Document ID: FDA-2010-N-0066-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Human Tissue Intended for Transplantation
Posted Date: 2010-08-02T04:00Z

[Federal Register: August 2, 2010 (Volume 75, Number 147)]
[Notices]               
[Page 45127-45128]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au10-73]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0066]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Human Tissue Intended 
for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
[September 1, 2010.].

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0302. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Human Tissue Intended for Transplantation--(OMB Control Number 0910-
0302)--Extension

    Under section 361 of the Public Health Service (PHS) Act (42 U.S.C. 
264), FDA issued regulations under part 1270 (21 CFR part 1270) to 
prevent the transmission of human immunodeficiency virus (HIV), 
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. Section 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 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 such records 
required under Sec.  1270.21. Section 1270.33(h) 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. 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, FDA estimates that there are approximately 257 tissue 
establishments of which 145 are conventional tissue banks and 112 are 
eye tissue banks. Based on information provided by industry, there are 
an estimated total of 1,959,270 conventional tissue products and 82,741 
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 57,275 donors of conventional tissue and 54,115 
donors of eye tissue each year.

[[Page 45128]]

    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 provided by CBER's 
database system, 90% of the conventional tissue banks are members of 
AATB (145 x 90% = 130), and 77% of eye tissue banks are members of EBAA 
(112 x 77% = 86). Therefore, recordkeeping by these 216 establishments 
(130 + 86 = 216) 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 41 establishments, which 
is 16% of all establishments (257 - 216 = 41, or 41/257 = 16%).
    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 Sec.  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 Sec.  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 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 FDA 
experience.
    In the Federal Register of March 1, 2010 (75 FR 9226), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this information collection as follows:

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d)                                           2                     1                  2                 64                128
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d)\2\                                       41                     1                 41                 24                984
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a) and (b)\3\                                                  41                     2                 82                  1                 82
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.33(a), (f), and (h), and 1270.35(a) and (b)                       41                 8,404            344,564                  1            344,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.35(c)                                                             41                15,938            653,458                  1            653,458
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.35(d)                                                             41                 1,992             81,672                  1             81,672
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                          1,080,888
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Review and update of SOPs.
\3\Documentation of deviations from SOPs.

    Dated: July 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-18851 Filed 7-30-10; 8:45 am]
BILLING CODE 4160-01-S