[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72895-72897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0797]


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 January 
3, 2014.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0302. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food

[[Page 72896]]

and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 
20850, [email protected].

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 Services (PHS) Act (42 
U.S.C. 264), FDA issued regulations under part 1270 (21 CFR part 1270) 
to prevent the transmission of human immunodeficiency virus, 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) requires written procedures be 
prepared and followed for the following steps: (1) All significant 
steps in the infectious disease testing process under Sec.  1270.21; 
(2) all significant steps for obtaining, reviewing, and assessing the 
relevant medical records of the donor as prescribed in Sec.  1270.21; 
(3) designating and identifying quarantined tissue; and (4) prevention 
of infectious disease contamination or cross-contamination by tissue 
during processing. Section 1270.31(a) and (b) also requires recording 
and justification of any deviation from the written procedures. Section 
1270.33(a) requires records to be maintained concurrently with the 
performance of each significant step required in the performance 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 of the records 
required under Sec.  1270.21. Section 1270.33(h) requires all records 
to be retained for at least 10 years beyond the date of transplantation 
if known, distribution, disposition, or expiration of the tissue, 
whichever is the latest. Section 1270.35(a) through (d) requires 
specific records to be maintained to document the following: (1) The 
results and interpretation of all required infectious disease tests; 
(2) information on the identity and relevant medical records of the 
donor; (3) the receipt and/or 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 
the Center for Biologics Evaluation and Research's (CBER's) database 
system, FDA estimates that there are approximately 281 tissue 
establishments of which 185 are conventional tissue banks and 96 are 
eye tissue banks. Based on information provided by industry, there are 
an estimated total of 1,959,270 conventional tissue products and 82,741 
eye tissue products distributed per year with an average of 25 percent 
of the tissue discarded due to unsuitability for transplant. In 
addition, there are an estimated 30,380 donors of conventional tissue 
and 49,026 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 
requirements in part 1270. Based on information provided by CBER's 
database system, 90 percent of the conventional tissue banks are 
members of AATB (185 x 90 percent = 166), and 85 percent of eye tissue 
banks are members of EBAA (96 x 85 percent = 82). Therefore, 
recordkeeping by these 248 establishments (166 + 82 = 248) 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 33 establishments, which is 12 percent of all establishments 
(281-248 = 33, or 33 / 281 = 12 percent).
    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 under 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 identity 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 July 10, 2013 (78 FR 41403), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One letter of comment was received from a 
trade organization. The comment requested that the notice be corrected 
to reflect that an estimated total of 1,959,270 conventional tissue 
products are distributed (not recovered) per year. The comment also 
requested a revision in the number of donors of conventional tissues 
based on the AATB Annual Survey 2007. FDA agrees with these comments 
and made the recommended changes.
    FDA estimates the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
           21 CFR Part                Number of     records per    Total annual         per         Total hours
                                    recordkeepers   recordkeeper      records      recordkeeping
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1270.31(a), (b), (c), and (d) \2\              33           1                 33              24             792
1270.31(a) and 1270.31(b) \3\....              33           2                 66               1              66
1270.33(a), (f), and (h), and                  33       7,714.24         254,570               1         254,570
 1270.35(a) and (b)..............
1270.35(c).......................              33      14,850.96         490,082               1         490,082
1270.35(d).......................              33       1,856.36          61,260               1          61,260
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[[Page 72897]]

 
    Total........................                                                                        806,770
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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: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28989 Filed 12-3-13; 8:45 am]
BILLING CODE 4160-01-P