[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Notices]
[Pages 65277-65278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0453]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by 
January 12, 1998.

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: 
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 section 3507 of the PRA 
(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 (OMB Control Number 0910-
0302)--Reinstatement

    FDA issued final regulations in the Federal Register of July 29, 
1997 (62 FR 40429) to prevent the transmission of human 
immunodeficiency virus (HIV), hepatitis B, and hepatitis C through the 
use of human tissue for transplantation. The final regulations closely 
parallel those contained in the interim rule on human tissue intended 
for transplantation. Both the interim and final rule 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 
ensure that records are kept documenting that the appropriate screening 
and testing have been completed.
    There are approximately 60 tissue establishments with 300 employees 
that are members of the American Association of Tissue Banks. There are 
an additional 600 individual members of which 50 percent are performing 
a tissue banking activity. The Eye Bank Association of America's 
membership consists of 120 eye banks of which 110 are in the 
continental United States.
    With the rare exceptions noted in the preamble of the rule, FDA 
believes that all respondents perform donor testing and screening for 
HIV and hepatitis and these regulations add no additional requirements. 
21 CFR 1270.31(c) and (d) require written procedures for the 
designation and identification of quarantined tissue and to prevent the 
contamination or cross-contamination of tissue during processing. 21 
CFR 1270.35(c) requires documentation of the distribution and receipt 
of human tissue, completing the accounting of tissue between 
determination of suitability, and the destruction or disposition of the 
tissue.
    When the interim rule was issued in the Federal Register of 
December 14, 1993 (58 FR 65514), accredited members of the American 
Association of Tissue Banks and the Eye Bank Association of America 
were already in compliance with the regulations by adhering to the 
standards established by these organizations. The requirements in the

[[Page 65278]]

final rule do not impose an additional burden since the members will be 
complying with the current organizations' standards which are 
comparable to the requirements in the final rule. To account for 
persons or establishments that may not be a member of an industry 
organization and, for whom therefore, the extent of compliance with the 
requirements of the final rule is unknown, FDA will be using 1 percent 
as an estimation of the information collection burden on the tissue 
industry.
    Industry estimates that in 1994 there were 350,000 bone 
transplants, 42,000 corneal transplants, 5,000 patellar tendon 
transplants, and the transplantation of 5,000 square feet of skin. 
There are approximately 300 persons and 170 tissue banks currently 
operating in the Untied States affected by the regulations.
    The total annual estimated burden imposed by this collection of 
information is 32,260 hours annually.

                                 Table 1--Estimated Annual Recordkeeping Burden                                 
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency of    Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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1270.31 (b)-(d)                        11               4              44              28             308       
1270.35 (a)-(b)                        11             420           4,620             290           3,190       
1270.35 (c)                            11           2,893          31,823           4,782          52,602       
1270.35 (d)                            11              17             187              17             187       
Total                             ..............  ..............  ..............  ..............   56,287       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   


    Dated: December 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32459 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F