OMB INFORMATION COLLECTION

[SUPPORTING STATEMENT]{.underline}

[0910-0302]{.underline}

Human Tissue Intended for Transplantation

**[JUSTIFICATION]{.underline}**

**1. [Circumstances Which Make This Information Collection
Necessary]{.underline}**

The Food and Drug Administration (FDA) is requesting an extension of
Office of Management and Budget (OMB) Control No. 0910-0302, and OMB
approval of the information collection requirements in 21 CFR Part 1270
(Tab A), Human Tissue Intended for Transplantation, listed below:

  ---------------- --------------- ----------------------------------------
  21 CFR           Recordkeeping   Requires written procedures to be
  1270.31(a)                       prepared and followed for: (a) All
  through (d)                      significant steps in the infectious
                                   disease testing process, and (b) all
                                   significant steps in reviewing the
                                   relevant medical record of the donor,
                                   (c) designating and identifying
                                   quarantined tissue, and (d) for
                                   prevention of infectious disease
                                   contamination or cross-contamination by
                                   tissue during processing. Section (a)
                                   and (b) also require recording and
                                   justification of any deviation from the
                                   written procedures.

  21 CFR           Recordkeeping   Requires records to be maintained
  1270.33(a)                       concurrently with the performance of
                                   each significant step in the procedures
                                   of infectious disease screening and
                                   testing of human tissue donors.

  21 CFR           Recordkeeping   Requires records to be retained
  1270.33(f)                       regarding the determination of the
                                   suitability of the donors and such
                                   records required under §1270.21.

  21 CFR           Recordkeeping   Requires all records to be retained at
  1270.33(h)                       least 10 years beyond the date of
                                   transplantation, distribution,
                                   disposition, or expiration of the
                                   tissue, whichever is latest.

  21 CFR 1270.35   Recordkeeping   Requires specific records to be
  (a), (b), (c) &                  maintained to document: (a) The results
  (d)                              and interpretation of all required
                                   infectious disease tests and results;
                                   (b) the identity and relevant medical
                                   records of the donor; (c) the receipt
                                   and distribution of human tissue; and,
                                   (d) the destruction or other disposition
                                   of human tissue.
  ---------------- --------------- ----------------------------------------

Under section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264,
Tab B), FDA issued regulations to prevent the transmission of human
immunodeficiency virus (HIV), hepatitis B, hepatitis C, and other
organisms causing infectious disease 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 ensure that
records are kept documenting that the appropriate screening and testing
have been completed.

**2. [How, By Whom, and the Purpose for Collecting This
Information]{.underline}**

These information collection requirements help prevent the transmission
of communicable diseases through transplantation by requiring that
written SOPs be prepared and followed for infectious disease testing,
for determining the medical history of each donor, for designating and
identifying quarantined tissue, and for preventing the contamination or
cross-contamination of tissue during processing; by requiring
maintenance of records of significant steps in testing, processing, and
distribution or final disposition of the tissue; and by allowing
inspection of these facilities. 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, retention, recall and destruction orders may be issued in
accordance with codified administrative procedures. Without this
information, FDA could not monitor the suitability of human tissue for
transplantation and fulfill its statutory responsibility to ensure that
communicable diseases are not spread into or throughout the United
States and its Possessions.

**3. [Use of Technology to Reduce the Burden on the
Public]{.underline}**

Establishments may use computer tapes or discs, microfiche or microfilm
to record and store data and information rather than hard copy records.
The use of this technology is specifically referenced in the
regulations. Section 1270.33(f) and (g) considers the retrieval of
records from another location and the maintenance of records by
electronic means as keeping in compliance. FDA is not aware of any other
improved technology to reduce the burden.

**4. [Identification and Use of Duplicate Information]{.underline}**

FDA is the only agency that requires this information. There is no
similar kind of information available from any other source.

**5. [FDA's Effort to Reduce Burden on Small Businesses ]{.underline}**

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 (CBER),
Office of Communication, Training, and Manufacturer's Assistance
provides assistance to small businesses subject to FDA's regulatory
requirements.

**6. [Impact of Not Collecting This Information or Collecting
Information Less Frequently]{.underline}**

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 and its final
distribution or disposition. Less frequent collection of information
would not ensure the safety of the tissue supply in this country. The
information provides to FDA inspectors the information necessary to
fulfill FDA's statutory responsibility to prevent the spread of
communicable diseases. FDA would be unable to fulfill these duties with
less frequent information collection.

There are no technical or legal obstacles to reducing the burden.

**7. [Special Circumstances That Occur When Collecting This Information
]{.underline}**

There is no special circumstance for the collection of information
requirements.

**8. [Identification of Outside FDA Sources]{.underline}**

In accordance with 5 CFR 1320.8(d), a 60-day notice for public comment
on the information collection provisions was published in the Federal
Register of October 1, 2003 (68 FR 56635, Tab C)*.* *[No comments were
received from the public]{.underline}*.

**9. [Payment or Gifts Offered to Respondents]{.underline}**

No payment or gift was provided to respondents.

**10. [Method of Ensuring Respondent Confidentiality]{.underline}**

The confidentiality of information received by FDA is consistent with
the Freedom of Information Act and the agency's regulations under 21 CFR
Part 20. Inspectors may copy records as part of the inspection of a
tissue establishment. Such information may be copied to document
distribution of potentially infectious tissue. This information is for
internal use and will be redacted from any information released by FDA
under the Freedom of Information Act and FDA regulations.

**11. [Use of Sensitive Questions]{.underline}**

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 not meeting 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. [Burden Hour and Costs Associated With This Information
Collection]{.underline}**

The estimated annual burden for this information collection is 592,166
hours.

  --------------- --------------- --------------- ---------- ----------- ---------
  Table 1. \--                                                           
  Estimated                                                              
  Annual                                                                 
  Recordkeeping                                                          
  Burden                                                                 

  21 CFR Section  No. of          Annual          Total      Hours per   Total
                  Recordkeepers   Frequency per   Annual     Record      Hours
                                  Recordkeeping   Records                

  1270.31(a)      2               1               2          64          128
  through (d)                                                            

  1270.31(a)      62              1               62         24          1,488
  through (d)^1^                                                         

  1270.31(a) and  62              2               124        1.0         124
  1270.31(b)^2^                                                          

  1270.33(a),     62              3,089           191,518    1.0         191,518
  (f), and (h),                                                          
  and 1270.35(a)                                                         
  and (b)                                                                

  1270.35(c)      62              5,719           354,578    1.0         354,578

  1270.35(d)      62              715             44,330     1.0         44,330

  Total                                                                  592,166
  --------------- --------------- --------------- ---------- ----------- ---------

^1\ Review\ and\ update\ of\ SOPs^

^2\ 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, the agency estimates that there are approximately
300 tissue establishments of which 166 are conventional tissue banks and
134 are eye tissue banks. Based on information provided by industry,
there are an estimated total of 750,000 conventional tissue products and
94,186 eye tissue products recovered per year with an average of 25% of
the tissue discarded due to unsuitability for transplant. In addition,
there are an estimated 20,000 donors of conventional tissue and 47,796
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 industry associations, 50-75
percent (average 63 percent) of the conventional tissue banks are
members of AATB (166 X 63% = 105), and 99 percent of eye tissue banks
are members of EBAA (134 X 99 percent = 133). Therefore, recordkeeping
by these 238 establishments (105 + 133 = 238) is excluded from the
burden estimates as usual and customary business activities (5 CFR §
1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the
remaining 62 establishments, which is 21 percent of all establishments
(300 - 238 = 62, or 62/300 = 21 percent).

Based on CBER's database system and information provided by industry,
FDA estimates an average of two new tissue banks annually, which may be
non-members of a trade association. Each new tissue bank requires an
estimated 64 hours to prepare standard operating procedures (SOPs) under
§ 1270.31(a) through (d). The requirement for the development of these
written procedures is considered an initial one-time burden. 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 for §
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.

### Cost to Respondents

The estimated annual cost to respondents is \$17,764,980.

  ----------------- ----------------- ----------------- -----------------
  Activity          No. of Hours      Cost per Hour     Total Cost

  Recordkeeping     592,166           \$30              \$17,764,980
  ----------------- ----------------- ----------------- -----------------

The cost estimate is based on a Donor Coordinator, at a pay rate of
\$30/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. [Annual Cost Estimate to Respondents]{.underline}**

There are no capital and start-up, operation, maintenance, or purchase
costs associated with

the information collection requirements.

**14. [Annual Cost Estimate to FDA]{.underline}**

The estimated annual cost to the Federal Government is \$270,000. There
are approximately 300 manufacturers of conventional tissue and eye
tissue that will be inspected on a biennial basis. Therefore, it is
estimated that approximately half (150 establishments) will be inspected
annually. The cost estimate is based on a FDA inspector at an average
grade of GS-12/5 (\$36/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              Number of     Hours per    Cost per    Total Cost
                        Respondents   Response     Hour        

  Inspection            150           50           \$36        \$270,000
  --------------------- ------------- ------------ ----------- -----------

**15. [Changes from Previous Approval]{.underline}**

The previous burden estimate was 382,388 hours. The increase in burden
to 592,166 hours is mostly attributed to a revised estimate for the
number of respondents (56 to 62) and the number of total annual records
(10,952 to 191,518) under §§ 1270.33(a), (f), and (h), and 1270.35(a)
and (b).

**16. [Publishing the Results of This Information
Collection]{.underline}**

There are no tabulated results to publish for this information
collection.

**17. [Reason for Not Displaying the OMB Approval Date]{.underline}**

FDA is not seeking approval to exempt display of the expiration date for
OMB approval.

**18. [Explanations to Section 19, "Certification for Paperwork
Reduction Act Submissions"]{.underline}**

There are no exceptions to Item 19 of OMB Form 83-I.