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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research CDER, Food and Drug Administration, 10001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
209930002; 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 The draft guidance may also be obtained by mail by calling CBER at 18008354709 or 240402
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INFORMATION section for electronic access to the draft guidance document.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 209930002, 3017966341;
Stephen Ripley, CBER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 209930002, 2404027911; or Andrew Yeatts, CDRH, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5510, Silver Spring, MD 209930002, 3017964539.
SUPPLEMENTARY INFORMATION:
I. Background
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In the Federal Register of May 20, 2021 86 FR 27437, FDA announced the availability of a draft guidance for industry entitled ICH Q12: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 Interested persons were originally given until July 19, 2021, to comment on the draft guidance.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 Electronic Access Persons with access to the internet may obtain the draft guidance at https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-

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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. 202119403 Filed 9821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0008

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 FDAs 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 COVID19 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 209930002, via email at CBERVRBPAC@fda.hhs.gov;
or FDA Advisory Committee Information Line, 18007418138
3014430572 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:

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provide timely notice. Therefore, you should always check the Agencys 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 FDAs 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
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