
1. Does the document address the
intention captured in the introduction/
scope or vice versa?
2. Does the document appropriately
translate and apply current clinical
vocabulary for SaMD?
3. Are there other types of SaMD
beyond those intended for nondiagnostic, diagnostic and therapeutic
purposes that should be highlighted/
considered in the document?
4. Does the document adequately
address the relevant clinical evaluation
methods and processes for SaMD to
generate clinical evidence?
5. Are there other appropriate
methods for generating clinical
evaluation evidence that are relevant for
SaMD beyond those described in the
document?
6. Are the recommendations
identified in section 7.2 related to the
‘‘importance of clinical evidence and
expectations’’ appropriate as outlined
for the different SaMD categories?
7. Are the recommendations
identified in section 7.3 related to the
‘‘importance of independent review’’
appropriate as outlined for the different
SaMD categories?
8. Given the uniqueness of SaMD and
the proposed framework—is there any
impact on currently regulated devices or
any possible adverse consequences?
The draft guidance and the IMDRF
comment page are available at https://
www.imdrf.org/consultations/
consultations.asp#current.
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 current thinking of FDA
on ‘‘Software as a Medical Device
(SaMD): Clinical Evaluation.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
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III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Software as a Medical Device
(SaMD): Clinical Evaluation’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 16039 to identify the
guidance you are requesting.
Dated: October 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–24805 Filed 10–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Antimicrobial
Drugs Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Antimicrobial Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Antimicrobial
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until October 7, 2018.
DATES: Authority for the Antimicrobial
Drugs Advisory Committee will expire
on October 7, 2016, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Lauren Tesh, 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, email:
AMDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
SUMMARY:
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rmajette on DSK2TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices
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
Antimicrobial Drugs Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Antimicrobial
Drugs 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
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of infectious
diseases and disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of infectious
disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Members will be invited to serve for
overlapping terms of up to four years.
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 consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
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/
Anti-InfectiveDrugsAdvisoryCommittee/
ucm094132.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
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.
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Dated: October 7, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–24810 Filed 10–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders in Newborns and Children
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
In accordance with section
10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92–463, codified
at 5 U.S.C. App.), notice is hereby given
that a meeting is scheduled for the
Advisory Committee on Heritable
Disorders in Newborns and Children.
This meeting will be open to the public
but advance registration is required to
ensure sufficient webinar capacity. The
registration link is https://
www.blsmeetings.net/
achdncnovember2016/. The registration
deadline is Wednesday, November 2,
2016, 11:59 p.m. Eastern Time.
DATES AND TIMES: November 3, 2016,
9:00 a.m. to 5:00 p.m. (Meeting time is
tentative.)
November 4, 2016, 9:00 a.m. to 1:00
p.m. (Meeting time is tentative.)
ADDRESSES: This meeting will be held
by webinar only.
FOR FURTHER INFORMATION CONTACT:
Anyone interested in obtaining other
relevant information should contact
Alaina Harris, Maternal and Child
Health Bureau, HRSA, Room 18W66,
5600 Fishers Lane, Rockville, Maryland
20857; email: aharris@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee), as authorized by the
Public Health Service Act, Title XI,
§ 1111 (42 U.S.C. 300b–10), was
established to advise the Secretary of
the Department of Health and Human
Services about the development of
newborn screening activities,
technologies, policies, guidelines, and
programs for effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders. In addition, the
Committee’s recommendations
regarding additional conditions/
inherited disorders for screening that
SUMMARY:
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71107
have been adopted by the Secretary are
included in the Recommended Uniform
Screening Panel and constitute part of
the comprehensive guidelines
supported by HRSA. Pursuant to section
2713 of the Public Health Service Act,
codified at 42 U.S.C. 300gg–13, nongrandfathered health plans are required
to cover screenings included in the
HRSA-supported comprehensive
guidelines without charging a copayment, co-insurance, or deductible for
plan years (i.e., policy years) beginning
on or after the date that is 1-year from
the Secretary’s adoption of the
condition for screening.
The Committee will hear
presentations and discussions on topics
related to newborn screening activities,
technologies, policies, guidelines, and
programs for effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders. The Committee will
also hear updates from the Laboratory
Standards and Procedures workgroup,
Follow-up and Treatment workgroup,
and Education and Training workgroup.
Agenda items are subject to changes as
priorities indicate. Tentatively, the
Committee is expected to review and/or
vote on the following: Approving
newborn screening surveillance case
definitions and whether or not the
nominated condition Guanidinoacetate
Methyltransferase deficiency should be
referred for a full evidence-based
review. The Committee will not be
voting on a proposed addition of a
condition to the Recommended Uniform
Screening Panel. The meeting agenda
will be available 2 days prior to the
meeting on the Committee’s Web site:
https://www.hrsa.gov/
advisorycommittees/mchbadvisory/
heritabledisorders.
Members of the public may submit
written and/or present oral comments at
the meeting. All comments are part of
the official Committee record. Advance
registration is required to submit written
comments and/or present oral
comments. Written comments must be
submitted by October 19, 2016, 11:59
p.m. Eastern Time in order to be
included in the November meeting
briefing book. Written comments should
identify the individual’s name, address,
email, telephone number, professional
or business affiliation, type of expertise
(i.e., parent, researcher, clinician, public
health, etc.), and the topic/subject
matter of comments.
Individuals who wish to provide oral
comments must register by October 30,
2016, 11:59 p.m. Eastern Time. To
ensure that all individuals who have
registered to make oral comments can be
accommodated, the allocated time may
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]]>Agencies
[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71106-71107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24810]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Antimicrobial Drugs Advisory Committee,
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Antimicrobial Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Antimicrobial
Drugs Advisory Committee for an additional 2 years beyond the charter
expiration date. The new charter will be in effect until October 7,
2018.
DATES: Authority for the Antimicrobial Drugs Advisory Committee will
expire on October 7, 2016, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Lauren Tesh, 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, email: AMDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the
[[Page 71107]]
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 Antimicrobial Drugs Advisory Committee. The committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Antimicrobial Drugs 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 available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of infectious diseases and disorders and makes appropriate
recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 13 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of infectious disease, internal medicine, microbiology,
pediatrics, epidemiology or statistics, and related specialties.
Members will be invited to serve for overlapping terms of up to four
years. 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 one non-voting member who is 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/Anti-InfectiveDrugsAdvisoryCommittee/ucm094132.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 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: October 7, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-24810 Filed 10-13-16; 8:45 am]
BILLING CODE 4164-01-P
