0302 Human tissue transplantation SSA 2020 EXT

United States Food and Drug Administration (FDA)
Human Tissue Intended for Transplantation
OMB Control No. 0910-0302
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
Under section 361 of the Public Health Services (PHS) Act (42 U.S.C. 264), FDA issued
regulations under part 1270 (21 CFR 1270) to prevent the transmission of human
immunodeficiency virus (HIV), hepatitis B and hepatitis C, and other organisms causing
infectious disease through the use of human tissue intended 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 ensure that records are kept documenting that the appropriate screening and testing
have been completed.
Accordingly, FDA requests an extension of OMB approval of the recordkeeping provisions found
in 21 CFR Part 1270 as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
These information collection requirements help prevent the transmission of communicable
diseases through human tissue transplantation by requiring that written Standard Operating
Procedures (SOPs) be prepared and followed that include: (1) infectious disease testing under
§1270.21; (2) determining the medical history of the donor; (3) designating and identifying
quarantined tissue; and (4) preventing infectious disease contamination or cross-contamination of
tissue during processing. The regulations require maintenance of records of all significant steps in
the infectious disease testing, and screening, and require that these records be made available for
FDA inspection. Adequate donor screening and testing must be recorded so that the suitability of
the tissue can be determined. If FDA is unable to ascertain how the tissue donor was screened or
tested, or if the tissue was distributed in violation of the regulations, then recall, retention, and/or
destruction orders may be issued by FDA in accordance with codified administrative procedures.
Without this information collection, FDA could not monitor the suitability of human tissue for
transplantation and could not fulfill its statutory responsibility to ensure that communicable
diseases are not spread into or throughout the United States and its Possessions.
3. Use of Improved Information Technology and Burden Reduction
Establishments may maintain records electronically or as original paper records, or as true copies
such as photocopies, microfiche, or microfilm. Electronic recordkeeping is specifically referred to
in the regulations under § 1270.33(g). Section 1270.33(f) considers that the retrieval of records
from another location by electronic means meets the requirements of the regulation.
FDA is not aware of any other improved technology to reduce the burden.

4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
This collection of information applies to small as well as large establishments, however it does not
impose undue burden on small entities. Although FDA must apply the statutory and regulatory
requirements equally to all enterprises, FDA does provide special help to small businesses. The
Center for Biologics Evaluation and Research’s (CBER), Office of Communication, Outreach and
Development, Division of Manufacturer’s Assistance and Training provides assistance to small
businesses.
6. Consequences of Collecting the Information Less Frequently
The information collection is consistent with statutory and regulatory requirements. Information
collection requires records for each tissue, at the time it is recovered, screened, tested, processed,
stored or distributed, and is used to determine the suitability of the human tissue for
transplantation and for its final distribution or disposition. The information provided to FDA
inspectors is the information necessary to fulfill FDA’s statutory responsibility to prevent the
spread of communicable diseases. Less frequent collection of information would not ensure the
safety of the tissue supply in this country or enable FDA to fulfill these duties. There are no
technical or legal obstacles to reducing the burden.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for the collection of information requirements.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of September 24, 2019 (84 FR 50039). Two comments were received but were
not responsive to the four information collection topics solicited and were therefore not discussed
in our 30-day notice of January 9, 2020 (85 FR 1167), and are not addressed in this supporting
statement.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments, or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
This information collection request (ICR) collects personally identifiable information (PII) or
other data of a personal nature. Under part 1270, tissue establishments must determine donor
suitability based on the results of donor screening and testing. According to §1270.21(f), donor
suitability determination by the responsible person that a donor of human tissue intended for
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transplantation is suitable shall include ascertainment of the donor's identity, and accurately
recorded relevant medical records (as defined in §1270.3(t)) which documents freedom from risk
factors for and clinical evidence of hepatitis B, hepatitis C, and HIV infection. The establishments
must also retain the donor screening and testing records, which were used for donor suitability
determination, and make those records available for authorized inspection or upon request by FDA
(§1270.33(f)). If records related to screening, testing, and suitability of tissue donors are
submitted to the FDA, the establishment redacts donor and/or patient identifying information
In consultation with our Privacy Office, we determined that although PII is collected, the
information collection is not subject to the Privacy Act of 1974 and the particular notice and other
requirements of the Act do not apply. Specifically, FDA does not use name or any other personal
identifier to routinely retrieve records from the information collected. FDA also minimizes the PII
collected to protect the privacy of the individuals. The confidentiality of information received by
FDA is consistent with the Freedom of Information Act (FOIA) and regulations pertaining to
“Public Information” under 21 CFR part 20. Inspectors may copy records as part of an inspection
of a tissue establishment. This information is for internal use and may be subject to, in whole or in
part, the FOIA and applicable FDA regulations.
11. Justification for Sensitive Questions
Questions of a sensitive nature, such as sexual behavior and other matters that are commonly
considered private, must be asked by the establishments as part of the donor medical history
evaluation. The answers to these questions help determine the suitability of a donor. Donors that
do not meet certain criteria would be deferred from donating. The collection of this information is
necessary to prevent the transmission of communicable diseases and to protect the public health.
Records of such information may be reviewed by FDA during an inspection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
The estimated annual burden for this information collection is 626,735 hours.
Table 1. -- Estimated Annual Recordkeeping Burden
21 CFR Section
1270.31(a), (b),
(c), and (d)1
1270.31(a) and
1270.31(b)2
1270.33(a), (f),
and (h), and
1270.35(a) and
(b)
1270.35(c)

No. of
Recordkeepers
32

No. of
Records per
Recordkeeper
1

32

2

32

32

Total
Annual
Records
32

Average
Burden per
Recordkeeping
24

Total
Hours
768

64

1.0

64

6,198.84

198,363

1.0

198,363

11,876.12

380,036

1.0

380,036

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1270.35(d)
1
2

32

1,484.50

47,504

19,562.46

625,999

1.0

47,504
626,735

Review and update of SOPs.
Documentation of deviations from SOPs.

Respondents to this collection of information are manufacturers of human tissue intended for
transplantation. The information collection provisions under 21 CFR Part 1270 include:
21 CFR 1270.31(a) through (d); Recordkeeping
Requires written procedures to be prepared and followed for the following steps: (1) All
significant steps in the infectious disease testing process under 21 CFR 1270.21; (2) all significant
steps for obtaining, reviewing, and assessing the relevant medical records of the donor as
prescribed in 21 CFR 1270.21; (3) designating and identifying quarantined tissue; and (4) for
prevention of infectious disease contamination or cross-contamination of tissues during
processing.
21 CFR 1270.31(a) and (b); Recordkeeping
Requires recording and justification of any deviation from the written procedures.
21 CFR 1270.33(a); Recordkeeping
Requires records to be maintained concurrently with the performance of each significant step in
the performance of infectious disease screening and testing of human tissue donors.
21 CFR 1270.33(f); Recordkeeping
Requires records to be retained regarding the determination of the suitability of the donors and of
the records required under 21 CFR 1270.21.
21 CFR 1270.33(h); Recordkeeping
Requires all records to be retained at least 10 years beyond the date of transplantation if known,
distribution, disposition, or expiration of the tissue, whichever is the latest.
21 CFR 1270.35(a) through (d); Recordkeeping
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.

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12b. Annualized Cost Burden Estimate
The estimated annual cost to respondents is $28,203,075.
Activity

Total Burden Hours

Wage Rate per Hour

Total Cost

Recordkeeping

626,735

$45

$28,203,075

The cost estimate is based on a Donor Coordinator, at a wage rate of $45/hour who is
responsible for maintaining accurate records for each of the units of tissue received, processed,
and distributed annually. This salary estimate includes benefits but no overhead costs.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs or operating and maintenance costs associated with this collection of
information.
14. Annualized Cost to the Federal Government
The estimated annual cost to the Federal Government is $595,200. There are approximately 383
manufacturers of conventional tissue and eye tissue that will be inspected on a biennial basis.
Therefore, it is estimated that approximately half (192 establishments) will be inspected annually.
The cost estimate is based on a FDA inspector at an average grade of GS-13/5 ($59/hour), who
takes an average of 50 hours for each establishment to perform the on-site inspection, review of its
records, and the report write-up.
Activity
Inspection

Number of
Respondents
192

Hours per
Respondent
50

Cost per
Hour
$62

Total Cost
$595,200

15. Explanation for Program Changes or Adjustments
There is no adjustment to the burden hours from the previous estimate, however, we have
uploaded cost information to appear at www.reginfo.gov.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt the display of the expiration date for OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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