[Federal Register: October 1, 2003 (Volume 68, Number 190)]
[Page 56635-56636]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0404]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements relating to FDA regulations for human tissue intended for 

DATES: Submit written or electronic comments on the collection of 
information by December 1, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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 
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 and Evaluation Research 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 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

[[Page 56636]]

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 
    FDA estimates the burden of this information collection as follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
                                                               Annual Frequency per
            21 CFR Section              No. of Recordkeepers      Recordkeeping       Total Annual Records     Hours per Record         Total Hours
1270.31(a) through (d)                                    2                      1                      2                     64                    128
1270.31(a) through (d)\2\                                62                      1                     62                     24                  1,488
1270.31(a) and (b)\3\                                    62                      2                    124                    1.0                    124
1270.33(a), (f), and (h) and                             62                  3,089                191,518                    1.0                191,518
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\ 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: September 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-24799 Filed 9-30-03; 8:45 am]