Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation, 36310-36312 [2016-13224]
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36310
Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices
5th Floor, Mail Room 5425, Washington,
DC 20201; telephone (202) 401–4870;
email: lauren.christopher@acf.hhs.gov.
It has been
determined that approximately
$1,230,022 in LIHEAP funds may be
available for reallotment during FY
2016. This determination is based on FY
2015 Carryover and Reallotment Reports
that showed that seven grantees
reported reallotment funds (Tennessee,
Puerto Rico, Coyote Valley Band of
Pomo Indians, Eastern Shoshone Tribe,
Passmaquoddy Tribe at Pleasant Point,
Poarch Band of Creek Indians, and The
Klamath Tribes). Grantees submitted the
FY 2015 Carryover and Reallotment
Reports to the Office of Community
Services (OCS), as required by
regulations applicable to LIHEAP at 45
CFR 96.82. This amount, however, may
increase because, as of April 1, 2016, the
report for 68 grantees remains pending.
The statute allows grantees who have
funds unobligated at the end of the
federal fiscal year for which they are
awarded to request that they be allowed
to carry over up to 10 percent of their
allotments to the next federal fiscal year.
Funds in excess of this amount must be
returned to HHS and are subject to
reallotment under section 2607(b)(1) of
the Act (42 U.S.C. 8626(b)(1)). The
amount described in this notice was
reported as unobligated FY 2015 funds
in excess of the amount that these
grantees could carry over to FY 2016.
OCS contacted each of the grantees to
confirm that the FY 2015 funds
indicated in the chart may be reallotted.
In accordance with section 2607(b)(3) of
the Act (42 U.S.C. 8626(b)(3)),
comments will be accepted for a period
of 30 days from the date of publication
of this notice.
After considering any comments
submitted, the Chief Executive Officers
of LIHEAP grantees will be notified of
the final reallotment amount. This
decision will be published in the
Federal Register.
If funds are reallotted, they will be
allocated in accordance with section
2604 of the Act (42 U.S.C. 8623) and
must be treated by LIHEAP grantees
receiving them as an amount
appropriated for FY 2016. As FY 2016
funds, they will be subject to all
requirements of the Act, including
section 2607(b)(2) (42 U.S.C. 8626(b)(2)),
which requires that a grantee obligate at
least 90 percent of its total block grant
allocation for a fiscal year by the end of
the fiscal year for which the funds are
appropriated, that is, by September 30,
2016.
sradovich on DSK3TPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
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Jkt 238001
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 301–
FY 2015
reallotment 796–3601.
amount
SUPPLEMENTARY INFORMATION: In the
$271,910 Federal Register of Tuesday, October
818,566 13, 2015, appearing on page 61426 in FR
Doc. 2015–25922, the following
9,025 correction is made:
37,413
On page 61426, in table 1, the entries
for NDAs 016096 and 016097 are
33,602
50,978 removed.
ESTIMATED REALLOTMENT AMOUNTS
OF FY 2015 LIHEAP FUNDS
Grantee name
Tennessee ..................................
Puerto Rico .................................
Coyote Valley Band of Pomo Indians ........................................
Eastern Shoshone Tribe .............
Passmaquoddy Tribe at Pleasant Point ..................................
Poarch Band of Creek Indians ...
The Klamath Tribes ....................
8,528
Total .....................................
1,230,022
Statutory Authority: 42 U.S.C. 8626.
Mary M. Wayland,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
[FR Doc. 2016–13217 Filed 6–3–16; 8:45 am]
Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–13182 Filed 6–3–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4184–80–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2013–N–0797]
Food and Drug Administration
[Docket No. FDA–2015–N–3432]
Organon USA et al.; Withdrawal of
Approval of 67 New Drug Applications
and 128 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 13, 2015 (80 FR
61426). The document announced the
withdrawal of approval of 67 new drug
applications (NDAs) and 128
abbreviated new drug applications from
multiple applicants, effective November
12, 2015. The document indicated that
FDA was withdrawing approval of the
following two NDAs after receiving a
request from the NDA holder, Merck
Sharp & Dohme Corp. (Merck), 1 Merck
Dr., P.O. Box 100, Whitehouse Station,
NJ 08889: NDA 016096, MINTEZOL
(thiabendazole) Tablets, and NDA
016097, MINTEZOL (thiabendazole)
Oral Suspension. Before withdrawal of
these NDAs became effective, Merck
informed FDA that it did not want
approval of the NDAs withdrawn.
Because Merck timely requested that
approval of these NDAs not be
withdrawn, the approval of NDAs
016096 and 016097 is still in effect.
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
SUMMARY:
PO 00000
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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) 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:
SUMMARY:
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
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Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices
sradovich on DSK3TPTVN1PROD with NOTICES
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): 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
https://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
VerDate Sep<11>2014
21:02 Jun 03, 2016
Jkt 238001
redacted/blacked out, will be available
for public viewing and posted on https://
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: https://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 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 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
PO 00000
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36311
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
§ 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
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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 × 90% = 236),
and 95 percent of eye tissue banks are
members of EBAA (121 × 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 § 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
§ 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 FDA experience.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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).
3 Documentation of deviations from SOPs.
2 Review
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3TPTVN1PROD with NOTICES
[Docket No. FDA–2016–N–1284]
Determination That APRESOLINE
(Hydralazine Hydrochloride) Injectable
and Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
16:36 Jun 03, 2016
Jkt 238001
The Food and Drug
Administration (FDA or Agency) has
determined that the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
PO 00000
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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 approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that 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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06JNN1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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) 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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 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): 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 https://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 https://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: https://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 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 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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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