Agency Information Collection Activities: Submission for OMB Review; Comment Request, 45126-45127 [2010-18862]
Download as PDF
<![CDATA[
45126
Federal Register / Vol. 75, No. 147 / Monday, August 2, 2010 / Notices
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
OAS, Room 7–1044, 1 Choke Cherry
Road, Rockville, MD 20857. Written
comments should be received by
October 1, 2010.
Dated: July 27, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–18877 Filed 7–30–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Reworded Topics/Questions
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
erowe on DSK5CLS3C1PROD with NOTICES
Project: Assessment of the Town Hall
Meetings on Underage Drinking
Prevention—Revision
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Substance Abuse
Prevention (CSAP), is proposing a
revision to the information collection
regarding the Assessment of the Town
Hall Meetings (THMs) on Underage
Drinking (UAD) Prevention. The current
data collection has approval under OMB
#0930–0288, which expires on January
31, 2011. Revisions were made to the
Town Hall Meeting Feedback Form,
now being referred to as the Organizers
Survey; the data collection method; and
the number of respondents.
Additionally, CSAP is adding a new
data collection component titled the
Participants Survey, which is the data
collection instrument for the
participants (or attendees) of the THM
events.
Changes
Under the current approval,
SAMHSA/CSAP distributes a brief
Town Hall Meeting Feedback Form to
all CBOs participating in THM events.
This paper-and-pencil based form
includes 14 items about the THM event,
among which—
• Where, when, and who conducted
the meeting;
• Number of attendees;
VerDate Mar<15>2010
15:04 Jul 30, 2010
Jkt 220001
• Format of the meeting;
• Participants in the presentations;
• Actions planned;
• Media coverage;
• Composition of the audience;
• Responses of the attendees;
• Materials provided;
• Indications of increased awareness;
and
• Indications of increased
involvement.
Under this revision, SAMHSA/CSAP
will provide organizers of THM events
with password-protected login
information to access the Organizers
Survey via the Internet. The Organizers
Survey includes 36 items about the
THM event. Listed below is a summary
of the revisions that were made—
• Date of THM event.
• Location of THM event.
• Organization(s) coordinating the THM
event.
• Format/Features of the THM event.
• Promotion of the THM event.
• Participants in the THM event presentations.
• Major actions planned as a result of the
THM event.
• Overall satisfaction with the THM event.
• Sharing of any other important features of
reactions to the THM event.
• Number/Composition of THM attendees.
Deleted Topics/Questions
•
•
•
•
Description of meeting.
Organization affiliation.
Overall response of THM event attendees.
Use of materials from the THM resource
kit.
• Indications of increased awareness.
• Indications of increased involvement.
New Topics/Questions
• Indication of whether a THM event was not
held and reason why the event was not
held.
• Venue in which THM event was held.
• Characterization of the THM event location.
• Duration of the THM event (in hours and
minutes).
• Youth involvement in the THM event.
• Topic of THM event, if other than underage
drinking.
• Demographics of the participants (age,
race, gender).
• Language of the THM event.
• Use of materials from the https://
www.stopalcoholabuse.gov Web site.
• Participation in THM-related webinars.
• Viewing of online training and requests for
technical assistance (TA).
• Satisfaction with training and/or TA received.
• Improved capacity to provide effective UAD
services due to training and/or TA received.
• Implementation of training and/or TA recommendations.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
• Indication of whether data were collected
about the THM event and willingness to
share those data with CSAP.
New Data Collection Component
SAMHSA/CSAP will provide
organizers of THM events with a unique
URL to make available to participants of
their THM event. This unique URL
provides access to the Participants
Survey.
The Participants Survey includes 17
items about the THM event, among
which—
• When and where the THM event
was held;
• Estimation of the number of
attendees at the THM event;
• Perception of increased awareness;
• Indication of reach of the underage
drinking prevention messages from the
THM event;
• Perception of increased
involvement;
• Indication of the most important
underage drinking issues facing the
community;
• Perception of how well the THM
event addressed those issues;
• Appropriateness of the THM event
in terms of length and duration;
• Overall assessment of the THM
event; and
• Demographics of the participants.
The Organizers Survey will be
completed by an estimated 3,400 THM
event organizers and will require only
one response per respondent. It will
take an average of 30 minutes (0.500
hours) to review the instructions and
complete the survey. This burden
estimate is based on comments from
several potential respondents who
reviewed the survey and provided
comments on how long it would take
them to complete it.
The Participants Survey will be
completed by an estimated nine
participants per THM event and will
require only one response per
respondent. The estimated number of
participant respondents is based on 21
percent of the average of the sum of
adult (66,519) and youth (53,554)
participants, as reported on the 2008
THM events feedback forms (1,492
forms reported adults as participants
and 1,316 forms reported youth as
participants) [(120,073/2,808 = 42.76) ×
0.21 = 8.9798]. It will take an average of
10 minutes (0.167 hours) to review the
instructions and complete the survey.
This burden estimate is based on
comments from several potential
respondents who reviewed the survey
and provided comments on how long it
would take them to complete it.
E:\FR\FM\02AUN1.SGM
02AUN1
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
]]>Agencies
[Federal Register Volume 75, Number 147 (Monday, August 2, 2010)]
[Notices]
[Pages 45126-45127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18862]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: Assessment of the Town Hall Meetings on Underage Drinking
Prevention--Revision
The Substance Abuse and Mental Health Services Administration's
(SAMHSA) Center for Substance Abuse Prevention (CSAP), is proposing a
revision to the information collection regarding the Assessment of the
Town Hall Meetings (THMs) on Underage Drinking (UAD) Prevention. The
current data collection has approval under OMB 0930-0288,
which expires on January 31, 2011. Revisions were made to the Town Hall
Meeting Feedback Form, now being referred to as the Organizers Survey;
the data collection method; and the number of respondents.
Additionally, CSAP is adding a new data collection component titled the
Participants Survey, which is the data collection instrument for the
participants (or attendees) of the THM events.
Changes
Under the current approval, SAMHSA/CSAP distributes a brief Town
Hall Meeting Feedback Form to all CBOs participating in THM events.
This paper-and-pencil based form includes 14 items about the THM event,
among which--
Where, when, and who conducted the meeting;
Number of attendees;
Format of the meeting;
Participants in the presentations;
Actions planned;
Media coverage;
Composition of the audience;
Responses of the attendees;
Materials provided;
Indications of increased awareness; and
Indications of increased involvement.
Under this revision, SAMHSA/CSAP will provide organizers of THM
events with password-protected login information to access the
Organizers Survey via the Internet. The Organizers Survey includes 36
items about the THM event. Listed below is a summary of the revisions
that were made--
------------------------------------------------------------------------
-------------------------------------------------------------------------
Reworded Topics/Questions
------------------------------------------------------------------------
Date of THM event.
Location of THM event.
Organization(s) coordinating the THM event.
Format/Features of the THM event.
Promotion of the THM event.
Participants in the THM event presentations.
Major actions planned as a result of the THM event.
Overall satisfaction with the THM event.
Sharing of any other important features of reactions to the THM
event.
Number/Composition of THM attendees.
------------------------------------------------------------------------
Deleted Topics/Questions
------------------------------------------------------------------------
Description of meeting.
Organization affiliation.
Overall response of THM event attendees.
Use of materials from the THM resource kit.
Indications of increased awareness.
Indications of increased involvement.
------------------------------------------------------------------------
New Topics/Questions
------------------------------------------------------------------------
Indication of whether a THM event was not held and reason why
the event was not held.
Venue in which THM event was held.
Characterization of the THM event location.
Duration of the THM event (in hours and minutes).
Youth involvement in the THM event.
Topic of THM event, if other than underage drinking.
Demographics of the participants (age, race, gender).
Language of the THM event.
Use of materials from the https://www.stopalcoholabuse.gov Web
site.
Participation in THM-related webinars.
Viewing of online training and requests for technical
assistance (TA).
Satisfaction with training and/or TA received.
Improved capacity to provide effective UAD services due to
training and/or TA received.
Implementation of training and/or TA recommendations.
Indication of whether data were collected about the THM event
and willingness to share those data with CSAP.
------------------------------------------------------------------------
New Data Collection Component
SAMHSA/CSAP will provide organizers of THM events with a unique URL
to make available to participants of their THM event. This unique URL
provides access to the Participants Survey.
The Participants Survey includes 17 items about the THM event,
among which--
When and where the THM event was held;
Estimation of the number of attendees at the THM event;
Perception of increased awareness;
Indication of reach of the underage drinking prevention
messages from the THM event;
Perception of increased involvement;
Indication of the most important underage drinking issues
facing the community;
Perception of how well the THM event addressed those
issues;
Appropriateness of the THM event in terms of length and
duration;
Overall assessment of the THM event; and
Demographics of the participants.
The Organizers Survey will be completed by an estimated 3,400 THM
event organizers and will require only one response per respondent. It
will take an average of 30 minutes (0.500 hours) to review the
instructions and complete the survey. This burden estimate is based on
comments from several potential respondents who reviewed the survey and
provided comments on how long it would take them to complete it.
The Participants Survey will be completed by an estimated nine
participants per THM event and will require only one response per
respondent. The estimated number of participant respondents is based on
21 percent of the average of the sum of adult (66,519) and youth
(53,554) participants, as reported on the 2008 THM events feedback
forms (1,492 forms reported adults as participants and 1,316 forms
reported youth as participants) [(120,073/2,808 = 42.76) x 0.21 =
8.9798]. It will take an average of 10 minutes (0.167 hours) to review
the instructions and complete the survey. This burden estimate is based
on comments from several potential respondents who reviewed the survey
and provided comments on how long it would take them to complete it.
[[Page 45127]]
----------------------------------------------------------------------------------------------------------------
Burden per
Form name Number of Responses per response Total burden
respondents respondent (hrs.)
----------------------------------------------------------------------------------------------------------------
Organizers Survey............................... 3,400 1 0.500 1,700.00
Participants Survey............................. \1\ 30,600 1 0.167 5,110.20
---------------------------------------------------------------
Totals...................................... 34,000 .............. .............. 6,810.20
----------------------------------------------------------------------------------------------------------------
\1\ 9 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 well-
received 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.
[FR Doc. 2010-18862 Filed 7-30-10; 8:45 am]
BILLING CODE 4162-20-P
