10582 Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices 

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. 

Dispute Resolution Procedures for 

Science-Based Decisions on Products by 

the Center for Veterinary Medicine—21 

CFR 10.75 

OMB Control Number 0910–0566— 

Extension 

The Center for Veterinary Medicine 

(CVM) Guidance for Industry (GFI) #79, 

‘‘Dispute Resolution Procedures for 

Science-Based Decisions on Products 

Regulated by the Center for Veterinary 

Medicine’’ (https://www.fda.gov/media/ 

70279/download), describes the process 

by which CVM formally resolves 

disputes relating to scientific 

controversies. A scientific controversy 

involves issues concerning a specific 

product regulated by CVM related to 

matters of technical expertise and 

requires specialized education, training, 

or experience to be understood and 

resolved. The guidance details 

information on how CVM intends to 

apply provisions of existing regulations 

regarding internal review of Agency 

decisions. In addition, the guidance 

outlines the established procedures for 

persons who are sponsors, applicants, or 

manufacturers of animal drugs or other 

products regulated by CVM who wish to 

submit a request for review of a 

scientific dispute. When a sponsor, 

applicant, or manufacturer has a 

scientific disagreement with a written 

decision by CVM, they may submit a 

request for a review of that decision by 

following the established procedures 

discussed in the guidance. 

CVM encourages applicants to begin 

the resolution of science-based disputes 

with discussions with the review team/ 

group, including the Team Leader or 

Division Director. The Center prefers 

that differences of opinion regarding 

science or science-based policy be 

resolved between the review team/group 

and the applicant. If the matter is not 

resolved by this preferred method, then 

CVM recommends that the applicant 

follow the procedures found in GFI #79. 

In the Federal Register of August 18, 

2020 (85 FR 50827), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

10.75, Request for review of a scientific dispute ................ 1 4 4 10 40 

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

We note that the 60-day notice 

included an inadvertent error in the 

estimated burden, which has been 

corrected in table 1. Based on a review 

of the information collection since our 

last request for OMB approval, we have 

made no adjustments to our burden 

estimate. 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03431 Filed 2–19–21; 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; Proposed Collection; 

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 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 the collection of 

information requirements relating to 

FDA’s regulation of current good 

manufacturing practice (CGMP) and 

related regulations for blood and blood 

components; and requirements for 

donation testing, donor notification, and 

‘‘lookback’’. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 23, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before April 23, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 23, 2021. 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’’). 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices 10583 

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– 

2017–N–6931 for ‘‘Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donation Testing, Donor Notification, 

and ‘Lookback’.’’ 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 

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: 

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: 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. 

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— 

Extension 

This information collection supports 

Agency regulations. 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(a)), drugs 

are deemed ‘‘adulterated’’ if the 

methods used in their manufacturing, 

processing, packing, or holding do not 

conform to 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 


tkelley on DSKBCP9HB2PROD with NOTICES
10584 Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices 

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. 

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 

(CBER) 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 information received from 

CBER’s database systems, 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 FDA experience. Based on 

information from industry, we estimate 

that there are approximately 53.5 

million donations of Source Plasma 

from approximately 2.5 million donors 

and approximately 12.3 million 

donations of Whole Blood and apheresis 

Red Blood Cells including 

approximately 10,000 (approximately 

0.081 percent of 12.3 million) 

autologous donations, from 

approximately 9 million donors. 

Assuming each autologous donor makes 

an average of 1.1 donations, FDA 

estimates that there are approximately 

9,090 autologous donors (10,000 

autologous/1.1 average donations). 

FDA estimates that approximately 

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). 

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 

transfusion-transmitted 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 information from CBER’s 

database system, FDA receives less than 

one application per year from 

manufacturers of Source Leukocytes. 

However, for calculation purposes, we 

are estimating one application annually. 

According to CBER’s database system, 

there are approximately 15 licensed 

manufacturers that ship known reactive 

human blood or blood components 

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

FDA estimates that each manufacturer 

would ship an estimated 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 that 

approximately 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 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), we estimate that the 

warning statement would be necessary 

no more than once a year. 

FDA estimates that approximately 

3,100 repeat donors will test reactive on 

a screening test for HIV. We also 

estimate that an average of three 

components was made from each 

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

and (a)(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 that approximately 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 that 

approximately 6,800 repeat donors per 

year would test reactive for antibody to 

HCV. Under §§ 610.47(a)(1)(ii)(B) and 

610.47(a)(3), collecting establishments 

would notify the consignee 2 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 estimate that approximately 4,961 

consignees would notify approximately 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices 10585 

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 

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 that only approximately onethird, or 869 of the 2,606 blood 

collecting establishments would need to 

provide, under § 630.40(a), additional 

information and onsite counseling to the 

estimated 848,000 (one-third of 

approximately 2,544,000) ineligible 

donors. 

It is estimated that another 0.6 percent 

of 14,018,000 potential donors (84,108 

donors) are deferred annually based on 

test results. We estimate that 

approximately 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 

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 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 estimate that 

approximately 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. 

The recordkeeping chart reflects the 

estimate that approximately 95 percent 

of the recordkeepers, which collect 99 

percent of the blood supply, 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), we estimate 

the total annual records based on the 

approximately 2,544,000 donors 

determined not to be eligible to donate 

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, which in turn will lead to the 

notification of their referring physicians. 

Under § 610.41(b), FDA estimates that 

there would be 25 submissions for 

requalification of donors each requiring 

7 hours per submission. In addition, 

FDA estimates that there would be only 

3 notifications for requalification of 

donors under § 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. 

The average burden per response 

(hours) and average burden per 

recordkeeping (hours) are based on 

estimates received from industry or FDA 

experience with similar reporting or 

recordkeeping requirements. 

FDA estimates 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). 

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 


tkelley on DSKBCP9HB2PROD with NOTICES
10586 Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

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). 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices 10587 

The burden for this information 

collection has changed since the last 

OMB approval. FDA estimates that the 

total burden for this collection will be 

583,473 hours (1,818 reporting + 

495,247 recordkeeping + 86,408 thirdparty disclosure). Our estimated burden 

for the information collection reflects an 

overall increase of 79,024 hours. We 

attribute this adjustment to an increase 

in the number of blood establishments 

during the last 3 years. 

Dated: February 10, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03434 Filed 2–19–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on HIV/AIDS 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services . 

ACTION: Notice of a virtual meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Service is hereby giving notice that the 

Presidential Advisory Council on HIV/ 

AIDS (PACHA or the Council) will be 

holding the 70th full Council meeting 

utilizing virtual technology on March 8– 

March 9, 2021. 

DATES: The meeting will be held on 

Monday, March 8 and Tuesday, March 

9, 2021, from approximately 2:00 p.m. 

to 5:00 p.m. (ET) on both days. This 

meeting will be conducted utilizing 

virtual technology. 

ADDRESSES: Instructions on attending 

this meeting virtually will be posted one 

week prior to the meeting at: https://

www.hiv.gov/federal-response/pacha/ 

about-pacha. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Caroline Talev, MPA, Public Health 

Analyst, Presidential Advisory Council 

on HIV/AIDS, 330 C Street SW, Room 

L609A, Washington, DC 20024; (202) 

795–7622 or PACHA@hhs.gov. 

Additional information can be obtained 

by accessing the Council’s page on the 

HIV.gov site at www.hiv.gov/pacha. 

SUPPLEMENTARY INFORMATION: PACHA 

was established by Executive Order 

12963, dated June 14, 1995, as amended 

by Executive Order 13009, dated June 

14, 1996 and is currently operating 

under the authority given in Executive 

Order 13889, dated September 27, 2019. 

The Council was established to provide 

advice, information, and 

recommendations to the Secretary 

regarding programs and policies 

intended to promote effective 

prevention and care of HIV infection 

and AIDS. The functions of the Council 

are solely advisory in nature. 

The Council consists of not more than 

25 members. Council members are 

selected from prominent community 

leaders with particular expertise in, or 

knowledge of, matters concerning HIV 

and AIDS, public health, global health, 

philanthropy, marketing or business, as 

well as other national leaders held in 

high esteem from other sectors of 

society. Council members are appointed 

by the Secretary or designee, in 

consultation with the White House. The 

meeting will be open to the public; a 

public comment session will be held 

during the meeting and PACHA 

members would like to hear from you, 

specifically: 

(1) What are the most meaningful 

actions that can be taken to implement 

the HIV National Strategic Plan and 

improve implementation of the Ending 

the HIV Epidemic initiative at the 

national level and in your community to 

meet the goal of ending HIV; and 

(2) How can domestic HIV/AIDS 

programs better meet the needs of 

underserved communities and address 

the systemic barriers that communities 

face in order to achieve the goals of the 

President’s Executive Order Advancing 

Racial Equity and Support for 

Underserved Communities? The 

Executive Order can be found here: 

https://www.whitehouse.gov/briefingroom/presidential-actions/2021/01/20/ 

executive-order-advancing-racialequity-and-support-for-underservedcommunities-through-the-federalgovernment/. 

Pre-registration is required to provide 

public comment during the meeting. To 

pre-register to attend or to provide 

public comment, please send an email 

to PACHA@hhs.gov and include your 

name, organization, and title by close of 

business Monday, March 1, 2021. If you 

decide you would like to provide public 

comment but do not pre-register, you 

may submit your written statement by 

emailing PACHA@hhs.gov by close of 

business Tuesday, March 16, 2021. The 

meeting agenda will be posted on the 

PACHA page on HIV.gov at https://

www.hiv.gov/federal-response/pacha/ 

about-pacha prior to the meeting. 

Dated: February 11, 2021. 

B. Kaye Hayes, 

Executive Director, Presidential Advisory 

Council on HIV/AIDS, Office of the Assistant 

Secretary for Health, Department of Health 

and Human Services. 

[FR Doc. 2021–03524 Filed 2–19–21; 8:45 am] 

BILLING CODE 4150–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0330] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before April 23, 2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0330– 

60D, and project title for reference, to 

Sherrette Funn, the Reports Clearance 

Officer, Sherrette.funn@hhs.gov, or call 

202–795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Appellant 

Climate Survey. 

Type of Collection: Revision. 

OMB No. 0990–0330. 

Abstract: The annual OMHA 

Appellant Climate Survey is a survey of 

Medicare beneficiaries, providers, 

suppliers, or their representatives who 

participated in a hearing before an 

Administrative Law Judge (ALJ) from 

OMHA. Appellants dissatisfied with the 


tkelley on DSKBCP9HB2PROD with NOTICES