[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]
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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.
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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\
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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)(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
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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.
[[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\
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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 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.
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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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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\
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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.
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