Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments; Reopening of the Comment Period, 65819-65820 [2020-22969]

Download as PDF Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices comments on the draft guidance and those comments were considered as the guidance was finalized. We considered comments on the recommended level of biotin concentration for evaluation. We decline to recommend evaluating a concentration level below 3,500 nanograms per milliliter. We believe this level is appropriate for minimizing the risk to patients from incorrect test results. Further, this level is consistent with best practices among the industry to test at three times the highest concentration levels observed, as recommended in the FDA-recognized standard published by the Clinical Laboratory Standards Institute. Other comments recommended FDA clarify or expand upon the necessity of mitigation strategies to address biotin interference other than labeling. We decline to recommend other specific mitigation strategies, but note that other mitigation strategies such as customer information letters and technical mitigations may be considered when the risk of potentially incorrect results from biotin interference could significantly affect patient or public health. Finally, we considered comments regarding additional types of information to be communicated to endusers, but we declined to provide more specific recommendations because manufacturers may not have sufficient data to provide more specific information in the labeling. In addition, editorial edits were made to improve clarity. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2019. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on testing for biotin interference in in vitro diagnostic devices. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. jbell on DSKJLSW7X2PROD with NOTICES II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 809 have been approved under OMB control number 0910–0485. VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances, https:// www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, or https:// www.regulations.gov. Dated: October 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22926 Filed 10–15–20; 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 the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: 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 a request for an extension to allow interested persons additional time to submit comments. 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 November 16, 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 November 16, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 65819 at the end of November 16, 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. 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, 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 E:\FR\FM\16OCN1.SGM 16OCN1 65820 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices 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 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: Elizabeth Giaquinto Friedman, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993–0002, 240– 402–7930. 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’’). jbell on DSKJLSW7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 The Agency has received a request for an extension of the comment period for the public docket in order to develop a response to the request for comment. FDA has considered the request and is reopening the comment period for the public docket for 30 days, until November 16, 2020. The Agency believes that an additional 30 days will allow adequate time for interested persons to submit comments. Dated: October 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22969 Filed 10–15–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–D–1136 and FDA– 2020–D–1106] Guidance Documents Related to Coronavirus Disease 2019 (COVID–19); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID–19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID–19-related guidances. The guidances identified in this notice address issues related to the COVID–19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices. DATES: The announcement of the guidances is published in the Federal Register on October 16, 2020. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 • 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 name of the guidance document that the comments address and the docket number for the guidance (see table 1). Received comments will be placed in the docket(s) 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 E:\FR\FM\16OCN1.SGM 16OCN1

Agencies

[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65819-65820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22969]


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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 the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the 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 a request for an extension to allow 
interested persons additional time to submit comments.

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 November 16, 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 November 16, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 16, 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.

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, 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

[[Page 65820]]

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 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: Elizabeth Giaquinto Friedman, Office 
of Generic Drugs, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, 
Silver Spring, MD 20993-0002, 240-402-7930.

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'').
    The Agency has received a request for an extension of the comment 
period for the public docket in order to develop a response to the 
request for comment.
    FDA has considered the request and is reopening the comment period 
for the public docket for 30 days, until November 16, 2020. The Agency 
believes that an additional 30 days will allow adequate time for 
interested persons to submit comments.

    Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22969 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P