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may obtain the draft guidance at either 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 

[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 

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/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. 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 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/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

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. 

SUMMARY: 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. 

ADDRESSES: 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. 

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. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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 

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. 


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