[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