Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use; Reopening of Comment Period, 33712-33713 [2021-13568]

Download as PDF 33712 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices on ‘‘Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to 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 part 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/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/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: June 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–13585 Filed 6–24–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration lotter on DSK11XQN23PROD with NOTICES1 [Docket No. FDA–2021–N–0352] Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-theCounter Use; Reopening of Comment Period Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of intent; reopening of comment period. AGENCY: VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 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 identified in the notice published May 13, 2021 (86 FR 26224). To ensure the Agency considers your comments before it begins work on the draft EIS, submit either electronic or written comments on the scoping process discussed in the notice by July 14, 2021. If a virtual public scoping meeting is scheduled, FDA will announce the date and time via the weblink ‘‘Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products’’ on the Agency’s web page ‘‘Guidance, Compliance, & Regulatory Information,’’ available at https://www.fda.gov/drugs/guidancecompliance-regulatory-information. 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 July 14, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 14, 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. SUMMARY: 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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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–0352 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, 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 E:\FR\FM\25JNN1.SGM 25JNN1 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 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-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, 240–402–7500. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: SUMMARY: Trang Q. Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New 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 noted that comments on scoping would need to be submitted prior to the close of this period. In response to a request submitted to the docket, FDA is reopening the comment period for public scoping on the EIS for an additional 30 days, until July 14, 2021. The Agency believes that a 30-day extension will allow adequate time for interested persons to submit comments without significantly delaying publication of the draft EIS. lotter on DSK11XQN23PROD with NOTICES1 II. Electronic Access Persons with access to the internet may obtain the notice of intent through the Agency’s weblink ‘‘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: June 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–13568 Filed 6–24–21; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 Food and Drug Administration [Docket No. FDA–2017–N–6931] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and ‘‘Lookback’’ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by July 26, 2021. To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0116. Also, include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and ‘‘Lookback’’ OMB Control Number 0910–0116— Revision This information collection supports Agency regulations and associated PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 33713 guidance. All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). Section 351(a) requires that manufacturers of biological products, which include blood and blood components intended for further manufacturing into products, have a license, issued upon a demonstration that the product is safe, pure, and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of the product. In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary of Health and Human Services, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Section 351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic Act (FD&C Act) also applies to biological products. Blood and blood components for transfusion or for further manufacturing into products are drugs, as that term is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and blood components are drugs under the FD&C Act, blood and plasma establishments must comply with the provisions and related regulatory scheme of the FD&C Act. For example, under section 501 of the FD&C Act (21 U.S.C. 351), drugs are deemed ‘‘adulterated’’ if the methods used in their manufacturing, processing, packing, or holding do not conform to current good manufacturing practice (CGMP) and related regulations. The CGMP regulations (part 606) (21 CFR part 606) and related regulations implement FDA’s statutory authority to ensure the safety, purity, and potency of blood and blood components. The public health objective in testing human blood donations for evidence of relevant transfusion-transmitted infections and in notifying donors is to prevent the transmission of relevant transfusiontransmitted infections. For example, the ‘‘lookback’’ requirements are intended to help ensure the continued safety of the blood supply by providing necessary information to consignees of blood and blood components and appropriate notification of recipients of blood components that are at increased risk for transmitting human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection. E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33712-33713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13568]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0352]


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

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of intent; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: 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 identified in the notice published May 13, 2021 (86 FR 26224). To 
ensure the Agency considers your comments before it begins work on the 
draft EIS, submit either electronic or written comments on the scoping 
process discussed in the notice by July 14, 2021. If a virtual public 
scoping meeting is scheduled, FDA will announce the date and time via 
the weblink ``Environmental Impact Statement (EIS) for Certain 
Sunscreen Drug Products'' on the Agency's web page ``Guidance, 
Compliance, & Regulatory Information,'' available at https://www.fda.gov/drugs/guidance-compliance-regulatory-information.

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 July 14, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 14, 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-0352 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, 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

[[Page 33713]]

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 Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Trang Q. Tran, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
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 noted that comments on scoping would 
need to be submitted prior to the close of this period. In response to 
a request submitted to the docket, FDA is reopening the comment period 
for public scoping on the EIS for an additional 30 days, until July 14, 
2021. The Agency believes that a 30-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 weblink ``Environmental Impact Statement (EIS) for 
Certain Sunscreen Drug Products,'' available at https://www.fda.gov/drugs/guidance-compliance-regulatory-information or by searching for 
the above docket number at https://www.regulations.gov.

    Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13568 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P

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