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”, 10582-10587 [2021-03434]
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Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices
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:
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
10.75, Request for review of a scientific dispute ................
1 There
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
tkelley on DSKBCP9HB2PROD with NOTICES
[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’’
Food and Drug Administration,
HHS.
ACTION:
1
Total
annual
responses
4
Average
burden per
response
4
Total
hours
10
40
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.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR part; activity
Notice.
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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
SUMMARY:
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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’’).
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Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices
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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-201509-18/pdf/2015-23389.pdf.
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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.
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.
SUPPLEMENTARY INFORMATION:
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10583
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
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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
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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.
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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
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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
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
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
1
0.0094
81
1
25
20
1
7
1,620
1
175
1
2,653
1
0.00113
1
3
1
7
1
21
Total ..............................................................................
........................
........................
........................
........................
1,818
1 There
2 The
are no capital costs or operating and maintenance costs associated with this collection of information.
reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).
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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 ............
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Number of
records per
recordkeeper
5 422
Total annual
records
Average
burden per
recordkeeping
6 43
1
10
1
422
4,220
43
24 .......................
1 .........................
0.5 (30 minutes)
5 422
12
5,064
0.08 (5 minutes)
5 422
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Total hours
10,128
4,220
22
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section; activity
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 ................
Total annual
records
Average
burden per
recordkeeping
Total hours
5 422
907.583
383,000
0.75 (45 minutes)
287,250
1,789
4,961
1,789
4,961
4,961
4,961
3,470
1,789
5 422
5 422
3,470
1,789
10.4533
3.6537
22.8060
8.2241
0.3538
0.4132
757.380
0.2286
907.583
12
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
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 .........................
3,179
3,081
6,936
6,936
298
349
131,405
20.5
30,640
5,064
1,735
1,789
1,789
1
1,789
1 .........................
1,789
........................
........................
........................
............................
495,247
606.160(b)(1)(viii); HCV consignee notification ..............
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
Total .........................................................................
Number of
records per
recordkeeper
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
tkelley on DSKBCP9HB2PROD with NOTICES
21 CFR section; activity
Number of
disclosures per
respondent
Average
burden per
disclosure
Total annual
disclosures
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
0.2822
1,400
2 422
3,470
12
0.0395
15
Total .......................................................................
Total hours
5,064
137
0.02 (90 seconds).
0.5 (30 minutes)
0.08 (5 minutes)
2,532
11
12
180
0.2 (12 minutes)
36
3,470
2.1614
7,500
0.08 (5 minutes)
600
1
1,789
1
5.1984
1
9,300
1 .........................
0.17 (10 minutes)
1
1,581
1,789
5.1984
9,300
0.17 (10 minutes)
1,581
4,961
1,789
0.3528
11.4030
1,750
20,400
1 .........................
0.17 (10 minutes)
1,750
3,468
1,789
11.4030
20,400
0.17 (10 minutes)
3,468
4,961
869
0.4132
975.834
2,050
848,000
1 .........................
0.08 (5 minutes)
2,050
67,840
133
6.323
841
1.5 ......................
1,262
89
2.247
200
1 .........................
200
........................
..........................
........................
............................
86,408
1 There
28
are no capital costs or operating and maintenance costs associated with this collection of information.
percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 ×
4,961 + 3,470 = 422).
2 Five
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Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices
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
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services .
ACTION: Notice of a virtual meeting.
AGENCY:
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.
tkelley on DSKBCP9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:48 Feb 19, 2021
Jkt 253001
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.
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10587
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
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
SUMMARY:
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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'').
[[Page 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,
[email protected].
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
