Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 46745-46747 [2018-20018]
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46745
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
recommends that 3P Review
Organizations establish a recordkeeping
system for tracking the submission of
those complaints and how those
complaints were resolved, or attempted
to be resolved. Therefore, we have
added an IC for ‘‘Recordkeeping system
regarding complaints.’’ Based on our
experience with the program and the
recommendations in the guidance, we
estimate the average burden per
recordkeeping to be 2 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Average
burden per
recordkeeping
Total annual
records
Total hours
510(k) reviews 3 ...................................................................
Records regarding qualifications to receive FDA recognition as a 3P Review Organization 4 .................................
Recordkeeping system regarding complaints 4 ...................
7
21
147
10
1,470
7
7
1
1
7
7
1
2
7
14
Total ..............................................................................
........................
........................
........................
........................
1,491
1 There
are no capital costs or operating and maintenance costs associated with this IC.
We revised our estimates for OMB
control number 0910–0375 by adding
new ICs, changing the title of the ICR,
and adjusting the existing ICs based on
current trends. Despite the addition of
new ICs, the estimated burden reflects
an overall decrease of 5,581 hours. We
attribute this adjustment to a decrease in
the number of submissions we received
over the last few years.
The draft guidance also refers to
previously approved ICs found in FDA
regulations. The ICs in 21 CFR part 807,
subpart E have been approved under
OMB control number 0910–0120; the
ICs regarding 3P Review of medical
devices under FDAMA have been
approved under OMB control number
0910–0375; the ICs for the device
appeals processes have been approved
under OMB control number 0910–0738;
the ICs in the guidance document
‘‘Requests for Feedback on Medical
Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
have been approved under OMB control
number 0910–0756.
Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–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.
VerDate Sep<11>2014
17:06 Sep 13, 2018
Jkt 244001
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 website. The guidances
identified in this notice were developed
using the process described in that
guidance.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by November 13, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
Electronic Submissions
[FR Doc. 2018–19992 Filed 9–13–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
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
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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 Dockets Management Staff
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
E:\FR\FM\14SEN1.SGM
14SEN1
46746
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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 Dockets Management
Staff. 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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). 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:
Wendy Good, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714,
Silver Spring, MD 20993–0002, 240–
402–9682.
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
VerDate Sep<11>2014
17:06 Sep 13, 2018
Jkt 244001
that would be used to make productspecific guidances available to the
public on FDA’s website 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 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 website
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 July 20, 2018. This notice announces
draft product-specific guidances, either
new or revised, that are posted on FDA’s
website.
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
Abemaciclib
Albuterol sulfate
Allopurinol; Lesinurad
Amantadine hydrochloride
Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine saccharate; Dextroamphetamine
sulfate
Azelaic acid
Benznidazole
Brigatinib
Brimonidine tartrate; Timolol maleate
Chlorzoxazone
Ciprofloxacin hydrochloride
Dapagliflozin propanediol; Saxagliptin hydrochloride
Delafloxacin meglumine
Desonide
Deutetrabenazine
Diazepam
Efinaconazole
Enasidenib mesylate
Glecaprevir; Pibrentasvir
Ibuprofen; Pseudoephedrine hydrochloride
Ivermectin
Lamotrigine
Luliconazole
Midostaurin
Miltefosine
Morphine sulfate
Neratinib maleate
Olaparib
Olive oil; Soybean oil
Oxycodone hydrochloride
Penciclovir
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TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued
Perflutren
Pilocarpine hydrochloride
Pitavastatin magnesium
Pitavastatin sodium
Pregabalin
Secnidazole
Sofosbuvir; Velpatasvir; Voxilaprevir
Spironolactone
Sulfur hexafluoride lipid-type a microspheres
Talc
Tavaborole
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 PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Acetazolamide
Chlorpromazine hydrochloride
Doxorubicin hydrochloride
Morphine sulfate
Nicotine polacrilex (multiple
Drugs)
Nisoldipine
Oxycodone
Raltegravir potassium
Tacrolimus (multiple strengths)
Reference
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
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. This
guidance is not subject to Executive
Order 12866.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
E:\FR\FM\14SEN1.SGM
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Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20018 Filed 9–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health
Office of Minority Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Advisory Committee on
Minority Health (ACMH) will hold a
meeting conducted as a telephone
conference call. This call will be open
to the public. Preregistration is required
for both public participation and
comment. Any individual who wishes
to participate in the call should email
OMH-ACMH@hhs.gov by October 11,
2018. Instructions regarding
participating in the call and how to
provide verbal public comments will be
given at the time of preregistration.
Information about the meeting is
available from the designated contact
and will be posted on the website for
the Office of Minority Health (OMH),
www.minorityhealth.hhs.gov.
Information about ACMH activities can
be found on the OMH website under the
heading About OMH.
DATES: The conference call will be held
on October 16, 2018, 1 p.m. to 3 p.m.
EST.
ADDRESSES: Instructions regarding
participating in the call will be given at
the time of preregistration.
FOR FURTHER INFORMATION CONTACT:
Violet Woo, Designated Federal Officer,
Advisory Committee on Minority
Health, Office of Minority Health,
Department of Health and Human
Services, Tower Building, 1101 Wootton
Parkway, Suite 600, Rockville,
Maryland 20852. Phone: 240–453–8222;
fax: 240–453–8223; email OMH-ACMH@
hhs.gov.
SUPPLEMENTARY INFORMATION: In
accordance with Public Law 105–392,
the ACMH was established to provide
advice to the Deputy Assistant Secretary
for Minority Health on improving the
health of each racial and ethnic
minority group and on the development
of goals and specific program activities
of the OMH.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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17:06 Sep 13, 2018
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The topics to be discussed during the
teleconference include finalizing
recommendations regarding innovative
systems of care, barriers to effective data
collection, and primary prevention
related serious mental illness;
discussing the framework and speakers
for the following disparities-themed
report that will include
recommendations; and discussing the
agenda for the next meeting. The
recommendations will be given to the
Deputy Assistant Secretary for Minority
Health.
This call will be limited to 125
participants. The OMH will make every
effort to accommodate persons with
special needs. Individuals who have
special needs for which special
accommodations may be required
should contact Professional and
Scientific Associates at (703) 234–1700
and reference this meeting. Requests for
special accommodations should be
made at least ten (10) business days
prior to the meeting.
Members of the public will have an
opportunity to provide comments at the
meeting. Public comments will be
limited to two minutes per speaker
during the time allotted. Individuals
who would like to submit written
statements should email, mail, or fax
their comments to the designated
contact at least seven (7) business days
prior to the meeting.
Any members of the public who wish
to have electronic or printed material
distributed to ACMH members should
email OMH-ACMH@hhs.gov or mail
their materials to the Designated Federal
Officer, ACMH, Tower Building, 1101
Wootton Parkway, Suite 600, Rockville,
Maryland 20852, prior to close of
business on October 11, 2018.
Dated: September 5, 2018.
Violet Woo,
Designated Federal Officer, Advisory
Committee on Minority Health.
[FR Doc. 2018–20040 Filed 9–13–18; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2018–0801]
Certificate of Alternative Compliance
for the TUG JUDY MORAN Hull 123
Coast Guard, DHS.
Notification of issuance of a
certificate of alternative compliance.
AGENCY:
Prevention Division has issued a
certificate of alternative compliance
from the International Regulations for
Preventing Collisions at Sea, 1972 (72
COLREGS), for the TUG JUDY MORAN,
Hull 123. We are issuing this notice
because its publication is required by
statute. Due to the construction and
placement of the vessel’s side lights and
stern lights, TUG JUDY MORAN cannot
fully comply with the light, shape, or
sound signal provisions of the 72
COLREGS without interfering with the
vessel’s design and construction. This
notification of issuance of a certificate of
alternative compliance promotes the
Coast Guard’s marine safety mission.
DATES: The Certificate of Alternative
Compliance was issued on 26 July,
2018.
For
information or questions about this
notice call or email Mr. Kevin Miller,
First District Towing Vessel/Barge
Safety Specialist, U.S. Coast Guard;
telephone (617) 223–8272, email
Kevin.L.Miller2@uscg.mil.
SUPPLEMENTARY INFORMATION:
The United States is signatory to the
International Maritime Organization’s
International Regulations for Preventing
Collisions at Sea, 1972 (72 COLREGS),
as amended. The special construction or
purpose of some vessels makes them
unable to comply with the light, shape,
or sound signal provisions of the 72
COLREGS. Under statutory law,
however, specified 72 COLREGS
provisions are not applicable to a vessel
of special construction or purpose if the
Coast Guard determines that the vessel
cannot comply fully with those
requirements without interfering with
the special function of the vessel.1
The owner, builder, operator, or agent
of a special construction or purpose
vessel may apply to the Coast Guard
District Office in which the vessel is
being built or operated for a
determination that compliance with
alternative requirements is justified,2
and the Chief of the Prevention Division
would then issue the applicant a
certificate of alternative compliance
(COAC) if he or she determines that the
vessel cannot comply fully with 72
COLREGS light, shape, and sound signal
provisions without interference with the
vessel’s special function.3 If the Coast
Guard issues a COAC, it must publish
notice of this action in the Federal
Register.4
FOR FURTHER INFORMATION CONTACT:
ACTION:
The Coast Guard announces
that the U. S. Coast Guard First District
SUMMARY:
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46747
1 33
U.S.C. 1605.
CFR 81.5.
3 33 CFR 81.9.
4 33 U.S.C. 1605(c) and 33 CFR 81.18.
2 33
E:\FR\FM\14SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46745-46747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20018]
-----------------------------------------------------------------------
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 website.
The guidances identified in this notice were developed using the
process described in that guidance.
DATES: Submit either electronic or written comments on the draft
guidance by November 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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 Dockets
Management Staff 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
[[Page 46746]]
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 Dockets
Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). 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: Wendy Good, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 240-402-9682.
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 website 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
website 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 July 20, 2018. This notice announces draft
product-specific guidances, either new or revised, that are posted on
FDA's website.
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
------------------------------------------------------------------------
-------------------------------------------------------------------------
Abemaciclib
Albuterol sulfate
Allopurinol; Lesinurad
Amantadine hydrochloride
Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine
saccharate; Dextroamphetamine sulfate
Azelaic acid
Benznidazole
Brigatinib
Brimonidine tartrate; Timolol maleate
Chlorzoxazone
Ciprofloxacin hydrochloride
Dapagliflozin propanediol; Saxagliptin hydrochloride
Delafloxacin meglumine
Desonide
Deutetrabenazine
Diazepam
Efinaconazole
Enasidenib mesylate
Glecaprevir; Pibrentasvir
Ibuprofen; Pseudoephedrine hydrochloride
Ivermectin
Lamotrigine
Luliconazole
Midostaurin
Miltefosine
Morphine sulfate
Neratinib maleate
Olaparib
Olive oil; Soybean oil
Oxycodone hydrochloride
Penciclovir
Perflutren
Pilocarpine hydrochloride
Pitavastatin magnesium
Pitavastatin sodium
Pregabalin
Secnidazole
Sofosbuvir; Velpatasvir; Voxilaprevir
Spironolactone
Sulfur hexafluoride lipid-type a microspheres
Talc
Tavaborole
------------------------------------------------------------------------
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
------------------------------------------------------------------------
-------------------------------------------------------------------------
Acetazolamide
Chlorpromazine hydrochloride
Doxorubicin hydrochloride
Morphine sulfate
Nicotine polacrilex (multiple Reference Listed Drugs)
Nisoldipine
Oxycodone
Raltegravir potassium
Tacrolimus (multiple strengths)
------------------------------------------------------------------------
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.
This guidance is not subject to Executive Order 12866.
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.
[[Page 46747]]
Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20018 Filed 9-13-18; 8:45 am]
BILLING CODE 4164-01-P
