[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Pages 41403-41404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16556]



Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 

DATES: Submit either electronic or written comments on the collection 
of information by September 9, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [email protected].

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 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.
    Sections 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 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) for 
prevention of infectious disease contamination or cross-contamination 
by tissue during processing. Sections 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 

[[Page 41404]]

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 recovered per year with an average of 25 percent of 
the tissue discarded due to unsuitability for transplant. In addition, 
there are an estimated 73,075 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.
    FDA estimates the burden of this information collection as follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
                                                           Number of      Number of  records     Total annual       Average burden
                   21 CFR Section                        recordkeepers     per  recordkeeper        records        per recordkeeping      Total hours
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 1270.35(a) and (b)....                  33            7,869.48             259,693                   1             259,693
1270.35(c)..........................................                  33           14,850.96             490,082                   1             490,082
1270.35(d)..........................................                  33            1,856.36              61,260                   1              61,260
    Total...........................................                                                                                             811,893
\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: July 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16556 Filed 7-9-13; 8:45 am]