[Federal Register Volume 71, Number 232 (Monday, December 4, 2006)]
[Notices]
[Pages 70410-70411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0475]


Agency Information Collection Activities; Proposed Collection; 
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 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 
transplantation.

DATES:  Submit written or electronic comments on the collection of 
information by February 2, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
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:  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: 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 (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 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

[[Page 70411]]

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 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 
experience.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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   21 CFR      No. of Record-   Annual Frequency per
  Section         keepers           Recordkeeping     Total Annual Records   Hours per Record     Total Hours
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1270.31(a),                  2                     1                     2                 64                128
 (b), (c),
 and (d)
1270.31(a),                 28                     1                    28                 24                672
 (b), (c),
 and (d)\2\
1270.31(a)                  28                     2                    46                  1                 46
 and
 1270.31(b)
 \3\
1270.33(a),                 28                 8,843               247,610                  1            247,610
 (f), and
 (h), and
 1270.35(a)
 and (b)
1270.35(c)                  28                16,980               475,436                  1            475,436
1270.35(d)                  28                 2,123                59,430                  1             59,430
Total        .................  ....................  ....................  .................            783,322
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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.


    Dated: November 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20477 Filed 12-01-06; 8:45 am]
BILLING CODE 4160-01-S