Document ID: FDA-2020-N-1127-0024
Agency: fda
Document Type: Notice
Title: Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments; 
Reopening of Comment Period
Posted Date: 2021-03-16T04:00Z

[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]

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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.

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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]
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