36512 Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Occasional updates ................................................... 60 2 120 0.5 (30 minutes) ...... 60 

Total .................................................................... ........................ ........................ 1,769 .................................. 7,451 

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

Based on a review of the information 

collection since our last request for 

OMB approval, the estimated burden for 

this information collection has 

decreased. The number of respondents 

has declined dramatically since we 

transitioned to using the ELM, which 

also allows us to collect more precise 

data. These changes resulted in overall 

decreases of 3,421 responses and 14,837 

burden hours. 

Dated: June 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13074 Filed 6–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0545] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Biological 

Products: Reporting of Biological 

Product Deviations and Human Cells, 

Tissues, and Cellular and TissueBased Product Deviations in 

Manufacturing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection requirements relating to the 

reporting of biological product 

deviations and human cells, tissues, and 

cellular and tissue-based product (HCT/ 

P) deviations in manufacturing, and 

Forms FDA 3486 and 3486A. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 16, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 16, 2022. 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– 

2009–N–0545 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Biological Products: Reporting of 

Biological Product Deviations and 

Human Cells, Tissues, and Cellular and 

Tissue-Based Deviations in 

Manufacturing; Forms FDA 3486 and 

3486A.’’ 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 

except in accordance with 21 CFR 10.20 


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Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 36513 

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: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

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, 

including each proposed extension of an 

existing 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. 

Biological Products: Reporting of 

Biological Product Deviations and 

Human Cells, Tissues, and Cellular and 

Tissue-Based Product Deviations in 

Manufacturing; Forms FDA 3486 and 

3486A 

OMB Control Number 0910–0458— 

Extension 

Under section 351 of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

262), all biological products, including 

human blood and blood components, 

offered for sale in interstate commerce 

must be licensed and meet standards, 

including those prescribed in the FDA 

regulations, designed to ensure the 

continued safety, purity, and potency of 

such products. In addition, under 

section 361 of the PHS Act (42 U.S.C. 

264), FDA may issue and enforce 

regulations necessary to prevent the 

introduction, transmission, or spread of 

communicable diseases between the 

States or possessions or from foreign 

countries into the States or possessions. 

Further, the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

351) provides that drugs and devices 

(including human blood and blood 

components) are adulterated if they do 

not conform with current good 

manufacturing practice (CGMP) assuring 

that they meet the requirements of the 

FD&C Act. Establishments 

manufacturing biological products, 

including human blood and blood 

components, must comply with the 

applicable CGMP regulations (parts 211, 

606, and 820 (21 CFR parts 211, 606, 

and 820)) and current good tissue 

practice (CGTP) regulations (part 1271 

(21 CFR part 1271)) as appropriate. FDA 

regards biological product deviation 

(BPD) reporting and HCT/P deviation 

reporting to be an essential tool in its 

directive to protect public health by 

establishing and maintaining 

surveillance programs that provide 

timely and useful information. 

Section 600.14 (21 CFR 600.14), in 

brief, requires the manufacturer who 

holds the biological product license, for 

other than human blood and blood 

components, and who had control over 

a distributed product when the 

deviation occurred, to report to the 

Center for Biologics Evaluation and 

Research (CBER) or to the Center for 

Drug Evaluation and Research (CDER) as 

soon as possible but at a date not to 

exceed 45 calendar days after acquiring 

information reasonably suggesting that a 

reportable event has occurred. Section 

606.171 (21 CFR 606.171), in brief, 

requires licensed manufacturers of 

human blood and blood components, 

including Source Plasma, unlicensed 

registered blood establishments, and 

transfusion services, who had control 

over a distributed product when the 

deviation occurred, to report to CBER as 

soon as possible but at a date not to 

exceed 45 calendar days after acquiring 

information reasonably suggesting that a 

reportable event has occurred. 

Similarly, § 1271.350(b) (21 CFR 

1271.350(b)), in brief, requires HCT/P 

establishments that manufacture nonreproductive HCT/Ps described in 

§ 1271.10 (21 CFR 1271.10) to 

investigate and report to CBER all HCT/ 

P deviations relating to a distributed 

HCT/P that relates to the core CGTP 

requirements, if the deviation occurred 

in the establishment’s facility or in a 

facility that performed a manufacturing 

step for the establishment under 

contract, agreement or other 

arrangement. Form FDA 3486 is used to 

submit BPD reports and HCT/P 

deviation reports. 

Respondents to this collection of 

information are: (1) licensed 

manufacturers of biological products 

other than human blood and blood 

components, (2) licensed manufacturers 

of blood and blood components 

including Source Plasma, (3) unlicensed 

registered blood establishments, (4) 

transfusion services, and (5) 

establishments that manufacture nonreproductive HCT/Ps regulated solely 

under section 361 of the PHS Act as 

described in § 1271.10. The number of 

respondents and total annual responses 

are based on the BPD reports and HCT/ 

P deviation reports FDA received in 

fiscal year (FY) 2021. The number of 

licensed manufacturers and total annual 

responses under § 600.14 include the 

estimates for BPD reports submitted to 

both CBER and CDER. Based on the 

information from industry, the 

estimated average time to complete a 

deviation report is 2 hours, which 

includes a minimal one-time burden to 

create a user account for those reports 

submitted electronically. The 

availability of the standardized report 

form, Form FDA 3486, and the ability to 

submit this report electronically to 

CBER (CDER does not currently accept 

electronic filings) further streamlines 

the report submission process. 

CBER has developed a web-based 

addendum to Form FDA 3486 (Form 

FDA 3486A) to provide additional 

information when a BPD report has been 

reviewed by FDA and evaluated as a 

possible recall. The additional 

information requested includes 

information not contained in the Form 

FDA 3486 such as: (1) distribution 

pattern; (2) method of consignee 


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36514 Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 

notification; (3) consignee(s) of products 

for further manufacture; (4) additional 

product information; (5) updated 

product disposition; and (6) industry 

recall contacts. This information is 

requested by CBER through email 

notification to the submitter of the BPD 

report. This information is used by 

CBER for recall classification purposes. 

CBER estimates that 3 percent of the 

total BPD reports submitted to CBER 

would need additional information 

submitted in the addendum. CBER 

further estimates that it would take 

between 10 and 20 minutes to complete 

the addendum. For calculation 

purposes, CBER is using 15 minutes. 

Activities such as investigating, 

changing standard operating procedures 

or processes, and follow up are 

currently required under parts 211 

(approved under OMB control number 

0910–0139), 606 (approved under OMB 

control number 0910–0116), 820 

(approved under OMB control number 

0910–0073), and 1271 (approved under 

OMB control number 0910–0543) and, 

therefore, are not included in the 

burden calculation for the separate 

requirement of submitting a deviation 

report to FDA. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

600.14; Reporting of product deviations 

by licensed manufacturers ................... 3486 103 6.864 707 2 1,414 

606.171; Reporting of product deviations 

by licensed manufacturers, unlicensed 

registered blood establishments, and 

transfusion services .............................. 3486 2,008 6.883 13,821 2 27,642 

1271.350(b); HCT/P deviations ............... 3486 80 2.575 206 2 412 

Web-based Addendum ............................ 2 3486A 66 6.69 442 0.25 110.5 

Total .................................................. ........................ ........................ ........................ 15,176 ........................ 29,578.5 

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

2Three percent of the number of respondents ((2,008 + 103 + 80) × 0.03 = 66) and total annual responses to CBER ((13,821 + 707 + 206) × 

0.03 = 442). 

Our estimated burden for the 

information collection reflects an 

overall decrease of approximately 

65,014 hours and a corresponding 

decrease of 34,152 responses. We 

attribute this adjustment to a decrease in 

the number of deviation reports we 

received in FY 2021 from licensed 

manufacturers and unlicensed 

registered blood establishments under 

§ 606.171. This is likely due to our 

issuance of the revised guidance 

document entitled ‘‘Biological Product 

Deviation Reporting for Blood and 

Plasma Establishments’’ (85 FR 14682, 

March 13, 2020), which provided blood 

and plasma establishments with revised 

recommendations related to BPD 

reporting. The revised guidance 

provided a less burdensome policy for 

reporting BPDs that is consistent with 

public health and eliminated the 

reporting of post donation information 

(PDI) events as BPD reports because 

these reports were no longer unexpected 

or unforeseeable. Given the substantial 

number of PDI reports FDA has 

received, the Agency is aware that these 

events occur, and the submission of 

additional PDI reports to FDA is 

unlikely to facilitate the identification of 

manufacturing or safety issues. 

Dated: June 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13086 Filed 6–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0721] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Accreditation of 

Third-Party Certification Bodies To 

Conduct Food Safety Audits and Issue 

Certifications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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: Fax written comments on the 

collection of information by July 18, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0750. 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–45, 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. 

Accreditation of Third-Party 

Certification Bodies To Conduct Food 

Safety Audits and Issue Certifications— 

21 CFR Part 1, Subpart M 

OMB Control Number 0910–0750— 

Extension 

This information collection helps to 

implement FDA’s Accredited ThirdParty Certification Program (also 

referred to as the third-party food 

program), established and administered 

under section 808 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 384d), and codified in 21 CFR 

part 1, subpart M (21 CFR parts 1.600 

through 1.725) of Agency regulations. 

The regulations communicate eligibility 

criteria, assessment standards, and 

establish procedures and requirements 


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