Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation, 41403-41404 [2013-16556]
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Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices
41403
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
State Feed Regulatory Programs in the United States .......
50
1
50
3,000
150,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated to
3,000 hours per respondent. The
estimate includes time for reviewing the
standards, gathering and maintaining
the data and documents for each
standard, and completing and reviewing
the data and documents that would be
spent to fully implement the 11
standards. FDA recognizes that full use
and implementation of the feed
standards by State feed programs will
occur over many years and the number
of years to fully implement the feed
standards will vary among States. This
burden was determined by averaging the
burden estimates received from five
respondents. The five respondents are
representative of the State feed
programs in the United States.
Dated: July 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16517 Filed 7–9–13; 8:45 am]
BILLING CODE 4160–01–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) 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.
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:42 Jul 09, 2013
Jkt 229001
Submit either electronic or
written comments on the collection of
information by September 9, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@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
DATES:
PO 00000
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Fmt 4703
Sfmt 4703
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 (PHS) 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.
Sections 1270.31(a) through (d)
require 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
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41404
Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices
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, FDA
estimates that there are approximately
281 tissue establishments, of which 185
are conventional tissue banks and 96 are
eye tissue banks. Based on information
provided by industry, there are an
estimated total of 1,959,270
conventional tissue products and 82,741
eye tissue products recovered per year
with an average of 25 percent of the
tissue discarded due to unsuitability for
transplant. In addition, there are an
estimated 73,075 donors of conventional
tissue and 49,026 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 (185 × 90 percent =
166), and 85 percent of eye tissue banks
are members of EBAA (96 × 85 percent
= 82). Therefore, recordkeeping by these
248 establishments (166 + 82 = 248) 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 33 establishments, which is
12 percent of all establishments (281 ¥
248 = 33, or 33/281 = 12 percent).
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
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
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) ....................................
Total annual
records
Average burden
per recordkeeping
Total hours
33
33
1
2
33
66
24
1
792
66
33
33
33
7,869.48
14,850.96
1,856.36
259,693
490,082
61,260
1
1
1
259,693
490,082
61,260
Total ......................................
811,893
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: July 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16556 Filed 7–9–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TKELLEY on DSK3SPTVN1PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
VerDate Mar<15>2010
17:42 Jul 09, 2013
Jkt 229001
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
SUMMARY:
PO 00000
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To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evaluating the Impact of 1115 Medicaid
Waivers on Ryan White HIV/AIDS
Program and Its Clients and Providers
OMB No. 0915–xxxx—NEW
Abstract: Section 1115 of the Social
Security Act allows states to develop,
test, and implement new approaches to
providing Medicaid coverage outside of
federal program rules. Leading up to full
implementation of the Affordable Care
Act, states have begun to use Section
1115 Medicaid demonstration waivers
as a ‘‘bridge’’ to 2014. This project will
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\10JYN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Notices]
[Pages 41403-41404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16556]
-----------------------------------------------------------------------
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 September 9, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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 (PHS) 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.
Sections 1270.31(a) through (d) require 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
[[Page 41404]]
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, FDA estimates that there are approximately 281 tissue
establishments, of which 185 are conventional tissue banks and 96 are
eye tissue banks. Based on information provided by industry, there are
an estimated total of 1,959,270 conventional tissue products and 82,741
eye tissue products recovered per year with an average of 25 percent of
the tissue discarded due to unsuitability for transplant. In addition,
there are an estimated 73,075 donors of conventional tissue and 49,026
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 (185 x 90 percent = 166), and 85 percent of eye tissue
banks are members of EBAA (96 x 85 percent = 82). Therefore,
recordkeeping by these 248 establishments (166 + 82 = 248) 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 33 establishments, which is 12 percent of all establishments
(281 - 248 = 33, or 33/281 = 12 percent).
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 Number of records Total annual Average burden
21 CFR Section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d) \2\................... 33 1 33 24 792
1270.31(a) and 1270.31(b) \3\....................... 33 2 66 1 66
1270.33(a), (f), and (h), and 1270.35(a) and (b).... 33 7,869.48 259,693 1 259,693
1270.35(c).......................................... 33 14,850.96 490,082 1 490,082
1270.35(d).......................................... 33 1,856.36 61,260 1 61,260
---------------------------------------------------------------------------------------------------
Total........................................... 811,893
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: July 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16556 Filed 7-9-13; 8:45 am]
BILLING CODE 4160-01-P
