80 FR 42829 - Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 138 (July 20, 2015)

Page Range		42829-42830
FR Document		2015-17726

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled ``Bioequivalence Recommendations for Lubiprostone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules.

Federal Register, Volume 80 Issue 138 (Monday, July 20, 2015)

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42829-42830]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-17726]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Bioequivalence Recommendations for Lubiprostone; Revised Draft
Guidance for Industry; Availability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availability of a revised draft guidance for industry on lubiprostone
capsules entitled ``Bioequivalence Recommendations for Lubiprostone.''
The recommendations provide specific guidance on the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for lubiprostone capsules.

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 comments 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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 18, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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section for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 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, ``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 as a means to
develop and disseminate product-specific BE recommendations and provide
a meaningful opportunity for the public to consider and comment on
those recommendations. This notice announces the availability of draft
BE recommendations for lubiprostone capsules.
FDA initially approved new drug application (NDA) 021908 for
AMITIZA capsules in January 2006. There are no approved ANDAs for this
product. In August 2010, we issued a draft guidance for industry on BE
recommendations for generic lubiprostone capsules. We are now issuing a
revised draft guidance for industry on BE recommendations for generic
lubiprostone capsules (``Bioequivalence Recommendations for
Lubiprostone'').
In January 2014, Sucampo Pharma Americas, LLC, manufacturer of the
reference listed drug, AMITIZA, submitted a citizen petition requesting
that FDA revise the BE requirements for any new drug product that
references AMITIZA and seeks approval by means of demonstrating BE to
AMITIZA. FDA has reviewed the issues raised in the petition and is
responding to the petition (Docket No. FDA-2014-P-0144).
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 Agency's current thinking on the design
of BE studies to support ANDAs for lubiprostone capsules. 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.

II. Comments

Interested persons may submit either electronic comments regarding
this document to http://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 http://www.regulations.gov.

III. Electronic Access

Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

[[Page 42830]]

Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17726 Filed 7-17-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42829

Application No. Drug Applicant

ANDA 088762 .... PROMETH W/DEXTROMETHORPHAN (dextromethorphan G&W Laboratories Inc.,111 Coolidge St., South Plainfield, NJ
hydrobromide; promethazine HCl) Syrup; Oral 15 mg/5 mL; 07080.
6.25 mg/5 mL.

FDA has reviewed its records and, DATES: Although you can comment on capsules in January 2006. There are no
under § 314.161, has determined that any guidance at any time (see 21 CFR approved ANDAs for this product. In
the drug products listed in this 10.115(g)(5)), to ensure that the Agency August 2010, we issued a draft guidance
document were not withdrawn from considers your comments on this draft for industry on BE recommendations for
sale for reasons of safety or guidance before it begins work on the generic lubiprostone capsules. We are
effectiveness. Accordingly, the Agency final version of the guidance, submit now issuing a revised draft guidance for
will continue to list the drug products either electronic or written comments industry on BE recommendations for
listed in this document in the on the draft guidance by September 18, generic lubiprostone capsules
‘‘Discontinued Drug Product List’’ 2015. (‘‘Bioequivalence Recommendations for
section of the Orange Book. The ADDRESSES: Submit written requests for Lubiprostone’’).
‘‘Discontinued Drug Product List’’ single copies of the draft guidance to the In January 2014, Sucampo Pharma
identifies, among other items, drug Division of Drug Information, Center for Americas, LLC, manufacturer of the
products that have been discontinued Drug Evaluation and Research, Food reference listed drug, AMITIZA,
from marketing for reasons other than and Drug Administration, 10001 New submitted a citizen petition requesting
safety or effectiveness. Hampshire Ave., Hillandale Building, that FDA revise the BE requirements for
Approved ANDAs that refer to the 4th Floor, Silver Spring, MD 20993– any new drug product that references
NDAs and ANDAs listed in this 0002. Send one self-addressed adhesive AMITIZA and seeks approval by means
document are unaffected by the label to assist that office in processing of demonstrating BE to AMITIZA. FDA
discontinued marketing of the products your requests. See the SUPPLEMENTARY has reviewed the issues raised in the
subject to those NDAs and ANDAs. INFORMATION section for electronic petition and is responding to the
Additional ANDAs that refer to these access to the draft guidance document. petition (Docket No. FDA–2014–P–
products may also be approved by the Submit electronic comments on the 0144).
Agency if they comply with relevant draft guidance to http://
legal and regulatory requirements. If www.regulations.gov. Submit written This draft guidance is being issued
FDA determines that labeling for these comments to the Division of Dockets consistent with FDA’s good guidance
drug products should be revised to meet Management (HFA–305), Food and Drug practices regulation (21 CFR 10.115).
current standards, the Agency will Administration, 5630 Fishers Lane, Rm. The draft guidance, when finalized, will
advise ANDA applicants to submit such 1061, Rockville, MD 20852. represent the Agency’s current thinking
labeling. on the design of BE studies to support
FOR FURTHER INFORMATION CONTACT:
ANDAs for lubiprostone capsules. It
Dated: July 15, 2015. Xiaoqiu Tang, Center for Drug does not create or confer any rights for
Leslie Kux, Evaluation and Research (HFD–600), or on any person and does not operate
Associate Commissioner for Policy. Food and Drug Administration, 10903 to bind FDA or the public. An
[FR Doc. 2015–17730 Filed 7–17–15; 8:45 am]
New Hampshire Ave., Bldg. 75, Rm. alternative approach may be used if
4730, Silver Spring, MD 20993–0002, such approach satisfies the
BILLING CODE 4164–01–P
301–796–5850. requirements of the applicable statutes
SUPPLEMENTARY INFORMATION: and regulations.
DEPARTMENT OF HEALTH AND I. Background
HUMAN SERVICES II. Comments
In the Federal Register of June 11,
Food and Drug Administration 2010 (75 FR 33311), FDA announced the Interested persons may submit either
availability of a guidance for industry, electronic comments regarding this
[Docket No. FDA–2007–D–0369] ‘‘Bioequivalence Recommendations for document to http://www.regulations.gov
Specific Products,’’ which explained the or written comments to the Division of
Bioequivalence Recommendations for Dockets Management (see ADDRESSES). It
Lubiprostone; Revised Draft Guidance process that would be used to make
product-specific BE recommendations is only necessary to send one set of
for Industry; Availability comments. Identify comments with the
available to the public on FDA’s Web
AGENCY: Food and Drug Administration, site at http://www.fda.gov/Drugs/ docket number found in brackets in the
HHS. GuidanceComplianceRegulatory heading of this document. Received
Information/Guidances/default.htm. As comments may be seen in the Division
ACTION: Notice.
described in that guidance, FDA of Dockets Management between 9 a.m.
SUMMARY: The Food and Drug adopted this process as a means to and 4 p.m., Monday through Friday, and
Administration (FDA) is announcing the develop and disseminate product- will be posted to the docket at http://
availability of a revised draft guidance specific BE recommendations and www.regulations.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES

for industry on lubiprostone capsules provide a meaningful opportunity for III. Electronic Access
entitled ‘‘Bioequivalence the public to consider and comment on
Recommendations for Lubiprostone.’’ those recommendations. This notice Persons with access to the Internet
The recommendations provide specific announces the availability of draft BE may obtain the document at either
guidance on the design of recommendations for lubiprostone http://www.fda.gov/Drugs/Guidance
bioequivalence (BE) studies to support capsules. ComplianceRegulatoryInformation/
abbreviated new drug applications FDA initially approved new drug Guidances/default.htm or http://
(ANDAs) for lubiprostone capsules. application (NDA) 021908 for AMITIZA www.regulations.gov.

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42830 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices

Dated: July 15, 2015. DEPARTMENT OF HEALTH AND The meeting will be closed to the
Leslie Kux, HUMAN SERVICES public in accordance with the
Associate Commissioner for Policy. provisions set forth in section 552b(c)(4)
National Institutes of Health and 552b(c)(6), Title 5 U.S.C., as
[FR Doc. 2015–17726 Filed 7–17–15; 8:45 am]
amended. The contract proposals and
BILLING CODE 4164–01–P Eunice Kennedy Shriver National the discussions could disclose
Institute of Child Health and Human confidential trade secrets or commercial
Development Notice of Closed Meeting property such as patentable material,
DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the and personal information concerning
HUMAN SERVICES
Federal Advisory Committee Act, as individuals associated with the contract
National Institutes of Health amended (5 U.S.C. App.), notice is proposals, the disclosure of which
hereby given of the following meeting. would constitute a clearly unwarranted
Center for Scientific Review; Notice of The meeting will be closed to the invasion of personal privacy.
Closed Meeting public in accordance with the Name of Committee: National Institute of
provisions set forth in section 552b(c)(4) Child Health and Human Development
Pursuant to section 10(d) of the and 552b(c)(6), Title 5 U.S.C., as Special Emphasis Panel.
Federal Advisory Committee Act, as amended. The grant applications and Date: August 12, 2015.
amended (5 U.S.C. App.), notice is the discussions could disclose Time: 1:00 p.m. to 3:00 p.m.
confidential trade secrets or commercial Agenda: To review and evaluate contract
hereby given of the following meeting. proposals.
property such as patentable material,
The meeting will be closed to the and personal information concerning
Place: National Institutes of Health, 6100
public in accordance with the Executive Boulevard, Rockville, MD 20852.
individuals associated with the grant Contact Person: Sathasiva B. Kandasamy,
provisions set forth in sections applications, the disclosure of which Ph.D., Scientific Review Officer, Scientific
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., would constitute a clearly unwarranted Review Branch, Eunice Kennedy Shriver
as amended. The grant applications and invasion of personal privacy. National Institute of Child Health and
the discussions could disclose Human Development, NIH, 6100 Executive
Name of Committee: National Institute of
confidential trade secrets or commercial Child Health and Human Development Boulevard, Room 5B01, Bethesda, MD
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individuals associated with the grant Time: 12:00 p.m. to 5:00 p.m. (Catalogue of Federal Domestic Assistance
applications, the disclosure of which Agenda: To review and evaluate grant Program Nos. 93.864, Population Research;
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would constitute a clearly unwarranted Place: National Institutes of Health, 6100 93.929, Center for Medical Rehabilitation
invasion of personal privacy. Executive Boulevard, Rockville, MD 20852. Research; 93.209, Contraception and
Name of Committee: Center for Scientific Contact Person: Cathy Wedeen, Ph.D., Infertility Loan Repayment Program, National
Review Special Emphasis Panel; Small Scientific Review Officer, Scientific Review Institutes of Health, HHS)
Branch, Eunice Kennedy Shriver National
Business: HIV/AIDS Innovative Research
Institute of Child Health and Human Dated: July 14, 2015.
Applications. Development, NIH, 6100 Executive Michelle Trout,
Date: August 4, 2015. Boulevard, Room 5B01, Bethesda, MD
Time: 11:00 a.m. to 3:00 p.m. Program Analyst, Office of Federal Advisory
20892–9304, (301) 435–6878,
Agenda: To review and evaluate grant Committee Policy.
wedeenc@mail.nih.gov.
applications. [FR Doc. 2015–17649 Filed 7–17–15; 8:45 am]
(Catalogue of Federal Domestic Assistance
Place: National Institutes of Health, 6701 Program Nos. 93.864, Population Research; BILLING CODE 4140–01–P
Rockledge Drive, Bethesda, MD 20892 93.865, Research for Mothers and Children;
(Virtual Meeting). 93.929, Center for Medical Rehabilitation
Contact Person: Mark P Rubert, Ph.D., Research; 93.209, Contraception and
DEPARTMENT OF HOMELAND
Scientific Review Officer, Center for Infertility Loan Repayment Program, National
Institutes of Health, HHS) SECURITY
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218, Dated: July 14, 2015. Federal Emergency Management
MSC 7852, Bethesda, MD 20892, 301–435– Michelle Trout, Agency
1775, rubertm@csr.nih.gov. Program Analyst, Office of Federal Advisory
Committee Policy. [Docket ID FEMA–2015–0001]
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine; [FR Doc. 2015–17646 Filed 7–17–15; 8:45 am]
Final Flood Hazard Determinations
93.333, Clinical Research, 93.306, 93.333, BILLING CODE 4140–01–P
93.337, 93.393–93.396, 93.837–93.844, AGENCY: Federal Emergency
93.846–93.878, 93.892, 93.893, National Management Agency, DHS.
Institutes of Health, HHS) DEPARTMENT OF HEALTH AND ACTION: Final Notice.
HUMAN SERVICES
Dated: July 14, 2015. SUMMARY: Flood hazard determinations,
Michelle Trout, National Institutes of Health which may include additions or
Program Analyst, Office of Federal Advisory modifications of Base Flood Elevations
Eunice Kennedy Shriver National
mstockstill on DSK4VPTVN1PROD with NOTICES

Committee Policy. (BFEs), base flood depths, Special Flood
Institute of Child Health and Human
[FR Doc. 2015–17648 Filed 7–17–15; 8:45 am] Hazard Area (SFHA) boundaries or zone
Development; Notice of Closed
designations, or regulatory floodways on
BILLING CODE 4140–01–P Meeting
the Flood Insurance Rate Maps (FIRMs)
Pursuant to section 10(d) of the and where applicable, in the supporting
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amended (5 U.S.C. App.), notice is have been made final for the
hereby given of the following meeting. communities listed in the table below.

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Document Created: 2015-12-15 12:58:06
Document Modified: 2015-12-15 12:58:06

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.
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 comments 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 18, 2015.
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		80 FR 42829

80 FR 42829 - Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 138 (July 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration