Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments; Reopening of Comment Period, 14450-14451 [2021-05327]
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section/activity
Average
burden per
response
Total annual
responses
Total hours
610.2, Requests for Samples and Protocols; Official Release .................................................................................
660.6(b), Protocols ...............................................................
660.36(a)(2) and (b), Samples and Protocols .....................
660.46(b), Protocols .............................................................
72
3
1
1
82.972
4
1
1
5,974
12
1
1
3
5
6
5
17,922
60
6
5
Total ..............................................................................
77
........................
5,988
........................
17,993
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 1,463 hours and a
corresponding decrease of 491
responses. We attribute this adjustment
to a decrease in the number of
submissions we received over the last
few years.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05367 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1127]
Listing of Patent Information in the
Orange Book; Establishment of a
Public Docket; Request for Comments;
Reopening of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notice entitled ‘‘Listing of Patent
Information in the Orange Book;
Establishment of a Public Docket;
Request for Comments’’ that appeared in
the Federal Register of June 1, 2020.
The notice announced the establishment
of a docket to solicit comments on the
listing of patent information in the FDA
publication ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations’’ (commonly known as the
‘‘Orange Book’’). The Agency is taking
this action in response to the recently
enacted Orange Book Transparency Act
of 2020, which was signed into law on
January 5, 2021.
DATES: FDA is reopening the comment
period for the notice published on June
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
1, 2020 (85 FR 33169). Submit either
electronic or written comments by April
15, 2021.
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 April 15,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 15, 2021. 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.
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:
PO 00000
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• 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–
2020–N–1127 for ‘‘Listing of Patent
Information in the Orange Book;
Establishment of a Public Docket;
Request for Comments; Reopening of
Comment Period.’’ 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, 240–402–7500.
• 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
E:\FR\FM\16MRN1.SGM
16MRN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
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-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Nicole Park, Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Rm. 1670, Silver Spring, MD
20993–0002, 240–402–7764.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 1, 2020 (85 FR
33169), FDA published a notice with a
90-day comment period to solicit
comments on the listing of patent
information in the FDA publication
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations’’
(commonly known as the ‘‘Orange
Book’’), including comments on the
types of patent information that should
be included in the Orange Book. In the
Federal Register of October 16, 2020 (85
FR 65819), FDA reopened the comment
period for the public docket for an
additional 30 days in response to a
request for an extension to allow
interested persons additional time to
submit comments.
On January 5, 2021, the President
signed into law the Orange Book
Transparency Act of 2020 (Pub. L. 116–
290). Section 2(e) of the Orange Book
Transparency Act of 2020 requires the
Agency to solicit public comment
regarding the types of patent
information that should be included on,
or removed from, the Orange Book and
to transmit to Congress a summary of
such comments and actions the Agency
is considering taking, if any, in response
to such public comment by January 5,
2022.
In accordance with section 2(e) of the
Orange Book Transparency Act of 2020,
FDA is reopening the comment period
for the public docket for 30 days, until
April 15, 2021, to allow interested
persons time to submit any additional
comments regarding the types of patent
information that should be included on,
or removed from, the Orange Book. The
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
Agency believes that an additional 30
days will allow adequate time for
interested persons to submit comments.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05327 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–1678]
Determination That NIPRIDE RTU
(Sodium Nitroprusside), 10 Milligrams/
50 Milliliters (0.2 Milligrams/Milliliters),
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that NIPRIDE RTU (sodium
nitroprusside), 10 milligrams (mg)/50
milliliters (mL) (0.2 mg/mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for sodium
nitroprusside, 10 mg/50 mL (0.2 mg/
mL), if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Michael Bernstein, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6240,
Silver Spring, MD 20993–0002, 301–
796–3478, michael.bernstein@
fda.hhs.gov.
SUMMARY:
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
SUPPLEMENTARY INFORMATION:
PO 00000
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14451
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), is the subject
of NDA 209387, held by Exela Pharma
Sciences, LLC, and initially approved
on March 8, 2017. NIPRIDE RTU is
indicated for immediate reduction of
blood pressure of adult and pediatric
patients in hypertensive crises;
induction and maintenance of
controlled hypotension in adults and
children during surgery, to reduce
bleeding; and treatment of acute heart
failure to reduce left ventricular enddiastolic pressure, pulmonary capillary
wedge pressure, peripheral vascular
resistance, and mean arterial blood
pressure.
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), is currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Cardinal Health Regulatory Sciences
submitted a citizen petition dated July
15, 2020 (Docket No. FDA–2020–P–
1678), under 21 CFR 10.30, requesting
that the Agency determine whether
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/
mL), was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
E:\FR\FM\16MRN1.SGM
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Agencies
[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14450-14451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05327]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1127]
Listing of Patent Information in the Orange Book; Establishment
of a Public Docket; Request for Comments; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice entitled ``Listing of
Patent Information in the Orange Book; Establishment of a Public
Docket; Request for Comments'' that appeared in the Federal Register of
June 1, 2020. The notice announced the establishment of a docket to
solicit comments on the listing of patent information in the FDA
publication ``Approved Drug Products With Therapeutic Equivalence
Evaluations'' (commonly known as the ``Orange Book''). The Agency is
taking this action in response to the recently enacted Orange Book
Transparency Act of 2020, which was signed into law on January 5, 2021.
DATES: FDA is reopening the comment period for the notice published on
June 1, 2020 (85 FR 33169). Submit either electronic or written
comments by April 15, 2021.
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 April 15, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 15, 2021. 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.
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-2020-N-1127 for ``Listing of Patent Information in the Orange Book;
Establishment of a Public Docket; Request for Comments; Reopening of
Comment Period.'' 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, 240-402-7500.
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
[[Page 14451]]
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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Nicole Park, Office of Generic Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993-0002, 240-
402-7764.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 1, 2020 (85
FR 33169), FDA published a notice with a 90-day comment period to
solicit comments on the listing of patent information in the FDA
publication ``Approved Drug Products With Therapeutic Equivalence
Evaluations'' (commonly known as the ``Orange Book''), including
comments on the types of patent information that should be included in
the Orange Book. In the Federal Register of October 16, 2020 (85 FR
65819), FDA reopened the comment period for the public docket for an
additional 30 days in response to a request for an extension to allow
interested persons additional time to submit comments.
On January 5, 2021, the President signed into law the Orange Book
Transparency Act of 2020 (Pub. L. 116-290). Section 2(e) of the Orange
Book Transparency Act of 2020 requires the Agency to solicit public
comment regarding the types of patent information that should be
included on, or removed from, the Orange Book and to transmit to
Congress a summary of such comments and actions the Agency is
considering taking, if any, in response to such public comment by
January 5, 2022.
In accordance with section 2(e) of the Orange Book Transparency Act
of 2020, FDA is reopening the comment period for the public docket for
30 days, until April 15, 2021, to allow interested persons time to
submit any additional comments regarding the types of patent
information that should be included on, or removed from, the Orange
Book. The Agency believes that an additional 30 days will allow
adequate time for interested persons to submit comments.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05327 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P