[Federal Register: October 1, 2003 (Volume 68, Number 190)]
[Notices]
[Page 56635-56636]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc03-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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
experience.
FDA estimates the burden of this information collection as follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency per
21 CFR Section No. of Recordkeepers Recordkeeping Total Annual Records Hours per 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 (d)\2\ 62 1 62 24 1,488
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1270.31(a) and (b)\3\ 62 2 124 1.0 124
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1270.33(a), (f), and (h) and 62 3,089 191,518 1.0 191,518
1270.35(a) and (b)
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1270.35(c) 62 5,719 354,578 1.0 354,578
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1270.35(d) 62 715 44,330 1.0 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 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]
BILLING CODE 4160-01-S