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”, 33713-33716 [2021-13575]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
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-201509-18/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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
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.
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:38 Jun 24, 2021
Jkt 253001
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.
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.
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.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
33713
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.
E:\FR\FM\25JNN1.SGM
25JNN1
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:38 Jun 24, 2021
Jkt 253001
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
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
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
E:\FR\FM\25JNN1.SGM
25JNN1
33715
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
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
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average
burden per
response
Total hours
606.170(b); 2 Donor or recipient fatality reporting .................................................
610.40(g)(2); Application for approval to ship ......................................................
610.41(b); Request for requalification of donor ....................................................
610.40(h)(2)(ii)(A); Application for approval for shipment or use .........................
630.35(b); Request for requalification of donor ....................................................
81
1
2,653
1
2,653
1
1
0.0094
1
0.00113
81
1
25
1
3
20
1
7
1
7
1,620
1
175
1
21
Total ...............................................................................................................
........................
........................
........................
........................
1,818
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).
VerDate Sep<11>2014
18:38 Jun 24, 2021
Jkt 253001
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
E:\FR\FM\25JNN1.SGM
25JNN1
33716
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
606.100(b); 2 Maintenance of SOPs .........................................................
606.100(c); Records of investigations ......................................................
606.110(a); 3 Documentation donor’s health permits plateletpheresis or
leukapheresis.
606.151(e); Records of emergency transfusions ......................................
606.160; 4 Records of collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components.
606.160(b)(1)(viii); HIV consignee notification ..........................................
Number of
records per
recordkeeper
5 422
Total
annual
records
Average
burden per
recordkeeping
Total hours
1
10
1
422
4,220
43
24 ...............................
1 .................................
0.5 (30 minutes) ........
10,128
4,220
22
5 422
12
907.583
5,064
383,000
0.08 (5 minutes) ........
0.75 (45 minutes) ......
405
287,250
HIV recipient notification ...........................................................................
HCV recipient notification ..........................................................................
606.160(b)(1)(ix); Donor notification records ............................................
606.160(b)(1)(xi); Physician notification records ......................................
606.165; Distribution and receipt records .................................................
606.170(a); Adverse reaction records ......................................................
610.40(g)(1); Documentation of medical emergency ...............................
630.15(a)(1)(ii)(B); Documentation required for dedicated donation ........
630.20(c); Documentation of exceptional medical need ..........................
1,789
4,961
1,789
4,961
4,961
4,961
3,470
1,789
5 422
5 422
3,470
1,789
1,789
10.4533
3.6537
22.8060
8.2241
0.3538
0.4132
757.380
0.2286
907.583
12
1
1
1
18,701
18,126
40,800
40,800
1,755
2,050
2,628,109
409
383,000
5,064
3,470
1,789
1,789
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.05 (3 minutes) ........
0.05 (3 minutes) ........
0.08 (5 minutes) ........
1 .................................
0.5 (30 minutes) ........
1 .................................
1 .................................
3,179
3,081
6,936
6,936
298
349
131,405
20.5
30,640
5,064
1,735
1,789
1,789
Total ...................................................................................................
........................
........................
........................
....................................
495,247
5 422
6 43
5 422
606.160(b)(1)(viii); HCV consignee notification ........................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The 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).
3 The 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).
4 The 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.
5 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 3,470 = 422).
6 Five percent of plateletpheresis and leukapheresis establishments (0.05 × 856 = 43).
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section; activity
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
606.145(c); Notification of bacterial contamination of platelets ..........
606.170(a); Reports of transfusion reaction .......................................
610.40(c)(1)(ii); Labeling of donation dedicated to single recipient ...
610.40(h)(2)(ii)(C) and (D); Labeling of reactive blood and blood
components.
610.40(h)(2)(vi); Labeling of reactive blood and blood components ..
610.42(a); Warning statement for medical devices ............................
610.46(a)(1)(ii)(B); Notification to consignees to quarantine (HIV
‘‘lookback’’).
610.46(a)(3); Notification to consignees of further testing .................
610.46(b)(3); Notification to recipients ................................................
610.47(a)(1)(ii)(B); Notification to consignees to quarantine (HCV
‘‘lookback’’).
610.47(a)(3); Notification to consignees of further testing .................
610.47(b)(3); Notification to recipients ................................................
630.40(a); Notification of donors determined not to be eligible for
donation.
630.40(a); Notification of donors deferred based on reactive test results.
630.40(d)(1); Notification to physician of autologous donor ...............
4,961
2 422
3,470
15
0.2822
12
0.0395
12
1,400
5,064
137
180
0.02 (90 seconds) .....
0.5 (30 minutes) ........
0.08 (5 minutes) ........
0.2 (12 minutes) ........
28
2,532
11
36
3,470
1
1,789
2.1614
1
5.1984
7,500
1
9,300
0.08 (5 minutes) ........
1 .................................
0.17 (10 minutes) ......
600
1
1,581
1,789
4,961
1,789
5.1984
0.3528
11.4030
9,300
1,750
20,400
0.17 (10 minutes) ......
1 .................................
0.17 (10 minutes) ......
1,581
1,750
3,468
1,789
4,961
869
11.4030
0.4132
975.834
20,400
2,050
848,000
0.17 (10 minutes) ......
1 .................................
0.08 (5 minutes) ........
3,468
2,050
67,840
133
6.323
841
1.5 ..............................
1,262
89
2.247
200
1 .................................
200
Total .............................................................................................
..........................
..........................
..........................
....................................
86,408
1 There
lotter on DSK11XQN23PROD with NOTICES1
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Five 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
VerDate Sep<11>2014
18:38 Jun 24, 2021
Jkt 253001
PO 00000
Frm 00084
Fmt 4703
Sfmt 9990
E:\FR\FM\25JNN1.SGM
25JNN1
]]>Agencies
[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33713-33716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13575]
-----------------------------------------------------------------------
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,
[email protected].
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 transfusion-transmitted
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.
[[Page 33714]]
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 Sec. 610.40(c)(1)(ii) (21 CFR 610.40(c)(1)(ii)).
Under Sec. 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 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 Sec. 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 Sec. 610.40(h)(2)(ii)(C) and the
other stating the exempted use specifically approved by FDA under Sec.
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 Sec.
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 Sec. 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 Sec. 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
x 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 x 3) notifications
to consignees of subsequent test results.
We estimate 4,961 consignees will be required under Sec.
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 x 3) notifications. Also, under Sec. 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 Sec. Sec. 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 x 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 x 20,400) notifications as an annual ongoing
burden. Under Sec. 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
[[Page 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 Sec. 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 T-Lymphotropic 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 Sec.
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 Sec. 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 Sec. 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 Sec.
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 Sec. 610.41 (21 CFR
610.41), which in turn will lead to the notification of their referring
physicians.
Under Sec. 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 Sec. 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 (Sec. 610.40(g)(1)). We estimate the
recordkeeping under Sec. 610.40(g)(1) to be minimal with one or fewer
occurrences per year. The reporting of test results to the consignee in
Sec. 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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
606.170(b); \2\ Donor or 81 1 81 20 1,620
recipient fatality reporting...
610.40(g)(2); Application for 1 1 1 1 1
approval to ship...............
610.41(b); Request for 2,653 0.0094 25 7 175
requalification of donor.......
610.40(h)(2)(ii)(A); Application 1 1 1 1 1
for approval for shipment or
use............................
630.35(b); Request for 2,653 0.00113 3 7 21
requalification of donor.......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,818
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The reporting requirement in Sec. 640.73, which addresses the reporting of fatal donor reactions, is
included in the estimate for Sec. 606.170(b).
[[Page 33716]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 \6\ 43 1 43 0.5 (30 minutes)........................ 22
permits plateletpheresis or leukapheresis.
606.151(e); Records of emergency transfusions. \5\ 422 12 5,064 0.08 (5 minutes)........................ 405
606.160; \4\ Records of collection, \5\ 422 907.583 383,000 0.75 (45 minutes)....................... 287,250
processing, compatibility testing, storage,
and distribution of each unit of blood and
blood components.
606.160(b)(1)(viii); HIV consignee 1,789 10.4533 18,701 0.17 (10 minutes)....................... 3,179
notification.
4,961 3.6537 18,126 0.17 (10 minutes)....................... 3,081
606.160(b)(1)(viii); HCV consignee 1,789 22.8060 40,800 0.17 (10 minutes)....................... 6,936
notification.
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 1,789 0.2286 409 0.05 (3 minutes)........................ 20.5
records.
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 3,470 1 3,470 0.5 (30 minutes)........................ 1,735
emergency.
630.15(a)(1)(ii)(B); Documentation required 1,789 1 1,789 1....................................... 1,789
for dedicated donation.
630.20(c); Documentation of exceptional 1,789 1 1,789 1....................................... 1,789
medical need.
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 495,247
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The recordkeeping requirements in Sec. Sec. 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 Sec. 606.100(b).
\3\ The recordkeeping requirements in Sec. 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in
the estimate for Sec. 606.110(a).
\4\ The recordkeeping requirements in Sec. Sec. 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 Sec. 606.160.
\5\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 +
3,470 = 422).
\6\ Five percent of plateletpheresis and leukapheresis establishments (0.05 x 856 = 43).
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.145(c); Notification of bacterial 4,961 0.2822 1,400 0.02 (90 seconds)...................... 28
contamination of platelets.
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 3,470 0.0395 137 0.08 (5 minutes)....................... 11
dedicated to single recipient.
610.40(h)(2)(ii)(C) and (D); Labeling of 15 12 180 0.2 (12 minutes)....................... 36
reactive blood and blood components.
610.40(h)(2)(vi); Labeling of reactive blood 3,470 2.1614 7,500 0.08 (5 minutes)....................... 600
and blood components.
610.42(a); Warning statement for medical 1 1 1 1...................................... 1
devices.
610.46(a)(1)(ii)(B); Notification to 1,789 5.1984 9,300 0.17 (10 minutes)...................... 1,581
consignees to quarantine (HIV ``lookback'').
610.46(a)(3); Notification to consignees of 1,789 5.1984 9,300 0.17 (10 minutes)...................... 1,581
further testing.
610.46(b)(3); Notification to recipients.... 4,961 0.3528 1,750 1...................................... 1,750
610.47(a)(1)(ii)(B); Notification to 1,789 11.4030 20,400 0.17 (10 minutes)...................... 3,468
consignees to quarantine (HCV ``lookback'').
610.47(a)(3); Notification to consignees of 1,789 11.4030 20,400 0.17 (10 minutes)...................... 3,468
further testing.
610.47(b)(3); Notification to recipients.... 4,961 0.4132 2,050 1...................................... 2,050
630.40(a); Notification of donors determined 869 975.834 848,000 0.08 (5 minutes)....................... 67,840
not to be eligible for donation.
630.40(a); Notification of donors deferred 133 6.323 841 1.5.................................... 1,262
based on reactive test results.
630.40(d)(1); Notification to physician of 89 2.247 200 1...................................... 200
autologous donor.
-----------------------------------------------------------------------------------------------------------
Total................................... ............... ............... ............... ....................................... 86,408
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 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
