[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50039-50041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20669]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 November 25, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 25, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to 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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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.''
[[Page 50040]]
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, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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, [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 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 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, 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
[[Page 50041]]
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.
We estimate the burden of this information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part 1270; human tissue Number of records per Total annual per Total hours
intended for transplantation recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart C--Procedures and Records
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
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: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20669 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P