Agency Information Collection Activities: Proposed Collection; Comment Request, 54902-54903 [2013-21700]
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54902
Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices
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access information after October 7,
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Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
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1061, Rockville, MD 20852. A transcript
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requests are to be sent to the Division
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1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
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transcript will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
SUPPLEMENTARY INFORMATION:
I. Background
Cataract surgery is the most
commonly performed elective
procedure in the United States with
over 3 million patients being implanted
with an IOL. Over the past two decades,
IOLs have undergone significant design
changes allowing them to correct for a
spectrum of visual distances and
refractive errors. As IOL technology
evolves, some endpoints for the
evaluation of the technology are also
evolving. Endpoints and strategies for
assessing the relative safety and
effectiveness of these innovative lens
designs are in various stages of
development. At this workshop, not
only will some of these novel endpoints
and the challenges with assessments of
these endpoints be identified, but these
endpoints also will be prioritized for
further discussion, development, and
validation. Breakout sessions following
the didactic portion of the workshop
will allow for more indepth group
discussions of potential approaches to
address these challenges.
The workshop seeks to involve
industry and academia in addressing the
challenges in the development of novel
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18:05 Sep 05, 2013
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endpoints for premium IOLs. By
bringing together all of the relevant
stakeholders, which include clinicians,
researchers, industry representatives,
and regulators, to this workshop, we
hope to facilitate the improvement of
regulatory science in this rapidly
evolving product area.
FDA and AAO recognize the unique
opportunity this workshop provides for
all stakeholders of the ophthalmic
device community and that the
knowledge and education provided
from this workshop will further
strengthen our mission of protecting the
public health.
II. Topics for Discussion at the Public
Workshop
Topics to be discussed at the public
workshop include, but are not limited
to:
• Safety assessments for premium
IOLs and how they could differ from
those for monofocal IOLs.
• Patient-reported outcome measures
and the need to develop and validate
them for assessing the safety and
effectiveness of premium IOLs.
• Objective assessments of
accommodation and their challenges.
• Subjective assessments of
accommodation and extended depth of
focus and their challenges.
These topics will be presented by
experts in the associated area, and the
afternoon will allow for more indepth
discussions of the given topics in small
breakout sessions.
Dated: September 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–21711 Filed 9–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: National Mental
Health Services Survey (N–MHSS)
(OMB No. 0930–0119)—Revision
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Behavioral
Health Statistics and Quality (CBHSQ),
is requesting a revision to the National
Mental Health Services Survey (N–
MHSS) (OMB No. 0930–0119), which
expires on June 30, 2015. The N–MHSS
provides national and state-level data on
the number and characteristics of
mental health treatment facilities in the
United States, annually, and national
and state-level data on the number and
characteristics of persons treated in
these facilities, biennially.
An immediate need under N–MHSS is
to update the information about
facilities on SAMHSA’s online
Behavioral Health Treatment Services
Locator (see: https://
findtreatment.samhsa.gov), which was
last updated with information from the
abbreviated N–MHSS (N–MHSS-Locator
Survey) in 2012. A full-scale N–MHSS
will be conducted in 2014 and 2016 to
collect (1) the information about
facilities needed to update the online
Locator, such as the facility name and
address, specific services offered, and
special client groups served, and (2)
additional information including client
counts and the demographics of persons
treated in these facilities. An
abbreviated N–MHSS (N–MHSS-Locator
Survey) will be conducted in 2015 to
update the information about facilities
on the online Locator. A data collection
in conjunction with adding new
facilities to the online Locator as they
become known to SAMHSA is also
being requested. Both the 2015 N–
MHSS-Locator Survey and the addition
of new facilities to the online Locator
will use the same N–MHSS-Locator
Survey instrument.
This requested revision seeks to
change the content of the currently
E:\FR\FM\06SEN1.SGM
06SEN1
54903
Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices
approved abbreviated N–MHSS (i.e., N–
MHSS-Locator) survey instrument, and
the previously approved 2010 full-scale
N–MHSS (OMB No. 0930–0119) to
accommodate two related N–MHSS
activities:
(1) collection of information from the
total N–MHSS universe of mental health
treatment facilities during 2014, 2015,
and 2016; and
(2) collection of information on newly
identified facilities throughout the year,
as they are identified, so that new
facilities can quickly be added to the
online Locator.
The survey mode for both data
collection activities will be web with
telephone follow-up.
The database resulting from the N–
MHSS will be used to update
SAMHSA’s online Behavioral Health
Treatment Services Locator and to
produce a national directory of mental
health facilities on compact disk (CD),
both for use by the general public,
behavioral health professionals, and
treatment service providers. In addition,
a data file derived from the survey will
be used to produce a summary report
providing national and state-level data.
The report and a public-use data file
will be used by researchers, mental
health professionals, State governments,
the U.S. Congress, and the general
public.
The request for OMB approval will
include a request to conduct the fullscale N–MHSS in 2014 and 2016 and an
abbreviated N–MHSS-Locator survey in
2015.
The following table summarizes the
estimated annual response burden for
the N–MHSS:
ESTIMATED ANNUAL RESPONSE BURDEN FOR THE N–MHSS
Type of
respondent
Number of
respondents
Responses per
respondent
Average hours
per response
Total burden
hours
Facilities in full-scale N–MHSS universe in 2014 and 2016 .............................
Newly identified facilities in Between-Survey Update in 2014, 2015, and
2016 1 .............................................................................................................
Facilities in N–MHSS-Locator Survey universe in 2015 ...................................
17,000
1
0.75
12,750
1,700
17,000
1
1
0.42
0.42
714
7,140
Average Annual Total .................................................................................
18,700
1
0.62
11,594
1 Collection of information on newly identified facilities throughout the year, as they are identified, so that new facilities can quickly be added to
the Locator.
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 2–1057, One Choke Cherry Road,
Rockville, MD 20857 or email her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
by November 5, 2013.
Summer King,
Statistician.
[FR Doc. 2013–21700 Filed 9–5–13; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories and
Instrumented Initial Testing Facilities
Which Meet Minimum Standards To
Engage in Urine Drug Testing for
Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the Laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
SUMMARY:
VerDate Mar<15>2010
18:05 Sep 05, 2013
Jkt 229001
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908);
September 30, 1997 (62 FR 51118);
April 13, 2004 (69 FR 19644); November
25, 2008 (73 FR 71858); December 10,
2008 (73 FR 75122); and on April 30,
2010 (75 FR 22809).
A notice listing all currently certified
laboratories and IITF is published in the
Federal Register during the first week of
each month. If any laboratory or IITF
certification is suspended or revoked,
the laboratory or IITF will be omitted
from subsequent lists until such time as
it is restored to full certification under
the Mandatory Guidelines.
If any laboratory or IITF 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.
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room 7–
1051, One Choke Cherry Road,
Rockville, Maryland 20857; 240–276–
2600 (voice), 240–276–2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were initially
developed in accordance with Executive
Order 12564 and section 503 of Public
Law 100–71. The ‘‘Mandatory
Guidelines for Federal Workplace Drug
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Testing Programs,’’ as amended in the
revisions listed above, requires strict
standards that laboratories and
Instrumented Initial Testing Facilities
(IITF) must meet in order to conduct
drug and specimen validity tests on
urine specimens for federal agencies.
To become certified, an applicant
Laboratory or IITF must undergo three
rounds of performance testing plus an
on-site inspection. To maintain that
certification, a Laboratory or IITF must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories and IITF in the applicant
stage of certification are not to be
considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines. A Laboratory or
IITF must have its letter of certification
from HHS/SAMHSA (formerly: HHS/
NIDA) which attests that it has met
minimum standards.
In accordance with the Mandatory
Guidelines dated November 25, 2008
(73 FR 71858), the following
Laboratories and Instrumented Initial
Testing Facilities (IITF) meet the
minimum standards to conduct drug
and specimen validity tests on urine
specimens:
Instrumented Initial Testing Facilities
(IITF): None.
Laboratories:
ACL Laboratories, 8901 W. Lincoln
Ave., West Allis, WI 53227, 414–328–
7840/800–877–7016 (Formerly:
Bayshore Clinical Laboratory).
E:\FR\FM\06SEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54902-54903]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21700]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: National Mental Health Services Survey (N-MHSS) (OMB
No. 0930-0119)--Revision
The Substance Abuse and Mental Health Services Administration
(SAMHSA), Center for Behavioral Health Statistics and Quality (CBHSQ),
is requesting a revision to the National Mental Health Services Survey
(N-MHSS) (OMB No. 0930-0119), which expires on June 30, 2015. The N-
MHSS provides national and state-level data on the number and
characteristics of mental health treatment facilities in the United
States, annually, and national and state-level data on the number and
characteristics of persons treated in these facilities, biennially.
An immediate need under N-MHSS is to update the information about
facilities on SAMHSA's online Behavioral Health Treatment Services
Locator (see: https://findtreatment.samhsa.gov), which was last updated
with information from the abbreviated N-MHSS (N-MHSS-Locator Survey) in
2012. A full-scale N-MHSS will be conducted in 2014 and 2016 to collect
(1) the information about facilities needed to update the online
Locator, such as the facility name and address, specific services
offered, and special client groups served, and (2) additional
information including client counts and the demographics of persons
treated in these facilities. An abbreviated N-MHSS (N-MHSS-Locator
Survey) will be conducted in 2015 to update the information about
facilities on the online Locator. A data collection in conjunction with
adding new facilities to the online Locator as they become known to
SAMHSA is also being requested. Both the 2015 N-MHSS-Locator Survey and
the addition of new facilities to the online Locator will use the same
N-MHSS-Locator Survey instrument.
This requested revision seeks to change the content of the
currently
[[Page 54903]]
approved abbreviated N-MHSS (i.e., N-MHSS-Locator) survey instrument,
and the previously approved 2010 full-scale N-MHSS (OMB No. 0930-0119)
to accommodate two related N-MHSS activities:
(1) collection of information from the total N-MHSS universe of
mental health treatment facilities during 2014, 2015, and 2016; and
(2) collection of information on newly identified facilities
throughout the year, as they are identified, so that new facilities can
quickly be added to the online Locator.
The survey mode for both data collection activities will be web
with telephone follow-up.
The database resulting from the N-MHSS will be used to update
SAMHSA's online Behavioral Health Treatment Services Locator and to
produce a national directory of mental health facilities on compact
disk (CD), both for use by the general public, behavioral health
professionals, and treatment service providers. In addition, a data
file derived from the survey will be used to produce a summary report
providing national and state-level data. The report and a public-use
data file will be used by researchers, mental health professionals,
State governments, the U.S. Congress, and the general public.
The request for OMB approval will include a request to conduct the
full-scale N-MHSS in 2014 and 2016 and an abbreviated N-MHSS-Locator
survey in 2015.
The following table summarizes the estimated annual response burden
for the N-MHSS:
Estimated Annual Response Burden for the N-MHSS
----------------------------------------------------------------------------------------------------------------
Number of Responses per Average hours Total burden
Type of respondent respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Facilities in full-scale N-MHSS universe in 2014 17,000 1 0.75 12,750
and 2016.........................................
Newly identified facilities in Between-Survey 1,700 1 0.42 714
Update in 2014, 2015, and 2016 \1\...............
Facilities in N-MHSS-Locator Survey universe in 17,000 1 0.42 7,140
2015.............................................
-------------------------------------------------------------
Average Annual Total.......................... 18,700 1 0.62 11,594
----------------------------------------------------------------------------------------------------------------
\1\ Collection of information on newly identified facilities throughout the year, as they are identified, so
that new facilities can quickly be added to the Locator.
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 2-1057, One Choke Cherry Road, Rockville, MD 20857 or email her a
copy at summer.king@samhsa.hhs.gov. Written comments should be received
by November 5, 2013.
Summer King,
Statistician.
[FR Doc. 2013-21700 Filed 9-5-13; 8:45 am]
BILLING CODE 4162-20-P
