[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1138-1140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1425]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments on the collection of information by 
February 5, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (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--Part 1270 (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 1 and 2, hepatitis B, and hepatitis C through 
human tissue intended 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 standards 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) and (b) 
require written procedures to be prepared and followed for: (1) All 
significant steps in the infectious disease testing process, and (2) 
all significant steps in reviewing the relevant medical record of the 
donor. Any deviation from the written procedures are to be recorded and 
justified. Section 1270.33(a) requires records to be maintained 
concurrently with the performance of each significant step in 
infectious disease screening and testing of human tissue donors. 
Section 1270.33(f) requires records 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 be 
retained at least 10 years beyond the date of transplantation, 
distribution, disposition, or expiration of the tissue, whichever is 
latest. Section 1270.35 requires specific records to be maintained to 
document: (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-based products. The following estimated numbers of 
establishments, donors, and products, which are based on information 
provided by industry associations, including the Eye Bank Association 
of America 1999 Eye Banking Statistical Report, revise the numbers from 
the 60-day notice (65 FR 48245, August 7, 2000). There are 
approximately 224 tissue establishments currently in operation, 110 
conventional tissue banks and 114 eye tissue banks. There are an 
estimated total of 750,000 conventional tissue products and 86,900

[[Page 1139]]

eye tissue products manufactured per year. In addition, there are an 
estimated 20,000 donors of conventional tissue and 43,800 donors of eye 
tissue each year, with an estimated 45,500 and 14,600 unsuitable donors 
of conventional tissue and eye tissue, respectively.
    On July 29, 1997 (62 FR 40429), FDA issued a final rule on human 
tissue intended for transplantation, part 1270, which finalized the 
interim rule implemented on December 14, 1993 (58 FR 65514). At that 
time, accredited members of the American Association of Tissue Banks 
(AATB) and the Eye Bank Association of America (EBAA) were adhering to 
the standards of those organizations, which were comparable to 
recordkeeping requirements in part 1270, and were thus already in 
compliance with the interim rule. In 1997, we estimated that 
approximately 99 percent of the 170 tissue establishments (60 
conventional tissue banks and 110 eye banks) then in operation, or 168 
establishments, were accredited members of AATB and EBAA. Therefore, 
recordkeeping by these 168 establishments is excluded from the burden 
estimates as usual and customary business activities (5 CFR 
1320.3(b)(2)). The recordkeeping burden below, thus, is estimated for 
the remaining 56 establishments (224 - 168 = 56).
    The requirement for the development of written procedures under 
Sec. 1270.31(a) and (b) is considered an initial one-time burden. FDA 
assumes that all current tissue establishments have developed written 
procedures in compliance with part 1270. FDA also assumes that no new 
tissue banks will begin operation in the next 3 years. Therefore, the 
information collection burden under Sec. 1270.31(a) and (b) is for the 
general review and update of written procedures, and the recording and 
justifying of any deviations from the written procedures, which we 
estimate to be an annual average of 24 hours for all written procedures 
per establishment. 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 below 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 August 7, 2000 (65 FR 48245), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. One letter of comment was received in response 
to the 60-day notice.
    The comment stated that the requirements for written procedures 
represent ongoing, not one-time, costs, in part because written 
procedures must be periodically reviewed and updated.
    FDA agrees that the review and update of written procedures are 
part of the information collection burden associated with the 
recordkeeping requirements and revised estimates are reflected in table 
1 of this document.
    The comment stated that there are costs associated in preparing 
different formats to comply with FDA requirements and tissue bank 
association standards.
    The provisions in part 1270 do not require that data be prepared in 
a specified recordkeeping format. Separate records for the same or 
similar information are not necessary.
    The comment also noted that there are other additional costs and 
recordkeeping burdens associated with an FDA inspection in that an 
establishment must review its records at that time.
    The regulations do not impose any additional recordkeeping 
requirements during inspections. Costs incurred by establishments 
during an inspection are beyond the scope of this PRA analysis.
    The comment was also concerned that the regulations created a 
burden by necessitating the direct observation of all testing performed 
by a contract laboratory.
    The requirement to have written procedures for and to document all 
significant steps in the infectious disease testing process does not 
require an establishment to directly observe the performance of all 
medical tests to ensure compliance with part 1270. A tissue 
establishment may have a written procedure for ensuring that contract 
laboratories comply with the testing requirements in part 1270, such as 
the requirement that laboratories are using FDA licensed tests, are 
Clinical Laboratory Improvement Amendments certified, and follow 
manufacturers instructions for performing the required tests. For 
example, an establishment may write a procedure that would include 
performance of a periodic audit or to review a laboratory's standard 
operating procedures (SOP's) to ensure compliance with part 1270.
    The comment also discussed the regulation's economic impacts, such 
as equipment costs and general operating costs, which go beyond the 
scope of information collection provisions. However, FDA will consider 
such issues when reviewing comments to the proposed rule on suitability 
determination for donors of human cellular and tissue-based products 
(64 FR 52696, September 30, 1999), which is intended to replace part 
1270 when finalized.

[[Page 1140]]



                              Table 1. -- Estimated Annual Recordkeeping Burden\1\
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    21 CFR         No. of      Annual Frequency per   Total Annual      Hours per
   Section      Recordkeepers      Recordkeeping         Records         Record              Total Hours
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1270.31(a)          56                  1                 56              24.0                1,344
 and
 1270.31(b)\2
 \
1270.31(a)          56                  2                102               1.0                  102
 and
 1270.31(b)\3
 \
1270.33(a),         56                195.57          10,952               1.0               10,952
 (f), and
 (h), and
 1270.35(a)
 and (b)
127.35(c)           56              6,222.79         348,476               1.0              348,476
1270.35(d)          56                384.18          21,514               1.0               21,514
Total                                                                                      382, 388
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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 SOP's.
\3\Documentation of deviations from SOP's.


    Dated: December 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-263 Filed 1-4-01; 8:45 am]
BILLING CODE: 4160-01-S