Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice, 18985-18989 [2020-06981]
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18985
Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
RegulatoryInformation/FOI/default.htm,
although if an individual requests one,
we will send it by mail or email. The
form is required only if an individual
makes an FOIA request or Privacy Act
request for records about himself and
has not provided sufficient assurances
of identity in the incoming FOIA or
Privacy Act request.
The FOIA grants the public a right to
access Federal records not normally
prepared for public distribution. The
Privacy Act grants a right of access to
members of the public who seek access
to one’s own records that are
maintained in an Agency’s system of
records (i.e., the records are retrieved by
that individual’s name or other personal
identifier). The statutes overlap, and
individuals who request their own
records are processed under both
statutes. The Agency may need to
confirm that the individual making the
FOIA or Privacy Act request is indeed
the same person named in the Agency
records. Respondents to the information
collection are asked for certain
information including name, citizenship
status, social security number, address,
date of birth, place of birth, signature,
and date of signature.
In the Federal Register of November
22, 2019 (84 FR 64539), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
stating it was important that FDA retain
the information collection to help
protect against potential identity fraud.
The comment also suggested that the
associated burden for completing and
submitting Form FDA 3975 may be
lower than estimated, but did not
provide alternative figures for us to
consider. We therefore retain our
burden estimate, which is as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA form No.
3975; Certification of Identity ...............................................
1 There
Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06996 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0731]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
50
Total annual
responses
1
50
Average
burden per
response
0.17
(10 minutes)
Total hours
8.5
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on Agency data, we have
received no more than 50 submissions
since establishing the collection in
2017.
AGENCY:
Number of
responses per
respondent
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17:45 Apr 02, 2020
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collection of information by May 4,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0543. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Human Cells, Tissues, and Cellular and
Tissue-Based Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice
OMB Control Number 0910–0543–
Extension
Under section 361 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 264), FDA may issue and enforce
regulations necessary to prevent the
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introduction, transmission, or spread of
communicable diseases between the
States or possessions or from foreign
countries into the States. As derivatives
of the human body, all human cells,
tissues, and cellular and tissue-based
products (HCT/Ps) pose some risk of
carrying pathogens that could
potentially infect recipients or handlers.
FDA has issued regulations related to
HCT/Ps involving electronic
establishment registration and listing
using an electronic system, eligibility
determination for donors, and current
good tissue practice (CGTP).
I. Electronic Establishment Registration
and Listing
The regulations in part 1271 (21 CFR
part 1271) require domestic and foreign
establishments that recover, process,
store, label, package, or distribute an
HCT/P regulated solely under section
361 of the PHS Act and described in
§ 1271.10(a) (21 CFR 1271.10(a)), or that
perform screening or testing of the cell
or tissue donor, to register electronically
with FDA (§§ 1271.1(a) (21 CFR
1271.1(a)) and 1271.10(b)(1)) and submit
a list electronically of each HCT/P
manufactured (§§ 1271.1(a) and
1271.10(b)(2)). Section 1271.21(a) (21
CFR 1271.21(a)) requires an
establishment to follow certain
procedures for initial registration and
listing of HCT/Ps, and § 1271.25(a) and
(b) (21 CFR 1271.25(a) and (b)) identify
the required initial registration and
HCT/P listing information. Section
1271.21(b), in brief, requires an annual
update of the establishment registration.
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Section 1271.21(c)(ii) requires
establishments to submit HCT/P listing
updates if a change as described in
§ 1271.25(c) has occurred. Section
1271.25(c) identifies the required HCT/
P listing update information. Section
1271.26 (21 CFR 1271.26) requires
establishments to submit an amendment
if ownership or location of the
establishment changes, or if there is a
change in the U.S. agent’s name,
address, telephone number, or email
address. FDA requires the use of an
electronic registration and listing system
entitled ‘‘eHCTERs’’ (Electronic Human
Cell and Tissue Establishment
Registration System) to submit the
required information (§§ 1271.10,
1271.21, 1271.25, and 1271.26)). Under
§ 1271.23 (21 CFR 1271.23),
manufacturers may request a waiver
from the requirements in 21 CFR
1271.22 that information must be
provided to FDA in electronic format.
II. Eligibility Determination for Donors
In brief, FDA requires certain HCT/P
establishments described in § 1271.1(b)
to determine donor eligibility based on
donor screening and testing for relevant
communicable disease agents and
diseases except as provided under 21
CFR 1271.90. The documented
determination of a donor’s eligibility is
made by a responsible person as defined
in § 1271.3(t) (21 CFR 1271.3(t)) and is
based on the results of required donor
screening, which includes a donor
medical history interview (defined in
§ 1271.3(n)), and testing (§ 1271.50(a)
(21 CFR 1271.50(a)). Certain records
must accompany an HCT/P once the
donor-eligibility determination has been
made (§ 1271.55(a) (21 CFR 1271.55(a))).
This requirement applies both to an
HCT/P from a donor who is determined
to be eligible as well as to an HCT/P
from a donor who is determined to be
ineligible or where the donor-eligibility
determination is not complete if there is
a documented urgent medical need, as
defined in § 1271.3(u) (§§ 1271.60 and
1271.65 (21 CFR 1271.60 and 1271.65)).
Once the donor-eligibility determination
has been made, the HCT/P must be
accompanied by a summary of records
used to make the donor-eligibility
determination (§ 1271.55(b)), and a
statement whether, based on the results
of the screening and testing of the
donor, the donor is determined to be
eligible or ineligible (§ 1271.55(a)(2)).
Records used in determining the
eligibility of a donor, i.e., results and
interpretations of testing for relevant
communicable disease agents, the
donor-eligibility determination, the
name and address of the testing
laboratory or laboratories, and the name
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of the responsible person (defined in
§ 1271.3(t)) who made the donoreligibility determination and the date of
the determination, must be maintained
(§ 1271.55(d)(1)). If any information on
the donor is not in English, the original
record must be maintained and
translated to English and accompanied
by a statement of authenticity by the
translator (§ 1271.55(d)(2)). HCT/P
establishments must retain the records
pertaining to a particular HCT/P at least
10 years after the date of its
administration, or, if the date of
administration is not known, then at
least 10 years after the date of the HCT/
P’s distribution, disposition, or
expiration, whichever is latest
(§ 1271.55(d)(4)).
When a product is shipped in
quarantine, as defined in § 1271.3(q),
before completion of screening and
testing, the HCT/P must be
accompanied by records identifying the
donor (e.g., by a distinct identification
code affixed to the HCT/P container)
stating that the donor-eligibility
determination has not been completed
and stating that the product must not be
implanted, transplanted, infused, or
transferred until completion of the
donor-eligibility determination, except
in cases of urgent medical need, as
defined in § 1271.3(u) (§ 1271.60(c)).
When an HCT/P is used in cases of
documented urgent medical need, the
results of any completed donor
screening and testing, and a list of any
required screening and testing that has
not yet been completed also must
accompany the HCT/P (§ 1271.60(d)(2)).
When a HCT/P is used in cases of urgent
medical need or from a donor who has
been determined to be ineligible (as
permitted under § 1271.65),
documentation by the HCT/P
establishment is required, showing that
the recipient’s physician received
notification that the testing and
screening were not complete (in cases of
urgent medical need), and upon the
completion of the donor-eligibility
determination, of the results of the
determination (§§ 1271.60(d)(3) and (4),
and 1271.65(b)(3)).
An HCT/P establishment is also
required to establish and maintain
procedures for all steps that are
performed in determining eligibility
(§ 1271.47(a) (21 CFR 1271.47(a)),
including the use of a product from a
donor of viable, leukocyte-rich cells or
tissue testing reactive for
cytomegalovirus (§ 1271.85(b)(2) (21
CFR 1271.85(b)(2))). The HCT/P
establishment must record and justify
any departure from a procedure relevant
to preventing risks of communicable
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disease transmission at the time of its
occurrence (§ 1271.47(d)).
III. Current Good Tissue Practice
FDA requires HCT/P establishments
that manufacture HCT/Ps that are
regulated solely under section 361 of the
PHS Act to follow CGTP (§ 1271.1(b)).
Section 1271.155(a) (21 CFR
1271.155(a)) permits the submission of
a request for FDA approval of an
exemption from or an alternative to any
requirement in subpart C or D of part
1271. Section 1271.290(c) (21 CFR
1271.290(c)) requires establishments to
affix a distinct identification code to
each HCT/P that they manufacture that
relates the HCT/P to the donor and to all
records pertaining to the HCT/P.
Whenever an establishment distributes
an HCT/P to a consignee, § 1271.290(f)
requires the establishment to inform the
consignee, in writing, of the product
tracking requirements and the methods
the establishment uses to fulfill these
requirements. Non-reproductive HCT/P
establishments described in § 1271.10
are required under § 1271.350(a)(1) and
(3) (21 CFR 1271.350(a)(1) and (3)) to
investigate and report to FDA adverse
reactions (defined in § 1271.3(y)) using
Form FDA–3500A (§ 1271.350(a)(2)).
Form FDA–3500A is approved under
OMB control number 0910–0291.
Section 1271.370(b) and (c) (21 CFR
1271.370(b) and (c)) requires
establishments to include specific
information either on the HCT/P label or
with the HCT/P.
The standard operating procedures
(SOPs) provisions under part 1271
include the following: (1) Section
1271.160(b)(2) (21 CFR 1271.160(b)(2))
(receiving, investigating, evaluating, and
documenting information relating to
core CGTP requirements, including
complaints, and for sharing information
with consignees and other
establishments); (2) § 1271.180(a) (21
CFR 1271.180(a)) (to meet core CGTP
requirements for all steps performed in
the manufacture of HCT/Ps); (3)
§ 1271.190(d)(1) (21 CFR 1271.190(d)(1))
(facility cleaning and sanitization); (4)
§ 1271.200(b) (21 CFR 1271.200(b))
(cleaning, sanitizing, and maintenance
of equipment); (5) § 1271.200(c)
(calibration of equipment); (6)
§ 1271.230(a) and (c) (21 CFR
1271.230(a) and (c)) (validation of a
process and review and evaluation of
changes to a validated process); (7)
§ 1271.250(a) (21 CFR 1271.250(a))
(controls for labeling HCT/Ps); (8)
§ 1271.265(e) (21 CFR 1271.265(e))
(receipt, predistribution shipment,
availability for distribution, and
packaging and shipping of HCT/Ps); (9)
§ 1271.265(f) (suitable for return to
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inventory); (10) § 1271.270(b) (21 CFR
1271.270(b)) (records management
system); (11) § 1271.290(b)(1) (21 CFR
1271.290(b)(1)) (system of HCT/P
tracking); and (12) § 1271.320(a) (21 CFR
1271.320(a)) (review, evaluation, and
documentation of complaints as defined
in § 1271.3(aa)).
Section 1271.155(f) requires an
establishment operating under the terms
of an exemption or alternative to
maintain documentation of FDA’s grant
of the exemption or approval and the
date on which it began operating under
the terms of the exemption or
alternative. Section 1271.160(b)(3)
requires the quality program of an
establishment that performs any step in
the manufacture of HCT/Ps to document
corrective actions relating to core CGTP
requirements. Section 1271.160(b)(6)
requires documentation of HCT/P
deviations. Section 1271.160(d)
requires, in brief, documentation of
validation of computer software if the
establishment relies upon it to comply
with core CGTP requirements. Section
1271.190(d)(2) requires documentation
of all cleaning and sanitation activities
performed to prevent contamination of
HCT/Ps. Section 1271.195(d) requires
documentation of environmental control
and monitoring activities. Section
1271.200(e) requires documentation of
all equipment maintenance, cleaning,
sanitizing, calibration, and other
activities. Section 1271.210(d) (21 CFR
1271.210(d)) requires, in brief,
documentation of the receipt,
verification, and use of each supply or
reagent. Section 1271.230(a) requires
documentation of validation activities
and results when the results of
processing described in 21 CFR
1271.220 cannot be fully verified by
subsequent inspection and tests. Section
1271.230(c) requires that when changes
to a validated process subject to
§ 1271.230(a) occur, documentation of
the review and evaluation of the process
and revalidation, if necessary, must
occur. Section 1271.260(d) and (e) (21
CFR 1271.260(d) and (e)) requires
documentation of any corrective action
taken when proper storage conditions
are not met and documentation of the
storage temperature for HCT/Ps. Section
1271.265(c)(1) requires documentation
that all release criteria have been met
before distribution of an HCT/P. Section
1271.265(c)(3) requires documentation
of any departure from a procedure
relevant to preventing risks of
communicable disease transmission at
the time of occurrence. Section
1271.265(e) requires documentation of
the activities in paragraphs (a) through
(d) of that section, which must include
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identification of the HCT/P and the
establishment that supplied the HCT/P,
activities performed and the results of
each activity, date(s) of activity,
quantity of HCT/P subject to the
activity, and disposition of the HCT/P.
Section 1271.270(a) requires
documentation of each step in
manufacturing required in part 1271,
subparts C and D. Section 1271.270(e)
requires documentation of the name and
address, and a list of responsibilities of
any establishment that performs a
manufacturing step for the
establishment. Section 1271.290(d) and
(e) require documentation of a method
for recording the distinct identification
code and type of each HCT/P
distributed to a consignee to enable
tracking from the consignee to the donor
and to enable tracking from the donor to
the consignee or final disposition.
Section 1271.320(b) requires an
establishment to maintain a record of
each complaint that it receives. The
complaint file must contain sufficient
information about each complaint for
proper review and evaluation of the
complaint and for determining whether
the complaint is an isolated event or
represents a trend.
Section 1271.420(a) (21 CFR
1271.420(a)) requires importers of HCT/
Ps to notify the FDA District Director
having jurisdiction over the port of
entry through which the HCT/Ps are
offered for import. The HCT/Ps must be
held intact or transported under
quarantine until they are inspected and
released by FDA.
Respondents to this information
collection are establishments that
recover, process, store, label, package, or
distribute any HCT/P that is regulated
solely under section 361 of the PHS Act
or perform donor screening or testing.
The estimates provided below are based
on most recent available information
from FDA’s database system and trade
organizations. The hours per response
and hours per record are based on data
provided by the Eastern Research
Group, or FDA experience with similar
recordkeeping or reporting
requirements.
There are an estimated 2,736 HCT/P
establishments (conventional tissue, eye
tissue, peripheral blood stem cell, stem
cell products from cord blood,
reproductive tissue, and sperm banks),
including 1,004 manufacturers of HCT/
Ps regulated under the Federal Food,
Drug, and Cosmetic Act and section 351
of the PHS Act (42 U.S.C 262), that have
registered and listed with FDA. In
addition, we estimate that 193 new
establishments have registered with
FDA (§§ 1271.10(b)(1) and (2) and
1271.25(a) and (b)). There are an
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18987
estimated 1,062 listing updates
(§§ 1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 358 location/ownership
amendments (§ 1271.26).
Under § 1271.23, FDA estimates an
average of one waiver request annually.
Under § 1271.55(a), an estimated total
of 2,594,415 HCT/Ps (which include
conventional tissues, eye tissues,
hematopoietic stem cells/progenitor
cells, and reproductive cells and
tissues), and an estimated total of
2,454,415 non-reproductive cells and
tissues (total HCT/Ps minus
reproductive cells and tissues) are
distributed per year by an estimated
1,632 establishments (2,736 ¥ 1,104 =
1,632).
Under § 1271.60(c) and (d)(2), FDA
estimates that 1,611 establishments
shipped an estimated 572,000 HCT/P
under quarantine, and that an estimated
15 establishments requested 64
exemptions from or alternative to any
requirement under part 1271, subpart C
or D, specifically under § 1271.155(a).
Under §§ 1271.290(c) and 1271.370(b)
and (c), the estimated 2,109 nonreproductive HCT/P establishments
label each of their 2,441,644 HCT/Ps
with certain information. These
establishments are also required to
inform their consignees in writing of the
requirements for tracking and of their
established tracking system under
§ 1271.290(f).
FDA estimates 13 HCT/P
establishments submitted 188 adverse
reaction reports with 162 involving a
communicable disease
(§ 1271.350(a)(1)).
FDA estimates that 193 new
establishments will create SOPs, and
that 2,736 establishments will review
and revise existing SOPs annually.
FDA estimates that 1,368 HCT/P
establishments (2,736 × 50 percent =
1,368) and 1,055 non-reproductive HCT/
P establishments (2,109 × 50 percent =
1,055) record and justify a departure
from the procedures (§§ 1271.47(d) and
1271.265(c)(3)).
Under § 1271.50(a), HCT/P
establishments are required to have a
documented medical history interview
about the donor’s medical history and
relevant social behavior as part of the
donor’s relevant medical records for
each of the estimated total of 109,019
donors (which include conventional
tissue donors, eye tissue donors,
peripheral and cord blood stem cell
donors, and reproductive cell and tissue
donors), and the estimated total of
103,419 non-reproductive cells and
tissue donors (total donors minus
reproductive cell and tissue donors).
FDA estimates that 821 HCT/P
establishments (2,736 × 30 percent =
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821) document an urgent medical need
of the product to notify the physician
using the HCT/P (§§ 1271.60(d)(3) and
1271.65(b)(3)).
FDA also estimates that 2,189 HCT/P
establishments (2,736 × 80 percent =
2,189) have to maintain records for an
average of 2 contract establishments to
perform their manufacturing process
(§ 1271.270(e) and 1,687 HCT/P
establishments (2,109 × 80 percent =
1,687) maintain an average of 5
complaint records annually
(§ 1271.320(b)).
FDA estimates that under
§ 1271.420(a), 200 establishments will
submit 560 reports of HCT/Ps offered for
imports.
In the Federal Register of December 5,
2019 (84 FR 66673), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 3
1271.10(b)(1) and 1271.21(b) 2 ............................
1271.10(b)(1) and (2), 1271.21(a), and
1271.25(a) and (b) 2.
1271.10(b)(2), 1271.21(c)(2)(ii), and 1271.25(c) 2
1271.23 ................................................................
1271.26 2 ..............................................................
1271.155(a) ..........................................................
1271.350(a)(1) and (3) .........................................
1271.420(a) ..........................................................
2,736
193
1
1
2,736
193
0.5 (30 minutes) ............
0.75 (45 minutes) ..........
1,368
145
1,062
1
358
15
13
200
1
1
1
4.27
14.46
2.8
1,062
1
358
64
188
560
0.5 (30 minutes) ............
1 ....................................
0.25 (15 minutes) ..........
3 ....................................
1 ....................................
0.25 (15 minutes) ..........
531
1
90
192
188
140
Total ..............................................................
........................
........................
........................
.......................................
2,655
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
eHCTERS.
3 Rounded to the nearest whole number.
2 Using
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
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21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours 3
New SOPs 2 ..........................................................
SOP Update 2 .......................................................
1271.47(d) ............................................................
1271.50(a) ............................................................
1271.55(d)(1) ........................................................
1271.55(d)(2) ........................................................
1271.55(d)(4) ........................................................
1271.60(d)(3) and (4); 1271.65(b)(3)(iii) ..............
1271.155(f) ...........................................................
1271.160(b)(3) and (6) .........................................
1271.160(d) ..........................................................
1271.190(d)(2) ......................................................
1271.195(d) ..........................................................
1271.200(e) ..........................................................
1271.210(d) ..........................................................
1271.230(a) ..........................................................
1271.230(c) ...........................................................
1271.260(d) ..........................................................
1271.260(e) ..........................................................
1271.265(c)(1) ......................................................
1271.265(c)(3) ......................................................
1271.265(e) ..........................................................
1271.270(a) ..........................................................
1271.270(e) ..........................................................
1271.290(d) and (e) ..............................................
1271.320(b) ..........................................................
193
2,736
1,368
2,736
2,736
2,736
2,736
821
15
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
1,055
2,109
2,109
2,189
2,109
1,687
1
1
1
39.846
39.846
1
1
1
4.27
12
12
12
12
12
12
12
1
12
365
1,163.781
1
1,163.781
1,163.781
2
49.037
5
193
2,736
1,368
109,019
109,019
2,736
2,736
821
64
25,308
25,308
25,308
25,308
25,308
25,308
25,308
2,109
25,308
769,785
2,454,415
1,055
2,454,415
2,454,415
4,378
103,419
8,435
48 ..................................
24 ..................................
1 ....................................
5 ....................................
1 ....................................
1 ....................................
120 ................................
2 ....................................
0.25 (15 minutes) .........
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
0.25 (15 minutes) .........
0.083 (5 minutes) .........
0.083 (5 minutes) .........
1 ....................................
0.083 (5 minutes) .........
0.25 (15 minutes) .........
0.5 (30 minutes) ...........
0.25 (15 minutes) .........
1 ....................................
9,264
65,664
1,368
545,095
109,019
2,736
328,320
1,642
16
25,308
25,308
25,308
25,308
25,308
25,308
25,308
2,109
6,327
63,892
203,716
1,055
203,716
613,604
2,189
25,855
8,435
Total ...............................................................
........................
........................
........................
.......................................
2,371,178
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a),
1271.250(a), and 1271.265(e).
3 Rounded to the nearest whole number.
2 Sections
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
18989
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
Number of
disclosures per
respondent
Number of
respondents
Total annual
disclosures
Average burden per
disclosure
Total hours
1271.55(a) ..........................................................
1271.60(c) and (d)(2) .........................................
1271.290(c) ........................................................
1271.290(f) .........................................................
1271.370(b) and (c) ...........................................
1,632
1,611
2,109
2,109
2,109
1,589.715
355.06
1,163.781
1
1,163.781
2,594,415
572,000
2,454,415
2,109
2,454,415
0.5 (30 minutes) ..........
0.5 (30 minutes) ..........
0.083 (5 minutes) ........
1 ...................................
0.25 (15 minutes) ........
1,297,208
286,000
203,716
2,109
613,604
Total ............................................................
........................
............................
........................
......................................
2,402,637
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest whole number.
2 Rounded
Our estimated burden for the
information collection reflects an
overall increase of 628,585 hours (111
reporting burden hours; 305,118
recordkeeping hours; and 323,356
disclosure burden hours) and a
corresponding increase of annual
responses, annual records, and annual
disclosures. We attribute this
adjustment to an increase in the number
of HCT/P establishments and an
increase in the number of HCT/Ps
distributed over the past few years.
Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06981 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2014–N–0487]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 for the ‘‘Generic Clearance
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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for the Collection of Qualitative
Feedback on Agency Service Delivery.’’
DATES: Submit either electronic or
written comments on the collection of
information by June 2, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
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The https://www.regulations.gov
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comments until 11:59 p.m. Eastern Time
at the end of June 2, 2020. 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.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
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including attachments, to https://
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comment will be made public, you are
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Submit written/paper submissions as
follows:
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• For written/paper comments
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Instructions: All submissions received
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ADDRESSES), will be placed in the docket
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]]>Agencies
[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18985-18989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06981]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0731]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Cells, Tissues,
and Cellular and Tissue-Based Products: Establishment Registration and
Listing; Eligibility Determination for Donors; and Current Good Tissue
Practice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by May 4, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0543. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Eligibility Determination for
Donors; and Current Good Tissue Practice
OMB Control Number 0910-0543[n x dash]Extension
Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign countries
into the States. As derivatives of the human body, all human cells,
tissues, and cellular and tissue-based products (HCT/Ps) pose some risk
of carrying pathogens that could potentially infect recipients or
handlers. FDA has issued regulations related to HCT/Ps involving
electronic establishment registration and listing using an electronic
system, eligibility determination for donors, and current good tissue
practice (CGTP).
I. Electronic Establishment Registration and Listing
The regulations in part 1271 (21 CFR part 1271) require domestic
and foreign establishments that recover, process, store, label,
package, or distribute an HCT/P regulated solely under section 361 of
the PHS Act and described in Sec. 1271.10(a) (21 CFR 1271.10(a)), or
that perform screening or testing of the cell or tissue donor, to
register electronically with FDA (Sec. Sec. 1271.1(a) (21 CFR
1271.1(a)) and 1271.10(b)(1)) and submit a list electronically of each
HCT/P manufactured (Sec. Sec. 1271.1(a) and 1271.10(b)(2)). Section
1271.21(a) (21 CFR 1271.21(a)) requires an establishment to follow
certain procedures for initial registration and listing of HCT/Ps, and
Sec. 1271.25(a) and (b) (21 CFR 1271.25(a) and (b)) identify the
required initial registration and HCT/P listing information. Section
1271.21(b), in brief, requires an annual update of the establishment
registration.
[[Page 18986]]
Section 1271.21(c)(ii) requires establishments to submit HCT/P listing
updates if a change as described in Sec. 1271.25(c) has occurred.
Section 1271.25(c) identifies the required HCT/P listing update
information. Section 1271.26 (21 CFR 1271.26) requires establishments
to submit an amendment if ownership or location of the establishment
changes, or if there is a change in the U.S. agent's name, address,
telephone number, or email address. FDA requires the use of an
electronic registration and listing system entitled ``eHCTERs''
(Electronic Human Cell and Tissue Establishment Registration System) to
submit the required information (Sec. Sec. 1271.10, 1271.21, 1271.25,
and 1271.26)). Under Sec. 1271.23 (21 CFR 1271.23), manufacturers may
request a waiver from the requirements in 21 CFR 1271.22 that
information must be provided to FDA in electronic format.
II. Eligibility Determination for Donors
In brief, FDA requires certain HCT/P establishments described in
Sec. 1271.1(b) to determine donor eligibility based on donor screening
and testing for relevant communicable disease agents and diseases
except as provided under 21 CFR 1271.90. The documented determination
of a donor's eligibility is made by a responsible person as defined in
Sec. 1271.3(t) (21 CFR 1271.3(t)) and is based on the results of
required donor screening, which includes a donor medical history
interview (defined in Sec. 1271.3(n)), and testing (Sec. 1271.50(a)
(21 CFR 1271.50(a)). Certain records must accompany an HCT/P once the
donor-eligibility determination has been made (Sec. 1271.55(a) (21 CFR
1271.55(a))). This requirement applies both to an HCT/P from a donor
who is determined to be eligible as well as to an HCT/P from a donor
who is determined to be ineligible or where the donor-eligibility
determination is not complete if there is a documented urgent medical
need, as defined in Sec. 1271.3(u) (Sec. Sec. 1271.60 and 1271.65 (21
CFR 1271.60 and 1271.65)). Once the donor-eligibility determination has
been made, the HCT/P must be accompanied by a summary of records used
to make the donor-eligibility determination (Sec. 1271.55(b)), and a
statement whether, based on the results of the screening and testing of
the donor, the donor is determined to be eligible or ineligible (Sec.
1271.55(a)(2)). Records used in determining the eligibility of a donor,
i.e., results and interpretations of testing for relevant communicable
disease agents, the donor-eligibility determination, the name and
address of the testing laboratory or laboratories, and the name of the
responsible person (defined in Sec. 1271.3(t)) who made the donor-
eligibility determination and the date of the determination, must be
maintained (Sec. 1271.55(d)(1)). If any information on the donor is
not in English, the original record must be maintained and translated
to English and accompanied by a statement of authenticity by the
translator (Sec. 1271.55(d)(2)). HCT/P establishments must retain the
records pertaining to a particular HCT/P at least 10 years after the
date of its administration, or, if the date of administration is not
known, then at least 10 years after the date of the HCT/P's
distribution, disposition, or expiration, whichever is latest (Sec.
1271.55(d)(4)).
When a product is shipped in quarantine, as defined in Sec.
1271.3(q), before completion of screening and testing, the HCT/P must
be accompanied by records identifying the donor (e.g., by a distinct
identification code affixed to the HCT/P container) stating that the
donor-eligibility determination has not been completed and stating that
the product must not be implanted, transplanted, infused, or
transferred until completion of the donor-eligibility determination,
except in cases of urgent medical need, as defined in Sec. 1271.3(u)
(Sec. 1271.60(c)). When an HCT/P is used in cases of documented urgent
medical need, the results of any completed donor screening and testing,
and a list of any required screening and testing that has not yet been
completed also must accompany the HCT/P (Sec. 1271.60(d)(2)). When a
HCT/P is used in cases of urgent medical need or from a donor who has
been determined to be ineligible (as permitted under Sec. 1271.65),
documentation by the HCT/P establishment is required, showing that the
recipient's physician received notification that the testing and
screening were not complete (in cases of urgent medical need), and upon
the completion of the donor-eligibility determination, of the results
of the determination (Sec. Sec. 1271.60(d)(3) and (4), and
1271.65(b)(3)).
An HCT/P establishment is also required to establish and maintain
procedures for all steps that are performed in determining eligibility
(Sec. 1271.47(a) (21 CFR 1271.47(a)), including the use of a product
from a donor of viable, leukocyte-rich cells or tissue testing reactive
for cytomegalovirus (Sec. 1271.85(b)(2) (21 CFR 1271.85(b)(2))). The
HCT/P establishment must record and justify any departure from a
procedure relevant to preventing risks of communicable disease
transmission at the time of its occurrence (Sec. 1271.47(d)).
III. Current Good Tissue Practice
FDA requires HCT/P establishments that manufacture HCT/Ps that are
regulated solely under section 361 of the PHS Act to follow CGTP (Sec.
1271.1(b)). Section 1271.155(a) (21 CFR 1271.155(a)) permits the
submission of a request for FDA approval of an exemption from or an
alternative to any requirement in subpart C or D of part 1271. Section
1271.290(c) (21 CFR 1271.290(c)) requires establishments to affix a
distinct identification code to each HCT/P that they manufacture that
relates the HCT/P to the donor and to all records pertaining to the
HCT/P. Whenever an establishment distributes an HCT/P to a consignee,
Sec. 1271.290(f) requires the establishment to inform the consignee,
in writing, of the product tracking requirements and the methods the
establishment uses to fulfill these requirements. Non-reproductive HCT/
P establishments described in Sec. 1271.10 are required under Sec.
1271.350(a)(1) and (3) (21 CFR 1271.350(a)(1) and (3)) to investigate
and report to FDA adverse reactions (defined in Sec. 1271.3(y)) using
Form FDA-3500A (Sec. 1271.350(a)(2)). Form FDA-3500A is approved under
OMB control number 0910-0291. Section 1271.370(b) and (c) (21 CFR
1271.370(b) and (c)) requires establishments to include specific
information either on the HCT/P label or with the HCT/P.
The standard operating procedures (SOPs) provisions under part 1271
include the following: (1) Section 1271.160(b)(2) (21 CFR
1271.160(b)(2)) (receiving, investigating, evaluating, and documenting
information relating to core CGTP requirements, including complaints,
and for sharing information with consignees and other establishments);
(2) Sec. 1271.180(a) (21 CFR 1271.180(a)) (to meet core CGTP
requirements for all steps performed in the manufacture of HCT/Ps); (3)
Sec. 1271.190(d)(1) (21 CFR 1271.190(d)(1)) (facility cleaning and
sanitization); (4) Sec. 1271.200(b) (21 CFR 1271.200(b)) (cleaning,
sanitizing, and maintenance of equipment); (5) Sec. 1271.200(c)
(calibration of equipment); (6) Sec. 1271.230(a) and (c) (21 CFR
1271.230(a) and (c)) (validation of a process and review and evaluation
of changes to a validated process); (7) Sec. 1271.250(a) (21 CFR
1271.250(a)) (controls for labeling HCT/Ps); (8) Sec. 1271.265(e) (21
CFR 1271.265(e)) (receipt, predistribution shipment, availability for
distribution, and packaging and shipping of HCT/Ps); (9) Sec.
1271.265(f) (suitable for return to
[[Page 18987]]
inventory); (10) Sec. 1271.270(b) (21 CFR 1271.270(b)) (records
management system); (11) Sec. 1271.290(b)(1) (21 CFR 1271.290(b)(1))
(system of HCT/P tracking); and (12) Sec. 1271.320(a) (21 CFR
1271.320(a)) (review, evaluation, and documentation of complaints as
defined in Sec. 1271.3(aa)).
Section 1271.155(f) requires an establishment operating under the
terms of an exemption or alternative to maintain documentation of FDA's
grant of the exemption or approval and the date on which it began
operating under the terms of the exemption or alternative. Section
1271.160(b)(3) requires the quality program of an establishment that
performs any step in the manufacture of HCT/Ps to document corrective
actions relating to core CGTP requirements. Section 1271.160(b)(6)
requires documentation of HCT/P deviations. Section 1271.160(d)
requires, in brief, documentation of validation of computer software if
the establishment relies upon it to comply with core CGTP requirements.
Section 1271.190(d)(2) requires documentation of all cleaning and
sanitation activities performed to prevent contamination of HCT/Ps.
Section 1271.195(d) requires documentation of environmental control and
monitoring activities. Section 1271.200(e) requires documentation of
all equipment maintenance, cleaning, sanitizing, calibration, and other
activities. Section 1271.210(d) (21 CFR 1271.210(d)) requires, in
brief, documentation of the receipt, verification, and use of each
supply or reagent. Section 1271.230(a) requires documentation of
validation activities and results when the results of processing
described in 21 CFR 1271.220 cannot be fully verified by subsequent
inspection and tests. Section 1271.230(c) requires that when changes to
a validated process subject to Sec. 1271.230(a) occur, documentation
of the review and evaluation of the process and revalidation, if
necessary, must occur. Section 1271.260(d) and (e) (21 CFR 1271.260(d)
and (e)) requires documentation of any corrective action taken when
proper storage conditions are not met and documentation of the storage
temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation
that all release criteria have been met before distribution of an HCT/
P. Section 1271.265(c)(3) requires documentation of any departure from
a procedure relevant to preventing risks of communicable disease
transmission at the time of occurrence. Section 1271.265(e) requires
documentation of the activities in paragraphs (a) through (d) of that
section, which must include identification of the HCT/P and the
establishment that supplied the HCT/P, activities performed and the
results of each activity, date(s) of activity, quantity of HCT/P
subject to the activity, and disposition of the HCT/P. Section
1271.270(a) requires documentation of each step in manufacturing
required in part 1271, subparts C and D. Section 1271.270(e) requires
documentation of the name and address, and a list of responsibilities
of any establishment that performs a manufacturing step for the
establishment. Section 1271.290(d) and (e) require documentation of a
method for recording the distinct identification code and type of each
HCT/P distributed to a consignee to enable tracking from the consignee
to the donor and to enable tracking from the donor to the consignee or
final disposition. Section 1271.320(b) requires an establishment to
maintain a record of each complaint that it receives. The complaint
file must contain sufficient information about each complaint for
proper review and evaluation of the complaint and for determining
whether the complaint is an isolated event or represents a trend.
Section 1271.420(a) (21 CFR 1271.420(a)) requires importers of HCT/
Ps to notify the FDA District Director having jurisdiction over the
port of entry through which the HCT/Ps are offered for import. The HCT/
Ps must be held intact or transported under quarantine until they are
inspected and released by FDA.
Respondents to this information collection are establishments that
recover, process, store, label, package, or distribute any HCT/P that
is regulated solely under section 361 of the PHS Act or perform donor
screening or testing. The estimates provided below are based on most
recent available information from FDA's database system and trade
organizations. The hours per response and hours per record are based on
data provided by the Eastern Research Group, or FDA experience with
similar recordkeeping or reporting requirements.
There are an estimated 2,736 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 1,004
manufacturers of HCT/Ps regulated under the Federal Food, Drug, and
Cosmetic Act and section 351 of the PHS Act (42 U.S.C 262), that have
registered and listed with FDA. In addition, we estimate that 193 new
establishments have registered with FDA (Sec. Sec. 1271.10(b)(1) and
(2) and 1271.25(a) and (b)). There are an estimated 1,062 listing
updates (Sec. Sec. 1271.10(b)(2), 1271.21(c)(ii), and 1271.25(c)) and
358 location/ownership amendments (Sec. 1271.26).
Under Sec. 1271.23, FDA estimates an average of one waiver request
annually.
Under Sec. 1271.55(a), an estimated total of 2,594,415 HCT/Ps
(which include conventional tissues, eye tissues, hematopoietic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,454,415 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,632 establishments (2,736 - 1,104 = 1,632).
Under Sec. 1271.60(c) and (d)(2), FDA estimates that 1,611
establishments shipped an estimated 572,000 HCT/P under quarantine, and
that an estimated 15 establishments requested 64 exemptions from or
alternative to any requirement under part 1271, subpart C or D,
specifically under Sec. 1271.155(a).
Under Sec. Sec. 1271.290(c) and 1271.370(b) and (c), the estimated
2,109 non-reproductive HCT/P establishments label each of their
2,441,644 HCT/Ps with certain information. These establishments are
also required to inform their consignees in writing of the requirements
for tracking and of their established tracking system under Sec.
1271.290(f).
FDA estimates 13 HCT/P establishments submitted 188 adverse
reaction reports with 162 involving a communicable disease (Sec.
1271.350(a)(1)).
FDA estimates that 193 new establishments will create SOPs, and
that 2,736 establishments will review and revise existing SOPs
annually.
FDA estimates that 1,368 HCT/P establishments (2,736 x 50 percent =
1,368) and 1,055 non-reproductive HCT/P establishments (2,109 x 50
percent = 1,055) record and justify a departure from the procedures
(Sec. Sec. 1271.47(d) and 1271.265(c)(3)).
Under Sec. 1271.50(a), HCT/P establishments are required to have a
documented medical history interview about the donor's medical history
and relevant social behavior as part of the donor's relevant medical
records for each of the estimated total of 109,019 donors (which
include conventional tissue donors, eye tissue donors, peripheral and
cord blood stem cell donors, and reproductive cell and tissue donors),
and the estimated total of 103,419 non-reproductive cells and tissue
donors (total donors minus reproductive cell and tissue donors).
FDA estimates that 821 HCT/P establishments (2,736 x 30 percent =
[[Page 18988]]
821) document an urgent medical need of the product to notify the
physician using the HCT/P (Sec. Sec. 1271.60(d)(3) and 1271.65(b)(3)).
FDA also estimates that 2,189 HCT/P establishments (2,736 x 80
percent = 2,189) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e) and 1,687 HCT/P establishments (2,109 x 80 percent = 1,687)
maintain an average of 5 complaint records annually (Sec.
1271.320(b)).
FDA estimates that under Sec. 1271.420(a), 200 establishments will
submit 560 reports of HCT/Ps offered for imports.
In the Federal Register of December 5, 2019 (84 FR 66673), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human cells, Number of
tissues, and cellular and Number of responses per Total annual Average burden Total hours
tissue-based products respondents respondent responses per response \3\
----------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b) 2,736 1 2,736 0.5 (30 minutes) 1,368
\2\.
1271.10(b)(1) and (2), 193 1 193 0.75 (45 145
1271.21(a), and 1271.25(a) minutes).
and (b) \2\.
1271.10(b)(2), 1,062 1 1,062 0.5 (30 minutes) 531
1271.21(c)(2)(ii), and
1271.25(c) \2\.
1271.23....................... 1 1 1 1............... 1
1271.26 \2\................... 358 1 358 0.25 (15 90
minutes).
1271.155(a)................... 15 4.27 64 3............... 192
1271.350(a)(1) and (3)........ 13 14.46 188 1............... 188
1271.420(a)................... 200 2.8 560 0.25 (15 140
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 2,655
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Using eHCTERS.
\3\ Rounded to the nearest whole number.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human cells, Number of Average burden
tissues, and cellular and Number of records per Total annual per Total hours
tissue-based products recordkeepers recordkeeper records recordkeeping \3\
----------------------------------------------------------------------------------------------------------------
New SOPs \2\.................. 193 1 193 48.............. 9,264
SOP Update \2\................ 2,736 1 2,736 24.............. 65,664
1271.47(d).................... 1,368 1 1,368 1............... 1,368
1271.50(a).................... 2,736 39.846 109,019 5............... 545,095
1271.55(d)(1)................. 2,736 39.846 109,019 1............... 109,019
1271.55(d)(2)................. 2,736 1 2,736 1............... 2,736
1271.55(d)(4)................. 2,736 1 2,736 120............. 328,320
1271.60(d)(3) and (4); 821 1 821 2............... 1,642
1271.65(b)(3)(iii).
1271.155(f)................... 15 4.27 64 0.25 (15 16
minutes).
1271.160(b)(3) and (6)........ 2,109 12 25,308 1............... 25,308
1271.160(d)................... 2,109 12 25,308 1............... 25,308
1271.190(d)(2)................ 2,109 12 25,308 1............... 25,308
1271.195(d)................... 2,109 12 25,308 1............... 25,308
1271.200(e)................... 2,109 12 25,308 1............... 25,308
1271.210(d)................... 2,109 12 25,308 1............... 25,308
1271.230(a)................... 2,109 12 25,308 1............... 25,308
1271.230(c)................... 2,109 1 2,109 1............... 2,109
1271.260(d)................... 2,109 12 25,308 0.25 (15 6,327
minutes).
1271.260(e)................... 2,109 365 769,785 0.083 (5 63,892
minutes).
1271.265(c)(1)................ 2,109 1,163.781 2,454,415 0.083 (5 203,716
minutes).
1271.265(c)(3)................ 1,055 1 1,055 1............... 1,055
1271.265(e)................... 2,109 1,163.781 2,454,415 0.083 (5 203,716
minutes).
1271.270(a)................... 2,109 1,163.781 2,454,415 0.25 (15 613,604
minutes).
1271.270(e)................... 2,189 2 4,378 0.5 (30 minutes) 2,189
1271.290(d) and (e)........... 2,109 49.037 103,419 0.25 (15 25,855
minutes).
1271.320(b)................... 1,687 5 8,435 1............... 8,435
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 2,371,178
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b),
1271.200(c), 1271.230(a), 1271.250(a), and 1271.265(e).
\3\ Rounded to the nearest whole number.
[[Page 18989]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human Number of
cells, tissues, and cellular Number of disclosures per Total annual Average burden Total hours
and tissue-based products respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
1271.55(a)................... 1,632 1,589.715 2,594,415 0.5 (30 1,297,208
minutes).
1271.60(c) and (d)(2)........ 1,611 355.06 572,000 0.5 (30 286,000
minutes).
1271.290(c).................. 2,109 1,163.781 2,454,415 0.083 (5 203,716
minutes).
1271.290(f).................. 2,109 1 2,109 1.............. 2,109
1271.370(b) and (c).......... 2,109 1,163.781 2,454,415 0.25 (15 613,604
minutes).
----------------------------------------------------------------------------------
Total.................... .............. ................ .............. ............... 2,402,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Rounded to the nearest whole number.
Our estimated burden for the information collection reflects an
overall increase of 628,585 hours (111 reporting burden hours; 305,118
recordkeeping hours; and 323,356 disclosure burden hours) and a
corresponding increase of annual responses, annual records, and annual
disclosures. We attribute this adjustment to an increase in the number
of HCT/P establishments and an increase in the number of HCT/Ps
distributed over the past few years.
Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06981 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P
