Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation, 50039-50041 [2019-20669]
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Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Notices
products posted between April 12, 2019,
and September 23, 2019, available on
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/Committees
MeetingMaterials/PediatricAdvisory
Committee/ucm510701.htm but not
presented at the September 26 or 27,
2019, Joint PAC or DSaRM meeting.
FDA welcomes comments by members
of the PAC, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act of 2003 (Pub. L. 108–155),
interested parties (such as academic
researchers, regulated industries,
consortia, and patient groups), and the
general public. The docket number is
FDA–2019–N–1215. The docket will
open on September 23, 2019, and
remain open until October 7, 2019. The
post-marketing pediatric-focused safety
reviews are for the following products
from the following centers at FDA:
khammond on DSKJM1Z7X2PROD with NOTICES
Center for Biologics Evaluation and
Research
(1) GAMMAPLEX—Immune Globulin
Intravenous (Human) 5% Liquid
(2) NUWIQ®—(simoctocog alfa)
(3) TACHOSIL®—Absorbable Fibrin
Sealant Patch
(4) WILATE—von Willebrand Factor/
Coagulation Factor VIII Complex
(Human)
17:37 Sep 23, 2019
Jkt 247001
Center for Devices and Radiological
Health
(1) CONTEGRA PULMONARY VALVED
CONDUIT—(Humanitarian Device
Exemption [HDE])
(2) ELANA SURGICAL KIT—(HDE)
(3) ENTERRA THERAPY SYSTEM—
(HDE)
(4) PLEXIMMUNETM IN–VITRO
DIAGNOSTIC TEST—(HDE)
(5) PULSERIDER ANEURYSM NECK
RECONSTRUCTION DEVICE—
(HDE)
Dated: September 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Center for Drug Evaluation and
Research
(1) ATIVAN INJECTION—(lorazepam
injection)
(2) E–Z–HD—(barium sulfate)
(3) LIQUID E–Z–PAQUE—(barium
sulfate)
(4) READI–CAT 2 and READI–CAT 2
SMOOTHIE—(barium sulfate)
(5) VARIBAR PUDDING—(barium
sulfate)
(6) CALCIUM GLUCONATE
INJECTION—(calcium gluconate)
(7) CEREBYX®—(fosphenytoin sodium)
(8) DOTAREM—(gadoterate meglumine)
(9) FYCOMPA ORAL TABLETS AND
SUSPENSION—(perampanel)
(10) HARVONI—(ledipasvir and
sofosbuvir)
(11) ISENTRESS AND ISENTRESS HD—
(raltegravir)
(12) LATUDA—(lurasidone
hydrochloride)
(13) RAPIVAB®—(peramivir)
(14) RYZODEG 70/30—(insulin
degludec and insulin aspart
injection) for subcutaneous use 100
units/mL (U–100) in 3ml FlexTouch
Pen
(15) SIMPONI—(golimumab SC) and
SIMPONI ARIA (golimumab IV)
(16) SOVALDI—(sofosbuvir)
(17) STRIBILD—(elvitegravir, cobicistat,
emtricitabine/tenofovir disoproxil
fumarate)
VerDate Sep<11>2014
(18) TRESIBA—(insulin degludec
injection), for subcutaneous use,
100 units/mL (U–100) in 3ml
single-patient-use FlexTouch Pen;
200 units/mL (U–200) in 3mL
single-patient-use FlexTouch Pen;
100 units/mL (U–100) 10mL in
multiple-dose vial
(19) VIGAMOX—(moxifloxacin
hydrocholoride ophthalmic
solution 0.5%)
(20) VISIPAQUE INJECTION—
(iodixanol)
(21) ZEMPLAR—(paricalcitol)
(22) ZYMAR® 0.3%—(gatifloxacin
ophthalmic solution)
[FR Doc. 2019–20658 Filed 9–23–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
PO 00000
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Sfmt 4703
50039
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.’’
E:\FR\FM\24SEN1.SGM
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khammond on DSKJM1Z7X2PROD with NOTICES
50040
Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Notices
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-201509-18/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, PRAStaff@fda.hhs.gov.
VerDate Sep<11>2014
17:37 Sep 23, 2019
Jkt 247001
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.
SUPPLEMENTARY INFORMATION:
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
PO 00000
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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
§ 1270.21; (2) all significant steps for
obtaining, reviewing, and assessing the
relevant medical records of the donor as
prescribed in § 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 § 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
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50041
Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Notices
CBER’s database system, 90 percent of
the conventional tissue banks are
members of AATB (262 × 90 percent =
236), and 95 percent of eye tissue banks
are members of EBAA (121 × 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 § 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
§ 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 § 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
21 CFR part 1270; human tissue intended for
transplantation
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Subpart C—Procedures and Records
1270.31(a), (b), (c), and (d) 2 ...............................................
1270.31(a) and 1270.31(b) 3 ................................................
1270.33(a), (f), and (h), and 1270.35(a) and (b) .................
1270.35(c) ............................................................................
1270.35(d) ............................................................................
32
32
32
32
32
1
2
6,198.84
11,876.12
1,454.50
32
64
198,363
380,036
47,504
24
1
1.0
1.0
1.0
768
64
198,363
380,036
47,504
Total ..............................................................................
........................
........................
........................
........................
626,735
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
and update of standard operating procedures (SOPs).
of deviations from SOPs.
2 Review
3 Documentation
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2019–P–2123]
Determination That ATROPINE
SULFATE ANSYR PLASTIC SYRINGE
(Atropine Sulfate Solution)
Intravenous, Intramuscular,
Subcutaneous, and Endotracheal, 0.5
Milligram/5 Milliliters (0.1 Milligram/
Milliliter), Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
SUMMARY:
VerDate Sep<11>2014
17:37 Sep 23, 2019
Jkt 247001
has determined that ATROPINE
SULFATE ANSYR PLASTIC SYRINGE
(atropine sulfate solution) intravenous,
intramuscular, subcutaneous, and
endotracheal, 0.5 milligram (mg)/5
milliliters (mL) (0.1 mg/mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for atropine
sulfate solution intravenous,
intramuscular, subcutaneous, and
endotracheal, 0.5 mg/5 mL (0.1 mg/mL),
if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Carlarease Hunter, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–3702, Carlarease.Hunter@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
PO 00000
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the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
E:\FR\FM\24SEN1.SGM
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]]>Agencies
[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
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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.
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
