80 FR 30255 - Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 101 (May 27, 2015)

Page Range		30255-30255
FR Document		2015-12847

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled ``Draft Guidance on Risperidone.'' The recommendations provide specific guidance on the design of studies to support abbreviated new drug applications (ANDAs) for risperidone injection. This draft guidance is the second revision of a previously issued draft guidance on the same subject.

Federal Register, Volume 80 Issue 101 (Wednesday, May 27, 2015)

[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Page 30255]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-12847]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Bioequivalence Recommendations for Risperidone; Draft Guidance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availability of a draft guidance for industry on risperidone injection
entitled ``Draft Guidance on Risperidone.'' The recommendations provide
specific guidance on the design of studies to support abbreviated new
drug applications (ANDAs) for risperidone injection. This draft
guidance is the second revision of a previously issued draft guidance
on the same subject.

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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 27, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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section for electronic access to the draft guidance document.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.

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 bioequivalence (BE)
recommendations and provide a meaningful opportunity for the public to
consider and comment on those recommendations. This notice announces
the availability of a second revision of draft BE recommendations for
risperidone injection.
FDA initially approved new drug application 021346 for Risperdal
Consta Long-Acting Injection in October 2003. There are no approved
ANDAs for this product. In February 2010, FDA issued a draft guidance
for industry on BE recommendations for generic risperidone injection.
In August 2013, we issued a revised draft guidance on the same subject.
We are now issuing a second revision of the draft guidance for industry
on BE recommendations for generic risperidone injection (Draft Guidance
on Risperidone).
In February 2011, Johnson & Johnson Pharmaceutical Research and
Development, LLC, manufacturer of Risperdal Consta, the reference
listed drug, submitted a citizen petition requesting that FDA require
that any ANDA referencing Risperdal Consta meet certain requirements,
including requirements related to demonstrating BE (Docket No. FDA-
2011-P-0086). FDA is reviewing the issues raised in the petition. FDA
will consider any comments on the revised draft BE recommendations in
responding to the petition.
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 risperidone injection. 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 to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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.

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.

Dated: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12847 Filed 5-26-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 101 / Wednesday, May 27, 2015 / Notices 30255

the Administration for Children and 4730, Silver Spring, MD 20993–0002, II. Comments
Families. 301–796–5850. Interested persons may submit to the
Robert Sargis, I. Background Division of Dockets Management (see
Reports Clearance Officer. ADDRESSES) either electronic or written
In the Federal Register of June 11, comments regarding this document. It is
[FR Doc. 2015–12693 Filed 5–26–15; 8:45 am] 2010 (75 FR 33311), FDA announced the only necessary to send one set of
BILLING CODE 4184–01–P availability of a guidance for industry, comments. Identify comments with the
‘‘Bioequivalence Recommendations for docket number found in brackets in the
Specific Products,’’ which explained the heading of this document. Received
DEPARTMENT OF HEALTH AND process that would be used to make
HUMAN SERVICES comments may be seen in the Division
product-specific BE recommendations of Dockets Management between 9 a.m.
available to the public on FDA’s Web and 4 p.m., Monday through Friday.
Food and Drug Administration
site at http://www.fda.gov/Drugs/
[Docket No. FDA–2007–D–0369] GuidanceComplianceRegulatory III. Electronic Access
Information/Guidances/default.htm. As Persons with access to the Internet
Bioequivalence Recommendations for described in that guidance, FDA may obtain the document at either
Risperidone; Draft Guidance for adopted this process as a means to http://www.fda.gov/Drugs/Guidance
Industry; Availability develop and disseminate product- ComplianceRegulatoryInformation/
specific bioequivalence (BE) Guidances/default.htm or http://
AGENCY: Food and Drug Administration, recommendations and provide a www.regulations.gov.
HHS. meaningful opportunity for the public to
ACTION: Notice. Dated: May 21, 2015.
consider and comment on those
recommendations. This notice Leslie Kux,
SUMMARY: The Food and Drug announces the availability of a second Associate Commissioner for Policy.
Administration (FDA) is announcing the revision of draft BE recommendations [FR Doc. 2015–12847 Filed 5–26–15; 8:45 am]
availability of a draft guidance for for risperidone injection. BILLING CODE 4164–01–P
industry on risperidone injection
FDA initially approved new drug
entitled ‘‘Draft Guidance on
application 021346 for Risperdal Consta
Risperidone.’’ The recommendations DEPARTMENT OF HEALTH AND
Long-Acting Injection in October 2003.
provide specific guidance on the design HUMAN SERVICES
There are no approved ANDAs for this
of studies to support abbreviated new
product. In February 2010, FDA issued
drug applications (ANDAs) for Health Resources and Services
a draft guidance for industry on BE
risperidone injection. This draft Administration
recommendations for generic
guidance is the second revision of a
risperidone injection. In August 2013, Agency Information Collection
previously issued draft guidance on the
we issued a revised draft guidance on Activities: Proposed Collection: Public
same subject.
the same subject. We are now issuing a Comment Request
DATES: Although you can comment on second revision of the draft guidance for
any guidance at any time (see 21 CFR industry on BE recommendations for AGENCY: Health Resources and Services
10.115(g)(5)), to ensure that the Agency generic risperidone injection (Draft Administration, HHS.
considers your comments on this draft Guidance on Risperidone). ACTION: Notice.
guidance before it begins work on the In February 2011, Johnson & Johnson
final version of the guidance, submit Pharmaceutical Research and SUMMARY: In compliance with the
either electronic or written comments Development, LLC, manufacturer of requirement for opportunity for public
on the draft guidance by July 27, 2015. Risperdal Consta, the reference listed comment on proposed data collection
ADDRESSES: Submit written requests for drug, submitted a citizen petition projects (Section 3506(c)(2)(A) of the
single copies of the draft guidance to the requesting that FDA require that any Paperwork Reduction Act of 1995), the
Division of Drug Information, Center for ANDA referencing Risperdal Consta Health Resources and Services
Drug Evaluation and Research, Food meet certain requirements, including Administration (HRSA) announces
and Drug Administration, 10001 New requirements related to demonstrating plans to submit an Information
Hampshire Ave., Hillandale Building, BE (Docket No. FDA–2011–P–0086). Collection Request (ICR), described
4th Floor, Silver Spring, MD 20993– FDA is reviewing the issues raised in below, to the Office of Management and
0002. Send one self-addressed adhesive the petition. FDA will consider any Budget (OMB). Prior to submitting the
label to assist that office in processing comments on the revised draft BE ICR to OMB, HRSA seeks comments
your requests. See the SUPPLEMENTARY recommendations in responding to the from the public regarding the burden
INFORMATION section for electronic petition. estimate, below, or any other aspect of
access to the draft guidance document. the ICR.
This draft guidance is being issued
Submit electronic comments on the consistent with FDA’s good guidance DATES: Comments on this Information
draft guidance to http:// practices regulation (21 CFR 10.115). Collection Request must be received no
www.regulations.gov. Submit written The draft guidance, when finalized, will later than July 27, 2015.
comments to the Division of Dockets represent the Agency’s current thinking ADDRESSES: Submit your comments to
Management (HFA–305), Food and Drug paperwork@hrsa.gov or mail the HRSA
mstockstill on DSK4VPTVN1PROD with NOTICES

on the design of BE studies to support
Administration, 5630 Fishers Lane, Rm. ANDAs for risperidone injection. It does Information Collection Clearance
1061, Rockville, MD 20852. not create or confer any rights for or on Officer, Room 10–29, Parklawn
FOR FURTHER INFORMATION CONTACT: any person and does not operate to bind Building, 5600 Fishers Lane, Rockville,
Xiaoqiu Tang, Center for Drug FDA or the public. An alternative MD 20857.
Evaluation and Research (HFD–600), approach may be used if such approach FOR FURTHER INFORMATION CONTACT: To
Food and Drug Administration, 10903 satisfies the requirements of the request more information on the
New Hampshire Ave., Bldg. 75, Rm. applicable statutes and regulations. proposed project or to obtain a copy of

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Document Created: 2015-12-15 15:35:44
Document Modified: 2015-12-15 15:35:44

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 July 27, 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 30255

80 FR 30255 - Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 101 (May 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration