82 FR 14003 - Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 50 (March 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 50 (March 16, 2017)
| Page Range | 14003-14004 | |
| FR Document | 2017-05245 |
[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)] [Notices] [Pages 14003-14004] From the Federal Register Online [www.thefederalregister.org] [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SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled ``Draft Guidance on Rifaximin.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 15, 2017.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.thefederalregister.org/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 http://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
![Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices 14003
infestation; malignancy of pancreas or advise ANDA applicants to submit such identifies you in the body of your
bowel; or folic acid deficiency. labeling. comments, that information will be
In a letter dated December 21, 2016, Dated: March 13, 2017. posted on https://www.regulations.gov.
Fresenius notified FDA that • If you want to submit a comment
Leslie Kux,
CYANOCOBALAMIN INJECTION, 1 with confidential information that you
milligram per milliliter in a 10 milliliter Associate Commissioner for Policy. do not wish to be made available to the
vial, was discontinued over 30 years [FR Doc. 2017–05246 Filed 3–15–17; 8:45 am] public, submit the comment as a
ago, and Fresenius had concluded that BILLING CODE 4164–01–P written/paper submission and in the
the drug was discontinued for reasons manner detailed (see ‘‘Written/Paper
other than safety or effectiveness. Submissions’’ and ‘‘Instructions’’).
Fresenius also conveyed that they DEPARTMENT OF HEALTH AND
HUMAN SERVICES Written/Paper Submissions
currently manufacture and market a 1
milliliter multiple dose vial of the 1 Submit written/paper submissions as
Food and Drug Administration follows:
milligram per milliliter concentration.
John R. Rapoza submitted a citizen [Docket No. FDA–2007–D–0369] • Mail/Hand delivery/Courier (for
petition dated June 16, 2016 (Docket No. written/paper submissions): Division of
FDA–2016–P–1676), under 21 CFR Product-Specific Guidances for Dockets Management (HFA–305), Food
10.30, requesting that the Agency Rifaximin; Revised Draft Guidance for and Drug Administration, 5630 Fishers
determine whether Industry; Availability Lane, Rm. 1061, Rockville, MD 20852.
CYANOCOBALAMIN INJECTION, 1 • For written/paper comments
AGENCY: Food and Drug Administration, submitted to the Division of Dockets
milligram per milliliter in a 10 milliliter
HHS. Management, FDA will post your
vial, was withdrawn from sale for
reasons of safety or effectiveness. ACTION: Notice of availability. comment, as well as any attachments,
After considering the citizen petition except for information submitted,
SUMMARY: The Food and Drug marked and identified, as confidential,
and reviewing Agency records and
Administration (FDA, the Agency, or if submitted as detailed in
based on the information we have at this
we) is announcing the availability of a ‘‘Instructions.’’
time, FDA has determined under
revised draft guidance for industry on Instructions: All submissions received
§ 314.161 that CYANOCOBALAMIN
generic rifaximin oral tablets entitled must include the Docket No. FDA–
INJECTION, 1 milligram per milliliter in
‘‘Draft Guidance on Rifaximin.’’ The 2007–D–0369 for ‘‘Draft Guidance on
a 10 milliliter vial, was not withdrawn
revised draft guidance, when finalized, Rifaximin.’’ Received comments will be
for reasons of safety or effectiveness.
will provide product-specific placed in the docket and, except for
The petitioner has identified no data or
recommendations on, among other those submitted as ‘‘Confidential
other information suggesting that
things, the design of bioequivalence Submissions,’’ will be publicly viewable
CYANOCOBALAMIN INJECTION, 1
milligram per milliliter in a 10 milliliter (BE) studies to support abbreviated new at https://www.regulations.gov or at the
vial, was withdrawn for reasons of drug applications (ANDAs) for rifaximin Division of Dockets Management
safety or effectiveness. We have oral tablets. between 9 a.m. and 4 p.m., Monday
carefully reviewed our files for records DATES: Although you can comment on through Friday.
concerning the withdrawal of any guidance at any time (see 21 CFR • Confidential Submissions—To
CYANOCOBALAMIN INJECTION, 1 10.115(g)(5)), to ensure that the Agency submit a comment with confidential
milligram per milliliter in a 10 milliliter considers your comment on this draft information that you do not wish to be
vial, from sale. We have also guidance before it begins work on the made publicly available, submit your
independently evaluated relevant final version of the guidance, submit comments only as a written/paper
literature and data for possible either electronic or written comments submission. You should submit two
postmarketing adverse events. We have on the draft guidance by May 15, 2017. copies total. One copy will include the
reviewed the available evidence and ADDRESSES: You may submit comments information you claim to be confidential
determined that this drug product was as follows: with a heading or cover note that states
not withdrawn from sale for reasons of ‘‘THIS DOCUMENT CONTAINS
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
safety or effectiveness.
Accordingly, the Agency will list Submit electronic comments in the Agency will review this copy, including
CYANOCOBALAMIN INJECTION, 1 following way: the claimed confidential information, in
milligram per milliliter in a 10 milliliter • Federal eRulemaking Portal: its consideration of comments. The
vial, in the ‘‘Discontinued Drug Product https://www.regulations.gov. Follow the second copy, which will have the
List’’ section of the Orange Book. The instructions for submitting comments. claimed confidential information
‘‘Discontinued Drug Product List’’ Comments submitted electronically, redacted/blacked out, will be available
delineates, among other items, drug including attachments, to https:// for public viewing and posted on
products that have been discontinued www.regulations.gov will be posted to https://www.regulations.gov. Submit
from marketing for reasons other than the docket unchanged. Because your both copies to the Division of Dockets
safety or effectiveness. FDA will not comment will be made public, you are Management. If you do not wish your
begin procedures to withdraw approval solely responsible for ensuring that your name and contact information to be
of approved ANDAs that refer to this comment does not include any made publicly available, you can
drug product. Additional ANDAs for confidential information that you or a provide this information on the cover
mstockstill on DSK3G9T082PROD with NOTICES
this drug product may also be approved third party may not wish to be posted, sheet and not in the body of your
by the Agency as long as they meet all such as medical information, your or comments and you must identify this
other legal and regulatory requirements anyone else’s Social Security number, or information as ‘‘confidential.’’ Any
for the approval of ANDAs. If FDA confidential business information, such information marked as ‘‘confidential’’
determines that labeling for this drug as a manufacturing process. Please note will not be disclosed except in
product should be revised to meet that if you include your name, contact accordance with 21 CFR 10.20 and other
current standards, the Agency will information, or other information that applicable disclosure law. For more
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![14004 Federal Register / Vol. 82, No. 50 / Thursday, March 16, 2017 / Notices
information about FDA’s posting of industry on generic 200 mg rifaximin DEPARTMENT OF HEALTH AND
comments to public dockets, see 80 FR oral tablets; in February 2012, FDA HUMAN SERVICES
56469, September 18, 2015, or access issued a draft guidance for industry on
the information at: https://www.gpo.gov/ generic 550 mg rifaximin oral tablets. Indian Health Service
fdsys/pkg/FR-2015-09-18/pdf/2015- We are now consolidating these two [Funding Announcement Number: HHS–
23389.pdf. guidances and issuing a single revised 2017–IHS–HLY–0001; Catalog of Federal
Docket: For access to the docket to draft guidance for industry on generic Domestic Assistance Number: 93.933]
read background documents or the rifaximin oral tablets (‘‘Draft Guidance
electronic and written/paper comments on Rifaximin’’). Healthy Lifestyles in Youth Project;
received, go to https:// Proposed Single Source Competing
www.regulations.gov and insert the In May 2008, Salix Pharmaceuticals, Continuation Cooperative Agreement
docket number, found in brackets in the Inc. (Salix), manufacturer of the with National Congress of American
heading of this document, into the reference listed drugs XIFAXAN 200 mg Indians
‘‘Search’’ box and follow the prompts and XIFAXAN 550 mg, submitted a
and/or go to the Division of Dockets citizen petition requesting that FDA Key Dates
Management, 5630 Fishers Lane, Rm. refrain from approving any ANDA Application Deadline Date: May 15,
1061, Rockville, MD 20852. referencing XIFAXAN 200 mg unless 2017
Submit written requests for single certain conditions were satisfied, Review Date: May 22–26, 2017
copies of the draft guidance to the including conditions related to Earliest Anticipated Start Date:
Division of Drug Information, Center for demonstrating BE. In October 2016, September 1, 2017
Drug Evaluation and Research, Food Baker & Hostetler LLP submitted a Proof of Non-Profit Status Due Date:
and Drug Administration, 10001 New citizen petition on behalf of Salix May 15, 2017
Hampshire Ave., Hillandale Building, requesting that FDA refrain from I. Funding Opportunity Description
4th Floor, Silver Spring, MD 20993– approving any ANDA referencing
0002. Send one self-addressed adhesive XIFAXAN 200 mg or XIFAXAN 550 mg Statutory Authority
label to assist that office in processing unless certain conditions were satisfied, The Indian Health Service (IHS)
your requests. See the SUPPLEMENTARY including conditions related to Office of Clinical and Preventive
INFORMATION section for electronic demonstrating BE. FDA has reviewed Services, Division of Diabetes Treatment
access to the draft guidance. the issues raised in these citizen and Prevention, is accepting
FOR FURTHER INFORMATION CONTACT: petitions and is responding to the applications for a single source
Xiaoqiu Tang, Center for Drug citizen petitions separately in the competing continuation cooperative
Evaluation and Research (HFD–600), dockets for those citizen petitions agreement with the National Congress of
Food and Drug Administration, 10903 (Docket Nos. FDA–2008–P–0300 and American Indians (NCAI) for the
New Hampshire Ave., Bldg. 75, Rm. FDA–2016–P–3418, available at https:// purpose of continued implementation of
4730, Silver Spring, MD 20993–0002, www.regulations.gov). the Healthy Lifestyles in Youth Project
301–796–5850. in selected Native American Boys and
SUPPLEMENTARY INFORMATION:
The revised draft guidance is being
Girls Clubs of America. This program is
issued consistent with FDA’s good authorized under the authority of the
I. Background guidance practices regulation (21 CFR Snyder Act, 25 U.S.C. 13; the Transfer
In the Federal Register of June 11, 10.115). The revised draft guidance, Act, 42 U.S.C. 2001; and the Public
2010 (75 FR 33311), FDA announced the when finalized, will represent the Health Service Act, as amended, 42
availability of a guidance for industry current thinking of FDA on ‘‘Draft U.S.C. 241(a). This program is described
entitled ‘‘Bioequivalence Guidance on Rifaximin.’’ It does not in the Catalog of Federal Domestic
Recommendations for Specific establish any rights for any person and Assistance (CFDA) under 93.933.
Products,’’ which explained the process is not binding on FDA or the public.
that would be used to make product- You can use an alternative approach if Background
specific guidances available to the it satisfies the requirements of the This program promotes healthy
public on FDA’s Web site at http:// applicable statutes and regulations. lifestyles among American Indian and
www.fda.gov/Drugs/ Alaska Native (AI/AN) youth using the
GuidanceCompliance II. Electronic Access curriculum ‘‘Together Raising
RegulatoryInformation/Guidances/ Persons with access to the Internet Awareness for Indian Life’’ (TRAIL)
default.htm. among selected Boys and Girls Club
may obtain the draft guidances at either
As described in that guidance, FDA sites. Under this cooperative agreement,
https://www.fda.gov/Drugs/
adopted this process to develop and IHS proposes to enter into a
disseminate product-specific guidances GuidanceCompliance
collaborative effort/initiative with
and to provide a meaningful RegulatoryInformation/Guidances/
NCAI, because of their unique
opportunity for the public to consider default.htm or https:// experience partnering with the IHS and
and comment on the guidances. This www.regulations.gov. Boys and Girls Clubs of America
notice announces the availability of a Dated: March 13, 2017. (BGCA) in successfully establishing this
revised draft guidance for generic Leslie Kux, program, as well as, their overall
rifaximin oral tablets.
mstockstill on DSK3G9T082PROD with NOTICES
Associate Commissioner for Policy. expertise and experience in addressing
FDA initially approved new drug and evaluating healthy lifestyle
[FR Doc. 2017–05245 Filed 3–15–17; 8:45 am]
application (NDA) 021361 for XIFAXAN techniques in AI/AN youth.
(rifaximin oral tablets) 200 milligram BILLING CODE 4164–01–P
(mg) in May 2004 and NDA 022554 for Purpose
XIFAXAN (rixaximin oral tablets) 550 This work will continue to support
mg in March 2010. In November 2011, the IHS mission to improve the health
FDA issued a draft guidance for of AI/AN youth through health
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Document Created: 2017-03-16 02:18:36
Document Modified: 2017-03-16 02:18:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 14003 |
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