Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products, 43567-43569 [2023-14467]
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Notices
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link or call the
advisory committee information line to
learn about possible modifications
before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing and/or video
conferencing platform. The committee
will discuss dosimetry data needed to
support the initial clinical study in an
original investigational new drug (IND)
application for certain new positron
emission tomography (PET) drugs. FDA
would like to obtain the committee’s
input on the following: (1) the
sufficiency of available data from
animal or human studies involving
certain positron emitting radionuclides
(e.g., C11, F18) to allow a reasonable
calculation of radiation-absorbed dose
to the whole body and critical organs
upon administration of a new PET drug
containing certain radionuclides to a
human subject in first-in-human
studies; and (2) the reasonableness of a
proposed list of numerical radioactivity
thresholds for new PET drugs
containing these radionuclides, such
that Phase 1 studies that will both (a)
administer sub-threshold activities and
(b) obtain sufficient human data for
dosimetry calculations may be found
safe-to-proceed in the absence of
dosimetry data based on prior animal
administration of the new PET drug
under investigation.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link. The meeting will include
slide presentations with audio and
video components to allow the
presentation of materials in a manner
that most closely resembles an in-person
advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
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orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
July 25, 2023, will be provided to the
committee. Oral presentations from the
public will be scheduled between
approximately 3 p.m. and 4 p.m. Eastern
Time. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 17, 2023. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 18, 2023.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Rhea Bhatt
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
No participant will be prejudiced by
this waiver, and the ends of justice will
be served by allowing for this
modification to FDA’s advisory
committee meeting procedures.
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43567
Dated: July 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–14460 Filed 7–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1168]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by August 9,
2023.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0543. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Notices
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,
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.
In the Federal Register of April 19,
2023 (88 FR 24193), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment in response to the notice. The
comment was outside the scope of the
four collection of information topics on
which the notice solicited comments.
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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21 CFR section; reporting activities
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours 2
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)(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
0.5 (30 minutes) .....
1,187
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
................................
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.
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Notices
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 Subparts C & 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
Average
burden per
recordkeeping 2
Total annual
records
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.
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
Disclosing information as required under applicable
good manufacturing practices/CGTP provisions.
1 There
1,611
Number of
disclosures
per
respondent 2
Average
burden per
disclosure 2
Total annual
disclosures
4,984.75
8,030,435
0.30 (∼18 minutes)
Total hours
2,389,226
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded to the nearest hundredth.
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2 Decimals
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: July 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–14467 Filed 7–7–23; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
the Committee on other proposed
policies.
Health Resources and Services
Administration
DATES:
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Committee on Organ
Transplantation (ACOT or Committee).
ACOT provides advice and
recommendations to the Secretary of
HHS (Secretary) on proposed Organ
Procurement and Transplantation
Network policies and such other matters
as the Secretary determines. The
Secretary also may seek the advice of
SUMMARY:
PO 00000
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Fmt 4703
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Written nominations for
membership on the ACOT will be
received on a continuous basis.
Nomination packages must
be submitted to the Executive Secretary,
ACOT, Healthcare Systems Bureau,
HRSA, Room 08W67, 5600 Fishers
Lane, Rockville, Maryland 20857, or via
email to: ACOTHRSA@hrsa.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Shelley Grant, Executive Secretary,
ACOT, at (301) 443–8036 or email
sgrant@hrsa.gov. A copy of the ACOT
charter and list of current members may
be obtained by accessing the ACOT
website at https://www.organdonor.gov/
about-dot/acot.html.
In
accordance with the Amended Final
Rule of the Organ Procurement and
Transplantation Network (42 CFR part
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43567-43569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14467]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1168]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 9, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0543. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 43568]]
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.
In the Federal Register of April 19, 2023 (88 FR 24193), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment in response to the
notice. The comment was outside the scope of the four collection of
information topics on which the notice solicited comments.
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.
FDA estimates the burden of this collection of information as
follows:
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)(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 15 14.266 214 1........................................ 214
report 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.
[[Page 43569]]
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 Subparts C & 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 1271--human cells, tissues, and Number of disclosures Total annual
cellular and tissue-based products; activity respondents per respondent disclosures Average burden per disclosure \2\ Total hours
\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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: July 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14467 Filed 7-7-23; 8:45 am]
BILLING CODE 4164-01-P
