57956 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 21, 2023. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2023–18221 Filed 8–23–23; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0588] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice for Blood and 

Blood Components and Reducing the 

Risk of Transfusion-Transmitted 

Infections 

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 September 

25, 2023. 

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: 

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: 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 Practice 

for Blood and Blood Components and 

Reducing the Risk of TransfusionTransmitted Infections 

OMB Control Number 0910–0116— 

Revision 

This information collection helps 

support FDA implementation of 

statutory and regulatory requirements 

that govern current good manufacturing 

practice (CGMP) for blood and blood 

components. We have issued 

regulations in parts 606, 610, 630, and 

640 (21 CFR parts 606, 610, 630, and 

640) setting forth applicable standards 

and procedures that include associated 

reporting, recordkeeping, and disclosure 

requirements. Respondents to the 

collection of information are licensed 

and registered-only establishments that 

collect blood and blood components 

intended for transfusion or further 

manufacturing use. We provide 

information on our website at https://

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

blood-blood-products regarding CGMP 

for blood and blood products, including 

available Agency resources. 

We are revising the information 

collection to support implementation of 

annual reporting to FDA of the release 

of unsuitable blood donations from 

establishments that intend for their 

activities to fall under the compliance 

policy set forth in the draft guidance for 

industry entitled ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements’’ (May 2022). The draft 

guidance describes FDA’s compliance 

policy for certain regulations. Blood 

establishments that collect blood and 

blood components, including Source 

Plasma, must comply with requirements 

in § 630.30 regarding donation 

suitability. However, 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 for 

such an establishment’s filing of annual 

reports on the release of unsuitable 

donations to FDA. Specifically, under 

this policy, when finalized, when the 

donation is otherwise suitable under 

§ 630.30(a), FDA does not intend to take 

regulatory action if blood 

establishments release donations for 

transfusion or further manufacture 

when the review of records, required 

after donation under § 630.30(a)(2), 

identifies the donation as unsuitable 

because of inadvertent failure to follow 

procedures to ensure that the donation 

would not adversely affect the health of 

the donor, namely for: 

• blood pressure (§ 630.10(f)(2)); 

• pulse (§ 630.10(f)(4)); 

• weight (§ 630.10(f)(5)); 

• donation frequency for Whole 

Blood and Red Blood Cells collected by 

apheresis (§ 630.15(a)(1)); 

• pregnancy (§ 630.10(e)(2)(v)); and 

• red blood cell loss for plasma 

collected by plasmapheresis 

(§ 630.15(b)(6)). 

The draft guidance sets forth that FDA 

intends to apply the compliance policy 

provided blood establishments that elect 

to release unsuitable units as described 

in the guidance report the release of 

unsuitable donations to FDA annually. 

The draft guidance document is 

available for download at https://

www.fda.gov/media/158608/download. 

We issued the guidance document 

consistent with our Good Guidance 

Practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. We intend on finalizing the 

guidance document upon OMB 

approval of the attendant information 

collection. When finalized, the guidance 

will supersede the guidance entitled, 

‘‘Alternative Procedures for Blood and 

Blood Components During the COVID– 

19 Public Health Emergency; Guidance 

for Industry,’’ dated April 2020. 

As explained in section III.A of the 

guidance, licensed and registered-only 

blood establishments must maintain 

records as required under § 606.160; 

investigate the error that resulted in the 

collection of an unsuitable donation 

under § 630.30(a)(2); and submit a 

report to FDA annually if they intend 

for their activities to fall under this 


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Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 57957 

compliance policy. The report should 

describe the number and type of 

donations released under these 

conditions. The report should also 

describe the corrective actions taken to 

prevent recurrence of errors and to 

ensure compliance with the applicable 

regulations. The final guidance will 

clarify that the report may be submitted 

in summary format. 

The submission of these reports will 

allow us to monitor error rates 

associated with the collection of 

unsuitable units and work with 

establishments to implement corrective 

actions, if necessary. We expect that this 

compliance policy 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. If, based upon the 

available scientific evidence, the risk to 

the safety of the blood supply or the risk 

to donors’ health significantly changes, 

FDA may revise this compliance policy 

as warranted. 

In the Federal Register of May 24, 

2022 (87 FR 31440), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. We received six comment 

letters, each of which contained 

multiple comments, in response to the 

notice. Some comments were not 

responsive to the four information 

collection topics solicited. 

(Comment 1) With regard to the 

statement in the draft guidance that 

‘‘licensed and registered-only blood 

establishments must maintain records as 

required under 21 CFR 606.160; 

investigate the error that resulted in the 

collection of an unsuitable donation 

under 21 CFR 630.30(a)(2); and submit 

a report to FDA annually if they intend 

for their activities to fall under this 

compliance policy,’’ one comment 

asked that we clarify whether postdonation information (PDI) related to 

blood pressure, pulse, weight, and red 

blood cell loss would need to be 

investigated and reported to us in the 

report on an annual basis. 

(Response 1) PDI is information 

received by the blood establishment 

after donation from the donor or another 

source that is out of the control of the 

establishments. We do not consider the 

receipt of PDI to be an error that must 

be reported to FDA on an annual basis 

as described in the guidance. However, 

the blood establishment’s measurement 

of a donor’s blood pressure, pulse or red 

blood cell loss are in the control of the 

establishment, and errors in such 

measurement would not be identified 

through PDI. 

We have considered the comment and 

have determined that the comment does 

not present information that would 

warrant changes to the guidance 

document at this time. 

(Comment 2) Another comment 

requested that the annual report not 

include corrective actions taken for each 

error because this would represent 

duplication of information already 

available to FDA via its inspection 

compliance program. The comment 

noted that each establishment has a 

defined deviation management and 

corrective action program and each error 

related to donor eligibility 

determination is investigated. The 

comment further noted that FDA should 

not request this report because the 

information can be reviewed during 

FDA’s inspection compliance program. 

(Response 2) We disagree that 

including a summary of corrective 

actions on the annual report would 

represent duplication of information. 

Establishments may submit the 

information already developed as part of 

their deviation management and 

corrective action program. A new 

investigation does not need to be 

completed and new documentation does 

not need to be created. Receiving annual 

information about the corrective actions 

taken will allow us to better assess the 

robustness of the establishment’s GMP 

system in a timely manner. We also note 

that blood establishments may elect not 

to use the enforcement discretion 

provided in the guidance to release 

certain unsuitable blood components, 

and therefore, would not submit a report 

to FDA. 

Comments are being considered as the 

guidance is being finalized. We are 

clarifying in the final guidance that the 

annual report about the corrective 

actions taken may be submitted in 

summary format. This change in 

wording did not affect our estimate of 

the burden. 

Description of Respondents: 

Respondents to the collection of 

information are licensed and registeredonly establishments that collect blood 

and blood components intended for 

transfusion or further manufacturing 

use. 

We estimate the burden of the 

information collection 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 of released unsuitable units—Licensed 

blood collection establishments/section III.A ................... 50 1 50 4 200 

Annual report of released unsuitable units—Registeredonly 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 on our experience with similar 

information collections and a review of 

similar reporting data. 

Dated: August 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18245 Filed 8–23–23; 8:45 am] 

BILLING CODE 4164–01–P 


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