Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 12567-12568 [2020-04320]
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Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ILUMYA is 3,452 days. Of this time,
3,089 days occurred during the testing
phase of the regulatory review period,
while 363 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: October 8, 2008. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
October 8, 2008.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): March 23, 2017. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
ILUMYA (BLA 761067) was initially
submitted on March 23, 2017.
3. The date the application was
approved: March 20, 2018. FDA has
verified the applicant’s claim that BLA
761067 was approved on March 20,
2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,149 days or 1,092
days of patent term extension.
lotter on DSKBCFDHB2PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
VerDate Sep<11>2014
17:19 Mar 02, 2020
Jkt 250001
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: February 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04362 Filed 3–2–20; 8:45 am]
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.
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 May 4, 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:
DATES:
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,
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
12567
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
E:\FR\FM\03MRN1.SGM
03MRN1
12568
Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices
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.govinfo.
gov/content/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:
Mara Miller, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4709C, Silver
Spring, MD 20993–0002, 301–796–0683.
SUPPLEMENTARY INFORMATION:
lotter on DSKBCFDHB2PROD with NOTICES
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
VerDate Sep<11>2014
17:19 Mar 02, 2020
Jkt 250001
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 November 22, 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:
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
Active ingredient(s)
Albuterol sulfate (multiple reference listed
drugs).
Beclomethasone dipropionate.
Calcitonin salmon.
Dapagliflozin; Metformin hydrochloride.
Edoxaban tosylate.
Ibrutinib.
Levalbuterol tartrate.
Olsalazine sodium.
Selexipag.
For a complete history of previously
published Federal Register notices
TABLE 1—NEW DRAFT PRODUCT-SPE- related to product-specific guidances, go
CIFIC GUIDANCES FOR DRUG PROD- to https://www.regulations.gov and
UCTS
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
Active ingredient(s)
issued consistent with FDA’s good
Albuterol sulfate.
guidance practices regulation (21 CFR
Amifampridine phosphate.
10.115). These draft guidances, when
Amino acids; Calcium chloride; Dextrose;
finalized, will represent the current
Magnesium sulfate; Potassium chloride;
thinking of FDA on, among other things,
Sodium acetate; Sodium
the product-specific design of BE
glycerophosphate; Soybean oil.
studies to support ANDAs. They do not
Besifloxacin hydrochloride.
Binimetinib.
establish any rights for any person and
Budesonide.
are not binding on FDA or the public.
Clevidipine.
You can use an alternative approach if
Dacomitinib.
it satisfies the requirements of the
Dapagliflozin; Metformin hydrochloride;
applicable statutes and regulations.
Saxagliptin hydrochloride.
Diltiazem hydrochloride.
Doravirine.
Doravirine; Lamivudine; Tenofovir disoproxil
fumarate.
Duloxetine hydrochloride.
Edaravone.
Elagolix sodium.
Granisetron.
Ivacaftor; Lumacaftor.
Liraglutide recombinant.
Lusutrombopag.
Mexiletine hydrochloride.
Moxidectin.
Propranolol hydrochloride.
Rifamycin sodium.
Selenious acid.
Semaglutide.
Stiripentol (multiple reference listed drugs).
Sumatriptan succinate.
Tacrolimus.
Tiopronin.
Tolvaptan.
Umeclidinium bromide; Vilanterol trifenatate.
Upadacitinib.
PO 00000
Frm 00075
Fmt 4703
Sfmt 9990
IV. Electronic Access
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.
Dated: February 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04320 Filed 3–2–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\03MRN1.SGM
03MRN1
Agencies
[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Pages 12567-12568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04320]
-----------------------------------------------------------------------
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 May 4, 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
[[Page 12568]]
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.govinfo.gov/content/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: Mara Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993-0002, 301-
796-0683.
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 November 22, 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:
Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
Active ingredient(s)
-------------------------------------------------------------------------
Albuterol sulfate.
Amifampridine phosphate.
Amino acids; Calcium chloride; Dextrose; Magnesium sulfate; Potassium
chloride; Sodium acetate; Sodium glycerophosphate; Soybean oil.
Besifloxacin hydrochloride.
Binimetinib.
Budesonide.
Clevidipine.
Dacomitinib.
Dapagliflozin; Metformin hydrochloride; Saxagliptin hydrochloride.
Diltiazem hydrochloride.
Doravirine.
Doravirine; Lamivudine; Tenofovir disoproxil fumarate.
Duloxetine hydrochloride.
Edaravone.
Elagolix sodium.
Granisetron.
Ivacaftor; Lumacaftor.
Liraglutide recombinant.
Lusutrombopag.
Mexiletine hydrochloride.
Moxidectin.
Propranolol hydrochloride.
Rifamycin sodium.
Selenious acid.
Semaglutide.
Stiripentol (multiple reference listed drugs).
Sumatriptan succinate.
Tacrolimus.
Tiopronin.
Tolvaptan.
Umeclidinium bromide; Vilanterol trifenatate.
Upadacitinib.
------------------------------------------------------------------------
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)
-------------------------------------------------------------------------
Albuterol sulfate (multiple reference listed drugs).
Beclomethasone dipropionate.
Calcitonin salmon.
Dapagliflozin; Metformin hydrochloride.
Edoxaban tosylate.
Ibrutinib.
Levalbuterol tartrate.
Olsalazine sodium.
Selexipag.
------------------------------------------------------------------------
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: February 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04320 Filed 3-2-20; 8:45 am]
BILLING CODE 4164-01-P