31440 Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Proposed Rules 

FDA has considered the request and 

is extending the comment period for the 

proposed rule for 90 days, until 

September 6, 2022. The Agency believes 

that a 90-day extension allows adequate 

time for interested persons to submit 

comments. 

Dated: May 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11116 Filed 5–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

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Requirements; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability, draft 

compliance policy. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

document entitled ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements; Draft Guidance for 

Industry.’’ The draft guidance document 

addresses certain requirements that 

apply to blood establishments that 

collect blood and blood components, 

including Source Plasma. Specifically, 

the draft guidance explains the 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 the 

biologics regulations regarding donation 

suitability, donor eligibility, and 

quarantine hold for Source Plasma. FDA 

expects that the compliance policy 

described in the draft guidance will 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. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 25, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

July 25, 2022. 

ADDRESSES: You may submit comments 

on any guidance 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; Draft 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 draft 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 draft 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 draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Phillip Kurs, Center for Biologics 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Proposed Rules 31441 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 240– 

402–7911. 

With regard to the proposed collection 

of information: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

5733,PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Compliance 

Policy Regarding Blood and Blood 

Component Donation Suitability, Donor 

Eligibility and Source Plasma 

Quarantine Hold Requirements.’’ The 

draft guidance document addresses 

certain requirements that apply to blood 

establishments that collect blood and 

blood components, including Source 

Plasma. Specifically, the draft 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 § 630.30 (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. 

To address the urgent and immediate 

need for blood and blood components 

during the Coronavirus Disease 2019 

(COVID–19) public health emergency, 

FDA issued certain exceptions and 

alternatives to the requirements 

regarding blood and blood components 

under 21 CFR 640.120(b) through the 

guidance entitled, ‘‘Alternative 

Procedures for Blood and Blood 

Components During the COVID–19 

Public Health Emergency; Guidance for 

Industry’’ dated April 2020 (April 2020 

guidance). 

Since publication of the April 2020 

guidance, FDA has received numerous 

comments from the blood industry 

requesting that FDA continue to permit 

the exceptions and alternatives beyond 

the public health emergency related to 

COVID–19 because the changes have 

increased availability of blood and 

blood components while maintaining 

the health of blood donors and safety of 

blood and blood components. Further, 

blood establishments have requested 

that FDA provide our recommendations 

before the end of the public health 

emergency to reduce the operational 

burdens associated with changes in 

standard operating procedures and 

blood establishment computer systems. 

FDA is issuing this guidance after 

considering the public comments, 

available data on donor health and the 

safety and availability of blood and 

blood components since publication of 

the April 2020 guidance, and the 

applicable regulations. 

FDA expects that the compliance 

policy described in this draft 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. 

While the April 2020 guidance is 

intended to remain in effect only for the 

duration of the public health emergency 

(PHE) related to COVID–19 declared by 

the Department of Health and Human 

Services (HHS), including any renewals 

made by the HHS Secretary in 

accordance with section 319(a)(2) of the 

Public Health Service Act (PHS Act), the 

draft guidance ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements,’’ when finalized, will 

remain in effect even after the HHS 

Secretary declares that this PHE no 

longer exists or the expiration of the 90- 

day period beginning on the date the 

HHS Secretary issues a renewal of the 

determination that a PHE exists. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on 

compliance with 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 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3521), 

Federal Agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Compliance Policy Regarding Blood 

and Blood Component Donation 

Suitability, Donor Eligibility and 

Source Plasma Quarantine Hold 

Requirements 

OMB Control Number 0910–0116— 

Revision 

As noted, blood establishments that 

collect blood and blood components, 

including Source Plasma, must comply 

with requirements in § 630.30 regarding 

donation suitability. The draft guidance 

explains the conditions under which 

FDA does not intend to take regulatory 

action for a blood establishment’s 

failure to comply with this requirement 

and describes proposed procedures in 

section III.A. under the heading ‘‘Record 

Maintenance, Investigation and Annual 

Reporting’’ for such an establishment’s 

filing of annual reports on the release of 

unsuitable donations to FDA. FDA will 

use the reports to monitor error rates 

associated with the collection of 

unsuitable donations and work with 

establishments to implement corrective 

actions, if necessary. The information is 

needed to support FDA’s efforts to 

protect the health of blood donors and 

the safety of blood and blood 

components. We are requesting 

approval to revise the scope of the 

information collections included in 

OMB control number 0910–0116 to 

include the information collection 

associated with the draft guidance. 

Description of Respondents: Licensed 

and registered-only establishments that 

collect blood and blood components for 

transfusion and further manufacturing, 

and elect to release unsuitable 

donations pursuant to the compliance 

policy described in the guidance. 


jspears on DSK121TN23PROD with PROPOSALS1
31442 Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Proposed Rules 

Burden Estimate: FDA estimates the 

burden of this collection of information 

as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/draft guidance section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Annual report—Licensed blood collection establishments/ 

Section III.A ...................................................................... 50 1 50 4 200 

Annual report—Registered-only blood establishments/Section III.A ............................................................................ 50 1 50 4 200 

Total .............................................................................. 400 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We base our estimate of the proposed 

reporting provisions in the guidance on 

our experience with similar information 

collections and a review of similar 

Agency data. 

This draft 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 and 

630 have been approved under OMB 

control number 0910–0116. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: May 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11120 Filed 5–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Part 1952 

[Docket No. OSHA–2021–0012] 

RIN 1218–AD43 

Arizona State Plan for Occupational 

Safety and Health; Proposed 

Reconsideration and Revocation; 

Extension of Comment Period; 

Extension of Hearing Request Period; 

Extension of Period To Submit Written 

Testimony; Extension of Period To 

Submit Notices of Intention To Appear 

at Public Hearing 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Labor. 

ACTION: Proposed rule; extension of 

comment period; extension of period for 

submitting request for an informal 

hearing; extension of period to submit 

written testimony; extension of deadline 

for submitting notices of intention to 

appear at public hearing. 

SUMMARY: The Occupational Safety and 

Health Administration (OSHA) is 

extending the deadlines for submitting 

comments on the Notice of Proposed 

Reconsideration and Revocation of Final 

Approval of the Arizona State Plan for 

Occupational Safety and Health 

(Notice), requests for an informal 

hearing, and submission of written 

testimony for an additional 40 days to 

July 5, 2022, and extending the deadline 

for submitting notices of intention to 

appear at its informal public hearing for 

an additional 55 days to July 5, 2022. In 

its prior Notice announcing this 

proposed action, OSHA advised the 

public that any informal public hearing 

to be held on this matter will begin on 

August 16, 2022, at 10:00 a.m., ET. 

DATES:

Written comments: Written comments 

on the Notice and requests for a hearing 

must be submitted electronically at 

www.regulations.gov, which is the 

Federal e-Rulemaking Portal, by July 5, 

2022. 

Informal public hearing: Any 

interested person may request an 

informal hearing concerning the 

proposed revocation. OSHA will hold 

such a hearing if the Assistant Secretary 

of Labor for Occupational Safety and 

Health (Assistant Secretary) finds that 

substantial objections have been filed. 

The agency will hold such an informal 

public hearing beginning on August 16, 

2022, virtually on WebEx. OSHA 

expects the hearing to last from 10:00 

a.m. to 6:00 p.m., ET; a schedule will be 

released prior to the start of the hearing. 

The exact daily schedule may be 

amended at the discretion of the 

presiding administrative law judge 

(ALJ). If necessary, the hearing will 

continue at the same time on 

subsequent days. 

Notice of intention to appear at the 

hearing: Interested persons who intend 

to present testimony or question 

witnesses at the hearing must submit a 

notice of their intention to do so by July 

5, 2022. 

Hearing testimony and documentary 

evidence: Interested persons who 

request more than 5 minutes to present 

testimony, or who intend to submit 

documentary evidence, at the hearing 

must submit the full text of their 

testimony and all documentary 

evidence by July 5, 2022. 

ADDRESSES:

Written comments: You may submit 

comments and attachments 

electronically at www.regulations.gov, 

which is the Federal e-Rulemaking 

Portal. Follow the instructions on-line 

for making electronic submissions. 

Informal public hearing: If the agency 

holds an informal public hearing, the 

hearing will be held virtually on WebEx. 

Additional information on how to 

access the informal hearing will be 


jspears on DSK121TN23PROD with PROPOSALS1