[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Notices]
[Pages 1167-1169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00144]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
February 10, 2020.

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.

[[Page 1168]]


FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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) (21 CFR 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 (21 CFR 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. Section 
1270.33(a) (21 CFR 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) (21 
CFR 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, we estimate 383 tissue establishments, of which 262 are 
conventional tissue banks and 121 are eye tissue banks. Based on 
information provided by industry, we estimate a total 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, we estimate 
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 included in CBER's 
database system, 90 percent of the conventional tissue banks are 
members of AATB (262 x 90 percent = 236), and 95 percent of eye tissue 
banks are members of EBAA (121 x 95 percent = 115). Therefore, we 
exclude burden for recordkeeping by these 351 establishments (236 + 115 
= 351) from our estimate as we believe such recordkeeping is usual and 
customary business activity (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 
percent).
    We assume that all current tissue establishments have developed 
written procedures in compliance with part 1270. Therefore, our 
estimated burden includes the general review and update of written 
procedures (an annual average of 24 hours), and the recording and 
justifying of any deviations from the written procedures under Sec.  
1270.31(a) and (b) (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 our experience with the information 
collection.
    In the Federal Register of September 24, 2019 (84 FR 50039), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 21 CFR part 1270; human tissue      Number of      records per    Total annual     burden per      Total hours
  intended for transplantation     recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
                                        Subpart C--Procedures and Records
----------------------------------------------------------------------------------------------------------------
1270.31(a) through (d) \2\......              32               1              32              24             768
1270.31(a) and (b) \3\..........              32               2              64               1              64
1270.33(a), (f), and (h), and                 32        6,198.84         198,363               1         198,363
 1270.35(a) and (b).............
1270.35(c)......................              32       11,876.12         380,036               1         380,036
1270.35(d)......................              32        1,484.50          47,504               1          47,504
                                 -------------------------------------------------------------------------------

[[Page 1169]]

 
    Total.......................  ..............  ..............  ..............  ..............         626,735
----------------------------------------------------------------------------------------------------------------
\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.

    Based on a review of the information collection since our last OMB 
approval, we have made no adjustments to our burden estimate.

    Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00144 Filed 1-8-20; 8:45 am]
 BILLING CODE 4164-01-P