[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
                                              ----------------------------------------------------------------------------------------------------------
    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.
                                              ----------------------------------------------------------------------------------------------------------
    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