[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Page 3585-3586]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0404]

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 
February 25, 2004.

ADDRESSES:  OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  JonnaLynn P. Capezzuto, Office of 
Management Programs (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--21 CFR Part 1270 (OMB 
Control Number 0910-0302)--Extension

    Under section 361 of the Public Health Service 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 kept documenting that the appropriate 
screening and testing have been completed.
    Section 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 reviewing the relevant 
medical record of the donor, (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 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 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 latest. Section 1270.35 (21 
CFR 1270.35) requires specific records be maintained to document the 
following outcomes: (1) The results and interpretation of all required 
infectious disease tests and results, (2) the identity and relevant 
medical records of the donor, (3) the receipt and 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 
FDA's Center for Biologics Evaluation and Research (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 percent of 
the tissue discarded due to

[[Page 3586]]

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 (21 CFR part 1270). Based on information 
provided by industry associations, 50 to 75 percent (average 63 
percent) of the conventional tissue banks are members of AATB (166 x 63 
percent = 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 nonmembers 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 identify 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 
    In the Federal Register of October 1, 2003 (68 FR 56635), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
                                               Annual Frequency     Total Annual      Hours per
    21 CFR Section      No. of Recordkeepers   per Recordkeeping       Records         Record       Total Hours
1270.31(a) through (d)            2                    1                   2            64               128
1270.31(a) through               62                    1                  62            24             1,488
1270.31(a) and (b)\3\            62                    2                 124             1               124
1270.33(a), (f), and             62                3,089             191,518             1           191,518
 (h) and 1270.35(a)
 and (b)
1270.35(c)                       62                5,719             354,578             1           354,578
1270.35(d)                       62                  715              44,330             1            44,330
Total                                                                                                592,166
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.

    Dated: January 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1493 Filed 1-23-04; 8:45 am]