Complicated Intra-Abdominal Infections: Developing Drugs for Treatment; Guidance for Industry; Availability, 7479-7480 [2015-02591]
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Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices
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[FR Doc. 2015–02698 Filed 2–9–15; 8:45 am]
rljohnson on DSK3VPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
VerDate Sep<11>2014
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Jkt 235001
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DEPARTMENT OF HEALTH AND
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Average
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1248
Hampshire Ave., Bldg. 22, Rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2012–D–0973]
I. Background
Complicated Intra-Abdominal
Infections: Developing Drugs for
Treatment; Guidance for Industry;
Availability
FDA is announcing the availability of
a guidance for industry entitled
‘‘Complicated Intra-Abdominal
Infections: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
development of drugs for the treatment
of cIAIs.
Intra-abdominal infections including
cIAIs are common in clinical practice
and comprise a wide variety of clinical
presentations and differing sources of
infection. Different bacterial pathogens
are responsible for cIAI, including
Gram-negative aerobic bacteria, Grampositive bacteria, and anaerobic
bacteria, including mixed infections.
This guidance describes the efficacy
endpoint of clinical success as
resolution of the baseline signs and
symptoms attributable to cIAI. The
guidance provides a scientific
justification for a noninferiority margin.
This guidance finalizes the draft
guidance of the same name issued
October 1, 2012. After consideration of
comments received in response to the
draft guidance, FDA updated the
guidance to include clarifications about
the primary efficacy endpoint and the
use of prior nontrial antibacterial drugs.
In addition, issuance of this guidance
fulfills a portion of the requirements of
Title VIII, section 804 of the Food and
Drug Safety and Innovation Act of 2012
(Pub. L. 112–144), which requires FDA
to review and, as appropriate, revise not
fewer than three guidance documents
per year for the conduct of clinical trials
with respect to antibacterial and
antifungal drugs.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on this topic. 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.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Complicated Intra-Abdominal
Infections: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of complicated intraabdominal infections (cIAIs).
Specifically, this guidance addresses
FDA’s current thinking regarding the
overall drug development program for
the treatment of cIAIs, including clinical
trial designs to support approval of
drugs. This guidance finalizes the draft
guidance of the same name issued
October 1, 2012.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993. 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
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:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
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Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices
II. The Paperwork Reduction Act of
1995
This 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 in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
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/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: February 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02591 Filed 2–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
rljohnson on DSK3VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Arthritis
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
VerDate Sep<11>2014
15:20 Feb 09, 2015
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Date and Time: The meeting will be
held on March 17, 2015, from 8 a.m. to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: 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, email: AAC@
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Committee Information Line, 1–800–
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Washington, DC area). A notice in the
Federal Register about last minute
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cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
biologics license application (BLA)
125544 for CT–P13, a proposed
biosimilar to Janssen Biotech Inc.’s
REMICADE (infliximab), submitted by
Celltrion, Inc. The proposed indications
(uses) for this product are: (1) Reducing
signs and symptoms and inducing and
maintaining clinical remission in adult
patients with moderately to severely
active Crohn’s disease who have had an
inadequate response to conventional
therapy; (2) reducing the number of
draining enterocutaneous and
rectovaginal fistulas and maintaining
fistula closure in adult patients with
fistulizing Crohn’s disease; (3) reducing
signs and symptoms and inducing and
maintaining clinical remission in
pediatric patients 6 years of age and
older with moderately to severely active
Crohn’s disease who have had an
inadequate response to conventional
therapy; (4) reducing signs and
symptoms, inducing and maintaining
clinical remission and mucosal healing,
and eliminating corticosteroid use in
adult patients with moderately to
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severely active ulcerative colitis who
have had an inadequate response to
conventional therapy; (5) reducing signs
and symptoms and inducing and
maintaining clinical remission in
pediatric patients 6 years of age and
older with moderately to severely active
ulcerative colitis who have had an
inadequate response to conventional
therapy; 1 (6) in combination with
methotrexate, reducing signs and
symptoms, inhibiting the progression of
structural damage, and improving
physical function in patients with
moderately to severely active
rheumatoid arthritis; (7) reducing signs
and symptoms in patients with active
ankylosing spondylitis; (8) reducing
signs and symptoms of active arthritis,
inhibiting the progression of structural
damage, and improving physical
function in patients with psoriatic
arthritis; and (9) treatment of adult
patients with chronic severe (i.e.,
extensive and/or disabling) plaque
psoriasis who are candidates for
systemic therapy and when other
systemic therapies are medically less
appropriate.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 3, 2015. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. 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 February
23, 2015. Time allotted for each
1 This indication is protected by orphan drug
exclusivity expiring on September 23, 2018. See the
Orphan Drug Designations and Approvals database
at https://www.accessdata.fda.gov/scripts/
opdlisting/oopd/index.cfm.
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7479-7480]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02591]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0973]
Complicated Intra-Abdominal Infections: Developing Drugs for
Treatment; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Complicated Intra-
Abdominal Infections: Developing Drugs for Treatment.'' The purpose of
this guidance is to assist sponsors in the clinical development of
drugs for the treatment of complicated intra-abdominal infections
(cIAIs). Specifically, this guidance addresses FDA's current thinking
regarding the overall drug development program for the treatment of
cIAIs, including clinical trial designs to support approval of drugs.
This guidance finalizes the draft guidance of the same name issued
October 1, 2012.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., 4th Floor, Silver Spring, MD 20993. 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 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: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Complicated Intra-Abdominal Infections: Developing Drugs for
Treatment.'' The purpose of this guidance is to assist sponsors in the
development of drugs for the treatment of cIAIs.
Intra-abdominal infections including cIAIs are common in clinical
practice and comprise a wide variety of clinical presentations and
differing sources of infection. Different bacterial pathogens are
responsible for cIAI, including Gram-negative aerobic bacteria, Gram-
positive bacteria, and anaerobic bacteria, including mixed infections.
This guidance describes the efficacy endpoint of clinical success as
resolution of the baseline signs and symptoms attributable to cIAI. The
guidance provides a scientific justification for a noninferiority
margin.
This guidance finalizes the draft guidance of the same name issued
October 1, 2012. After consideration of comments received in response
to the draft guidance, FDA updated the guidance to include
clarifications about the primary efficacy endpoint and the use of prior
nontrial antibacterial drugs. In addition, issuance of this guidance
fulfills a portion of the requirements of Title VIII, section 804 of
the Food and Drug Safety and Innovation Act of 2012 (Pub. L. 112-144),
which requires FDA to review and, as appropriate, revise not fewer than
three guidance documents per year for the conduct of clinical trials
with respect to antibacterial and antifungal drugs.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this topic. 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.
[[Page 7480]]
II. The Paperwork Reduction Act of 1995
This 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 in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: February 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02591 Filed 2-9-15; 8:45 am]
BILLING CODE 4164-01-P
