The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Reopening of the Comment Period, 15685-15686 [2021-06053]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices workshop-06232021-06232021. Registration may be performed at any time before or during the workshop. Requests for Oral Presentations: During online registration you may indicate if you wish to present your public comments. Public comment presentation requests must be submitted by 11:59 p.m. Eastern Time at the end of April 30, 2021. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the workshop. Following the close of registration on April 30, 2021, at 11:59 p.m. Eastern Time, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin; we will select and notify participants by May 21, 2021. All requests to make oral presentations must be received by the close of registration on April 30, 2021. If selected for presentation, any presentation materials must be emailed to GDUFARegulatoryScience@ fda.hhs.gov no later than June 18, 2021, 11:59 p.m. Eastern Time. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will be webcast. Please register online (as described above) to attend the workshop remotely. Unless scheduled to participate in advance, attendees will not be able to speak or make presentations during the public comment period or during any other session of the workshop. To join the workshop via the webcast, please go to https://www.fda.gov/drugs/news-eventshuman-drugs/fy-2021-generic-drugscience-and-research-initiatives-publicworkshop-06232021-06232021. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: As soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov or at https:// www.fda.gov/gdufaregscience. It may be viewed at the Dockets Management Staff (see ADDRESSES). Closed caption scrolling text will be generated by the VerDate Sep<11>2014 16:30 Mar 23, 2021 Jkt 253001 Adobe Connect system and displayed in real time. The closed caption scrolling text will also display when streaming the recorded presentations for viewing at a later date. Dated: March 19, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–06096 Filed 3–23–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1862] The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; 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 ‘‘The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments’’ that appeared in the Federal Register of October 28, 2020. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period for the notice published on October 28, 2020 (85 FR 68342). Submit either electronic or written comments by June 22, 2021 to ensure that the Agency considers your comment. 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 June 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 22, 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. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 15685 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–1862 for ‘‘The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; 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 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 E:\FR\FM\24MRN1.SGM 24MRN1 15686 Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices 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: Kristle Green, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301– 796–3130, CDERODSIRPublicMeetings@ fda.hhs.gov. In the Federal Register of October 28, 2020 (85 FR 68342), FDA published a notice with a 60-day comment period to announce and request comments on a virtual public meeting entitled ‘‘The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security’’ held on December 8 and 9, 2020. FDA is reopening the comment period until June 22, 2021. The Agency believes that an additional 90 days will allow adequate time for interested persons to submit comments. Materials from the public meeting are on FDA’s website at https:// www.fda.gov/drugs/news-eventshuman-drugs/drug-supply-chainsecurity-act-pilot-project-program-andenhanced-drug-distribution-security. khammond on DSKJM1Z7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:30 Mar 23, 2021 Jkt 253001 Dated: March 19, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–06053 Filed 3–23–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2018–M–3841, FDA– 2018–M–3842, FDA–2018–M–3983, FDA– 2018–M–4033, FDA–2018–M–4205, FDA– 2018–M–4580, FDA–2018–M–4582, FDA– 2018–M–4665, FDA–2018–M–4777, FDA– 2018–M–4778, FDA–2018–M–4779, FDA– 2018–M–4780, FDA–2018–M–4916, FDA– 2019–M–0027, FDA–2019–M–0028, FDA– 2019–M–0505, FDA–2019–M–0645, FDA– 2019–M–0802, FDA–2019–M–0885, FDA– 2019–M–0995, FDA–2019–M–1214, FDA– 2019–M–1251, FDA–2019–M–1310, FDA– 2019–M–1313, FDA–2019–M–1465, FDA– 2019–M–1506, FDA–2019–M–1582, FDA– 2019–M–1763, FDA–2019–M–1848, FDA– 2019–M–1979, FDA–2019–M–1998, FDA– 2019–M–2052, FDA–2019–M–2193, FDA– 2019–M–2408, FDA–M–2522, FDA–2019–M– 2560, FDA–2019–M–2561, FDA–2019–M– 2671, FDA–2019–M–2732, FDA–2019–M– 2753, FDA–2019–M–2782, FDA–2019–M– 3309, FDA–2019–M–3513, FDA–2019–M– 3652, FDA–2019–M–3845, FDA–2019–M– 3863, FDA–2019–M–3844, FDA–2019–M– 4007, FDA–2019–M–4153, FDA–2019–M– 4186, FDA–2019–M–4238, FDA–2019–M– 4928, FDA–2019–M–4978, FDA–2019–M– 5393, FDA–2019–M–5438, FDA–2019–M– 5534, FDA–2019–M–5605, FDA–2019–M– 5683, FDA–2019–M–5741, FDA–2019–M– 5857, FDA–2019–M–5961, FDA–2020–M– 0097, FDA–2020–M–0107, FDA–2020–M– 0108, FDA–2020–M–0495, FDA–2020–M– 0985, FDA–2020–M–0984, FDA–2020–M– 0986, FDA–2020–M–1083, FDA–2020–M– 1115, FDA–2020–M–1116, FDA–2020–M– 1175, FDA–2020–M–1213, FDA–2020–M– 1214, FDA–2020–M–1267, FDA–2020–M– 1286, FDA–2020–M–1290, FDA–2020–M– 1299, FDA–2020–M–1300, FDA–2020–M– 1311, FDA–2020–M–1358, FDA–2020–M– 1367, FDA–2020–M–1410, FDA–2020–M– 1420, FDA–2020–M–1527, FDA–2020–M– 1583, FDA–2020–M–1600, FDA–2020–M– 1612, FDA–2020–M–1613, FDA–2020–M– 1715, FDA–2020–M–1724, FDA–2020–M– 1726, FDA–2020–M–1748, FDA–2020–M– 1752, FDA–2020–M–1760, FDA–2020–M– 1821, FDA–2020–M–1783, FDA–2020–M– 1822, FDA–2020–M–1828, FDA–2020–M– 1830, FDA–2020–M–1829, FDA–2020–M– 1835, FDA–2020–M–1838, FDA–2020–M– 1868, FDA–2020–M–1986, FDA–2020–M– 2021, FDA–2020–M–2288, FDA–2020–M– 2248, and FDA–2020–M–2339] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 ACTION: Notice. The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from October 1, 2018, through December 31, 2020. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency’s Dockets Management Staff. ADDRESSES: You may submit comments as follows: 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 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 Nos. FDA– 2018–M–3841, FDA–2018–M–3842, FDA–2018–M–3983, FDA–2018–M– 4033, FDA–2018–M–4205, FDA–2018– M–4580, FDA–2018–M–4582, FDA– E:\FR\FM\24MRN1.SGM 24MRN1

Agencies

[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15685-15686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1862]


The Drug Supply Chain Security Act Pilot Project Program and 
Enhanced Drug Distribution Security; Public Meeting; 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 ``The Drug Supply 
Chain Security Act Pilot Project Program and Enhanced Drug Distribution 
Security; Public Meeting; Request for Comments'' that appeared in the 
Federal Register of October 28, 2020. The Agency is taking this action 
to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice published on 
October 28, 2020 (85 FR 68342). Submit either electronic or written 
comments by June 22, 2021 to ensure that the Agency considers your 
comment.

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 June 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 22, 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-1862 for ``The Drug Supply Chain Security Act Pilot Project 
Program and Enhanced Drug Distribution Security; Public Meeting; 
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 
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

[[Page 15686]]

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: Kristle Green, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 28, 2020 
(85 FR 68342), FDA published a notice with a 60-day comment period to 
announce and request comments on a virtual public meeting entitled 
``The Drug Supply Chain Security Act Pilot Project Program and Enhanced 
Drug Distribution Security'' held on December 8 and 9, 2020. FDA is 
reopening the comment period until June 22, 2021.
    The Agency believes that an additional 90 days will allow adequate 
time for interested persons to submit comments. Materials from the 
public meeting are on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06053 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P

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