Product-Specific Guidances; Final Guidances for Industry; Availability, 36792-36794 [2017-16581]
Download as PDF
36792
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must be
timely (see DATES) and contain sufficient
facts to merit an FDA investigation. (See
H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41–42, 1984.) Petitions should
be in the format specified in 21 CFR
10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16516 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0041]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Safety Assurance
Case; Withdrawal of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of a notice that was
published in the Federal Register of
March 15, 2017.
DATES: August 7, 2017.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
March 15, 2017 (82 FR 13817), ‘‘Agency
Information Collection Activities;
Proposed Collection; Comment Request;
Safety Assurance Case,’’ FDA requested
comment on the information collection
associated with safety assurance cases
(SACs).
Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
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including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice.
In the March 15, 2017, Federal
Register notice, FDA proposed to extend
the information collection related to
SACs (OMB control number 0910–
0766). However, we are withdrawing the
notice because, upon further review of
the information collection request (ICR)
associated with the notice and
comments received on the information
collection, we have determined that the
estimated burden expressed in the SAC
ICR is included as part of the estimated
burden for the information collections
in the premarket notification (510(k))
ICR (OMB control number 0910–0120).
Because the information collected for
safety assurance cases is already
included under another information
collection approval, we have
discontinued the ICR and we are
withdrawing the March 15, 2017, notice
requesting comment on the information
collection.
The guidance entitled ‘‘Infusion
Pumps Total Product Life Cycle;
Guidance for Industry and FDA Staff’’
(https://www.fda.gov/ucm/groups/
fdagov-public/@fdagov-meddev-gen/
documents/document/ucm209337.pdf),
which provides recommendations on
the inclusion of safety assurance cases
as part of the premarket submissions for
new, changed, or modified infusion
pumps submitted by device
manufacturers, continues to provide the
Agency’s current thinking on this topic.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16561 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
product-specific guidances identified in
this notice were developed using the
process described in that guidance.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
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
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances; Final
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 final
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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
E:\FR\FM\07AUN1.SGM
07AUN1
mstockstill on DSK30JT082PROD with NOTICES
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
Guidances; Final 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
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.
Submit written requests for single
copies of a final guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to a final guidance document.
VerDate Sep<11>2014
18:14 Aug 04, 2017
Jkt 241001
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 productspecific guidances available to the
public on FDA’s Web site at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/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. Final productspecific guidances were last announced
in the Federal Register on September
21, 2015 (80 FR 57000). This notice
announces final product-specific
guidances that are posted on FDA’s Web
site.
II. Drug Products For Which Final
Product-Specific Guidances Are
Available
FDA is announcing the availability of
final product-specific guidances for
industry for drug products containing
the following active ingredients:
TABLE 1—FINAL PRODUCT-SPECIFIC
GUIDANCES FOR DRUG PRODUCTS
Acarbose.
Acetaminophen; Aspirin, Caffeine.
Acetaminophen; Butalbital; Caffeine; Codeine
phosphate.
Acitretin.
Amoxicillin (multiple reference listed drugs).
Amoxicillin; Clavulanate potassium.
Aspirin; Butalbital; Caffeine (multiple reference listed drugs).
Aspirin; Butalbital; Caffeine; Codeine Phosphate.
Atenolol.
PO 00000
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36793
TABLE 1—FINAL PRODUCT-SPECIFIC
GUIDANCES FOR DRUG PRODUCTS—
Continued
Atenolol and Chlorthalidone.
Cetirizine HCl.
Chlorthalidone.
Citalopram HBr.
Citalopram hydrobromide.
Clarithromycin.
Clindamycin HCl.
Clomiphene Citrate.
Clonazepam.
Clozapine.
Cyclobenzaprine HCL.
Cycloserine.
Dapsone.
Desipramine HCl.
Desmopressin Acetate.
Diflunisal.
Diphenhydramine HCl.
Dipyridamole.
Disulfiram.
Donepezil HCl.
Doxazosin mesylate.
Doxepin HCl.
Doxercalciferol.
Eprosartan Mesylate.
Ethambutol HCl.
Hydrochlorothiazide; Losartan Potassium.
Hydrochlorothiazide; Triamterene.
Hydrochlorothiazide; Valsartan.
Hydrocodone bitartrate; Ibuprofen.
Hydrocortisone.
Hydromorphone HCl.
Selegiline hydrochloride.
Sotalol HCl.
Tenofovir Disoproxil Fumarate.
Tiagabine HCl.
Valproic acid.
Verapamil HCl.
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 final guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
These guidances 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.
III. Electronic Access
Persons with access to the internet
may obtain the final guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
E:\FR\FM\07AUN1.SGM
07AUN1
36794
Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16581 Filed 8–4–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–2171, FDA–
2016–E–2169, and FDA–2016–E–2170]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VONVENDI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for VONVENDI and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 6, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 5, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 6,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 6, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
18:14 Aug 04, 2017
Jkt 241001
• 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 Nos. FDA–
2016–E–2171, FDA–2016–E–2169, and
FDA–2016–E–2170 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
VONVENDI.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
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.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
E:\FR\FM\07AUN1.SGM
07AUN1
Agencies
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36792-36794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16581]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidances; Final 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 final 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 BE
recommendations available to the public on FDA's Web site. The product-
specific guidances identified in this notice were developed using the
process described in that guidance.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
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): 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
[[Page 36793]]
Guidances; Final 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 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.
Submit written requests for single copies of a final guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to a final guidance document.
FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific 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. Final product-specific guidances
were last announced in the Federal Register on September 21, 2015 (80
FR 57000). This notice announces final product-specific guidances that
are posted on FDA's Web site.
II. Drug Products For Which Final Product-Specific Guidances Are
Available
FDA is announcing the availability of final product-specific
guidances for industry for drug products containing the following
active ingredients:
Table 1--Final Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
-------------------------------------------------------------------------
Acarbose.
Acetaminophen; Aspirin, Caffeine.
Acetaminophen; Butalbital; Caffeine; Codeine phosphate.
Acitretin.
Amoxicillin (multiple reference listed drugs).
Amoxicillin; Clavulanate potassium.
Aspirin; Butalbital; Caffeine (multiple reference listed drugs).
Aspirin; Butalbital; Caffeine; Codeine Phosphate.
Atenolol.
Atenolol and Chlorthalidone.
Cetirizine HCl.
Chlorthalidone.
Citalopram HBr.
Citalopram hydrobromide.
Clarithromycin.
Clindamycin HCl.
Clomiphene Citrate.
Clonazepam.
Clozapine.
Cyclobenzaprine HCL.
Cycloserine.
Dapsone.
Desipramine HCl.
Desmopressin Acetate.
Diflunisal.
Diphenhydramine HCl.
Dipyridamole.
Disulfiram.
Donepezil HCl.
Doxazosin mesylate.
Doxepin HCl.
Doxercalciferol.
Eprosartan Mesylate.
Ethambutol HCl.
Hydrochlorothiazide; Losartan Potassium.
Hydrochlorothiazide; Triamterene.
Hydrochlorothiazide; Valsartan.
Hydrocodone bitartrate; Ibuprofen.
Hydrocortisone.
Hydromorphone HCl.
Selegiline hydrochloride.
Sotalol HCl.
Tenofovir Disoproxil Fumarate.
Tiagabine HCl.
Valproic acid.
Verapamil HCl.
------------------------------------------------------------------------
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 final guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These guidances
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.
III. Electronic Access
Persons with access to the internet may obtain the final guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
[[Page 36794]]
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16581 Filed 8-4-17; 8:45 am]
BILLING CODE 4164-01-P