Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability, 14003-14004 [2017-05245]
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices
infestation; malignancy of pancreas or
bowel; or folic acid deficiency.
In a letter dated December 21, 2016,
Fresenius notified FDA that
CYANOCOBALAMIN INJECTION, 1
milligram per milliliter in a 10 milliliter
vial, was discontinued over 30 years
ago, and Fresenius had concluded that
the drug was discontinued for reasons
other than safety or effectiveness.
Fresenius also conveyed that they
currently manufacture and market a 1
milliliter multiple dose vial of the 1
milligram per milliliter concentration.
John R. Rapoza submitted a citizen
petition dated June 16, 2016 (Docket No.
FDA–2016–P–1676), under 21 CFR
10.30, requesting that the Agency
determine whether
CYANOCOBALAMIN INJECTION, 1
milligram per milliliter in a 10 milliliter
vial, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CYANOCOBALAMIN
INJECTION, 1 milligram per milliliter in
a 10 milliliter vial, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
CYANOCOBALAMIN INJECTION, 1
milligram per milliliter in a 10 milliliter
vial, was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
CYANOCOBALAMIN INJECTION, 1
milligram per milliliter in a 10 milliliter
vial, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will list
CYANOCOBALAMIN INJECTION, 1
milligram per milliliter in a 10 milliliter
vial, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
VerDate Sep<11>2014
17:12 Mar 15, 2017
Jkt 241001
advise ANDA applicants to submit such
labeling.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05246 Filed 3–15–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances for
Rifaximin; Revised Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
revised draft guidance for industry on
generic rifaximin oral tablets entitled
‘‘Draft Guidance on Rifaximin.’’ The
revised draft guidance, when finalized,
will provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs) for rifaximin
oral tablets.
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 May 15, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
14003
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Draft Guidance on
Rifaximin.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ will be publicly viewable
at https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
E:\FR\FM\16MRN1.SGM
16MRN1
14004
Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, 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 draft guidance.
FOR FURTHER INFORMATION CONTACT:
Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm.
4730, Silver Spring, MD 20993–0002,
301–796–5850.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific guidances available to the
public on FDA’s Web site at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
As described in that guidance, FDA
adopted this process to develop and
disseminate product-specific guidances
and to provide a meaningful
opportunity for the public to consider
and comment on the guidances. This
notice announces the availability of a
revised draft guidance for generic
rifaximin oral tablets.
FDA initially approved new drug
application (NDA) 021361 for XIFAXAN
(rifaximin oral tablets) 200 milligram
(mg) in May 2004 and NDA 022554 for
XIFAXAN (rixaximin oral tablets) 550
mg in March 2010. In November 2011,
FDA issued a draft guidance for
VerDate Sep<11>2014
17:12 Mar 15, 2017
Jkt 241001
industry on generic 200 mg rifaximin
oral tablets; in February 2012, FDA
issued a draft guidance for industry on
generic 550 mg rifaximin oral tablets.
We are now consolidating these two
guidances and issuing a single revised
draft guidance for industry on generic
rifaximin oral tablets (‘‘Draft Guidance
on Rifaximin’’).
In May 2008, Salix Pharmaceuticals,
Inc. (Salix), manufacturer of the
reference listed drugs XIFAXAN 200 mg
and XIFAXAN 550 mg, submitted a
citizen petition requesting that FDA
refrain from approving any ANDA
referencing XIFAXAN 200 mg unless
certain conditions were satisfied,
including conditions related to
demonstrating BE. In October 2016,
Baker & Hostetler LLP submitted a
citizen petition on behalf of Salix
requesting that FDA refrain from
approving any ANDA referencing
XIFAXAN 200 mg or XIFAXAN 550 mg
unless certain conditions were satisfied,
including conditions related to
demonstrating BE. FDA has reviewed
the issues raised in these citizen
petitions and is responding to the
citizen petitions separately in the
dockets for those citizen petitions
(Docket Nos. FDA–2008–P–0300 and
FDA–2016–P–3418, available at https://
www.regulations.gov).
The revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on ‘‘Draft
Guidance on Rifaximin.’’ 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.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05245 Filed 3–15–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[Funding Announcement Number: HHS–
2017–IHS–HLY–0001; Catalog of Federal
Domestic Assistance Number: 93.933]
Healthy Lifestyles in Youth Project;
Proposed Single Source Competing
Continuation Cooperative Agreement
with National Congress of American
Indians
Key Dates
Application Deadline Date: May 15,
2017
Review Date: May 22–26, 2017
Earliest Anticipated Start Date:
September 1, 2017
Proof of Non-Profit Status Due Date:
May 15, 2017
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS)
Office of Clinical and Preventive
Services, Division of Diabetes Treatment
and Prevention, is accepting
applications for a single source
competing continuation cooperative
agreement with the National Congress of
American Indians (NCAI) for the
purpose of continued implementation of
the Healthy Lifestyles in Youth Project
in selected Native American Boys and
Girls Clubs of America. This program is
authorized under the authority of the
Snyder Act, 25 U.S.C. 13; the Transfer
Act, 42 U.S.C. 2001; and the Public
Health Service Act, as amended, 42
U.S.C. 241(a). This program is described
in the Catalog of Federal Domestic
Assistance (CFDA) under 93.933.
Background
This program promotes healthy
lifestyles among American Indian and
Alaska Native (AI/AN) youth using the
curriculum ‘‘Together Raising
Awareness for Indian Life’’ (TRAIL)
among selected Boys and Girls Club
sites. Under this cooperative agreement,
IHS proposes to enter into a
collaborative effort/initiative with
NCAI, because of their unique
experience partnering with the IHS and
Boys and Girls Clubs of America
(BGCA) in successfully establishing this
program, as well as, their overall
expertise and experience in addressing
and evaluating healthy lifestyle
techniques in AI/AN youth.
Purpose
This work will continue to support
the IHS mission to improve the health
of AI/AN youth through health
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Agencies
[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Pages 14003-14004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05245]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidances for Rifaximin; Revised Draft Guidance
for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a revised draft guidance for industry on
generic rifaximin oral tablets entitled ``Draft Guidance on
Rifaximin.'' The revised draft guidance, when finalized, will provide
product-specific recommendations on, among other things, the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for rifaximin oral tablets.
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 May 15, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Draft Guidance on Rifaximin.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' will be publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
[[Page 14004]]
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, 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 draft guidance.
FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002,
301-796-5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a revised draft guidance for
generic rifaximin oral tablets.
FDA initially approved new drug application (NDA) 021361 for
XIFAXAN (rifaximin oral tablets) 200 milligram (mg) in May 2004 and NDA
022554 for XIFAXAN (rixaximin oral tablets) 550 mg in March 2010. In
November 2011, FDA issued a draft guidance for industry on generic 200
mg rifaximin oral tablets; in February 2012, FDA issued a draft
guidance for industry on generic 550 mg rifaximin oral tablets. We are
now consolidating these two guidances and issuing a single revised
draft guidance for industry on generic rifaximin oral tablets (``Draft
Guidance on Rifaximin'').
In May 2008, Salix Pharmaceuticals, Inc. (Salix), manufacturer of
the reference listed drugs XIFAXAN 200 mg and XIFAXAN 550 mg, submitted
a citizen petition requesting that FDA refrain from approving any ANDA
referencing XIFAXAN 200 mg unless certain conditions were satisfied,
including conditions related to demonstrating BE. In October 2016,
Baker & Hostetler LLP submitted a citizen petition on behalf of Salix
requesting that FDA refrain from approving any ANDA referencing XIFAXAN
200 mg or XIFAXAN 550 mg unless certain conditions were satisfied,
including conditions related to demonstrating BE. FDA has reviewed the
issues raised in these citizen petitions and is responding to the
citizen petitions separately in the dockets for those citizen petitions
(Docket Nos. FDA-2008-P-0300 and FDA-2016-P-3418, available at https://www.regulations.gov).
The revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Draft Guidance on Rifaximin.'' 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.
II. Electronic Access
Persons with access to the Internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05245 Filed 3-15-17; 8:45 am]
BILLING CODE 4164-01-P