Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation, 45127-45128 [2010-18851]
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45127
Federal Register / Vol. 75, No. 147 / Monday, August 2, 2010 / Notices
Responses
per
respondent
Number of
respondents
Form name
Total burden
Organizers Survey ...........................................................................................
Participants Survey ..........................................................................................
1 30,600
1
1
0.500
0.167
1,700.00
5,110.20
Totals ........................................................................................................
34,000
........................
........................
6,810.20
19
responses per THM event [3,400].
SAMHSA/CSAP intends to support
THM events every other year. The
information collected will be used by
SAMHSA/CSAP to help plan for these
biennial events, to provide technical
assistance and training to organizations
that sponsor the events, and to comply
with the reporting requirements of the
Government Performance Results Act of
1993. The information collected will
also provide a descriptive picture of the
nationwide initiative, and it will
indicate how the THM events were
received by the community and factors
that may be associated with wellreceived events.
Written comments and
recommendations concerning the
proposed information collection should
be sent by September 1, 2010 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
5806.
Dated: July 20, 2010.
Elaine Parry,
Director, Office of Program Services.
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0066]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Tissue
Intended for Transplantation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Mar<15>2010
15:04 Jul 30, 2010
Jkt 220001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by [September
1, 2010.].
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0302. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Human Tissue Intended for
Transplantation—(OMB Control
Number 0910–0302)—Extension
[FR Doc. 2010–18862 Filed 7–30–10; 8:45 am]
erowe on DSK5CLS3C1PROD with NOTICES
3,400
Burden per response (hrs.)
Under section 361 of the Public
Health Service (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 (HIV), 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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. Section
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 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 such records required under
§ 1270.21. Section 1270.33(h) requires
all records to be retained 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
257 tissue establishments of which 145
are conventional tissue banks and 112
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% of the tissue
discarded due to unsuitability for
transplant. In addition, there are an
estimated 57,275 donors of conventional
tissue and 54,115 donors of eye tissue
each year.
E:\FR\FM\02AUN1.SGM
02AUN1
45128
Federal Register / Vol. 75, No. 147 / Monday, August 2, 2010 / Notices
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% of the
conventional tissue banks are members
of AATB (145 x 90% = 130), and 77%
of eye tissue banks are members of
EBAA (112 x 77% = 86). Therefore,
recordkeeping by these 216
establishments (130 + 86 = 216) 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 41 establishments, which is
16% of all establishments (257 - 216 =
41, or 41/257 = 16%).
Based on CBER’s database system and
information provided by industry, FDA
estimates an average of two new tissue
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.
In the Federal Register of March 1,
2010 (75 FR 9226), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
information collection as follows:
banks annually, which may be nonmembers of a trade association. Each
new tissue bank requires an estimated
64 hours to prepare standard operating
procedures (SOPs) under § 1270.31(a)
through (d). The requirement for the
development of these written
procedures is considered an initial onetime burden. 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
for § 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
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
1270.31(a), (b), (c), and (d)
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
2
1
2
64
128
41
1
41
24
984
1270.31(a) and (b)3
41
2
82
1
82
1270.33(a), (f), and (h), and
1270.35(a) and (b)
41
8,404
344,564
1
344,564
1270.35(c)
41
15,938
653,458
1
653,458
1270.35(d)
41
1,992
81,672
1
81,672
1270.31(a), (b), (c), and
(d)2
Total
1,080,888
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2Review and update of SOPs.
3Documentation of deviations from SOPs.
Dated: July 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–18851 Filed 7–30–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
erowe on DSK5CLS3C1PROD with NOTICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories Which
Meet Minimum Standards To Engage in
Urine Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
AGENCY:
ACTION:
Notice.
VerDate Mar<15>2010
15:04 Jul 30, 2010
Jkt 220001
The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories currently
certified to meet the standards of
Subpart C of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908),
on September 30, 1997 (62 FR 51118),
and on April 13, 2004 (69 FR 19644).
A notice listing all currently certified
laboratories is published in the Federal
Register during the first week of each
month. If any laboratory’s certification
is suspended or revoked, the laboratory
will be omitted from subsequent lists
until such time as it is restored to full
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
certification under the Mandatory
Guidelines.
If any laboratory has withdrawn from
the HHS National Laboratory
Certification Program (NLCP) during the
past month, it will be listed at the end,
and will be omitted from the monthly
listing thereafter.
This notice is also available on the
Internet at https://
www.workplace.samhsa.gov and https://
www.drugfreeworkplace.gov.
FOR FURTHER INFORMATION CONTACT: Mrs.
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room
2–1042, One Choke Cherry Road,
Rockville, Maryland 20857; 240–276–
2600 (voice), 240–276–2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were developed
in accordance with Executive Order
12564 and section 503 of Public Law
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 75, Number 147 (Monday, August 2, 2010)]
[Notices]
[Pages 45127-45128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18851]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0066]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Tissue Intended
for Transplantation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
[September 1, 2010.].
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0302.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Human Tissue Intended for Transplantation--(OMB Control Number 0910-
0302)--Extension
Under section 361 of the Public Health Service (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 (HIV),
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. Section 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 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 such records
required under Sec. 1270.21. Section 1270.33(h) requires all records
to be retained 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 257 tissue
establishments of which 145 are conventional tissue banks and 112 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% of the
tissue discarded due to unsuitability for transplant. In addition,
there are an estimated 57,275 donors of conventional tissue and 54,115
donors of eye tissue each year.
[[Page 45128]]
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% of the conventional tissue banks are members of
AATB (145 x 90% = 130), and 77% of eye tissue banks are members of EBAA
(112 x 77% = 86). Therefore, recordkeeping by these 216 establishments
(130 + 86 = 216) 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 41 establishments, which
is 16% of all establishments (257 - 216 = 41, or 41/257 = 16%).
Based on CBER's database system and information provided by
industry, FDA estimates an average of two new tissue banks annually,
which may be non-members of a trade association. Each new tissue bank
requires an estimated 64 hours to prepare standard operating procedures
(SOPs) under Sec. 1270.31(a) through (d). The requirement for the
development of these written procedures is considered an initial one-
time burden. 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 for 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.
In the Federal Register of March 1, 2010 (75 FR 9226), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
FDA estimates the burden of this information collection as follows:
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d) 2 1 2 64 128
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d)\2\ 41 1 41 24 984
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.31(a) and (b)\3\ 41 2 82 1 82
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.33(a), (f), and (h), and 1270.35(a) and (b) 41 8,404 344,564 1 344,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.35(c) 41 15,938 653,458 1 653,458
--------------------------------------------------------------------------------------------------------------------------------------------------------
1270.35(d) 41 1,992 81,672 1 81,672
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,080,888
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Review and update of SOPs.
\3\Documentation of deviations from SOPs.
Dated: July 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-18851 Filed 7-30-10; 8:45 am]
BILLING CODE 4160-01-S
