
[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Pages 36310-36312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13224]


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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) 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 
transplantation.

DATES: Submit either electronic or written comments on the collection 
of information by August 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to

[[Page 36311]]

the docket unchanged. Because your comment will be made public, you are 
solely responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0797 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Human Tissue Intended for 
Transplantation.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 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. 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 
records to be retained for at least 10 years beyond the date of 
transplantation if

[[Page 36312]]

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 
an estimated 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, 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 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\
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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)                 32               1              32              24             768
 \2\............................
1270.31(a) and 1270.31(b) \3\...              32               2              64               1              64
1270.33(a), (f), and (h), and                 32        6,198.84         198,363             1.0         198,363
 1270.35(a) and (b).............
1270.35(c)......................              32       11,876.12         380,036             1.0         380,036
1270.35(d)......................              32        1,454.50          47,504             1.0          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: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13224 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P


