Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability, 37273-37275 [2015-16013]
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Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
37273
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Type of respondent
LGBT young adults aged
18–24 in the select
media markets—Recruited via social media.
Number of
respondents
Activity
Second follow up young
adult outcome evaluation questionnaire.
Third follow up young
adult outcome evaluation questionnaire.
1st media tracking
screener.
Total ..........................
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
Food and Drug Administration,
HHS.
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 productspecific 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
SUMMARY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1
788
0.667 (40 min.) .....
526
788
1
788
0.667 (40 min.) .....
526
1667
..........................................
[FR Doc. 2015–16020 Filed 6–29–15; 8:45 am]
ACTION:
Total hours
1
1667
0.083 (5 min.) .......
138
500
1
500
0.667 (40 min.) .....
334
1667
1
1667
0.083 (5 min.) .......
138
500
1
500
0.667 (40 min.) .....
334
1667
1
1667
0.083 (5 min.) ......
138
500
1
500
0.667 (40 min.) .....
334
37,477
........................
........................
..............................
10,819
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Average
burden per
response
Total annual
responses
788
1st media tracking questionnaire.
2nd media tracking
screener.
2nd media tracking questionnaire.
3rd media tracking
screener.
3rd media tracking questionnaire.
1 There
Number of
responses per
respondent
VerDate Sep<11>2014
17:34 Jun 29, 2015
Jkt 235001
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 August 31, 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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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 productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
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 March 9,
2015 (80 FR 12502). This notice
announces draft product-specific
E:\FR\FM\30JNN1.SGM
30JNN1
37274
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
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
product-specific BE recommendations
for drug products containing the
following active ingredients:
FDA is announcing the availability of
a new draft guidance for industry on
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS
Abacavir sulfate; Dolutegravir sodium; Lamivudine.
Afatinib dimaleate.
Alendronate sodium.
Aspirin.
Azelastine hydrochloride; Fluticasone propionate.
Budesonide; Formoterol fumarate dihydrate.
Calcium carbonate; Famotidine; Magnesium hydroxide.
Canagliflozin; Metformin hydrochloride.
Cyclophosphamide.
Cyproheptadine hydrochloride.
Dabrafenib mesylate.
Dapagliflozin propanediol.
Dexbrompheniramine maleate and Pseudoephedrine sulfate.
Dolutegravir sodium.
Donepezil hydrochloride; Memantine hydrochloride.
Doxycycline hyclate.
Droxidopa.
Eliglustat tartrate.
Empagliflozin.
Emtricitabine; Tenofovir disoproxil fumarate.
Enzalutamide.
Fentanyl.
Indomethacin.
Lanthanum carbonate.
Levalbuterol tartrate.
Levomilnacipran hydrochloride.
Macitentan.
Methazolamide.
Miglitol.
Naloxegol oxalate.
Naproxen sodium.
Nitroglycerin.
Omeprazole; Sodium bicarbonate.
Oxybutynin (multiple reference listed drugs and dosage forms).
Oxycodone hydrochloride.
Primaquine phosphate.
Sildenafil citrate.
Simeprevir sodium.
Sofosbuvir.
Tolcapone.
Vemurafenib.
Vismodegib.
Vortioxetine hydrobromide.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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:
These draft and revised draft
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS guidances are being issued consistent
FOR
DRUG
PRODUCTS with FDA’s good guidance practices
regulation (21 CFR 10.115). These
CHOLESTYRAMINE—Continued
Prasugrel hydrochloride.
Tiagabine hydrochloride.
TABLE 2—REVISED DRAFT PRODUCTFor a complete history of previously
SPECIFIC BE RECOMMENDATIONS
FOR
DRUG
PRODUCTS published Federal Register notices
related to product-specific BE
CHOLESTYRAMINE
recommendations, go to https://
www.regulations.gov and enter Docket
No. FDA–2007–D–0369.
Doxycycline hyclate.
VerDate Sep<11>2014
17:34 Jun 29, 2015
Jkt 235001
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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
E:\FR\FM\30JNN1.SGM
30JNN1
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
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.
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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–16013 Filed 6–29–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2261]
Premarket Notification Requirements
Concerning Gowns Intended for Use in
Health Care Settings; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Premarket Notification
Requirements Concerning Gowns
Intended for Use in Health Care
Settings.’’ FDA is issuing this draft
guidance to describe the Agency’s
premarket regulatory requirements and
the performance testing needed to
support liquid barrier claims for gowns
intended for use in health care settings.
This draft guidance is being issued in
light of the public health importance of
personal protective equipment in health
care settings and the recognition that
terminology used to describe gowns has
evolved, including by industry, the
standards community, and health care
professionals. This draft guidance is not
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:34 Jun 29, 2015
Jkt 235001
10.115(g)(5)), to ensure that the Agency
considers your comment of 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 August 31,
2015.
An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Premarket
Notification Requirements Concerning
Gowns Intended for Use in Health Care
Settings’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit electronic comments on the
draft guidance 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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Claverie, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2508, Silver Spring,
MD 20993–0002, 301–796–6298.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
FDA issued a final rule on June 24,
1988 (53 FR 23874), defining ‘‘surgical
apparel’’ under 21 CFR 878.4040. Under
this 1988 final rule, surgical gowns and
surgical masks were classified as Class
II subject to premarket review under
section 510(k) (21 U.S.C. 351) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), and surgical apparel
other than surgical gowns and surgical
masks were classified as Class I also
subject to 510(k) premarket review
requirements. On January 14, 2000, FDA
issued a final rule (65 FR 2318) to
designate as exempt from premarket
notification requirements surgical
apparel other than surgical gowns and
surgical masks, subject to the limitations
of exemptions under 21 CFR 878.9,
which includes requiring a premarket
notification for devices intended for a
use different from the intended use of a
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
37275
legally marketed device in that generic
type of device.
Since the original 1988 final rule, a
number of terms have been used to refer
to gowns intended for use in health care
settings including, but not limited to,
surgical gowns, isolation gowns,
surgical isolation gowns, nonsurgical
gowns, procedural gowns, and operating
room gowns. In 2004, FDA recognized
the consensus standard American
National Standards Institute/
Association of the Advancement of
Medical Instrumentation (ANSI/AAMI)
PB70:2003, ‘‘Liquid barrier performance
and classification of protective apparel
and drapes intended for use in health
care facilities.’’ ANSI/AAMI PB 70
utilized new terminology for barrier
performance of gowns. This terminology
described and assessed the barrier
protection levels of gowns and other
protective apparel intended for use in
health care facilities, by specifying test
methods and performance results
necessary to verify and validate the
newly defined levels of barrier
protection. The definitions and
terminology used in this standard are
inconsistent with FDA’s historical
definitions of these terms and thus have
added confusion in the marketplace.
The purpose of this draft guidance is to
clarify and describe the premarket
regulatory requirements pertaining to
gowns regulated under § 878.4040 and
the performance testing needed to
support liquid barrier claims for gowns
intended for use in health care settings.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance represents the
Agency’s current thinking on
performance testing to support liquid
barrier claims for gowns intended for
use in health care settings. 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.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Premarket Notification
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37273-37275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16013]
-----------------------------------------------------------------------
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-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 August 31, 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
March 9, 2015 (80 FR 12502). This notice announces draft product-
specific
[[Page 37274]]
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
------------------------------------------------------------------------
-------------------------------------------------------------------------
Abacavir sulfate; Dolutegravir sodium; Lamivudine.
Afatinib dimaleate.
Alendronate sodium.
Aspirin.
Azelastine hydrochloride; Fluticasone propionate.
Budesonide; Formoterol fumarate dihydrate.
Calcium carbonate; Famotidine; Magnesium hydroxide.
Canagliflozin; Metformin hydrochloride.
Cyclophosphamide.
Cyproheptadine hydrochloride.
Dabrafenib mesylate.
Dapagliflozin propanediol.
Dexbrompheniramine maleate and Pseudoephedrine sulfate.
Dolutegravir sodium.
Donepezil hydrochloride; Memantine hydrochloride.
Doxycycline hyclate.
Droxidopa.
Eliglustat tartrate.
Empagliflozin.
Emtricitabine; Tenofovir disoproxil fumarate.
Enzalutamide.
Fentanyl.
Indomethacin.
Lanthanum carbonate.
Levalbuterol tartrate.
Levomilnacipran hydrochloride.
Macitentan.
Methazolamide.
Miglitol.
Naloxegol oxalate.
Naproxen sodium.
Nitroglycerin.
Omeprazole; Sodium bicarbonate.
Oxybutynin (multiple reference listed drugs and dosage forms).
Oxycodone hydrochloride.
Primaquine phosphate.
Sildenafil citrate.
Simeprevir sodium.
Sofosbuvir.
Tolcapone.
Vemurafenib.
Vismodegib.
Vortioxetine hydrobromide.
------------------------------------------------------------------------
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 Cholestyramine
------------------------------------------------------------------------
-------------------------------------------------------------------------
Doxycycline hyclate.
Prasugrel hydrochloride.
Tiagabine hydrochloride.
------------------------------------------------------------------------
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
[[Page 37275]]
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. 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: June 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16013 Filed 6-29-15; 8:45 am]
BILLING CODE 4164-01-P
