81 FR 76361 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 212 (November 2, 2016)

The Food and Drug Administration (FDA or we) 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 (the PRA).

[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76361-76362]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26398]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by 
December 2, 2016.

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 and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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 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 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. Section 1270.31(a) and (b) also requires 
recording and justification of any deviation from the written 
procedures.

[[Page 76362]]

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 383 tissue 
establishments, of which 262 are conventional tissue banks and 121 are 
eye tissue banks. Based on information provided by industry, there are 
estimated totals of 2,141,960 conventional tissue products and 130,987 
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 29,799 deceased donors of conventional 
tissue and 70,027 deceased 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 (262 x 90% = 236), and 95 percent of eye tissue banks 
are members of EBAA (121 x 95% = 115). Therefore, recordkeeping by 
these 351 establishments (236 + 115 = 351) 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 32 establishments, which is 8.36 percent of all 
establishments (383 - 351 = 32, or 32/383 = 8.36%).
    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. 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 June 6, 2016 (81 FR 36310), we published 
a 60-day notice requesting public comment on the proposed extension of 
this collection of information. No comments were received.
    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 Section                               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\..................................               32                1               32               24              768
1270.31(a) and 1270.31(b) \3\......................................               32                2               64                1               64
1270.33(a), (f), and (h), and 1270.35(a) and (b)...................               32         6,198.84          198,363                1          198,363
1270.35(c).........................................................               32        11,876.12          380,036                1          380,036
1270.35(d).........................................................               32         1,484.50           47,504                1           47,504
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    Total..........................................................  ...............  ...............  ...............  ...............          626,735
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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: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26398 Filed 11-1-16; 8:45 am]
 BILLING CODE 4164-01-P