Allergenic Products Advisory Committee; Notice of Meeting, 50540-50541 [2021-19436]

Download as PDF 50540 Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993–0002; Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002; or Office of Policy, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 240–402– 8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Ashley Boam, CDER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993–0002, 301–796–6341; Stephen Ripley, CBER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911; or Andrew Yeatts, CDRH, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5510, Silver Spring, MD 20993–0002, 301–796–4539. SUPPLEMENTARY INFORMATION: I. Background lotter on DSK11XQN23PROD with NOTICES1 In the Federal Register of May 20, 2021 (86 FR 27437), FDA announced the availability of a draft guidance for industry entitled ‘‘ICH Q12: Implementation Considerations for FDA-Regulated Products.’’ Interested persons were originally given until July 19, 2021, to comment on the draft guidance. However, the Agency believes that reopening the comment period for an additional 30 days from the date of publication of this notice will allow adequate time for interested persons to submit comments without significantly delaying Agency decision-making on these important issues. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidance- VerDate Sep<11>2014 19:38 Sep 08, 2021 Jkt 253001 compliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, or https:// www.regulations.gov. Dated: September 1, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–19403 Filed 9–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0008] Allergenic Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. Members will participate via teleconference. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on October 28, 2021, from 9:30 a.m. to 1:20 p.m. EST. ADDRESSES: Please note that due to the impact of this COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. The online web conference meeting will be available at the following link on the day of the meeting: https://youtu.be/ OHRWDuihDns. FOR FURTHER INFORMATION CONTACT: Kathleen Hayes or Monique Hill, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 6306, Silver Spring, MD 20993–0002, via email at CBERVRBPAC@fda.hhs.gov; or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to SUMMARY: PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 provide timely notice. Therefore, you should always check the Agency’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: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 28, 2021, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Immunobiochemistry (LIB), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). 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 location 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/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On October 28, 2021, from 9:30 a.m. to 12:20 p.m., 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. Written submissions may be made to the contact person on or before October 13, 2021. Oral presentations from the public will be scheduled between approximately 11:20 a.m. to 12:20 p.m. 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 addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 13, 2021. 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 E:\FR\FM\09SEN1.SGM 09SEN1 Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices person will notify interested persons regarding their request to speak by October 14, 2021. Closed Committee Deliberations: On October 28, 2021, from 12:20 p.m.to 1:20 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the individual investigator’s research programs, along with other information, will be discussed during this session. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy. 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 Kathleen Hayes (CBERVRBPAC@fda.hhs.gov) 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/about-advisory-committees/ public-conduct-during-fda-advisorycommittee-meetings 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: September 2, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–19436 Filed 9–8–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0951] lotter on DSK11XQN23PROD with NOTICES1 Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA, the Agency, or SUMMARY: VerDate Sep<11>2014 19:38 Sep 08, 2021 Jkt 253001 we) is announcing the following public workshop entitled ‘‘Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis.’’ Convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and DukeMargolis, the purpose of the public workshop is to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS. We expect interested stakeholders to include healthcare providers, healthcare professional associations, pharmacists, pharmacy benefit managers, public and private insurers, patient organizations, Federal and State Agencies, providers of continuing education for healthcare professionals, and the public. A second public workshop is being planned to solicit input on additional issues associated with a move to mandatory prescriber education under a REMS, such as operational and technical issues related to such a system and what should be included in potential mandatory prescriber education. DATES: The public workshop will be held on October 13, 2021, from 1 p.m. to 5 p.m. Eastern Time and October 14, 2021, from 1 p.m. to 4:05 p.m. Eastern Time. Submit either electronic or written comments on this public workshop by December 3, 2021. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: Due to the impact of the COVID–19 pandemic, these meetings will be held virtually to help protect the public and limit the spread of the virus. 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 December 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 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, PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 50541 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– 2021–N–0951 for ‘‘Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis.’’ Comments filed and received 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 Agency will review this copy, including the claimed confidential information, in its consideration of comments. The E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50540-50541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19436]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0008]


Allergenic Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) announces 
a forthcoming public advisory committee meeting of the Allergenic 
Products Advisory Committee. The general function of the committee is 
to provide advice and recommendations to the Agency on FDA's regulatory 
issues. Members will participate via teleconference. At least one 
portion of the meeting will be closed to the public.

DATES: The meeting will be held on October 28, 2021, from 9:30 a.m. to 
1:20 p.m. EST.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing platform. The online 
web conference meeting will be available at the following link on the 
day of the meeting: https://youtu.be/OHRWDuihDns.

FOR FURTHER INFORMATION CONTACT: Kathleen Hayes or Monique Hill, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave. Bldg. 71, Rm. 6306, Silver Spring, MD 20993-
0002, via email at [email protected]; or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last-minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency'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:
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On October 
28, 2021, the committee will meet in open session to hear an overview 
of the research programs in the Laboratory of Immunobiochemistry (LIB), 
Division of Bacterial, Parasitic and Allergenic Products (DBPAP), 
Office of Vaccines Research and Review (OVRR), Center for Biologics 
Evaluation and Research (CBER).
    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 location 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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On October 28, 2021, from 9:30 a.m. to 12:20 p.m., 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. Written submissions may be made to the contact person on 
or before October 13, 2021. Oral presentations from the public will be 
scheduled between approximately 11:20 a.m. to 12:20 p.m. 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 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
October 13, 2021. 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

[[Page 50541]]

person will notify interested persons regarding their request to speak 
by October 14, 2021.
    Closed Committee Deliberations: On October 28, 2021, from 12:20 
p.m.to 1:20 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory 
committee regarding the progress of the individual investigator's 
research programs, along with other information, will be discussed 
during this session. We believe that public discussion of these 
recommendations on individual scientists would constitute an 
unwarranted invasion of personal privacy.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] 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 Kathleen Hayes ([email protected]) 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19436 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P
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