Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products, 24193-24196 [2023-08277]
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Federal Register / Vol. 88, No. 75 / Wednesday, April 19, 2023 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Part 1141 and activity
Average
burden per
recordkeeping
Total annual
records
Total hours
Original Submission (Initial Plan) Records ........................
59
1.5
89
3
267
Total ............................................................................
........................
........................
........................
..........................
267
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 59 recordkeepers
will keep a total of about 89 records at
3 hours per record for a total of 267
hours. As stated previously, these
estimates are based on FDA’s experience
with information collections for other
tobacco product plans (i.e., smokeless,
OMB control number 0910–0671 and
cigars, OMB control number 0910–
0768). Based on our estimates for the
submission of one-time, initial plans
and supplements (i.e., that all
respondents will submit one-time,
initial plans and about half of
respondents will submit supplements to
FDA-approved plans), we estimate that
each recordkeeper will keep an average
of 1.5 records.
FDA concludes that the required
warnings for cigarette packages and
cigarette advertisements in § 1141.10 are
not subject to review by OMB because
they do not constitute a ‘‘collection of
information’’ under the PRA (44 U.S.C.
3501–3521). Rather, these labeling
statements are a ‘‘public disclosure’’ of
information originally supplied by the
Federal Government to the recipient for
the purpose of ‘‘disclosure to the
public’’ (5 CFR 1320.3(c)(2)).
Since our last request for OMB
approval, we have made no adjustments
to our burden estimate.
Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08280 Filed 4–18–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1168]
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Number of
records per
recordkeeper
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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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 https://
www.regulations.gov 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.
SUMMARY:
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
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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–
2023–N–1168 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Human
Cells, Tissues, and Cellular and TissueBased 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 https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
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Federal Register / Vol. 88, No. 75 / Wednesday, April 19, 2023 / Notices
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.gpoinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
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, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
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SUPPLEMENTARY INFORMATION:
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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 (§§ 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 § 1271.10. Provisions in part 1271,
subpart B (§§ 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,
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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 § 1271.22.
However, a request for waiver of the
electronic submission requirement may
be submitted pursuant to § 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 (https://
www.fda.gov/vaccines-blood-biologics/
biologics-establishment-registration/
tissue-establishment-registration)
provides access to eHCTERs,
instructions for using eHCTERs, and
other resource information that may be
helpful to respondents.
Provisions in part 1271, subpart C
(§§ 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 (§§ 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 (§§ 1271.330 through
1271.440), establish additional
requirements for establishments
described in § 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:
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Federal Register / Vol. 88, No. 75 / Wednesday, April 19, 2023 / Notices
24195
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; reporting activities
Number of
responses per
respondent
Total annual
responses
Average burden
per response
1271.10(b)(1) and 1271.21(b); register and submit list
of each HCT/P manufactured by existing establishments.
1271.10(b)(1) and (2), 1271.21(a), and 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 1271.25(c); update list.
1271.23; request electronic format waiver ....................
1271.26; location/ownership amendments ....................
1271.155(a); request exemption or alternative to any
requirement.
1271.350(a)(1) and (3); investigate and report adverse
actions.
1271.420(a); notify FDA (imports) .................................
2,374
1
2,374
157
1
157
0.75 (45 minutes)
118
566
1
566
0.5 (30 minutes) ...
283
1
346
18
1
1
1.333
1
346
24
1 ...........................
0.25 (15 minutes)
3 ...........................
1
87
72
15
14.266
214
1 ...........................
214
200
2.8
560
0.25 (15 minutes)
140
Total .......................................................................
........................
23.399
4,242
1 There
0.5 (30 minutes) ...
Total hours 2
..............................
1,187
2,102
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest whole number.
2 Rounded
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
Number of
recordkeepers
Number of
records per
recordkeeper 2
1271.47; Establishing SOPs ........................................
1271.47; Updating SOPs .............................................
1271 Subpart C & Subpart D: Establishing and 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.
157
2,374
2,531
1
1
3,311.36
157
2,374
8,381,049
48 ...........................
24 ...........................
0.26 (∼15 minutes)
7,536
56,976
2,170,493
Total ......................................................................
........................
........................
8,383,580
................................
2,235,005
21 CFR part 1271; establish and maintain records
1 There
Total annual
records
Average
burden per
recordkeeping 2
Total hours 3
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded to the nearest hundredth.
to the nearest whole number.
2 Decimals
3 Rounded
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.
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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR part 1271—human cells, tissues, and cellular
and tissue-based products; activity
Number of
respondents
Number of
disclosures
per
respondent 2
Total annual
disclosures
Disclosing information as required under applicable
good manufacturing practices/CGTP provisions.
1,611
4,984.75
8,030,435
1 There
Average
burden per
disclosure 2
0.30 (∼18 minutes)
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded to the nearest hundredth.
2 Decimals
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Total hours
2,389,226
24196
Federal Register / Vol. 88, No. 75 / Wednesday, April 19, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Tribal Self-Governance Planning
Cooperative Agreement Program
Announcement Type: New.
Funding Announcement Number:
[HHS–2023–IHS–TSGP–0001].
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.444.
Key Dates
Application Deadline Date: June 20,
2023.
Earliest Anticipated Start Date: July
18, 2023.
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I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for cooperative
agreements for the Tribal SelfGovernance Planning Cooperative
Agreement Program. This program is
authorized under the Snyder Act, 25
U.S.C. 13; the Transfer Act, 42 U.S.C.
2001(a); and Title V of the Indian SelfDetermination and Education
Assistance Act (ISDEAA), 25 U.S.C.
5383(e). The Assistance Listings section
of SAM.gov (https://same.gov/content/
home) describes this program under
93.444.
Background
The Tribal Self-Governance Program
(TSGP) is more than an IHS program; it
is an expression of the Government-to-
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Government relationship between the
United States (U.S.) and Indian Tribes.
Through the TSGP, Tribes negotiate
with the IHS to assume Programs,
Services, Functions, and Activities
(PSFAs), or portions thereof, which
gives Tribes the authority to manage and
tailor health care programs in a manner
that best fits the needs of their
communities.
Participation in the TSGP affords
Tribes the most flexibility to tailor their
health care needs by choosing one of
three ways to obtain health care from
the Federal Government for their
citizens. Specifically, Tribes can choose
to: (1) receive health care services
directly from the IHS; (2) contract with
the IHS to administer individual
programs and services the IHS would
otherwise provide (referred to as Title I
Self-Determination Contracting); and (3)
compact with the IHS to assume control
over health care programs the IHS
would otherwise provide (referred to as
Title V Self-Governance Compacting or
the TSGP). These options are not
exclusive and Tribes may choose to
combine options based on their
individual needs and circumstances.
The TSGP is a tribally-driven
initiative and strong Federal-Tribal
partnerships are essential to the
program’s success. The IHS established
the Office of Tribal Self-Governance
(OTSG) to implement the SelfGovernance authorities under the
ISDEAA. The primary OTSG functions
are to: (1) serve as the primary liaison
and advocate for Tribes participating in
the TSGP; (2) develop, direct, and
implement TSGP policies and
procedures; (3) provide information and
technical assistance to Self-Governance
Tribes; and (4) advise the IHS Director
on compliance with TSGP policies,
regulations, and guidelines. Each IHS
Area has an Agency Lead Negotiator
(ALN), designated by the IHS Director to
act on his or her behalf, who has
authority to negotiate Self-Governance
Compacts and Funding Agreements.
Tribes interested in participating in the
TSGP should contact their respective
ALN to begin the Self-Governance
planning and negotiation process.
Tribes currently participating in the
TSGP that are interested in expanding
existing or adding new PSFAs should
also contact their respective ALN to
discuss the best methods for expanding
or adding new PSFAs.
Purpose
The purpose of this Planning
Cooperative Agreement is to provide
resources to Tribes interested in
entering the TSGP and to existing SelfGovernance Tribes interested in
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Sfmt 4703
assuming new or expanded PSFAs. Title
V of the ISDEAA requires a Tribe or
Tribal organization (T/TO) to complete
a planning phase to the satisfaction of
the Tribe. The planning phase must
include legal and budgetary research
and internal Tribal government
planning and organizational preparation
relating to the administration of health
care programs. See 25 U.S.C. 5383(d).
The planning phase is critical to
negotiations and helps Tribes make
informed decisions about which PSFAs
to assume and what organizational
changes or modifications are necessary
to successfully support those PSFAs. A
thorough planning phase improves
timeliness and efficient negotiations and
ensures that the Tribe is fully prepared
to assume the transfer of IHS PSFAs to
the Tribal health program.
A Planning Cooperative Agreement is
not a prerequisite to enter the TSGP and
a Tribe may use other resources to meet
the planning requirement. Tribes that
receive Planning Cooperative
Agreements are not obligated to
participate in the TSGP and may choose
to delay or decline participation based
on the outcome of their planning
activities. This also applies to existing
Self-Governance Tribes exploring the
option to expand their current PSFAs or
assume additional PSFAs.
II. Award Information
Funding Instrument—Cooperative
Agreement
Estimated Funds Available
The total funding identified for fiscal
year (FY) 2023 is approximately
$900,000. Individual award amounts are
anticipated to be $180,000. The funding
available for competing awards issued
under this announcement is subject to
the availability of appropriations and
budgetary priorities of the Agency. The
IHS is under no obligation to make
awards that are selected for funding
under this announcement.
Anticipated Number of Awards
The IHS anticipates issuing
approximately five awards under this
program announcement.
Period of Performance
The period of performance is for 1
year.
Cooperative Agreement
Cooperative agreements awarded by
the Department of Health and Human
Services (HHS) are administered under
the same policies as grants. However,
the funding agency, IHS, is anticipated
to have substantial programmatic
involvement in the project during the
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]]>Agencies
[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Pages 24193-24196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08277]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov 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:
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-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 https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information
[[Page 24194]]
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.gpoinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: 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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 (https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration) 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; reporting activities Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
---------------------------------------------------------------------------------------------------------
Total..................................... .............. 23.399 4,242 ........................................ 2,102
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. 8,383,580 ......................................... 2,235,005
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded to the nearest hundredth.
[[Page 24196]]
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
