Agency Information Collection Activities: Submission for OMB Review; Comment Request, 38195-38196 [E9-18313]
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38195
Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices
of the public the opportunity to provide
comments to the Board. Public
participation and ability to comment
will be limited to time and space
available. Public comment will be
limited to no more than 3 minutes per
speaker. To be placed on the public
participant list, you should notify the
operator when you enter the call-in
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Any members of the public who wish
to have printed material distributed to
the NBSB should submit materials via
email at NBSB@HHS.GOV, with ‘‘NBSB
Public Comment’’ as the subject line,
prior to the close of business one week
before each meeting (conference call). A
draft agenda and any additional
materials/agendas will be posted on the
NBSB Web site (https://
WWW.HHS.GOV/ASPR/OMSPH/NBSB/)
prior to the meeting.
Dated: July 24, 2009.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response, Rear Admiral, U.S. Public Health
Service.
[FR Doc. E9–18372 Filed 7–30–09; 8:45 am]
BILLING CODE 4150–37–P
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: Drug and Alcohol Services
Information System (DASIS)—(OMB
No. 0930–0106)—Revision
The DASIS consists of three related
data systems: the Inventory of Substance
Abuse Treatment Services (I–SATS); the
National Survey of Substance Abuse
Treatment Services (N–SSATS), and the
Treatment Episode Data Set (TEDS). The
I–SATS includes all substance abuse
treatment facilities known to SAMHSA.
The N–SSATS is an annual survey of all
substance abuse treatment facilities
listed in the I–SATS. The TEDS is a
compilation of client-level admission
data and discharge data submitted by
States on clients treated in facilities that
receive State funds. Together, the three
DASIS components provide information
on the location, scope and
characteristics of all known drug and
alcohol treatment facilities in the United
States, the number of persons in
treatment, and the characteristics of
clients receiving services at publicly
funded facilities. This information is
needed to assess the nature and extent
of these resources, to identify gaps in
services, to provide a database for
treatment referrals, and to assess
demographic and substance-related
trends in treatment. In addition, several
National Outcome Measures (NOMS)
data elements are collected in TEDS to
Type of
respondent and activity
Number of
respondents
assess the performance of the Substance
Abuse Prevention and Treatment
(SAPT) Block Grant.
The request for OMB approval will
include a request to conduct the 2010
through 2012 N–SSATS and Mini-N–
SSATS. The Mini-N–SSATS is a
procedure for collecting services data
from newly identified facilities between
main cycles of the survey and will be
used to improve the listing of treatment
facilities in the on-line treatment facility
Locator. The N–SSATS questionnaire is
expected to remain unchanged except
for minor modifications to wording. If
there is a need for substantial revision
to the N–SSATS questionnaire during
the period of this clearance, a
supplemental request for clearance will
be submitted.
The OMB request will also include
the collection of TEDS data, including
the addition of two new NOMS data
elements to the TEDS client-level
record. To the extent that states already
collect the elements from their
treatment providers, the following
elements will be included in the TEDS
data collection: Frequency of attendance
at self-help programs in past 30 days at
admission; and frequency of attendance
at self-help programs in past 30 days at
discharge. No significant changes are
expected in the other DASIS activities.
Estimated annual burden for the
DASIS activities is shown below:
Responses
per
respondent
Hours per
response
Total burden
hours
52
52
5
56
4
4
1
70
6.25
8.25
10
.08
1,300
1,716
50
314
State Subtotal ....................................................................................
PWALKER on DSK8KYBLC1PROD with NOTICES
States:
TEDS Admission Data ..............................................................................
TEDS Discharge Data ..............................................................................
TEDS Discharge Crosswalks ...................................................................
I–SATS Update 1 .......................................................................................
56
........................
........................
3,380
Facilities:
I–SATS Update 2 .......................................................................................
N–SSATS questionnaire ...........................................................................
Augmentation screener ............................................................................
Mini N–SSATS ..........................................................................................
200
17,000
1,000
2,000
1
1
1
1
.08
.67
.08
.42
16
11,390
80
840
Facility Subtotal .................................................................................
20,200
........................
........................
12,326
Total ...................................................................................................
20,256
........................
........................
15,706
1 States forward to SAMHSA information on newly licensed/approved facilities and on changes in facility name, address, status, etc. This is
submitted electronically by nearly all States.
2 Facilities forward to SAMHSA information on new facilities and on changes to existing facilities. This is submitted by e-mail by nearly all
facilities.
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38196
Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices
Written comments and
recommendations concerning the
proposed information collection should
be sent by August 31, 2009 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: 202–395–6974.
Dated: July 27, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–18313 Filed 7–30–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0092]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Class II Special
Controls Guidance Document:
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Separation Principle
AGENCY:
Food and Drug Administration,
HHS.
PWALKER on DSK8KYBLC1PROD with NOTICES
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 August 31,
2009.
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0594. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
VerDate Nov<24>2008
16:38 Jul 30, 2009
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Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle—(OMB Control
Number 0910–0594)—Extension
Under the Safe Medical Devices Act
of 1990 (Public Law 101–629, 104 Stat.
4511), FDA may establish special
controls, including performance
standards, postmarket surveillance,
patient registries, guidelines, and other
appropriate actions it believes necessary
to provide reasonable assurance of the
safety and effectiveness of the device.
The special control guidance serves to
support the reclassification from class
III to class II of the automated blood cell
separator device operating on a
centrifugal separation principle
intended for the routine collection of
blood and blood components as well as
the special control for the automated
blood cell separator device operating on
a filtration separation principle
intended for the routine collection of
blood and blood components
reclassified as class II (§ 864.9245 (21
CFR 864.9245)).
For currently marketed products not
approved under the premarket approval
process, the manufacturer should file
with FDA for 3 consecutive years an
annual report on the anniversary date of
the device reclassification from class III
to class II or, on the anniversary date of
the section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360) clearance. Any subsequent
change to the device requiring the
submission of a premarket notification
in accordance with section 510(k) of the
act should be included in the annual
report. Also, a manufacturer of a device
determined to be substantially
equivalent to the centrifugal or
filtration-based automated cell separator
device intended for the routine
collection of blood and blood
components, should comply with the
same general and special controls.
The annual report should include, at
a minimum, a summary of anticipated
and unanticipated adverse events that
have occurred and that are not required
to be reported by manufacturers under
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Frm 00032
Fmt 4703
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Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation.
Reclassification of this device from
class III to class II for the intended use
of routine collection of blood and blood
components relieves manufacturers of
the burden of complying with the
premarket approval requirements of
section 515 of the act (21 U.S.C. 360e),
and may permit small potential
competitors to enter the marketplace by
reducing the burden. Although the
special control guidance recommends
that manufacturers of these devices file
with FDA an annual report for 3
consecutive years, this would be less
burdensome than the current
postapproval under part 814, subpart E
(21 CFR part 814, subpart E), including
the submission of periodic reports
under § 814.84.
Collecting or transfusing facilities and
manufacturers have certain
responsibilities under the Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the manufacturer is
responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b)). In addition, manufacturers
of medical devices are required to
submit to FDA individual adverse event
reports of death, serious injury, and
malfunctions (§ 803.50).
In the special control guidance
document, FDA recommends that
manufacturers include in their three
annual reports a summary of adverse
events that have occurred and that are
not required to be reported by
manufacturers under MDR. The
MedWatch medical device reporting
code instructions (https://www.fda.gov/
cdrh/mdr/373.html) contains a
comprehensive list of adverse events
associated with device use, including
most of those events that we
recommend summarizing in the annual
report.
In the Federal Register of March 2,
2009 (74 FR 9097), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\31JYN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 146 (Friday, July 31, 2009)]
[Notices]
[Pages 38195-38196]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18313]
-----------------------------------------------------------------------
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: Drug and Alcohol Services Information System (DASIS)--(OMB No.
0930-0106)--Revision
The DASIS consists of three related data systems: the Inventory of
Substance Abuse Treatment Services (I-SATS); the National Survey of
Substance Abuse Treatment Services (N-SSATS), and the Treatment Episode
Data Set (TEDS). The I-SATS includes all substance abuse treatment
facilities known to SAMHSA. The N-SSATS is an annual survey of all
substance abuse treatment facilities listed in the I-SATS. The TEDS is
a compilation of client-level admission data and discharge data
submitted by States on clients treated in facilities that receive State
funds. Together, the three DASIS components provide information on the
location, scope and characteristics of all known drug and alcohol
treatment facilities in the United States, the number of persons in
treatment, and the characteristics of clients receiving services at
publicly funded facilities. This information is needed to assess the
nature and extent of these resources, to identify gaps in services, to
provide a database for treatment referrals, and to assess demographic
and substance-related trends in treatment. In addition, several
National Outcome Measures (NOMS) data elements are collected in TEDS to
assess the performance of the Substance Abuse Prevention and Treatment
(SAPT) Block Grant.
The request for OMB approval will include a request to conduct the
2010 through 2012 N-SSATS and Mini-N-SSATS. The Mini-N-SSATS is a
procedure for collecting services data from newly identified facilities
between main cycles of the survey and will be used to improve the
listing of treatment facilities in the on-line treatment facility
Locator. The N-SSATS questionnaire is expected to remain unchanged
except for minor modifications to wording. If there is a need for
substantial revision to the N-SSATS questionnaire during the period of
this clearance, a supplemental request for clearance will be submitted.
The OMB request will also include the collection of TEDS data,
including the addition of two new NOMS data elements to the TEDS
client-level record. To the extent that states already collect the
elements from their treatment providers, the following elements will be
included in the TEDS data collection: Frequency of attendance at self-
help programs in past 30 days at admission; and frequency of attendance
at self-help programs in past 30 days at discharge. No significant
changes are expected in the other DASIS activities.
Estimated annual burden for the DASIS activities is shown below:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
Type of respondent and activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
States:
TEDS Admission Data......................... 52 4 6.25 1,300
TEDS Discharge Data......................... 52 4 8.25 1,716
TEDS Discharge Crosswalks................... 5 1 10 50
I-SATS Update \1\........................... 56 70 .08 314
---------------------------------------------------------------
State Subtotal.......................... 56 .............. .............. 3,380
================================================================================================================
Facilities:
I-SATS Update \2\........................... 200 1 .08 16
N-SSATS questionnaire....................... 17,000 1 .67 11,390
Augmentation screener....................... 1,000 1 .08 80
Mini N-SSATS................................ 2,000 1 .42 840
---------------------------------------------------------------
Facility Subtotal....................... 20,200 .............. .............. 12,326
================================================================================================================
Total................................... 20,256 .............. .............. 15,706
----------------------------------------------------------------------------------------------------------------
\1\ States forward to SAMHSA information on newly licensed/approved facilities and on changes in facility name,
address, status, etc. This is submitted electronically by nearly all States.
\2\ Facilities forward to SAMHSA information on new facilities and on changes to existing facilities. This is
submitted by e-mail by nearly all facilities.
[[Page 38196]]
Written comments and recommendations concerning the proposed
information collection should be sent by August 31, 2009 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: 202-395-6974.
Dated: July 27, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-18313 Filed 7-30-09; 8:45 am]
BILLING CODE 4162-20-P
