Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 64531-64533 [2019-25326]
Download as PDF
<![CDATA[
64531
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
of project management staff, or to the
division director of the appropriate
product office within CBER, but only
after first contacting the appropriate
review division or the Biosimilars
Program staff, CDER, Office of New
Drugs to determine to whom the request
should be directed, how it should be
submitted, and the appropriate format
for the request and to arrange for
confirmation of receipt of the request.
We recommend the following
information be included in the meeting
request:
1. Application number (if previously
assigned),
2. development-phase code name of
the product (if prelicensure),
3. proper name (if post licensure),
4. structure (if applicable),
5. proper and proprietary names of
the reference product,
6. proposed indication(s) or context of
product development,
7. pediatric study plans, if applicable,
8. human factors engineering plan, if
applicable,
9. combination product information
(e.g., constituent parts, including details
of the device constituent part, intended
packaging, planned human factors
studies), if applicable,
10. meeting type being requested (the
rationale for requesting the meeting type
should be included),
11. proposed format of the meeting
(face to face, tele-conference/videoconference/WRO),
12. a brief statement of the purpose of
the meeting, including a brief
background of the issues underlying the
agenda. It can also include a brief
summary of completed or planned
studies and clinical trials or data the
sponsor or applicant intends to discuss
at the meeting, the general nature of the
critical questions to be asked, and where
the meeting fits in the overall
development plans.
13. a list of specific objectives/
outcomes expected from the meeting,
14. a proposed agenda, including
times required for each agenda item,
15. a list of questions grouped by
discipline and a brief explanation of the
context and purpose of each question,
16. a list of all individuals with their
titles and affiliations who will attend
the requested meeting from the
requestor’s organization and any
consultants and interpreters,
17. a list of FDA staff, if known, or
disciplines asked to participate in the
requested meeting, and
18. suggested dates and times for the
meeting.
We use the information to determine the
utility of the meeting, to identify FDA
staff necessary to discuss proposed
agenda items, and to schedule the
meeting.
B. Information Package
We recommend that a sponsor or
applicant submit a meeting package to
the appropriate review division with the
meeting request and that the following
information be included in the package:
1. Application number (if previously
assigned),
2. development-phase code name of
product (if pre-licensure) or proper
name (if post-licensure),
3. structure (if applicable),
4. proprietary and proper names of
the reference product,
5. proposed indication(s) or context of
product development,
6. dosage form, route of
administration, dosing regimen
(frequency and duration), and
presentation(s),
7. pediatric study plans, if applicable,
8. human factors engineering plan, if
applicable,
9. combination product information,
if applicable,
10. a list of all individuals with their
titles and affiliations who will attend
the requested meeting from the
requestor’s organization and any
consultants and interpreters,
11. background that includes a brief
history of the development program and
the status of product development (e.g.,
chemistry, manufacturing, and controls;
nonclinical; and clinical, including any
development outside the United States,
as applicable),
12. a brief statement summarizing the
purpose of the meeting,
13. the proposed agenda, and
14. a list of questions for discussion
grouped by discipline and with a brief
summary for each question to explain
the need or context for the question, and
data to support discussion organized by
discipline and question.
The purpose of the meeting package is
to provide FDA staff the opportunity to
adequately prepare for the meeting,
including the review of relevant data
concerning the product.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
BsUFA information collection
Average
burden per
response
Total annual
responses
Total hours
CDER Meeting Requests .....................................................
CDER Information Packages ...............................................
CBER Meeting Requests .....................................................
CBER Information Packages ...............................................
36
29
2
2
2.5
2.2
1
2
89
64
2
4
15
30
15
30
1,335
1,920
30
120
Total ..............................................................................
........................
........................
........................
........................
3,405
1 There
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Since last OMB review of the
information collection we have
increased our burden estimate by 95
annual responses and 1,965 annual
hours. This adjustment corresponds
with an increase in submissions
received by the Agency over the past 3
years.
Dated: November 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25328 Filed 11–21–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
BILLING CODE 4164–01–P
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
E:\FR\FM\22NON1.SGM
22NON1
64532
ACTION:
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
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 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 January 21, 2020 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:
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
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
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.
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
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–
402–1146.
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 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 September 17, 2019. 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
new draft product-specific guidances for
industry for drug products containing
the following active ingredients:
E:\FR\FM\22NON1.SGM
22NON1
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS—Continued
64533
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25326 Filed 11–21–19; 8:45 am]
Active ingredient(s)
Active ingredient(s)
Acetaminophen; Benzhydrocodone hydrochloride.
Betamethasone dipropionate; Calcipotriene.
Cefaclor.
Chlorzoxazone (multiple reference listed
drugs).
Copper.
Dolutegravir sodium; Rilpivirine hydrochloride.
Doxycycline hyclate.
Encorafenib.
Fluorometholone acetate.
Indocyanine green.
Isoniazid; Pyrazinamide; Rifampin.
Isosorbide dinitrate.
Ketoprofen.
Latanoprost; Netarsudil dimesylate.
Lidocaine.
Lorlatinib.
Lovastatin.
Lutetium dotatate Lu-177.
Medroxyprogesterone acetate.
Meloxicam.
Mifepristone.
Migalastat hydrochloride.
Omadacycline tosylate (multiple reference
listed drugs).
Oxymetazoline hydrochloride.
Pimavanserin tartrate.
Sumatriptan succinate.
Tetracaine hydrochloride.
Timolol maleate.
Disopyramide phosphate.
Doxepin hydrochloride.
Estradiol (multiple reference listed drugs).
Estradiol; Levonorgestrel.
Estradiol; Norethindrone acetate.
Ethinyl estradiol; Norelgestromin.
Fentanyl.
Flavoxate hydrochloride.
Granisetron.
Indapamide.
Lidocaine.
Lithium carbonate.
Menthol; Methyl salicylate.
Metformin hydrochloride; Repaglinide.
Methylphenidate.
Mifepristone.
Molindone hydrochloride.
Mycophenolate mofetil.
Nicotine.
Nitrofurantoin, Macrocrystalline.
Nitrofurantoin;
Nitrofurantoin,
Macrocrystalline.
Nitroglycerin (multiple reference listed drugs).
Oxybutynin (multiple reference listed drugs).
Pimecrolimus.
Prednisolone sodium phosphate.
Rivastigmine.
Roflumilast.
Rotigotine.
Scopolamine.
Selegiline.
Sulfacetamide sodium.
Sulfadiazine.
Tazarotene (multiple reference listed drugs).
Terazosin hydrochloride.
Testosterone.
Tinidazole.
Tipiracil hydrochloride; Trifluridine.
Tretinoin (multiple reference listed drugs).
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
khammond on DSKJM1Z7X2PROD with NOTICES
Active ingredient(s)
Adapalene (multiple reference listed drugs).
Adapalene; Benzoyl peroxide (multiple reference listed drugs).
Azacitidine.
Baclofen.
Benzoyl peroxide; Clindamycin phosphate
(multiple reference listed drugs).
Benzoyl peroxide; Erythromycin (multiple reference listed drugs).
Capsaicin.
Cariprazine hydrochloride.
Clindamycin phosphate (multiple reference
listed drugs).
Clindamycin phosphate; Tretinoin.
Clonidine.
Clonidine hydrochloride.
Dapsone (multiple reference listed drugs).
Diclofenac epolamine.
Didanosine.
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0736]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Tracking Network
for PETNet, LivestockNet, and
SampleNet
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
Agency. 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,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on our use of a
tracking network to collect and share
safety information about animal food
from Federal, State, and Territorial
Agencies.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by January 21, 2020.
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 January 21,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 21, 2020.
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.
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.
DATES:
IV. Electronic Access
Electronic Submissions
Persons with access to the internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
E:\FR\FM\22NON1.SGM
22NON1
]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64531-64533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25326]
-----------------------------------------------------------------------
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.
[[Page 64532]]
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 January 21, 2020 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 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, 240-402-1146.
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 September 17, 2019. 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 new draft product-specific
guidances for industry for drug products containing the following
active ingredients:
[[Page 64533]]
Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
Active ingredient(s)
-------------------------------------------------------------------------
Acetaminophen; Benzhydrocodone hydrochloride.
Betamethasone dipropionate; Calcipotriene.
Cefaclor.
Chlorzoxazone (multiple reference listed drugs).
Copper.
Dolutegravir sodium; Rilpivirine hydrochloride.
Doxycycline hyclate.
Encorafenib.
Fluorometholone acetate.
Indocyanine green.
Isoniazid; Pyrazinamide; Rifampin.
Isosorbide dinitrate.
Ketoprofen.
Latanoprost; Netarsudil dimesylate.
Lidocaine.
Lorlatinib.
Lovastatin.
Lutetium dotatate Lu-177.
Medroxyprogesterone acetate.
Meloxicam.
Mifepristone.
Migalastat hydrochloride.
Omadacycline tosylate (multiple reference listed drugs).
Oxymetazoline hydrochloride.
Pimavanserin tartrate.
Sumatriptan succinate.
Tetracaine hydrochloride.
Timolol maleate.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
Active ingredient(s)
-------------------------------------------------------------------------
Adapalene (multiple reference listed drugs).
Adapalene; Benzoyl peroxide (multiple reference listed drugs).
Azacitidine.
Baclofen.
Benzoyl peroxide; Clindamycin phosphate (multiple reference listed
drugs).
Benzoyl peroxide; Erythromycin (multiple reference listed drugs).
Capsaicin.
Cariprazine hydrochloride.
Clindamycin phosphate (multiple reference listed drugs).
Clindamycin phosphate; Tretinoin.
Clonidine.
Clonidine hydrochloride.
Dapsone (multiple reference listed drugs).
Diclofenac epolamine.
Didanosine.
Disopyramide phosphate.
Doxepin hydrochloride.
Estradiol (multiple reference listed drugs).
Estradiol; Levonorgestrel.
Estradiol; Norethindrone acetate.
Ethinyl estradiol; Norelgestromin.
Fentanyl.
Flavoxate hydrochloride.
Granisetron.
Indapamide.
Lidocaine.
Lithium carbonate.
Menthol; Methyl salicylate.
Metformin hydrochloride; Repaglinide.
Methylphenidate.
Mifepristone.
Molindone hydrochloride.
Mycophenolate mofetil.
Nicotine.
Nitrofurantoin, Macrocrystalline.
Nitrofurantoin; Nitrofurantoin, Macrocrystalline.
Nitroglycerin (multiple reference listed drugs).
Oxybutynin (multiple reference listed drugs).
Pimecrolimus.
Prednisolone sodium phosphate.
Rivastigmine.
Roflumilast.
Rotigotine.
Scopolamine.
Selegiline.
Sulfacetamide sodium.
Sulfadiazine.
Tazarotene (multiple reference listed drugs).
Terazosin hydrochloride.
Testosterone.
Tinidazole.
Tipiracil hydrochloride; Trifluridine.
Tretinoin (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: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25326 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P
