[Federal Register Volume 72, Number 79 (Wednesday, April 25, 2007)]
[Notices]
[Pages 20555-20557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0475]


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.

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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 May 25, 
2007.

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: 202-395-6974. 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:  Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 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

[[Page 20556]]

kept documenting that the appropriate screening and testing have been 
completed.
    Sections 1270.31(a) through (d) (21 CFR 1270.31(a) through (d)) 
require written procedures to be prepared and followed for the 
following steps: (1) All significant steps in the infectious disease 
testing process; (2) all significant steps in obtaining, reviewing, and 
assessing the relevant medical records of the donor; (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 require recording 
and justification of any deviation from the written procedures. Section 
1270.33(a) (21 CFR 1270.33(a)) requires records to be maintained 
concurrently with the performance of each significant step in the 
procedures 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 (21 CFR 1270.21). Section 1270.33(h) 
requires all records be retained at least 10 years beyond the date of 
transplantation, distribution, disposition, or expiration of the 
tissue, whichever is the latest. Section 1270.35 (21 CFR 1270.35) 
requires specific records 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 190 tissue 
establishments, of which 105 are conventional tissue banks and 85 are 
eye tissue banks. Based on information provided by industry, there are 
an estimated total of 1,500,000 conventional tissue products and 84,789 
eye tissue products recovered per year with an average of 25 percent of 
the tissue discarded due to unsuitability for transplant. In addition, 
there are an estimated 23,295 donors of conventional tissue and 42,649 
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 21 CFR part 1270. Based on information provided by 
CBER's database system, 76 percent of the conventional tissue banks are 
members of AATB (105 x 76 percent = 80), and 96 percent of eye tissue 
banks are members of EBAA (85 x 96 percent = 82). Therefore, 
recordkeeping by these 162 establishments (80 + 82 = 162) 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 28 establishments, which is 15 percent of all establishments 
(190 - 162 = 28, or 28/190 = 15 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 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 December 4, 2006 (71 FR 70410), FDA 
published a 60-day notice on human tissue intended for transplantation 
requesting public comment on the information collection provisions. No 
comments were received. The notice contained an error in the third line 
of the table for estimated annual recordkeeping burden. The following 
table corrects that error.

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                No. of Record-  Annual Frequency per
21 CFR Section      keepers         Recordkeeping     Total Annual Records    Hours per Record      Total Hours
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1270.31(a),                 28                     1                     2                    64             128
 (b), (c), and
 (d)
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Total                  783,332
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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 SOPs.
\3\Documentation of deviations from SOPs.



[[Page 20557]]

    Dated: April 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-7815 Filed 4-24-07; 8:45 am]
BILLING CODE 4160-01-S