[Federal Register Volume 86, Number 33 (Monday, February 22, 2021)]
[Notices]
[Pages 10582-10587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03434]


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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.

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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:
    <bullet> 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.
    <bullet> 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'').

[[Page 10583]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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, 
<a href="/cdn-cgi/l/email-protection#affffdeefcdbcec9c9efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="114143504265707777517775703f7979623f767e67">[email protected]</span></a>.

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 transfusion-transmitted 
infections. For example, the ``lookback'' requirements are intended

[[Page 10584]]

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 Sec.  610.40(c)(1)(ii).
    Under Sec. 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 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 Sec. Sec.  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 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 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 
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 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), 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 Sec. Sec.  
610.46(a)(1)(ii)(B) and (a)(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 that approximately 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 that approximately 6,800 repeat donors per 
year would test reactive for antibody to HCV. Under Sec. Sec.  
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 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 estimate that approximately 4,961 
consignees would notify approximately

[[Page 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 
one-third, or 869 of the 2,606 blood collecting establishments would 
need to provide, under Sec.  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 T-
Lymphotropic 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 Sec.  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 Sec.  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 Sec.  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 
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, which in 
turn will lead to the notification of their referring physicians.
    Under Sec.  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 Sec.  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.
    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
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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).


                                                    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

[[Page 10586]]

 
606.160; \4\ Records of collection, processing,         \5\ 422         907.583         383,000  0.75 (45 minutes)......................         287,250
 compatibility testing, storage, and
 distribution of each unit of blood and blood
 components.
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                 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 for           1,789               1           1,789  1......................................           1,789
 dedicated donation.
630.20(c); Documentation of exceptional medical           1,789               1           1,789  1......................................           1,789
 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).


[[Page 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 third-party 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


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