Document ID: FDA-2013-N-0731-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice
Posted Date: 2019-12-05T05:00Z

[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66673-66678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26234]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0731]

Agency Information Collection Activities; Proposed Collection; 
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 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 information collection requirements for 
FDA regulations related to human cells, tissues, and cellular and 
tissue-based products (HCT/Ps) involving establishment registration and 
listing; eligibility determination for donors; and current good tissue 
practice (CGTP).

DATES: Submit either electronic or written comments on the collection 
of information by February 3, 2020.

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 February 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 3, 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.

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'').

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-2013-N-0731 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Human Cells, Tissues, and 
Cellular and Tissue-Based Products: Establishment Registration and 
Listing; Eligibility Determination for Donors; and Current Good Tissue 
Practice.'' 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.
     Confidential Submissions--To submit a comment with 
confidential

[[Page 66674]]

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.gpo.gov/fdsys/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.

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: 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.

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 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 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 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)) identifies the 
required initial registration and HCT/P listing information. Section 
1271.21(b), in brief, requires an annual update of the establishment 
registration. 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

[[Page 66675]]

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 (CGTP)

    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 (SOP) 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 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

[[Page 66676]]

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 = 
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.
    FDA estimates the burden of this collection of information 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).

[[Page 66677]]

 
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.

                           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

[[Page 66678]]

adjustment to an increase in the number HCT/P establishments and an 
increase in the number HCT/Ps distributed over the past few years.

    Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26234 Filed 12-4-19; 8:45 am]
 BILLING CODE 4164-01-P