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Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 have been approved under OMB control number 09100001 and in 21 CFR part 601 under OMB control number 0910
0338.
III. Electronic Access Persons with access to the internet may obtain the draft guidance at https
www.regulations.gov, https
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: September 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202119410 Filed 9821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0352

Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-theCounter Use; Reopening of the Comment Period AGENCY:

Food and Drug Administration,
HHS.
Notice of intent; reopening of the comment period.

ACTION:

The Food and Drug Administration FDA or Agency is reopening the comment period for public scoping on the environmental impact statement EIS described in the notice entitled Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use that appeared in the Federal Register of May 13, 2021.
The Agency is taking this action to allow interested persons additional time to submit comments.
DATES: FDA is reopening the comment period for public scoping on the EIS

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SUMMARY:

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identified in the notice published May 13, 2021 86 FR 26224. To ensure the Agency considers your comments on the draft EIS, submit either electronic or written comments on the scoping process discussed in the notice by September 23, 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 September 23, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 23, 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 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
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identified, as confidential, if submitted as detailed in Instructions.
Instructions: All submissions received must include the Docket No. FDA
2021N0352 for Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use. 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 Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Trang Q. Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New
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