Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products

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Published

April 19, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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 associated with statutory and regulatory requirements that govern certain human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Full Text

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<title>Federal Register, Volume 88 Issue 75 (Wednesday, April 19, 2023)</title>
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[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Pages 24193-24196]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08277]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1168]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 associated with
statutory and regulatory requirements that govern certain human cells,
tissues, and cellular and tissue-based products (HCT/Ps).

DATES: Either electronic or written comments on the collection of
information must be submitted by June 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 20, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-1168 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Cells, Tissues, and
Cellular and Tissue-Based Products.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information

[[Page 24194]]

redacted/blacked out, will be available for public viewing and posted
on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.gpoinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpoinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#e3b3b1a2b097828585a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="07575546547366616147616366296f6f7429606871">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Human Cells, Tissues, and Cellular and Tissue-Based Products--21 CFR
Part 1271

OMB Control Number 0910-0543--Extension

This information collection helps support the implementation of
statutory and regulatory requirements that govern certain human cells,
tissues, and cellular and tissue-based products (HCT/Ps). Manufacturers
of HCT/Ps regulated solely under the authority of section 361 of the
Public Health Service Act (the PHS Act) (42 U.S.C. 264) are required to
register and list HCT/Ps pursuant to part 1271 (21 CFR part 1271)
whether or not the HCT/P enters into interstate commerce. Manufacturers
of HCT/Ps regulated as drugs, devices and/or biological products under
section 351 of the PHS Act (42 U.S.C. 262) and/or section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), are required to
register and list HCT/Ps following the procedures in part 207 (21 CFR
part 207) (if a drug and/or biological product) or part 807 (21 CFR
part 807) (if a device). Information collection associated with the
registration and listing requirements in parts 207 and 807 are
currently approved in OMB control numbers 0910-0045 and 0910-0625,
respectively.
Agency regulations in part 1271 set forth general provisions
applicable to HCT/Ps in subpart A (Sec. Sec. 1271.1 through 1271.20).
Those HCT/Ps that are regulated solely under the authority of section
361 of the PHS Act are described in Sec. 1271.10. Provisions in part
1271, subpart B (Sec. Sec. 1271.21 through 1271.37), establish
procedures for registration and listing including format and content
elements along with scheduled timeframes for the submission of certain
information and action by FDA. The regulations also provide for waivers
from the electronic format requirement, amendments to establishment
registration, and requesting information on registration and listing
from FDA.
Registrants use Form FDA 3356, Establishment Registration and
Listing for HCT/Ps, to submit HCT/P establishment registration and
listing information to the Electronic Human Cell and Tissue
Establishment Registration System (eHCTERs). Electronic submission of
HCT/P establishment and product listing information is required under
Sec. 1271.22. However, a request for waiver of the electronic
submission requirement may be submitted pursuant to Sec. 1271.23. If
the waiver request is granted, Form FDA 3356 (and accompanying
instructions) may be downloaded to complete and submit by mail. The
Tissue Establishment Registration page (<a href="https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration">https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration</a>) provides access to eHCTERs, instructions
for using eHCTERs, and other resource information that may be helpful
to respondents.
Provisions in part 1271, subpart C (Sec. Sec. 1271.45 through
1271.90), establish requirements for determining donor eligibility,
including donor screening and testing, explaining these requirements
are a component of current good tissue practice (CGTP) requirements set
forth in part 1271, subpart D (Sec. Sec. 1271.145 through 1271.320).
The provisions in part 1271, subparts C and D, govern the methods used
in, and the facilities and controls used for, the manufacture of HCT/
Ps, including but not limited to all steps in recovery, donor
screening, donor testing, processing, storage, labeling, packaging, and
distribution.
The regulations in part 1271, subpart E and subpart F (Sec. Sec.
1271.330 through 1271.440), establish additional requirements for
establishments described in Sec. 1271.10, including inspection and
enforcement provisions, and recordkeeping requirements providing for
the retention, notification to third parties, and disclosure of such
records to FDA.
Description of Respondents: 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 and regulations in part 1271 or perform donor
screening or testing.
We estimate the burden of the information collection as follows:

[[Page 24195]]

Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; reporting activities Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
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1271.10(b)(1) and 1271.21(b); register and 2,374 1 2,374 0.5 (30 minutes)........................ 1,187
submit list of each HCT/P manufactured by
existing establishments.
1271.10(b)(1) and (2), 1271.21(a), and 157 1 157 0.75 (45 minutes)....................... 118
1271.25(a) and (b); register and submit list
of each HCT/P manufactured by new
establishments.
1271.10(b)(2), 1271.21(c)(2)(ii), and 566 1 566 0.5 (30 minutes)........................ 283
1271.25(c); update list.
1271.23; request electronic format waiver..... 1 1 1 1....................................... 1
1271.26; location/ownership amendments........ 346 1 346 0.25 (15 minutes)....................... 87
1271.155(a); request exemption or alternative 18 1.333 24 3....................................... 72
to any requirement.
1271.350(a)(1) and (3); investigate and report 15 14.266 214 1....................................... 214
adverse actions.
1271.420(a); notify FDA (imports)............. 200 2.8 560 0.25 (15 minutes)....................... 140
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Total..................................... .............. 23.399 4,242 ........................................ 2,102
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest whole number.

Based on current data from eHCTERS, we estimate there are 2,374
HCT/P current registrants and 157 new registrants, for a total of 2,531
respondents annually. Information collection provisions that include
reporting activities are identified in table 1. The estimated burden
for each of the individual reporting activities was calculated based on
the annual number of submissions, averaged among respondents, and based
on informal communications with industry.

Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR part 1271; establish and maintain Number of records per Total annual Total hours
records recordkeepers recordkeeper records Average burden per recordkeeping \2\ \3\
\2\
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1271.47; Establishing SOPs................... 157 1 157 48....................................... 7,536
1271.47; Updating SOPs....................... 2,374 1 2,374 24....................................... 56,976
1271 Subpart C & Subpart D: Establishing and 2,531 3,311.36 8,381,049 0.26 (~15 minutes)....................... 2,170,493
maintaining records documenting methods used
in, and the facilities and controls used
for, the manufacture of HCT/Ps, including
but not limited to all steps in recovery,
donor screening, donor testing, processing,
storage, labeling, packaging, and
distribution.
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Total.................................... .............. .............. 8,383,580 ......................................... 2,235,005
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded to the nearest hundredth.
\3\ Rounded to the nearest whole number.

To calculate burden associated with the establishment and
maintenance of operating procedures in accordance with applicable CGTP
requirements, we assume twice the time is necessary for new
establishments. Burden we attribute to recordkeeping activities
associated with the remaining provisions in part 1271 is assumed to be
distributed among the individual elements and averaged among
respondents.

Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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21 CFR part 1271--human cells, tissues, and Number of
cellular and tissue-based products; Number of disclosures per Total annual Average burden per disclosure \2\ Total hours
activity respondents respondent \2\ disclosures
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Disclosing information as required under 1,611 4,984.75 8,030,435 0.30 (~18 minutes)..................... 2,389,226
applicable good manufacturing practices/
CGTP provisions.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded to the nearest hundredth.

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As part of the recordkeeping requirements, certain provisions in
part 1271 require the disclosure of information to third parties,
particularly as it pertains to the distribution of HCT/Ps. We estimate
a proportion of the respondents to the information collection (1,611)
will incur burden resulting from these disclosures and have therefore
accounted for burden that may be attributable to these distinct
activities.
Our estimated burden for the information collection reflects an
overall reduction of 150,137 hours and 347,843 responses annually,
which corresponds to a decrease in the number HCT/P establishments and
a decrease in the number HCT/Ps distributed since our last evaluation.

Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08277 Filed 4-18-23; 8:45 am]
BILLING CODE 4164-01-P

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