[Federal Register Volume 65, Number 152 (Monday, August 7, 2000)]
[Notices]
[Pages 48245-48246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1425]


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 comments on the collection of information by 
October 6, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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: 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: 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 request 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: (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--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 (HIV), hepatitis B, hepatitis C, and other 
organisms causing infectious disease 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 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 determining 
the medical history 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 the procedures of 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. Based on information provided by industry 
associations, there are approximately 224 manufacturers of conventional 
tissue and eye tissue. An estimated total of 309,000 conventional 
tissue products and 86,000 eye tissue products are manufactured per 
year. There are an estimated 6,500 donors of conventional tissue and 
43,300 donors of eye tissue each year, with an estimated 12,900 
unsuitable donors. In estimating the burden, FDA compared the agency 
regulations with the current voluntary standards of a number of 
industry organizations, such as the American Association of Tissue 
Banks and the Eye Bank Association of America. In those cases where a 
voluntary industry standard appears to be equivalent to the agency 
regulation, FDA has assumed that any recordkeeping burden would 
continue as customary and usual business practice of an establishment 
that are members of those organizations and therefore no additional 
burden is calculated. To account for establishments that may not be a 
member of an industry organization and would not perform these 
provisions as customary and usual practice, FDA is using 1 percent of 
the number of recordkeepers and total annual records as an estimation 
of the information collection burden on the tissue industry. The 
requirement for written procedures is considered a one-time burden, 
therefore, the information collection burden under Sec. 1270.31(a) and 
(b) is for the recording and justifying of any deviations from the 
written procedures. The information collection burden for the 
regulation under Sec. 1270.33 is being calculated with Sec. 1270.35(a) 
because it

[[Page 48246]]

would be duplicating burden and difficult to calculate separately. The 
following recordkeeping estimates for the number of recordkeepers, 
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
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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1270.31(a) and 1270.31(b)               2               2               4               1.0             4
1270.33(a), (f), and (h), and           2             498             996               1.0           996
 1270.35(a) and (b)
1270.35(c)                              2           1,975           3,950               1.0         3,950
1270.35(d)                              2              65             130               1.0           130
Total                                                                                              5,080
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 28, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-19864 Filed 8-4-00; 8:45 am]
BILLING CODE 4160-01-F