2014 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments, 40113-40114 [2014-16207]
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Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
Supplements Under GDUFA.’’ The
Generic Drug User Fee Amendments of
2012 (GDUFA) enables FDA to assess
user fees to fund critical and measurable
improvements to FDA’s generic drugs
program. This draft guidance is
intended to assist applicants preparing
to submit to FDA prior approval
supplements (PASs) and amendments to
PASs for abbreviated new drug
applications (ANDAs). It describes
FDA’s performance metric goals for
PASs and clarifies how FDA will handle
a PAS and amendments to a PAS for an
ANDA subject to the GDUFA
performance metric goals.
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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by September 9,
2014.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
the Division of Drug Information, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 71, rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
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draft guidance to https://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.
FOR FURTHER INFORMATION CONTACT:
Benjamin Chacko, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673,
Silver Spring, MD 20993–0002, 240–
402–7924 or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘ANDA Submissions—Prior Approval
Supplements Under GDUFA.’’ On July
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9, 2012, the President signed GDUFA
(Pub. L. 112–144, Title III) into law.
GDUFA is based on an agreement
negotiated by FDA and representatives
of the generic drug industry to address
a growing number of regulatory
challenges. GDUFA aims to ensure
timely access to safe, high-quality, lowcost generic drugs. GDUFA enables FDA
to assess user fees to fund critical and
measurable improvements to FDA’s
generic drugs program and to bring
greater predictability and timeliness to
the review of generic drug applications.
GDUFA requires that FDA and human
generic drug manufacturers meet certain
commitments. In the GDUFA
Commitment Letter, FDA committed to
review and act on a certain percentage
of PASs within a specified time period
from the date of submission for receipts
in fiscal years (FY) 2015–2017. The
percentage of PASs that FDA has
committed to review and act on varies
for each fiscal year, and the deadlines
for review depend on whether a PAS
requires an inspection.
This draft guidance describes the
performance metric goals that FDA
agreed to in the Commitment Letter and
clarifies how FDA will review a PAS
and amendments to a PAS for an ANDA
subject to the GDUFA performance
metric goals. The GDUFA performance
metrics described in this draft guidance
only apply to ANDA applicants that
submit a PAS on or after October 1,
2014. These performance metrics do not
apply to new drug applications (NDAs),
biologics license applications (BLAs),
supplements filed for NDAs or BLAs, or
changes being effected (CBE)
supplements and annual report filings
to NDAs, BLAs, or ANDAs.
Elsewhere in this issue of the Federal
Register, FDA is publishing another
draft guidance entitled ‘‘ANDA
Submissions—Amendments and Easily
Correctable Deficiencies Under
GDUFA,’’ which explains how the
GDUFA performance metric goals apply
to amendments made to ANDAs and to
PASs.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance, when finalized, will
represent the Agency’s current thinking
on how GDUFA relates to prior approval
supplements for ANDAs. 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 statutes and regulations.
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40113
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that 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 for
supplements and amendments in 21
CFR part 314 have been approved under
OMB control number 0910–0001. The
collection of information for
manufacturer registration in 21 CFR part
207 has been approved under OMB
control number 0910–0045. The
collection of information for
manufacturer compliance with current
good manufacturing practices in 21 CFR
part 211 has been approved under OMB
control number 0910–0139.
III. 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
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidance/default.htm, or
https://www.regulations.gov.
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16236 Filed 7–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0894]
2014 Scientific Meeting of the National
Antimicrobial Resistance Monitoring
System; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
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11JYN1
40114
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘2014 Scientific
Meeting of the National Antimicrobial
Resistance Monitoring System.’’ The
purpose of the meeting is to discuss
progress made in achieving the goals of
the National Antimicrobial Resistance
Monitoring System (NARMS) Strategic
Plan: 2012–2016.
Dates And Time: The public meeting
will be held on August 12 and 13, 2014,
from 8 a.m. to 5 p.m.
ADDRESSES: Location: The public
meeting will be held at the FDA White
Oak Campus, 10903 New Hampshire
Ave., Building 31, Great Room (rm.
1503A), Silver Spring, MD 20993–0002.
Please note that visitors to the White
Oak Campus must enter through
Building 1. The White Oak Campus
location is a Federal facility with
security procedures. For parking and
security information, please refer to
https://www.fda.gov/AboutFDA/Working
atFDA/BuildingsandFacilities/White
OakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Laura Bradbard, Center for Veterinary
Medicine (HFV–12), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9109,
FAX: 240–276–9115, laura.bradbard@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: NARMS
periodically conducts public meetings
to inform stakeholders of NARMS
activities and receive comments on
ways to improve. The last two public
NARMS meetings (held in 2010 and
2011) focused on recommendations
made by the FDA Science Board
Advisory Subcommittee in 2007. These
meetings dealt with enhancing
international partnerships, and
improving NARMS sampling. Since
then, NARMS created the 2012–2016
Strategic Plan that addressed all of the
Science Board’s recommendations
(https://www.fda.gov/downloads/Animal
Veterinary/SafetyHealth/Antimicrobial
Resistance/NationalAntimicrobial
ResistanceMonitoringSystem/UCM2362
83.pdf). A number of strategic planning
goals already have been achieved and
several of the objectives outlined in the
plan are ongoing. The purpose of this
meeting will be to provide updates on
progress of the NARMS 2012–2016
strategic plan, discuss possible future
activities, and receive comments for the
official record. A number of items will
be discussed including comparisons of
new and old slaughter sampling
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:23 Jul 10, 2014
Jkt 232001
methods, the role of NARMS in
foodborne outbreaks, results of
interagency research projects using
advanced detection methods, and how
these scientific advances impact FDA
decisionmaking.
Registration and Requests for Oral
Presentations: Interested persons may
make oral presentations on the topic of
the discussion of the meeting. Oral
presentations from the public during the
open public comment period will be
scheduled between approximately 3:50
p.m. and 4:50 p.m. on August 13, 2014.
Those desiring to make oral
presentations should notify the contact
person by July 29, 2014, and submit a
brief statement of the general nature of
information they wish to present. In an
effort to accommodate all who desire to
speak, time allotted for each
presentation may be limited. The
contact person will inform each speaker
of their schedule prior to the meeting.
Registration is required for the
meeting. Please send registration
information (including name, title,
organization, address, and telephone
and fax numbers) by email to Laura
Bradbard (see FOR FURTHER INFORMATION
CONTACT) by July 29, 2014. There is no
fee to register for the public meeting,
and registration will be on a first-come,
first-served basis.
If you need special accommodations
due to a disability, please contact Laura
Bradbard (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance.
Comments: Regardless of attendance
at the public meeting, interested persons
may submit either electronic or written
comments regarding the topic to be
discussed at the meeting. Submit
electronic comments 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. 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.
The docket will remain open for written
or electronic comments for 30 days
following the meeting.
Agenda: The meeting will address
monitoring and research for NARMS.
The final agenda for the public meeting
will be made available on the Agency’s
Web site at https://www.fda.gov/Animal
Veterinary/SafetyHealth/Antimicrobial
Resistance/NationalAntimicrobial
ResistanceMonitoringSystem/ucm0591
35.htm and will be posted to the docket
PO 00000
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athttps://www.regulations.gov no later
than 2 weeks prior to the meeting.
Transcripts: FDA will prepare a
meeting transcript and make it available
on the Agency’s Web site (see Agenda)
after the meeting. FDA anticipates that
transcripts will be available
approximately 60 business days after
the meeting. The transcript will be
available for public examination at the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. A transcript
will also be available in either hardcopy
or on CD–ROM after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857.
Dated: July 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16207 Filed 7–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Solicitation of Information and
Recommendations for Revising OIG’s
Non-Binding Criteria for Implementing
Permissive Exclusion Authority Under
Section 1128(b)(7) of the Social
Security Act
Office of Inspector General
(OIG), HHS.
ACTION: Notice and Opportunity for
Comment.
AGENCY:
This Federal Register notice
informs the public that OIG: (1) Is
considering revising the Non-Binding
Criteria for Implementing Permissive
Exclusion Authority Under Section
1128(b)(7) of the Social Security Act (62
FR 67392, December 24, 1997), and (2)
is soliciting input from the public for
OIG to consider in developing the
revised criteria.
DATES: To ensure consideration, public
comments must be delivered to the
address provided below by no later than
5 p.m. on September 9, 2014.
ADDRESSES: In commenting, please refer
to file code OIG–1271–N. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
three ways (no duplicates, please):
SUMMARY:
E:\FR\FM\11JYN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40113-40114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16207]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0894]
2014 Scientific Meeting of the National Antimicrobial Resistance
Monitoring System; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
[[Page 40114]]
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``2014 Scientific Meeting of the National
Antimicrobial Resistance Monitoring System.'' The purpose of the
meeting is to discuss progress made in achieving the goals of the
National Antimicrobial Resistance Monitoring System (NARMS) Strategic
Plan: 2012-2016.
Dates And Time: The public meeting will be held on August 12 and
13, 2014, from 8 a.m. to 5 p.m.
ADDRESSES: Location: The public meeting will be held at the FDA White
Oak Campus, 10903 New Hampshire Ave., Building 31, Great Room (rm.
1503A), Silver Spring, MD 20993-0002. Please note that visitors to the
White Oak Campus must enter through Building 1. The White Oak Campus
location is a Federal facility with security procedures. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Laura Bradbard, Center for Veterinary
Medicine (HFV-12), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9109, FAX: 240-276-9115,
laura.bradbard@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: NARMS periodically conducts public meetings
to inform stakeholders of NARMS activities and receive comments on ways
to improve. The last two public NARMS meetings (held in 2010 and 2011)
focused on recommendations made by the FDA Science Board Advisory
Subcommittee in 2007. These meetings dealt with enhancing international
partnerships, and improving NARMS sampling. Since then, NARMS created
the 2012-2016 Strategic Plan that addressed all of the Science Board's
recommendations (https://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/UCM236283.pdf). A
number of strategic planning goals already have been achieved and
several of the objectives outlined in the plan are ongoing. The purpose
of this meeting will be to provide updates on progress of the NARMS
2012-2016 strategic plan, discuss possible future activities, and
receive comments for the official record. A number of items will be
discussed including comparisons of new and old slaughter sampling
methods, the role of NARMS in foodborne outbreaks, results of
interagency research projects using advanced detection methods, and how
these scientific advances impact FDA decisionmaking.
Registration and Requests for Oral Presentations: Interested
persons may make oral presentations on the topic of the discussion of
the meeting. Oral presentations from the public during the open public
comment period will be scheduled between approximately 3:50 p.m. and
4:50 p.m. on August 13, 2014. Those desiring to make oral presentations
should notify the contact person by July 29, 2014, and submit a brief
statement of the general nature of information they wish to present. In
an effort to accommodate all who desire to speak, time allotted for
each presentation may be limited. The contact person will inform each
speaker of their schedule prior to the meeting.
Registration is required for the meeting. Please send registration
information (including name, title, organization, address, and
telephone and fax numbers) by email to Laura Bradbard (see FOR FURTHER
INFORMATION CONTACT) by July 29, 2014. There is no fee to register for
the public meeting, and registration will be on a first-come, first-
served basis.
If you need special accommodations due to a disability, please
contact Laura Bradbard (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.
Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments
regarding the topic to be discussed at the meeting. Submit electronic
comments 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. 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. The docket will remain open for written or
electronic comments for 30 days following the meeting.
Agenda: The meeting will address monitoring and research for NARMS.
The final agenda for the public meeting will be made available on the
Agency's Web site at https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm059135.htm and will
be posted to the docket athttps://www.regulations.gov no later than 2
weeks prior to the meeting.
Transcripts: FDA will prepare a meeting transcript and make it
available on the Agency's Web site (see Agenda) after the meeting. FDA
anticipates that transcripts will be available approximately 60
business days after the meeting. The transcript will be available for
public examination at the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. A
transcript will also be available in either hardcopy or on CD-ROM after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857.
Dated: July 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16207 Filed 7-10-14; 8:45 am]
BILLING CODE 4164-01-P
