Document ID: FDA-2013-N-0797-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
Posted Date: 2019-09-24T04:00Z

[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50039-50041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20669]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0797]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 
requirements relating to FDA regulations for human tissue intended for 
transplantation.

DATES: Submit either electronic or written comments on the collection 
of information by November 25, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 25, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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.''

[[Page 50040]]

    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0797 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Human Tissue Intended for 
Transplantation.'' 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.
     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 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.govinfo.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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 Tissue Intended for Transplantation--21 CFR Part 1270

OMB Control Number 0910-0302--Extension

    Under section 361 of the Public Health Services Act (42 U.S.C. 
264), FDA issued regulations under part 1270 (21 CFR part 1270) to 
prevent the transmission of human immunodeficiency virus, hepatitis B, 
and hepatitis C, through the use of human tissue for transplantation. 
The regulations provide for inspection by FDA of persons and tissue 
establishments engaged in the recovery, screening, testing, processing, 
storage, or distribution of human tissue. These facilities are required 
to meet provisions intended to ensure appropriate screening and testing 
of human tissue donors and to ensure that records are kept documenting 
that the appropriate screening and testing have been completed.
    Section 1270.31(a) through (d) requires written procedures to be 
prepared and followed for the following steps: (1) All significant 
steps in the infectious disease testing process under Sec.  1270.21; 
(2) all significant steps for obtaining, reviewing, and assessing the 
relevant medical records of the donor as prescribed in Sec.  1270.21; 
(3) designating and identifying quarantined tissue; and (4) for 
prevention of infectious disease contamination or cross-contamination 
by tissue during processing. Sections 1270.31(a) and (b) also requires 
recording and justification of any deviation from the written 
procedures. Section 1270.33(a) requires records to be maintained 
concurrently with the performance of each significant step required in 
the performance of infectious disease screening and testing of human 
tissue donors. Section 1270.33(f) requires records to be retained 
regarding the determination of the suitability of the donors and of the 
records required under Sec.  1270.21. Section 1270.33(h) requires all 
records to be retained for at least 10 years beyond the date of 
transplantation if known, distribution, disposition, or expiration of 
the tissue, whichever is the latest. Section 1270.35(a) through (d) 
requires specific records to be maintained to document the following: 
(1) The results and interpretation of all required infectious disease 
tests; (2) information on the identity and relevant medical records of 
the donor; (3) the receipt and/or distribution of human tissue, and (4) 
the destruction or other disposition of human tissue.
    Respondents to this collection of information are manufacturers of 
human tissue intended for transplantation. Based on information from 
the Center for Biologics Evaluation and Research's (CBER's) database 
system, we estimate 383 tissue establishments, of which 262 are 
conventional tissue banks and 121 are eye tissue banks. Based on 
information provided by industry, we estimate a total of 2,141,960 
conventional tissue products, and 130,987 eye tissue products 
distributed per year with an average of 25 percent of the tissue 
discarded due to unsuitability for transplant. In addition, we estimate 
29,799 deceased donors of conventional tissue and 70,027 deceased 
donors of eye tissue each year.
    Accredited members of the American Association of Tissue Banks 
(AATB) and Eye Bank Association of America (EBAA) adhere to standards 
of those organizations that are comparable to the recordkeeping 
requirements in part 1270. Based on information included in

[[Page 50041]]

CBER's database system, 90 percent of the conventional tissue banks are 
members of AATB (262 x 90 percent = 236), and 95 percent of eye tissue 
banks are members of EBAA (121 x 95 percent = 115). Therefore, we 
exclude burden for recordkeeping by these 351 establishments (236 + 115 
= 351) from our estimate as we believe such recordkeeping is usual and 
customary business activity (5 CFR 1320.3(b)(2)). The recordkeeping 
burden, thus, is estimated for the remaining 32 establishments, which 
is 8.36 percent of all establishments (383 - 351 = 32, or 32/383 = 8.36 
percent).
    We assume that all current tissue establishments have developed 
written procedures in compliance with part 1270. Therefore, our 
estimated burden includes the general review and update of written 
procedures (an annual average of 24 hours), and the recording and 
justifying of any deviations from the written procedures under Sec.  
1270.31(a) and (b) (an annual average of 1 hour). The information 
collection burden for maintaining records concurrently with the 
performance of each significant screening and testing step and for 
retaining records for 10 years under Sec.  1270.33(a), (f), and (h) 
include documenting the results and interpretation of all required 
infectious disease tests and results and the identity and relevant 
medical records of the donor required under Sec.  1270.35(a) and (b). 
Therefore, the burden under these provisions is calculated together in 
table 1 of this document. The recordkeeping estimates for the number of 
total annual records and hours per record are based on information 
provided by industry and our experience with the information 
collection.
    We estimate the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
 21 CFR part 1270; human tissue      Number of      records per    Total annual         per         Total hours
  intended for  transplantation    recordkeepers   recordkeeper       records      recordkeeping
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                                        Subpart C--Procedures and Records
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1270.31(a), (b), (c), and (d)                 32               1              32              24             768
 \2\............................
1270.31(a) and 1270.31(b) \3\...              32               2              64               1              64
1270.33(a), (f), and (h), and                 32        6,198.84         198,363             1.0         198,363
 1270.35(a) and (b).............
1270.35(c)......................              32       11,876.12         380,036             1.0         380,036
1270.35(d)......................              32        1,454.50          47,504             1.0          47,504
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    Total.......................  ..............  ..............  ..............  ..............         626,735
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.

    Based on a review of the information collection since our last OMB 
approval, we have made no adjustments to our burden estimate.

    Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20669 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P