[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Notices]
[Page 3585-3586]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja04-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
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
experience.
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\
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Annual Frequency Total Annual Hours per
21 CFR Section No. of Recordkeepers per Recordkeeping Records Record Total Hours
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1270.31(a) through (d) 2 1 2 64 128
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1270.31(a) through 62 1 62 24 1,488
(d)\2\
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1270.31(a) and (b)\3\ 62 2 124 1 124
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1270.33(a), (f), and 62 3,089 191,518 1 191,518
(h) and 1270.35(a)
and (b)
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1270.35(c) 62 5,719 354,578 1 354,578
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1270.35(d) 62 715 44,330 1 44,330
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Total 592,166
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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 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]
BILLING CODE 4160-01-S