81 FR 4913 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

Page Range		4913-4914
FR Document		2016-01682

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

Federal Register, Volume 81 Issue 18 (Thursday, January 28, 2016)

[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4913-4914]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-01682]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Product-Specific Bioequivalence Recommendations; Draft and
Revised Draft Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific BE recommendations available to the public on FDA's
Web site. The BE recommendations identified in this notice were
developed using the process described in that guidance.

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 March 28, 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 ``Product-Specific Bioequivalence Recommendations;
Draft and Revised Draft Guidances for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' 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, 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'' that 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/Guidance

[[Page 4914]]

ComplianceRegulatoryInformation/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. Under that process, draft recommendations are
posted on FDA's Web site and announced periodically in the Federal
Register. The public is encouraged to submit comments on those
recommendations within 60 days of their announcement in the Federal
Register. FDA considers any comments received and either publishes
final recommendations or publishes revised draft recommendations for
comment. Recommendations were last announced in the Federal Register on
September 21, 2015 (80 FR 57000). This notice announces draft product-
specific recommendations, either new or revised, that are posted on
FDA's Web site.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations are Available

FDA is announcing the availability of new draft guidances for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
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Alprostadil.
Atazanavir sulfate; cobicistat.
Beclomethasone dipropionate.
Betamethasone dipropionate.
Betamethasone valerate.
Betaxolol hydrochloride.
Ciclesonide.
Clobetasol propionate.
Desonide (multiple reference listed drugs).
Diflorasone diacetate (multiple reference listed drugs).
Difluprednate emulsion.
Elvitegravir.
Erythromycin.
Ethinyl estradiol; norethindrone acetate.
Flurandrenolide.
Formoterol fumarate; mometasone furoate.
Ingenol mebutate (multiple strengths).
Mercaptopurine.
Methylphenidate hydrocholoride.
Metronidazole.
Mometasone furoate.
Naftifine hydrochloride (multiple reference listed drugs).
Nicotine.
Olanzapine pamoate.
Omega-3-carboxylic acids.
Prednisone.
Ranitidine hydrochloride.
Riociguat.
Spinosad.
Trametinib dimethyl sulfoxide.
Vorapaxar sulfate.
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III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations are Available

FDA is announcing the availability of a revised draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

Table 2--Revised Draft Product-Specific BE Recommendations for Drug
Products
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Abiraterone acetate.
Amphotericin B.
Ciprofloxacin hydrochloride; hydrocortisone.
Colesevelam hydrochloride.
Drospirenone; estradiol.
Guanfacine hydrochloride.
Lidocaine.
Lomitapide mesylate.
Methylphenidate hydrochloride.
Phytonadione.
Rivastigmine tartrate.
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For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, go to http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on the
product-specific design of BE studies to support ANDAs. They do not
establish any rights for any person and are 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: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01682 Filed 1-27-16; 8:45 am]
BILLING CODE 4164-01-P

4914 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices

ComplianceRegulatoryInformation/ TABLE 1—NEW DRAFT PRODUCT-SPE- DEPARTMENT OF HEALTH AND
Guidances/default.htm. CIFIC BE RECOMMENDATIONS FOR HUMAN SERVICES
As described in that guidance, FDA DRUG PRODUCTS—Continued
adopted this process as a means to Food and Drug Administration
develop and disseminate product- Spinosad.
specific BE recommendations and Trametinib dimethyl sulfoxide. [Docket No. FDA–2012–N–0438]
provide a meaningful opportunity for Vorapaxar sulfate.
the public to consider and comment on Agency Information Collection
those recommendations. Under that III. Drug Products for Which Revised Activities; Announcement of Office of
process, draft recommendations are Draft Product-Specific BE Management and Budget Approval;
posted on FDA’s Web site and Recommendations are Available Early Food Safety Evaluation of New
announced periodically in the Federal Non-Pesticidal Proteins Produced by
Register. The public is encouraged to FDA is announcing the availability of
a revised draft guidance for industry on New Plant Varieties Intended for Food
submit comments on those Use
recommendations within 60 days of product-specific BE recommendations
their announcement in the Federal for drug products containing the
AGENCY: Food and Drug Administration,
Register. FDA considers any comments following active ingredients:
HHS.
received and either publishes final
recommendations or publishes revised TABLE 2—REVISED DRAFT PRODUCT- ACTION: Notice.
draft recommendations for comment. SPECIFIC BE RECOMMENDATIONS
Recommendations were last announced FOR DRUG PRODUCTS SUMMARY: The Food and Drug
in the Federal Register on September Administration (FDA) is announcing
21, 2015 (80 FR 57000). This notice Abiraterone acetate. that a collection of information entitled
announces draft product-specific Amphotericin B. ‘‘Early Food Safety Evaluation of New
recommendations, either new or Ciprofloxacin hydrochloride; hydrocortisone. Non-Pesticidal Proteins Produced by
revised, that are posted on FDA’s Web Colesevelam hydrochloride. New Plant Varieties Intended for Food
site. Drospirenone; estradiol. Use’’ has been approved by the Office of
Guanfacine hydrochloride. Management and Budget (OMB) under
II. Drug Products for Which New Draft
Lidocaine. the Paperwork Reduction Act of 1995.
Product-Specific BE Recommendations
Lomitapide mesylate.
are Available FOR FURTHER INFORMATION CONTACT: FDA
Methylphenidate hydrochloride.
FDA is announcing the availability of Phytonadione. PRA Staff, Office of Operations, Food
new draft guidances for industry on Rivastigmine tartrate. and Drug Administration, 8455
product-specific BE recommendations Colesville Rd., COLE–14526, Silver
for drug products containing the For a complete history of previously Spring, MD 20993–0002,
following active ingredients: published Federal Register notices PRAStaff@fda.hhs.gov.
related to product-specific BE
TABLE 1—NEW DRAFT PRODUCT-SPE- recommendations, go to http:// SUPPLEMENTARY INFORMATION: On
CIFIC BE RECOMMENDATIONS FOR www.regulations.gov and enter Docket October 8, 2015, the Agency submitted
DRUG PRODUCTS a proposed collection of information
No. FDA–2007–D–0369.
entitled ‘‘Early Food Safety Evaluation
Alprostadil.
These draft guidances are being of New Non-Pesticidal Proteins
Atazanavir sulfate; cobicistat. issued consistent with FDA’s good Produced by New Plant Varieties
Beclomethasone dipropionate. guidance practices regulation (21 CFR Intended for Food Use’’ to OMB for
Betamethasone dipropionate. 10.115). These draft guidances, when review and clearance under 44 U.S.C.
Betamethasone valerate. finalized, will represent the current 3507. An Agency may not conduct or
Betaxolol hydrochloride. thinking of FDA on the product-specific
Ciclesonide. sponsor, and a person is not required to
design of BE studies to support ANDAs.
Clobetasol propionate. respond to, a collection of information
They do not establish any rights for any
Desonide (multiple reference listed drugs). unless it displays a currently valid OMB
person and are not binding on FDA or
Diflorasone diacetate (multiple reference list- control number. OMB has now
ed drugs). the public. You can use an alternative
approved the information collection and
Difluprednate emulsion. approach if it satisfies the requirements
of the applicable statutes and has assigned OMB control number
Elvitegravir.
Erythromycin. regulations. 0910–0583. The approval expires on
Ethinyl estradiol; norethindrone acetate. November 30, 2018. A copy of the
Flurandrenolide. II. Electronic Access supporting statement for this
Formoterol fumarate; mometasone furoate. information collection is available on
Ingenol mebutate (multiple strengths). Persons with access to the Internet
the Internet at http://www.reginfo.gov/
Mercaptopurine. may obtain the draft guidance at either
public/do/PRAMain.
Methylphenidate hydrocholoride. http://www.fda.gov/Drugs/Guidance
Metronidazole. ComplianceRegulatoryInformation/ Dated: January 22, 2016.
Mometasone furoate. Guidances/default.htm or http:// Leslie Kux,
wgreen on DSK2VPTVN1PROD with NOTICES

Naftifine hydrochloride (multiple reference www.regulations.gov. Associate Commissioner for Policy.
listed drugs).
Nicotine. Dated: January 22, 2016. [FR Doc. 2016–01686 Filed 1–27–16; 8:45 am]
Olanzapine pamoate. Leslie Kux, BILLING CODE 4164–01–P
Omega-3-carboxylic acids. Associate Commissioner for Policy.
Prednisone.
Ranitidine hydrochloride. [FR Doc. 2016–01682 Filed 1–27–16; 8:45 am]
Riociguat. BILLING CODE 4164–01–P

VerDate Sep<11>2014 13:19 Jan 27, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4703 Sfmt 9990 E:\FR\FM\28JAN1.SGM 28JAN1

Document Created: 2018-02-02 12:41:01
Document Modified: 2018-02-02 12:41:01

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 March 28, 2016.
Contact		Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850.
FR Citation		81 FR 4913

81 FR 4913 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration