Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 22668-22669 [2017-09961]
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22668
Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices
Synopsis: The Agreement authorizes
HLAG to sell space to CMA CGM on its
MGX service in the trade between ports
on the U.S. Gulf Coast on the one hand,
and ports on the Gulf Coast of Mexico
and in Italy, Spain and Jamaica on the
other hand.
Agreement No.: 012484.
Title: Port of New York & New Jersey/
OCEMA Discussion Agreement.
Parties: Port Authority of New York
and New Jersey and the Ocean Carrier
Equipment Management Association,
Inc., FMC Agreement No. 011284
(OCEMA).
Filing Party: Sam Ruda; Port
Authority of NY & NJ; 4 World Trade
Center; 150 Greenwich Street—17th
Floor; New York, NY 10007.
Synopsis: The Agreement authorizes
the Port of New York and New Jersey
and OCEMA to collect and exchange
information, discuss, and reach
agreement upon matters relating to the
Cargo Facility Charge levied by the Port
Authority of New York and New Jersey.
By Order of the Federal Maritime
Commission.
Dated: May 12, 2017.
Rachel E. Dickon,
Assistant Secretary.
[FR Doc. 2017–09987 Filed 5–16–17; 8:45 am]
BILLING CODE 6731–AA–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of
additional draft and revised draft
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(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 guidances available to the
public on FDA’s Web site. The
guidances identified in this notice were
nlaroche on DSK30NT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:18 May 16, 2017
Jkt 241001
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(s) on these
draft guidances before it begins work on
the final version of such guidances,
submit either electronic or written
comments on the draft guidance by July
17, 2017.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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
Guidances; Draft and Revised Draft
Guidances for Industry.’’ Received
comments will be placed in the docket
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://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
https://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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 guidances 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 documents.
FOR FURTHER INFORMATION CONTACT:
Xiaoqiu Tang, Center for Drug
E:\FR\FM\17MYN1.SGM
17MYN1
Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices
TABLE 1—NEW DRAFT PRODUCT-SPE- Guidances/default.htm or https://
CIFIC GUIDANCES FOR DRUG PROD- www.regulations.gov.
UCTS—Continued
Dated: May 11, 2017.
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 productspecific guidances available to the
public on FDA’s Web site at https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
As described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific guidances and provide a
meaningful opportunity for the public to
consider and comment on those
guidances. Under that process, draft
guidances 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
guidances or publishes revised draft
guidances for comment. Guidances were
last announced in the Federal Register
on December 23, 2016 (81 FR 94394).
This notice announces draft productspecific guidances, either new or
revised, that are posted on FDA’s Web
site.
Hydrocortisone
Hydrocortisone butyrate
Linagliptin; Metformin hydrochloride
Lorcaserin hydrochloride
Methylnaltrexone bromide
Nitroglycerin
Nystatin; Triamcinolone acetonide (multiple
reference listed drugs)
Oxymetazoline hydrochloride; Tetracaine hydrochloride
Sofosbuvir; Velpatasvir
Venetoclax
FDA is announcing the availability of
revised draft product-specific guidances
for industry for drug products
containing the following active
ingredients:
nlaroche on DSK30NT082PROD with NOTICES
VerDate Sep<11>2014
15:18 May 16, 2017
Acamprosate calcium
Apixaban
Bexarotene
Calcium acetate (multiple reference listed
drugs)
Deferiprone
Dolutegravir sodium
Emtricitabine; Tenofovir disoproxil fumarate
Fingolimod
Lanthanum carbonate
Nevirapine
Phenytoin (multiple reference listed drugs)
Propafenone hydrochloride
Trospium chloride (multiple reference listed
drugs)
IV. Electronic Access
Jkt 241001
[FR Doc. 2017–09961 Filed 5–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Determination That CALCIJEX
(Calcitriol) Injectable, 1 Microgram/
Milliliter and 2 Micrograms/Milliliter,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
TABLE 2—REVISED DRAFT PRODUCT- SUMMARY: The Food and Drug
SPECIFIC GUIDANCES FOR DRUG Administration (FDA or Agency) has
PRODUCTS
determined that the drug product listed
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://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
TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when
CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current
thinking of FDA on, among other things,
UCTS
the product-specific design of BE
studies to support ANDAs. They do not
Acetylcysteine
establish any rights for any person and
Amphetamine
are not binding on FDA or the public.
Aprepitant
You can use an alternative approach if
Azelastine hydrochloride
Bisacodyl; polyethylene glycol 3350; potasit satisfies the requirements of the
sium chloride; sodium bicarbonate; sodium
applicable statutes and regulations.
Clidinium
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[Docket No. FDA–2017–N–2364]
III. Drug Products for Which Revised
Draft Product-Specific Guidances are
Available
II. Drug Products for Which New Draft
Product-Specific Guidances are
Available
FDA is announcing the availability of
a new draft product-specific guidances
for industry for drug products
containing the following active
ingredients:
chloride
Carbidopa; levodopa
Chlordiazepoxide hydrochloride;
bromide
Clonazepam
Edoxaban tosylate
Gentamicin sulfate
22669
Persons with access to the Internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
in this document was not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
this drug product, and it will allow FDA
to continue to approve ANDAs that refer
to the product as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
E:\FR\FM\17MYN1.SGM
17MYN1
Agencies
[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Pages 22668-22669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09961]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (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 guidances available to the public on FDA's Web site.
The guidances 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(s) on
these draft guidances before it begins work on the final version of
such guidances, submit either electronic or written comments on the
draft guidance by July 17, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 Guidances; 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 https://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 https://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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 guidances 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 documents.
FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
[[Page 22669]]
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 guidances
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 guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances 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 guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on December 23, 2016 (81 FR 94394). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's Web site.
II. Drug Products for Which New Draft Product-Specific Guidances are
Available
FDA is announcing the availability of a new draft product-specific
guidances for industry for drug products containing the following
active ingredients:
Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
-------------------------------------------------------------------------
Acetylcysteine
Amphetamine
Aprepitant
Azelastine hydrochloride
Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium
bicarbonate; sodium chloride
Carbidopa; levodopa
Chlordiazepoxide hydrochloride; Clidinium bromide
Clonazepam
Edoxaban tosylate
Gentamicin sulfate
Hydrocortisone
Hydrocortisone butyrate
Linagliptin; Metformin hydrochloride
Lorcaserin hydrochloride
Methylnaltrexone bromide
Nitroglycerin
Nystatin; Triamcinolone acetonide (multiple reference listed drugs)
Oxymetazoline hydrochloride; Tetracaine hydrochloride
Sofosbuvir; Velpatasvir
Venetoclax
------------------------------------------------------------------------
III. Drug Products for Which Revised Draft Product-Specific Guidances
are Available
FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:
Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
-------------------------------------------------------------------------
Acamprosate calcium
Apixaban
Bexarotene
Calcium acetate (multiple reference listed drugs)
Deferiprone
Dolutegravir sodium
Emtricitabine; Tenofovir disoproxil fumarate
Fingolimod
Lanthanum carbonate
Nevirapine
Phenytoin (multiple reference listed drugs)
Propafenone hydrochloride
Trospium chloride (multiple reference listed drugs)
------------------------------------------------------------------------
For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://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, among
other things, 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.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: May 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09961 Filed 5-16-17; 8:45 am]
BILLING CODE 4164-01-P