0302 SS for 2016 Extension

Human Tissue Intended for Transplantation
OMB Control No. 0910-0302
SUPPORTING STATEMENT
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, the Food and Drug Administration (FDA) is requesting to extend OMB approval of
the information collection provisions found in the applicable regulations:
21 CFR 1270.31(a) through (d); Recordkeeping
Requires written procedures to be prepared and followed for the following steps: (a) All
significant steps in the infectious disease testing process under § 1270.21; (b) all significant
steps for obtaining, reviewing, and assessing the relevant medical records of the donor as
prescribed in § 1270.21; (c) designating and identifying quarantined tissue; and (d) 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
such records required under §1270.21.

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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: (a) The results and
interpretation of all required infectious disease tests; (b) information on the identity and relevant
medical records of the donor; (c) the receipt and/or distribution of human tissue; and (d) the
destruction or other disposition of human tissue.
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 for the following: (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
FDA is the only agency that requires this information. There is no similar kind of information
available from any other source.

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5. Impact on Small Businesses or Other Small Entities
This collection of information applies to small as well as large establishments. 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 provided by the records for each tissue, at the time it is recovered, screened,
tested, processed, stored or distributed, 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 June 6, 2016 (81 FR 36310). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift was provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA is consistent with the Freedom of
Information Act (FOIA) and the FDA’s published regulations of “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

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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

No. of
Recordkeepers

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)

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No. of
Records per
Recordkeeper
1

32

2

32

1270.35(d)

2

Average
Burden per
Recordkeeping
24

Total
Hours
768

64

1

64

6,198.84

198,363

1

198,363

32

11,876.12

380,036

1

380,036

32

1,484.50

47,504

1

47,504
626,735

Total
1

Total
Annual
Records
32

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

Respondents to this collection of information are manufacturers of human tissue intended for
transplantation. Based on information from FDA’s CBER database system, FDA estimates that
there are approximately 383 tissue establishments of which 262 are conventional tissue banks
and 121 are eye tissue banks. Based on information provided by industry, there are an estimated
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, there are an estimated 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 requirement in Part 1270. Based on information provided by 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, recordkeeping by these 351 establishments (236 + 115 = 351) is excluded from
the burden estimates as usual and customary business activities (5 CFR 1320.3(b)(2)). The

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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).
FDA assumes that all current tissue establishments have developed written procedures in
compliance with part 1270. Therefore, their information collection burden is for the general
review and update of written procedures estimated to take an annual average of 24 hours, and for
the recording and justifying of any deviations from the written procedures under § 1270.31(a)
and (b), estimated to take 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 § 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 § 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 FDA experience.
12b. Annualized Cost Burden Estimate
The estimated annual cost to respondents is $26,949,605.
Activity

Total Burden Hours

Wage Rate per Hour

Total Cost

Recordkeeping

626,735

$43

$26,949,605

The cost estimate is based on a Donor Coordinator, at a wage rate of $43/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 $566,400. 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

5

Cost per
Hour
$59

Total Cost
$566,400

15. Explanation for Program Changes or Adjustments
The information collection reflects an overall decrease. We have adjusted our estimate based on
one fewer respondent, and this results in a corresponding decrease to the annual burden hours by
180,035 and a decrease to annual responses by 180,012.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
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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