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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices Hampshire Ave., Bldg. 22, Rm. 4139, Silver Spring, MD 20993; 240402
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 Agencys 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. 202119402 Filed 9821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021D0166

lotter on DSK11XQN23PROD with NOTICES1

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Draft Guidance for Industry;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.
Notice; reopening of the comment period.

ACTION:

The Food and Drug Administration FDA, Agency, or we is
SUMMARY:

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reopening the comment period for the draft guidance for industry entitled ICH Q12: Implementation Considerations for FDA-Regulated Products published in the Federal Register of May 20, 2021.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 elses 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 HFA305, Food and
PO 00000

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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
2021D0166 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, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/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
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