[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
