Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability, 57000-57002 [2015-23571]
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57000
Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2994]
Draft Compliance Policy Guide
Crotalaria spp. Seeds in Grains;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
Compliance Policy Guide (CPG) entitled
‘‘Compliance Policy Guide Sec. 100.101
Crotalaria spp. Seeds in Grains’’ (the
draft CPG). The draft CPG, when
finalized, will provide guidance for FDA
staff on our regulatory action guidance
criteria for Crotalaria species (spp.)
seeds in grains.
DATES: Although you can comment on
any CPG at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on the draft CPG before
we begin work on the final version of
the CPG, submit written or electronic
comments on the draft CPG by
November 20, 2015.
ADDRESSES: Submit electronic
comments on the draft CPG to https://
www.regulations.gov. Submit written
comments on the draft CPG to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Submit written requests for
single copies of the draft CPG to the
Office of Policy and Risk Management,
Office of Regulatory Affairs, Office of
Global Regulatory Operations and
Policy, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857. Send two self-addressed
adhesive labels to assist that office in
processing your request, or fax your
request to 240–632–6861. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft CPG.
FOR FURTHER INFORMATION CONTACT:
George C. Ziobro, Center for Food Safety
and Applied Nutrition (HFS–316), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1700; or Amber M. McCoig,
Center for Veterinary Medicine (HFV–
230), Food and Drug Administration,
7519 Standish Place, Rockville, MD
20855, 240–402–5556.
SUPPLEMENTARY INFORMATION:
rmajette on DSK7SPTVN1PROD with NOTICES
SUMMARY:
I. Background
We are announcing the availability of
a draft CPG entitled ‘‘Compliance Policy
VerDate Sep<11>2014
15:14 Sep 18, 2015
Jkt 235001
Guide Sec. 100.101 Crotalaria spp.
Seeds in Grain.’’ We previously
provided guidance on Crotalaria
spectabilis and Crotalaria striata seeds
in grains in a CPG entitled ‘‘Compliance
Policy Guide 7126.15 Crotalaria Seeds
in Grains and Feeds’’ (CPG 7126.15),
which we issued on December 1, 1980.
We revoked CPG 7126.15 on July 22,
1994, because at the time we deemed
the CPG to be no longer relevant (59 FR
37498). However, because Crotalaria
plants persist in the agricultural
environment and still present a
potential public health risk, we
continue to monitor grains for the
presence of Crotalaria spp. seeds.
We are making available the draft CPG
because the revocation of CPG 7126.15
in 1994 inadvertently affected
interactions between FDA and the U.S.
Department of Agriculture’s (USDA’s)
Federal Grain Inspection Service (FGIS).
Under a Memorandum of
Understanding between FDA and USDA
(MOU 225–80–2000; https://
www.fda.gov/AboutFDA/
PartnershipsCollaborations/
MemorandaofUnderstandingMOUs/
DomesticMOUs/ucm116312.htm), FGIS
reports to FDA’s district offices the
results of FGIS’s analysis that may be
actionable under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act).
FGIS has been using the CPG 7126.15
criteria for reporting their analytical
results relating to Crotalaria in grain to
FDA.
CPG 7126.25 established a regulatory
action criterion of ‘‘an average of at least
one whole seed of Crotalaria spectabilis
and/or Crotalaria striata per pound’’ of
grain. In developing the draft CPG, we
converted the unit of weight from
pounds to kilograms because metric
units of measurement (e.g., kilograms)
are generally used for scientific
calculations. The conversion from
‘‘seeds per pound’’ to ‘‘seeds per
kilogram’’ resulted in 2.2 seeds per
kilogram. Because the analytical method
is based on determining whole seeds,
we rounded 2.2 to the nearest number
of whole seeds (i.e., 2 whole seeds). The
draft CPG also refers to Crotalaria spp.
seeds in grain instead of Crotalaria
spectabilis and Crotalaria striata
because it is impracticable to
distinguish between Crotalaria seeds
based on species. Thus, the draft CPG
states that FDA may regard grain that
contains more than two whole
Crotalaria spp. seeds per one kilogram
of grain to be adulterated within the
meaning of section 402(a)(1) of the
FD&C Act (21 U.S.C. 342(a)(1)).
The draft CPG is being made available
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
The draft CPG, when finalized, will
represent our current thinking on
Crotalaria spp. seeds in grains. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternate
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 the draft CPG. 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
may be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the draft CPG from FDA’s
Office of Regulatory Affairs Compliance
Policy Guide Revision/Update History
page. It may be accessed at https://
www.fda.gov/ICECI/
ComplianceManuals/
CompliancePolicyGuidanceManual/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–23619 Filed 9–18–15; 8:45 am]
BILLING CODE 4164–01–P
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.
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-
SUMMARY:
E:\FR\FM\21SEN1.SGM
21SEN1
Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
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 productspecific 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 comments on these draft
and revised draft guidances before it
begins work on the final versions of the
guidances, submit either electronic or
written comments on the draft and
revised draft product-specific BE
recommendations listed in this notice
by November 20, 2015.
ADDRESSES: Submit written requests for
single copies of the individual BE
guidances to the Division of Drug
Information, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Bldg., 4th Floor, Silver
Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance recommendations.
Submit electronic comments on the
draft product-specific BE
recommendations to https://
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, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730,
Silver Spring, MD 20993–0002, 301–
796–5850.
SUPPLEMENTARY INFORMATION:
rmajette on DSK7SPTVN1PROD with NOTICES
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 productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/
GuidanceCompliance
VerDate Sep<11>2014
15:14 Sep 18, 2015
Jkt 235001
RegulatoryInformation/Guidances/
default.htm.
As described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific 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 June 30, 2015
(80 FR 37273). 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
a new draft guidance 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
Aclidinium bromide
Acyclovir
Aminocaproic acid
Apremilast
Benazepril hydrochloride; Hydrochlorothiazide
Brimonidine tartrate
Carbidopa; Levodopa
Ceritinib
Clobetasol propionate
Clomipramine hydrochloride
Clonidine hydrochloride
Cobicistat
Cysteamine bitartrate
Dapagliflozin propanediol; Metformin hydrochloride
Dasabuvir
sodium;
Ombitasvir;
Paritaprevir;
Ritonavir
Desvenlafaxine fumarate
Eslicarbazepine acetate
Esomeprazole magnesium
Ferric citrate
Fluticasone propionate (multiple reference listed
drugs)
Formoterol fumarate
Idelalisib
Ledipasvir; Sofosbuvir
Levocarnitine
Loperamide hydrochloride; Simethicone
Mometasone furoate monohydrate
Naltrexone HCL; Bupropion HCL
Netupitant; Palonosetron hydrochloride
Nintedanib esylate
Nortriptyline hydrochloride
Pirfenidone
Pomalidomide
PO 00000
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Fmt 4703
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57001
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR
DRUG PRODUCTS—Continued
Ponatinib hydrochloride
Rivaroxaban
Ruxolitinib phosphate
Suvorexant
Tasimelteon
Tedizolid phosphate
Tramadol hydrochloride
Trimipramine maleate
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 PRODUCTSPECIFIC BE RECOMMENDATIONS
FOR DRUG PRODUCTS
Acitretin
Amantadine hydrochloride
Benzonatate
Carbamazepine
Colesevelam hydrochloride
Cyclophosphamide
Dabigatran etexilate mesylate
Dasatinib
Desvenlafaxine succinate
Esomeprazole magnesium
Estradiol
Ethinyl estradiol; Norethindrone
Gabapentin
Isotretinoin
Minocycline hydrochloride
Naltrexone
Sevelamer carbonate
Sirolimus
For a complete history of previously
published Federal Register notices
related to product-specific BE
recommendations, go to https://
www.regulations.gov and enter Docket
No. FDA–2007–D–0369.
These draft and revised draft
guidances are being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). These
guidances represent the Agency’s
current thinking on product-specific
design of BE studies to support ANDAs.
They do not establish any rights for
anyone and are not binding on FDA or
the public. You may use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
IV. Comments
Interested persons may submit either
electronic comments on any of the
specific BE recommendations posted on
FDA’s Web site to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
E:\FR\FM\21SEN1.SGM
21SEN1
57002
Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
Identify comments with the docket
number found in brackets in the
heading of this document. The
guidances, notices, and 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 https://
www.regulations.gov.
OMB control number 0910–0721. The
approval expires on August 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
[FR Doc. 2015–23566 Filed 9–18–15; 8:45 am]
Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[Docket No. FDA–2015–N–3224]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations of Individuals
and Consumer Organizations for the
Patient Engagement Advisory
Committee
[FR Doc. 2015–23571 Filed 9–18–15; 8:45 am]
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2009–N–0025]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Animal Food Labeling; Declaration of
Certifiable Color Additives
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Animal Food Labeling; Declaration of
Certifiable Color Additives’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On July
16, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Animal Food Labeling;
Declaration of Certifiable Color
Additives’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
rmajette on DSK7SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:14 Sep 18, 2015
Jkt 235001
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of a
voting consumer representative to serve
on the Patient Engagement Advisory
Committee (the Committee) notify FDA
in writing. FDA is also requesting
nominations for a voting consumer
representative to serve on the
Committee. Nominees recommended to
serve as a voting consumer
representative may either be selfnominated or may be nominated by a
consumer organization. Nominations
will be accepted for the current vacancy
effective with this notice.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting
member to represent consumer interests
on the Committee may send a letter or
email stating that interest to FDA by
October 21, 2015. Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
October 21, 2015.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
should be sent electronically to
Kimberly Hamilton (see FOR FURTHER
INFORMATION CONTACT). All Consumer
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Representative nominations may be
submitted electronically by accessing
the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm, by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002, or FAX: 301–847–
8640. Information about becoming a
member of an FDA advisory committee
can also be obtained by visiting FDA’s
Web site at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: For
questions relating to participation in the
selection process: Kimberly Hamilton,
Advisory Committee Oversight and
Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5117, Silver Spring,
MD 20993–0002, 301–796–6319,
kimberly.hamilton@fda.hhs.gov.
For questions relating to the
Committee: Letise Williams, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441,
Silver Spring, MD 20993–0002, 301–
796–8398, letise.williams@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for a voting
consumer representative on the
Committee.
Elsewhere in this issue of the Federal
Register, FDA is publishing separate
documents regarding:
1. Patient Engagement Advisory
Committee; Notice of Establishment.
2. Request for Nominations for Voting
Members for the Patient Engagement
Advisory Committee.
3. Request for Nominations of
Individuals and Industry Organizations
for the Patient Engagement Advisory
Committee.
I. General Description of the
Committee’s Duties
The Committee provides advice on
complex issues relating to medical
devices, the regulation of devices, and
their use by patients. Agency guidance
and policies, clinical trial or registry
design, patient preference study design,
benefit-risk determinations, device
labeling, unmet clinical needs, available
alternatives, patient reported outcomes
and device-related quality of life or
health status issues are among the topics
that may be considered by the
Committee. Members are knowledgeable
in areas such as clinical research,
primary care patient experience, health
care needs of patient groups in the
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57000-57002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23571]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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-
[[Page 57001]]
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 comments on
these draft and revised draft guidances before it begins work on the
final versions of the guidances, submit either electronic or written
comments on the draft and revised draft product-specific BE
recommendations listed in this notice by November 20, 2015.
ADDRESSES: Submit written requests for single copies of the individual
BE guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 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 recommendations.
Submit electronic comments on the draft product-specific BE
recommendations to https://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, 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 https://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. 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
June 30, 2015 (80 FR 37273). 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 a new draft guidance 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
------------------------------------------------------------------------
-------------------------------------------------------------------------
Aclidinium bromide
Acyclovir
Aminocaproic acid
Apremilast
Benazepril hydrochloride; Hydrochlorothiazide
Brimonidine tartrate
Carbidopa; Levodopa
Ceritinib
Clobetasol propionate
Clomipramine hydrochloride
Clonidine hydrochloride
Cobicistat
Cysteamine bitartrate
Dapagliflozin propanediol; Metformin hydrochloride
Dasabuvir sodium; Ombitasvir; Paritaprevir; Ritonavir
Desvenlafaxine fumarate
Eslicarbazepine acetate
Esomeprazole magnesium
Ferric citrate
Fluticasone propionate (multiple reference listed drugs)
Formoterol fumarate
Idelalisib
Ledipasvir; Sofosbuvir
Levocarnitine
Loperamide hydrochloride; Simethicone
Mometasone furoate monohydrate
Naltrexone HCL; Bupropion HCL
Netupitant; Palonosetron hydrochloride
Nintedanib esylate
Nortriptyline hydrochloride
Pirfenidone
Pomalidomide
Ponatinib hydrochloride
Rivaroxaban
Ruxolitinib phosphate
Suvorexant
Tasimelteon
Tedizolid phosphate
Tramadol hydrochloride
Trimipramine maleate
------------------------------------------------------------------------
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
------------------------------------------------------------------------
-------------------------------------------------------------------------
Acitretin
Amantadine hydrochloride
Benzonatate
Carbamazepine
Colesevelam hydrochloride
Cyclophosphamide
Dabigatran etexilate mesylate
Dasatinib
Desvenlafaxine succinate
Esomeprazole magnesium
Estradiol
Ethinyl estradiol; Norethindrone
Gabapentin
Isotretinoin
Minocycline hydrochloride
Naltrexone
Sevelamer carbonate
Sirolimus
------------------------------------------------------------------------
For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
These draft and revised draft guidances are being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). These
guidances represent the Agency's current thinking on product-specific
design of BE studies to support ANDAs. They do not establish any rights
for anyone and are not binding on FDA or the public. You may use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
IV. Comments
Interested persons may submit either electronic comments on any of
the specific BE recommendations posted on FDA's Web site to https://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments.
[[Page 57002]]
Identify comments with the docket number found in brackets in the
heading of this document. The guidances, notices, and 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 https://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23571 Filed 9-18-15; 8:45 am]
BILLING CODE 4164-01-P
