71736 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 630 and 640 

[Docket No. FDA–2022–D–0588] 

Compliance Policy Regarding Blood 

and Blood Component Donation 

Suitability, Donor Eligibility and 

Source Plasma Quarantine Hold 

Requirements; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Announcement of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Compliance Policy Regarding Blood 

and Blood Component Donation 

Suitability, Donor Eligibility and Source 

Plasma Quarantine Hold 

Requirements.’’ The guidance document 

addresses certain requirements that 

apply to blood establishments that 

collect blood and blood components, 

including Source Plasma. Specifically, 

the guidance explains the conditions 

under which FDA does not intend to 

take regulatory action for a blood 

establishment’s failure to comply with 

certain requirements in FDA’s 

regulations regarding donation 

suitability, donor eligibility, and 

quarantine hold for Source Plasma. FDA 

expects that the compliance policy 

described in the guidance will increase 

the availability of blood and blood 

components, including Source Plasma, 

while maintaining the health of blood 

donors and the safety of blood and 

blood components. The guidance 

announced in this document finalizes 

the draft guidance of the same title 

dated May 2022, and supersedes the 

guidance entitled ‘‘Alternative 

Procedures for Blood and Blood 

Components During the COVID–19 

Public Health Emergency; Guidance for 

Industry,’’ dated April 2020. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 18, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2022–D–0588 for ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements; Guidance for Industry.’’ 

Received comments 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 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the 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. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The 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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Phillip Kurs, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Compliance 

Policy Regarding Blood and Blood 

Component Donation Suitability, Donor 

Eligibility and Source Plasma 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Rules and Regulations 71737 

Quarantine Hold Requirements.’’ The 

guidance document addresses certain 

requirements that apply to blood 

establishments that collect blood and 

blood components, including Source 

Plasma. Specifically, the guidance 

explains the conditions under which 

FDA does not intend to take regulatory 

action for a blood establishment’s 

failure to comply with certain 

requirements in Title 21 of the Code of 

Federal Regulations (21 CFR 630.30) 

regarding donation suitability; 21 CFR 

630.10(c)(2) regarding donor eligibility; 

and 21 CFR 640.69(f) regarding 

quarantine hold for Source Plasma. 

In the Federal Register of May 24, 

2022 (87 FR 31440), FDA announced the 

availability of the draft guidance of the 

same title dated May 2022. FDA 

received several comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. A summary of changes 

includes clarifying the format of the 

report discussed in the guidance and 

clarifying the scope of the compliance 

policy. In addition, editorial changes 

were made to improve clarity. The 

guidance announced in this document 

finalizes the draft guidance dated May 

2022, and supersedes the guidance 

entitled ‘‘Alternative Procedures for 

Blood and Blood Components During 

the COVID–19 Public Health 

Emergency; Guidance for Industry,’’ 

dated April 2020. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements.’’ 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 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information 

have been approved under OMB control 

number 0910–0116. This guidance also 

refers to previously approved FDA 

collections of information. The 

collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338 and 

the collections of information in 21 CFR 

parts 606, 630, and 640 have been 

approved under OMB control number 

0910–0116. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: October 10, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22957 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 171 

[Public Notice 12153] 

RIN 1400–AE00 

Public Access to Information 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State (the 

Department) finalizes the proposed rule 

it published on March 3, 2020, relating 

to the availability to the public of 

information that is under the control of 

the Department. These changes were 

prompted by changes in the law 

governing disclosure of such 

information, including the Freedom of 

Information Act Improvement Act of 

2016. This final rule reflects changes in 

the FOIA and consequent changes in the 

Department’s procedures since the last 

major revision of the Department’s 

regulations on public access to 

information, which occurred in 2016. 

DATES: This rule is effective on 

November 17, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Kellie Robinson, Office of Information 

Programs and Services, FOIAstatus@

state.gov, 202–261–8484. 

SUPPLEMENTARY INFORMATION: This rule 

finalizes the Notice of Proposed 

Rulemaking that was published on 

March 3, 2020. 85 FR 13104. It 

implements the Freedom of Information 

Act (FOIA) Improvement Act of 2016, 

Public Law 114–185, and updates the 

Department’s FOIA regulations at 22 

CFR part 171. The following summary 

of the substantive changes to Part 171 

was included in the NPRM but is 

provided here for convenience. 

The rule, in § 171.4, provides updated 

procedures and addresses for submitting 

FOIA requests to the Department, 

including procedures for requesting 

information about the requester and 

requests for visa information. 

Subpart B of the rule (§§ 171.10 

through 171.17) contains the rules 

governing the processing of a FOIA 

request. Section 171.11 covers the 

Department’s initial processing of a 

request; it clarifies the information that 

is to be provided as part of a request, the 

Department’s process for responding to 

requests, and consultation and referral 

with respect to requests. Section 171.12 

covers the timing of responses to a 

request, including multi-track 

processing, expedited processing, and 

‘‘unusual circumstances’’ (as defined in 

the FOIA) that might affect the 

Department’s ability to respond. Section 

171.13 covers responses to requests, 

including the procedures upon denial of 

a request. The updates add a provision 

for consultation with the Department of 

Justice’s Office of Information Policy 

with respect to invocation of a FOIA 

exclusion. Section 171.14 modifies the 

Department’s process with respect to 

reviews of confidential commercial 

information, including procedures for 

the owner of the information to object 

to the release of the information. 

Section 171.15 revises the timeline for 

submission of appeals to 90 days and 

provides for information to be given to 

requesters about dispute resolution 

services at various stages of the 

processing of a request, in accordance 

with the FOIA Improvement Act of 

2016. Section 171.16 provides updates 

on the fees to be charged for FOIA 

requests, including how fees are 

calculated. This section provides an 

updated explanation of the term, 

‘‘representative of the news media.’’ 

Subpart C contains the rule’s Privacy 

Act provisions. There are two 

substantive changes in this subpart from 

that published in the NPRM. The first 

relates to a Privacy Act exemption that 

was published after the NPRM was 

published. See the final rule on March 

9, 2020, ‘‘Privacy Act; STATE–01, Email 

Archive Management Records,’’ 85 FR 

13482. This SORN was added to the 

lists in paragraph (a)(2)(iii), and (b)(1), 

(2), (3), (4), (5), (6) and (7). However, the 

Department has now determined that 

this item was added in error, and the 

Department is removing STATE–01 

from the lists of Privacy Act exemptions 

in §§ 171.26(a)(2)(iii), (b)(2), (b)(3), 

(b)(4), (b)(5), (b)(6), and (b)(7). The 

reason for this action is that the 

Department has determined that its 

email records do not constitute a system 

of records under the Privacy Act; 

therefore, STATE–01, ‘‘Email Archive 

Management Records’’, will be 


ddrumheller on DSK120RN23PROD with RULES1