Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Correction, 16217-16218 [2022-06006]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 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., Eastern Time 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.’’ FDA will review this copy, including the claimed confidential information, in its consideration of comments. 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Therefore, you should always check the FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Consistent with FDA’s regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This notice could not be published 15 days prior to the date of the meeting due to the need for prompt discussion regarding considerations for use of COVID–19 vaccine booster doses and the process for COVID–19 vaccine strain selection to address current and emerging variants given the COVID–19 pandemic. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On April 6, 2022, the committee will meet in open session to discuss considerations for use of additional COVID–19 vaccine booster doses and the process for COVID–19 vaccine strain selection to address current and emerging variants. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/Advisory Committees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: On April 6, 2022, from 8:30 a.m. to 5 p.m. Eastern Time, the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before March 31, 2022, will be provided to the committee. Comments received after March 31, 2022, and by PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 16217 April 5, 2022, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and email addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 29, 2022. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 30, 2022. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Prabhakara Atreya or Christina Vert (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 15, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–06053 Filed 3–21–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–3462] Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Correction Food and Drug Administration, Department of Health and Human Services (HHS). AGENCY: E:\FR\FM\22MRN1.SGM 22MRN1 16218 ACTION: Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices Notice; correction. The Food and Drug Administration (FDA) is correcting a notice entitled ‘‘Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry’’ that appeared in the Federal Register of March 10, 2022. The document omitted the date by which comments on the draft guidance should be submitted to FDA. This error is corrected in this document for clarity. FOR FURTHER INFORMATION CONTACT: Sarah Venti, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3130, drugtrackandtrace@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of March 10, 2022 (87 FR 13738), appearing on page 13738, in FR Doc. 2022–05018, in the second column, the DATES section is corrected to read as follows: DATES: The announcement of the guidance is published in the Federal Register on March 10, 2022. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 9, 2022. SUMMARY: Dated: March 17, 2022. Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, U.S. Food and Drug Administration. [FR Doc. 2022–06006 Filed 3–21–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, March 23, 2022, 09:00 a.m. to March 24, 2022, 04:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on February 25, 2022, 308582. Dr. Kozel wants to change the date for his meeting. The meeting is closed to the public. VerDate Sep<11>2014 18:24 Mar 21, 2022 Jkt 256001 Dated: March 16, 2022. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2022–05966 Filed 3–21–22; 8:45 am] Center for Scientific Review; Amended Notice of Meeting BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Microbiology, Infectious Diseases and AIDS Initial Review Group; Acquired Immunodeficiency Syndrome Research Study Section; Acquired Immunodeficiency Syndrome Research Study Section (AIDS). Date: April 20, 2022. Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F40A, Rockville, MD 20892 (Virtual Meeting). Contact Person: Dimitrios Nikolaos Vatakis, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, MSC– 9823, Bethesda, MD 20892, (301) 761–7176, dimitrios.vatakis@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: March 16, 2022. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–05968 Filed 3–21–22; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 National Institutes of Health Notice is hereby given of a change in the meeting of the Sleep Disorders Research Advisory Board, April 7, 2022, 12:00 p.m. to 5:00 p.m., Virtual Meeting, which was published in the Federal Register on March 09, 2022, V 87 Vol. 46, Page 13302, FR Doc No. 2022– 04982. Meeting is being amended to change the telephone call in number to 1–669– 254–5252 (Meeting ID: 161 532 8417 Passcode: 330488). The meeting is open to the public. Dated: March 16, 2022. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–05969 Filed 3–21–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Clinical Trials and Comparative Effectiveness Studies in Neurology. Date: March 28–29, 2022. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Shanta Rajaram, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, E:\FR\FM\22MRN1.SGM 22MRN1

Agencies

[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16217-16218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06006]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3462]


Verification Systems Under the Drug Supply Chain Security Act for 
Certain Prescription Drugs; Draft Guidance for Industry; Correction

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

[[Page 16218]]


ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
entitled ``Verification Systems Under the Drug Supply Chain Security 
Act for Certain Prescription Drugs; Draft Guidance for Industry'' that 
appeared in the Federal Register of March 10, 2022. The document 
omitted the date by which comments on the draft guidance should be 
submitted to FDA. This error is corrected in this document for clarity.

FOR FURTHER INFORMATION CONTACT: Sarah Venti, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 10, 2022 
(87 FR 13738), appearing on page 13738, in FR Doc. 2022-05018, in the 
second column, the DATES section is corrected to read as follows:

DATES: The announcement of the guidance is published in the Federal 
Register on March 10, 2022. Although you can comment on any guidance at 
any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers 
your comment on this draft guidance before it begins work on the final 
version of the guidance, submit either electronic or written comments 
on the draft guidance by May 9, 2022.

    Dated: March 17, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs, 
U.S. Food and Drug Administration.
[FR Doc. 2022-06006 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P


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