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copies of the draft guidance to the 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 The draft guidance may 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access to the draft guidance document.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 

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availability of a draft guidance for 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may obtain the draft guidance at https:// 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/guidancecompliance-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. 

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 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 

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 


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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 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 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] 

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. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

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, 

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 


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