Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices 50539 

Hampshire Ave., Bldg. 22, Rm. 4139, 

Silver Spring, MD 20993; 240–402– 

7945. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 13, 

2021 (86 FR 26224), FDA published a 

notice entitled ‘‘Intent To Prepare an 

Environmental Impact Statement for 

Certain Sunscreen Drug Products for 

Over-the-Counter Use,’’ which 

announced the initiation of a public 

scoping period that would end on June 

14, 2021, and stated that comments on 

scoping would need to be submitted 

prior to the close of this period. In the 

Federal Register of June 25, 2021 (86 FR 

33712), FDA reopened the docket to 

allow comments on scoping to be filed 

until July 14, 2021. To allow additional 

comments to be submitted to the docket, 

FDA is reopening the comment period 

for public scoping on the EIS for an 

additional 14 days, until September 23, 

2021. The Agency believes that a 14-day 

extension will allow adequate time for 

interested persons to submit comments 

without significantly delaying 

publication of the draft EIS. 

II. Electronic Access 

Persons with access to the internet 

may obtain the notice of intent through 

the Agency’s web link ‘‘Environmental 

Impact Statement (EIS) for Certain 

Sunscreen Drug Products,’’ available at 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information or 

by searching for the above docket 

number at https://www.regulations.gov. 

Dated: September 1, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19402 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–D–0166] 

International Council for 

Harmonisation Q12: Implementation 

Considerations for Food and Drug 

Administration-Regulated Products; 

Draft Guidance for Industry; 

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, Agency, or we) is 

reopening the comment period for the 

draft guidance for industry entitled 

‘‘ICH Q12: Implementation 

Considerations for FDA-Regulated 

Products’’ published in the Federal 

Register of May 20, 2021. FDA is 

reopening the comment period to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is reopening the comment 

period on the notice published May 20, 

2021 (86 FR 27437). Submit either 

electronic or written comments by 

October 12, 2021. 

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 October 12, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of October 12, 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–D–0166 for ‘‘ICH Q12: 

Implementation Considerations for 

FDA-Regulated Products; Draft 

Guidance for Industry; Reopening of the 

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 

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 


lotter on DSK11XQN23PROD with NOTICES1
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 


lotter on DSK11XQN23PROD with NOTICES1