81 FR 57921 - Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 164 (August 24, 2016)

Page Range		57921-57922
FR Document		2016-20146

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on generic fidaxomicin tablets entitled ``Draft Guidance on Fidaxomicin.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fidaxomicin tablets.

Federal Register, Volume 81 Issue 164 (Wednesday, August 24, 2016)

[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57921-57922]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-20146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Bioequivalence Recommendations for Fidaxomicin; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry on generic fidaxomicin
tablets entitled ``Draft Guidance on Fidaxomicin.'' The recommendations
provide specific guidance on the design of bioequivalence (BE) studies
to support abbreviated new drug applications (ANDAs) for fidaxomicin
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 24, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 Fidaxomicin.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' will be publicly viewable at http://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 http://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 information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 document.

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 BE
recommendations 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 BE recommendations and to provide a
meaningful opportunity for the public to consider and comment on those
recommendations. This notice announces the availability of draft BE
recommendations for generic fidaxomicin tablets.
FDA initially approved new drug application (NDA) 201699 for
DIFICID (fidaxomicin) in May 2011. Currently, there are no approved
ANDAs for this product. We are now issuing a draft guidance for
industry on BE recommendations for generic fidaxomicin tablets (``Draft
Guidance on Fidaxomicin'').
On May 6, 2015, Cubist Pharmaceuticals, Inc. submitted a

[[Page 57922]]

citizen petition requesting that ``FDA impose scientifically-
appropriate standards for demonstrating BE for ANDAs and 505(b)(2) new
drug applications'' citing to DIFICID as the reference listed drug. FDA
has reviewed the issues raised in the citizen petition and is
responding to the citizen petition (Docket No. FDA-2015-P-1595,
available at http://www.regulations.gov).
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 the design of
BE studies to support ANDAs for fidaxomicin tablets. 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 guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

Dated: August 18, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20146 Filed 8-23-16; 8:45 am]
BILLING CODE 4164-01-P

57922 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices

citizen petition requesting that ‘‘FDA Status: The meeting will be open to Public Comment: It is preferred that
impose scientifically-appropriate the public. persons interested in providing an oral
standards for demonstrating BE for Purpose: Pursuant to Public Law 109– presentation email a written request,
ANDAs and 505(b)(2) new drug 129, 42 U.S.C. 274k (session 379 of the along with a copy of your presentation,
applications’’ citing to DIFICID as the Public Health Service Act, as amended), to Robert Walsh, Executive Secretary, at
reference listed drug. FDA has reviewed the ACBSCT advises the Secretary of the RWalsh@hrsa.gov. Requests should
the issues raised in the citizen petition Department of Health and Human contain the name, address, telephone
and is responding to the citizen petition Services and Administrator, Health number, email address, and any
(Docket No. FDA–2015–P–1595, Resources and Services Administration business or professional affiliation of
available at http://www.regulations.gov). (HRSA), on matters related to the the person desiring to make an oral
This draft guidance is being issued activities of the C.W. Bill Young Cell presentation. Groups having similar
consistent with FDA’s good guidance Transplantation Program (Program) and interests are encouraged to combine
practices regulation (21 CFR 10.115). the National Cord Blood Inventory their comments and present them
The draft guidance, when finalized, will Program. through a single representative.
represent the current thinking of FDA Agenda: The Council will discuss The allocation of time may be
on the design of BE studies to support trends in the usage of various sources of adjusted to accommodate the level of
ANDAs for fidaxomicin tablets. It does blood stem cells used in unrelated blood expressed interest. Persons who do not
not establish any rights for any person stem cell transplants, utilization of cord file an advance request for a
and is not binding on FDA or the public. blood, blood stem cell transplantation presentation, but desire to make an oral
You can use an alternative approach if for treatment of sickle cell disease, and statement, may request it during the
it satisfies the requirements of the late effects in blood and marrow public comment period. Public
applicable statutes and regulations. transplantation, among other topics. The participation and ability to comment
Council will also receive a program will be limited as time permits.
II. Electronic Access
update from the HRSA Division of
Persons with access to the Internet Transplantation (DoT). Agenda items Jason E. Bennett
may obtain the draft guidance at either are subject to change as priorities Director, Division of the Executive Secretariat.
http://www.fda.gov/Drugs/Guidance indicate. [FR Doc. 2016–20198 Filed 8–23–16; 8:45 am]
ComplianceRegulatoryInformation/ After Council discussions, members BILLING CODE 4165–15–P
Guidances/default.htm or http:// of the public will have an opportunity
www.regulations.gov. to provide comment. Because of the
Dated: August 18, 2016. Council’s full agenda and timeframe in DEPARTMENT OF HEALTH AND
Jeremy Sharp, which to cover the agenda topics, public HUMAN SERVICES
Deputy Commissioner for Policy, Planning, comment will be limited. All public
Legislation, and Analysis. comments will be included in the Office of the Secretary
[FR Doc. 2016–20146 Filed 8–23–16; 8:45 am] record of the ACBSCT meeting.
The draft meeting agenda will be [Document Identifier: OMB # 0990–0424–
BILLING CODE 4164–01–P 30D]
posted on www.ACBSCTmeeting.org.
Those participating at this meeting Agency Information Collection
DEPARTMENT OF HEALTH AND should pre-register by visiting Activities; Proposed Collection; Public
HUMAN SERVICES www.ACBSCTmeeting.org. The deadline Comment Request
to pre-register for this meeting is Friday,
Health Resources and Services September 9, 2016. Registration will be AGENCY: Office of the Assistant
Administration confirmed on site. For all logistical Secretary for Health, Office of
questions and concerns, please contact Adolescent Health, HHS.
Advisory Council on Blood Stem Cell Susie Gingrich, Leonard Resource ACTION: Notice.
Transplantation; Notice of Meeting Group, at (202) 289–8322 or send an
email to sgringrich@lrginc.com. SUMMARY: In compliance with section
SUMMARY: In accordance with section
Participants can also join this meeting 3506(c)(2)(A) of the Paperwork
10(a)(2) of the Federal Advisory
via teleconference by: Reduction Act of 1995, the Office of the
Committee Act, notice is hereby given of
1. (Audio Portion) Calling the Conference Secretary (OS), Department of Health
the following meeting of the Advisory
Phone Number (1–800–832–0736) and and Human Services, announces plans
Council on Blood Stem Cell
providing the Participant Passcode to submit a Information Collection
Transplantation (ACBSCT).
(1337210); and Request (ICR), described below, to the
DATES: 2. (Visual Portion) Connecting to the Office of Management and Budget
September 13, 2016, from 8:00 a.m. to ACBSCT Adobe Connect Pro Meeting using (OMB). Prior to submitting that ICR to
4:00 p.m. Eastern Time. the following URL https://
September 14, 2016, from 8:00 a.m. to OMB, OS seeks comments from the
lrg.adobeconnect.com/acbsct/ and entering
12:30 p.m. Eastern Time. as GUEST: (Copy and paste the link into your public regarding the burden estimate,
browser if it does not work directly, and below, or any other aspect of the ICR.
ADDRESSES: Crystal Gateway Marriott,
enter as a guest). Participants should plan to DATES: Comments on the ICR must be
1700 Jefferson Davis Highway, call and connect 15 minutes prior to the
Arlington, VA 22202. received on or before September 23,
meeting for logistics to be set up. If you have 2016.
FOR FURTHER INFORMATION CONTACT: never attended an Adobe Connect meeting,
mstockstill on DSK3G9T082PROD with NOTICES

Robert Walsh, Executive Secretary, please test your connection using the ADDRESSES: Submit your comments to
Division of Transplantation, Healthcare following URL: http://www.adobe.com/go/ Information.CollectionClearance@
Systems Bureau, Health Resources and meeting_test. In order to obtain a quick hhs.gov or by calling (202) 690–6162.
Services Administration, 5600 Fishers overview, go to the following URL: http://
www.adobe.com/go/connectpro_overview. FOR FURTHER INFORMATION CONTACT:
Lane, Room 8W60, Rockville, MD Call (202) 289–8322 or email Susie Gingrich Information Collection Clearance staff,
20857; telephone (301) 443–6839. at sgringrich@lrginc.com if you are having Information.CollectionClearance@
SUPPLEMENTARY INFORMATION: trouble connecting to the meeting site. hhs.gov or (202) 690–6162.

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Document Created: 2016-08-24 03:02:16
Document Modified: 2016-08-24 03:02:16

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 October 24, 2016.
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		81 FR 57921

81 FR 57921 - Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 164 (August 24, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration