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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33714 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

The information collection 

requirements in the CGMP, donation 

testing, donor notification, and 

‘‘lookback’’ regulations provide FDA 

with the necessary information to 

perform its duty to ensure the safety, 

purity, and potency of blood and blood 

components. These requirements 

establish accountability and traceability 

in the processing and handling of blood 

and blood components and enable FDA 

to perform meaningful inspections. 

The recordkeeping requirements serve 

preventive and remedial purposes. The 

third-party disclosure requirements 

identify various blood and blood 

components and important properties of 

the product, demonstrate that the CGMP 

requirements have been met, and 

facilitate the tracing of a product back 

to its original source. The reporting 

requirements inform FDA’s Center for 

Biologics Evaluation and Research of 

certain information that may require 

immediate corrective action. 

Respondents to this collection of 

information are licensed and unlicensed 

blood establishments that collect blood 

and blood components, including 

Source Plasma and Source Leukocytes, 

inspected by FDA, and transfusion 

services inspected by Centers for 

Medicare and Medicaid Services (CMS). 

Based on submission data, there are 

approximately 864 licensed Source 

Plasma establishments and 

approximately 1,789 licensed blood 

collection establishments, for an 

estimated total of 2,653 (864 + 1,789) 

licensed blood collection 

establishments. Also, there are an 

estimated total of 817 unlicensed, 

registered blood collection 

establishments for an approximate total 

of 3,470 collection establishments (864 

+ 1,789 + 817 = 3,470 establishments). 

Of these establishments, approximately 

856 perform plateletpheresis (777) and 

leukapheresis (79). These 

establishments annually collect 

approximately 73.7 million units of 

Whole Blood and blood components, 

including Source Plasma and Source 

Leukocytes, and are required to follow 

FDA ‘‘lookback’’ procedures. In 

addition, there are another estimated 

4,961 establishments that fall under the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) (formerly 

referred to as facilities approved for 

Medicare reimbursement) that transfuse 

blood and blood components. 

The following reporting and 

recordkeeping estimates are based on 

information provided by industry, CMS, 

and our experience with the information 

collection. We estimate 53.5 million 

donations of Source Plasma from 

approximately 2.5 million donors and 

estimate 12.3 million donations of 

Whole Blood and apheresis Red Blood 

Cells, including an estimated 10,000 

(approximately 0.081 percent of 12.3 

million) autologous donations, from 9 

million donors. Assuming each 

autologous donor makes an average of 

1.1 donations, we estimate there are 

9,090 autologous donors (10,000 

autologous/1.1 average donations). 

We estimate 0.53 percent (56,000 ÷ 

10,654,000) of the 77,000 donations that 

are donated specifically for the use of an 

identified recipient would be tested 

under the dedicated donors’ testing 

provisions in § 610.40(c)(1)(ii) (21 CFR 

610.40(c)(1)(ii)). 

Under § 610.40(g)(2) and (h)(2)(ii)(A), 

Source Leukocytes, a licensed product 

that is used in the manufacture of 

interferon, which requires rapid 

preparation from blood, is currently 

shipped prior to completion of testing 

for evidence of relevant transfusiontransmitted infections. Shipments of 

Source Leukocytes are approved under 

a biologics license application and each 

shipment does not have to be reported 

to the Agency. Based on a review of 

data, FDA receives less than one 

application per year from manufacturers 

of Source Leukocytes; however, we 

estimate one annually for this analysis. 

Also according to Agency data, there 

are approximately 15 licensed 

manufacturers that ship known reactive 

human blood or blood components 

under § 610.40(h)(2)(ii)(C) and (D). We 

estimate each manufacturer would ship 

an average of 1 unit of human blood or 

blood components per month (12 per 

year) that would require two labels: One 

as reactive for the appropriate screening 

test under § 610.40(h)(2)(ii)(C) and the 

other stating the exempted use 

specifically approved by FDA under 

§ 610.40(h)(2)(ii)(D). 

Based on information received from 

industry, we estimate 7,500 donations 

that test reactive by a screening test for 

syphilis and are determined to be 

biological false positives by additional 

testing annually. These units would be 

labeled according to § 610.40(h)(2)(vi). 

Human blood or a blood component 

with a reactive screening test, as a 

component of a medical device, is an 

integral part of the medical device; e.g., 

a positive control for an in vitro 

diagnostic testing kit. It is the usual and 

customary business practice for 

manufacturers to include on the 

container label a warning statement 

indicating that the product was 

manufactured from a donation found to 

be reactive for the identified relevant 

transfusion-transmitted infection(s). In 

addition, on the rare occasion when a 

human blood or blood component with 

a reactive screening test is the only 

component available for a medical 

device that does not require a reactive 

component, then a warning statement 

must be affixed to the medical device. 

To account for this rare occasion under 

§ 610.42(a) (21 CFR 610.42(a)), we 

estimate that the warning statement 

would be necessary no more than once 

a year. 

We estimate 3,100 repeat donors will 

test reactive on a screening test for HIV. 

We assume an average of three 

components was made from each 

donation. Under § 610.46(a)(1)(ii)(B) and 

(a)(3) (21 CFR 610.46(a)(1)(ii)(B) and 

(b)(3)), this estimate results in 9,300 

(3,100 × 3) notifications of the HIV 

screening test results to consignees by 

collecting establishments for the 

purpose of quarantining affected blood 

and blood components, and another 

9,300 (3,100 × 3) notifications to 

consignees of subsequent test results. 

We estimate 4,961 consignees will be 

required under § 610.46(b)(3) to notify 

transfusion recipients, their legal 

representatives, or physicians of record 

an average of 0.35 times per year 

resulting in a total number of 1,755 (585 

confirmed positive repeat donors × 3) 

notifications. Also, under § 610.46(b)(3), 

we estimate and include the time to 

gather test results and records for each 

recipient and to accommodate multiple 

attempts to contact the recipient. 

Furthermore, we estimate 6,800 repeat 

donors per year would test reactive for 

antibody to HCV. Under 

§§ 610.47(a)(1)(ii)(B) and (a)(3) (21 CFR 

610.47(a)(1)(ii)(B) and (a)(3)), collecting 

establishments would notify the 

consignee two times for each of the 

20,400 (6,800 × 3 components) 

components prepared from these 

donations: Once for quarantine 

purposes and again with additional 

HCV test results for a total of 40,800 (2 

× 20,400) notifications as an annual 

ongoing burden. Under § 610.47(b)(3), 

we assume 4,961 consignees notify 

approximately 2,050 recipients or their 

physicians of record annually. 

Based on industry estimates, 

approximately 18.15 percent of 

approximately 14,018,000 million 

potential donors (2,544,000 donors) who 

come to donate annually are determined 

not to be eligible for donation prior to 

collection because of failure to satisfy 

eligibility criteria. It is the usual and 

customary business practice of 

approximately 2,606 (1,789 + 817) blood 

collecting establishments to notify 

onsite and to explain why the donor is 

determined not to be suitable for 

donating. Based on such available 

information, we estimate that two-thirds 

(1,737) of the 2,606 blood collecting 


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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33715 

establishments provided onsite 

additional information and counseling 

to a donor determined not to be eligible 

for donation as usual and customary 

business practice. Consequently, we 

estimate one-third, or 869 of the 2,606 

blood collecting establishments, would 

need to provide, under § 630.40(a) (21 

CFR 630.40(a)), additional information 

and onsite counseling to the estimated 

848,000 (one-third of approximately 

2,544,000) ineligible donors. 

We estimate another 0.6 percent of 

14,018,000 potential donors (84,108 

donors) are deferred annually based on 

test results. We assume 95 percent of the 

establishments that collect 99 percent of 

the blood and blood components notify 

donors who have reactive test results for 

HIV, Hepatitis B Virus, HCV, Human TLymphotropic Virus, and syphilis as 

their usual and customary business 

practice. Consequently, 5 percent of the 

2,653 licensed establishments (133) 

collecting 1 percent (841) of the deferred 

donors (84,108) would notify donors 

under § 630.40(a). 

As part of their usual and customary 

business practice, collecting 

establishments notify an autologous 

donor’s referring physician of reactive 

test results obtained during the donation 

process required under § 630.40(d)(1). 

However, we assume 5 percent of the 

1,789 blood collection establishments 

(89) may not notify the referring 

physicians of the estimated 2 percent of 

10,000 autologous donors with the 

initial reactive test results (200) as their 

usual and customary business practice. 

We assume 95 percent of 

recordkeepers, which account for 99 

percent of blood donations, have 

developed standard operating 

procedures (SOPs) as part of their 

customary and usual business practice. 

Establishments may minimize burdens 

associated with CGMP and related 

regulations by using model standards 

developed by industries’ accreditation 

organizations. These accreditation 

organizations represent almost all 

registered blood establishments. 

Under § 606.160(b)(1)(ix) (21 CFR 

606.160(b)(1)(ix)), we assume a total 

number of annual records based on 

2,544,000 ineligible donors and each of 

the estimated 2,628,108 (2,544,000 + 

84,108) donors deferred based on 

reactive test results for evidence of 

infection because of relevant 

transfusion-transmitted infections. 

Under § 606.160(b)(1)(xi), only the 1,789 

registered blood establishments collect 

autologous donations and, therefore, are 

required to notify referring physicians. 

We estimate that 4.5 percent of the 

9,090 autologous donors (409) will be 

deferred under § 610.41 (21 CFR 

610.41), which in turn will lead to the 

notification of their referring physicians. 

Under § 610.41(b), we estimate 25 

submissions for requalification of 

donors each requiring 7 hours per 

submission. In addition, we assume that 

there would be only three notifications 

for requalification of donors under 

§ 630.35(b) (21 CFR 630.35(b)), which 

would also require 7 hours for each 

submission. 

FDA permits the shipment of untested 

or incompletely tested human blood or 

blood components in rare medical 

emergencies and when appropriately 

documented (§ 610.40(g)(1)). We 

estimate the recordkeeping under 

§ 610.40(g)(1) to be minimal with one or 

fewer occurrences per year. The 

reporting of test results to the consignee 

in § 610.40(g) is part of the usual and 

customary business practice of blood 

establishments. 

In the Federal Register of February 

22, 2021 (86 FR 10582), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. On our own initiative, 

however, and for efficiency of Agency 

operations, we are revising the 

information collection to include and 

consolidate related information 

collection found in Agency guidance. 

The guidance documents were issued 

consistent with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

We are revising the information 

collection to reference the Agency 

guidance document entitled ‘‘Bacterial 

Risk Control Strategies for Blood 

Collection Establishments and 

Transfusion Services to Enhance the 

Safety and Availability of Platelets for 

Transfusion’’ (December 2020), which 

provides blood collection 

establishments and transfusion services 

with recommendations to control the 

risk of bacterial contamination of room 

temperature stored platelets intended 

for transfusion. The guidance is 

available for download from our website 

at: https://www.fda.gov/media/123448/ 

download. 

The guidance recommends blood 

collection establishments notify 

transfusion services if a distributed 

platelet product is subsequently 

identified as positive for bacterial 

contamination and that blood 

establishments communicate to their 

consignees the type of storage container 

the platelets are stored in. We assume 

such notification is a usual and 

customary business practice for blood 

establishments and, therefore, estimate 

no burden estimate for the information 

collection. 

We also developed the guidance 

entitled ‘‘Labeling of Red Blood Cell 

Units with Historical Antigen Typing 

Results’’ (December 2018) to provide 

establishments that collect blood and 

blood components for transfusion with 

recommendations for labeling Red 

Blood Cell units with non-ABO/Rh(D) 

antigen typing results obtained from 

previous donations (historical antigen 

typing results). The guidance is 

available for download from our website 

at: https://www.fda.gov/media/119376/ 

download. 

The guidance recommends disclosing 

non-ABO/Rh(D) historical antigen 

typing results on a tie-tag or directly on 

the container label. We assume such 

information disclosures would be usual 

and customary for blood establishments 

and, therefore, estimate no burden for 

the information collection, currently 

approved under OMB control number 

0910–0862. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

606.170(b); 2 Donor or recipient fatality reporting ................................................. 81 1 81 20 1,620 

610.40(g)(2); Application for approval to ship ...................................................... 1 1 1 1 1 

610.41(b); Request for requalification of donor .................................................... 2,653 0.0094 25 7 175 

610.40(h)(2)(ii)(A); Application for approval for shipment or use ......................... 1 1 1 1 1 

630.35(b); Request for requalification of donor .................................................... 2,653 0.00113 3 7 21 

Total ............................................................................................................... ........................ ........................ ........................ ........................ 1,818 

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

2The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b). 


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33716 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

606.100(b); 2 Maintenance of SOPs ......................................................... 5 422 1 422 24 ............................... 10,128 

606.100(c); Records of investigations ...................................................... 5 422 10 4,220 1 ................................. 4,220 

606.110(a); 3 Documentation donor’s health permits plateletpheresis or 

leukapheresis.

6 43 1 43 0.5 (30 minutes) ........ 22 

606.151(e); Records of emergency transfusions ...................................... 5 422 12 5,064 0.08 (5 minutes) ........ 405 

606.160; 4 Records of collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components.

5 422 907.583 383,000 0.75 (45 minutes) ...... 287,250 

606.160(b)(1)(viii); HIV consignee notification .......................................... 1,789 10.4533 18,701 0.17 (10 minutes) ...... 3,179 

4,961 3.6537 18,126 0.17 (10 minutes) ...... 3,081 

606.160(b)(1)(viii); HCV consignee notification ........................................ 1,789 22.8060 40,800 0.17 (10 minutes) ...... 6,936 

4,961 8.2241 40,800 0.17 (10 minutes) ...... 6,936 

HIV recipient notification ........................................................................... 4,961 0.3538 1,755 0.17 (10 minutes) ...... 298 

HCV recipient notification .......................................................................... 4,961 0.4132 2,050 0.17 (10 minutes) ...... 349 

606.160(b)(1)(ix); Donor notification records ............................................ 3,470 757.380 2,628,109 0.05 (3 minutes) ........ 131,405 

606.160(b)(1)(xi); Physician notification records ...................................... 1,789 0.2286 409 0.05 (3 minutes) ........ 20.5 

606.165; Distribution and receipt records ................................................. 5 422 907.583 383,000 0.08 (5 minutes) ........ 30,640 

606.170(a); Adverse reaction records ...................................................... 5 422 12 5,064 1 ................................. 5,064 

610.40(g)(1); Documentation of medical emergency ............................... 3,470 1 3,470 0.5 (30 minutes) ........ 1,735 

630.15(a)(1)(ii)(B); Documentation required for dedicated donation ........ 1,789 1 1,789 1 ................................. 1,789

630.20(c); Documentation of exceptional medical need .......................... 1,789 1 1,789 1 ................................. 1,789 

Total ................................................................................................... ........................ ........................ ........................ .................................... 495,247 

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

2The recordkeeping requirements in §§ 606.171, 630.5(d), 630.10(c)(1) and (2), and 640.66, which address the maintenance of SOPs, are included in the estimate 

for § 606.100(b). 3The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in the estimate for 

§ 606.110(a). 4The recordkeeping requirements in §§ 606.110(a)(2), 630.5(b)(1)(i), 630.10(f)(2) and (4), 630.10(g)(2)(i), 630.15(a)(1)(ii)(A) and (B), 630.15(b)(2), (b)(7)(i) and (iii), 

630.20(a) and (b), 640.21(e)(4), 640.25(b)(4) and (c)(1), 640.31(b), 640.33(b), 640.51(b), 640.53(b) and (c), 640.56(b) and (d), 630.15(b)(2), 640.65(b)(2)(i), 

640.65(b)(2)(i), 640.71(b)(1), 640.72, 640.73, and 640.76(a) and (b), which address the maintenance of various records are included in the estimate for § 606.160. 5Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 3,470 = 422). 6Five percent of plateletpheresis and leukapheresis establishments (0.05 × 856 = 43). 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

606.145(c); Notification of bacterial contamination of platelets .......... 4,961 0.2822 1,400 0.02 (90 seconds) ..... 28 

606.170(a); Reports of transfusion reaction ....................................... 2 422 12 5,064 0.5 (30 minutes) ........ 2,532 

610.40(c)(1)(ii); Labeling of donation dedicated to single recipient ... 3,470 0.0395 137 0.08 (5 minutes) ........ 11 

610.40(h)(2)(ii)(C) and (D); Labeling of reactive blood and blood 

components.

15 12 180 0.2 (12 minutes) ........ 36 

610.40(h)(2)(vi); Labeling of reactive blood and blood components .. 3,470 2.1614 7,500 0.08 (5 minutes) ........ 600 

610.42(a); Warning statement for medical devices ............................ 1 1 1 1 ................................. 1 

610.46(a)(1)(ii)(B); Notification to consignees to quarantine (HIV 

‘‘lookback’’).

1,789 5.1984 9,300 0.17 (10 minutes) ...... 1,581 

610.46(a)(3); Notification to consignees of further testing ................. 1,789 5.1984 9,300 0.17 (10 minutes) ...... 1,581 

610.46(b)(3); Notification to recipients ................................................ 4,961 0.3528 1,750 1 ................................. 1,750 

610.47(a)(1)(ii)(B); Notification to consignees to quarantine (HCV 

‘‘lookback’’).

1,789 11.4030 20,400 0.17 (10 minutes) ...... 3,468 

610.47(a)(3); Notification to consignees of further testing ................. 1,789 11.4030 20,400 0.17 (10 minutes) ...... 3,468 

610.47(b)(3); Notification to recipients ................................................ 4,961 0.4132 2,050 1 ................................. 2,050 

630.40(a); Notification of donors determined not to be eligible for 

donation.

869 975.834 848,000 0.08 (5 minutes) ........ 67,840 

630.40(a); Notification of donors deferred based on reactive test results.133 6.323 841 1.5 .............................. 1,262 

630.40(d)(1); Notification to physician of autologous donor ............... 89 2.247 200 1 ................................. 200 

Total ............................................................................................. .......................... .......................... .......................... .................................... 86,408 

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

2Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 3,470 = 422). 

We have adjusted our burden estimate 

for this information collection since last 

OMB review to reflect an overall 

increase of 79,024 hours annually. We 

attribute this adjustment to an increase 

in the number of registered blood 

establishments over the last 3 years. 

Dated: June 21, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13575 Filed 6–24–21; 8:45 am] 

BILLING CODE 4164–01–P 


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