Submission for OMB Review; Comment Request, 68194-68195 [2011-28510]
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68194
Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
that consists of three criteria, weighted
equally and combined to result in the
total score. The three criteria are: (1)
Frequency of occurrence at NPL sites;
(2) toxicity; and (3) potential for human
exposure. The site-specific information
used to develop the priority list has
been collected from ATSDR public
health assessments and from site-file
data packages used to develop the
public health assessments. Since the
development of the 2007 substance
priority list, additional site specific
information has been collected. The
new information may include more
recent NPL frequency-of-occurrence
data, additional concentration data, and
more information on exposure to
substances at NPL sites. Using these
additional data, seven substances have
been replaced on the list of 275
substances since the 2007 publication;
the replacement substances were
previously under consideration.
Changes in the order of substances
appearing on the Priority List of
Hazardous Substances will be reflected
in program activities that rely on the list
for future direction. Using the current
algorithm, a total of 847 candidate
substances have been analyzed and
ranked. Of these candidates, the 275
substances on the priority list may in
the future become the subject of
toxicological profiles.
In two years ATSDR intends to
publish the next revised list of
hazardous substances, with an informal
review and revision performed in one
year. These revisions will reflect
changes and improvements in data
collection and availability. Additional
information on the existing
methodology used in the development
of the Priority List of Hazardous
Substances can be found in the Support
Document and in the above-referenced
Federal Register notices.
In addition to the revised priority list,
ATSDR is also releasing a revised
Completed Exposure Pathway Site
Count Report. A completed exposure
pathway (CEP) links a contaminant
source to a receptor population. The
CEP ranking is similar to a
subcomponent of the substance priority
list algorithm’s potential-for-humanexposure component. The CEP ranking
is based on a site frequency count and
thus lists the number of sites at which
a substance has been found in a CEP.
This information is derived from
ATSDR public health assessments and
from health consultations. The CEP
report therefore focuses on documented
exposure, and lists hazardous
substances according to exposure
frequency.
The substances in the CEP report are
similar to those in the Priority List of
Hazardous Substances. However, some
substances in the CEP report have a very
low toxicity (e.g., sodium) and as a
result are not included in the substance
priority list. Since the substance priority
list uses toxicity, frequency of
occurrence, and potential for human
exposure to determine its priority
substances, other low-toxicity
substances will not appear on the list
and, consequently, will not become
subjects of toxicological profiles.
In addition, because CERCLA
mandates the preparation of the Priority
List of Hazardous Substances, that list
only incorporates data from CERCLA
NPL sites. The CEP report, on the other
hand, uses data from all ATSDR-activity
sites at which a CEP has been detected.
Dated: October 28, 2011.
Ken Rose,
Director, Office of Policy Planning and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2011–28477 Filed 11–2–11; 8:45 am]
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
OMB No.: 0970–0230.
Description: There is no longer a High
Performance Bonus associated with this
information collection. The Deficit
Reduction Act of 2005 (Pub. L. 109–171)
eliminated the funding for the High
Performance Bonus (HPB), but we are
still requesting that States continue to
submit data necessary to calculate the
work measures previously reported
under the HPB.
Specifically, The TANF program was
reauthorized under the Deficit
Reduction Act of 2005. The statute
eliminated the funding for the HPB
under section 403(a)(4). Nevertheless
the Department is required under
section 413(d) to annually rank State
performance in moving TANF recipients
into private sector employment. We are,
therefore, requesting that States
continue to transmit monthly files of
adult TANF recipients necessary to
calculate the work measures
performance data. To the extent States
do not provide the requested
information, we will extract the
matching information from the TANF
Data Report. This may result in
calculation of the work performance
measures based on sample data, which
would provide us less precise
information on States’ performance.
The Transmission File Layouts form
provides the format that States will
continue to use for the quarterly
electronic transmission of monthly data
on TANF adult recipients. States that
have separate TANF–MOE files on these
programs are also requested to transmit
similar files. We are not requesting any
changes to the Transmission File
Layouts form.
Respondents: Respondents may
include any of the 50 States, the District
of Columbia, Guam, Puerto Rico, and
the Virgin Islands.
Title: State High Performance Bonus
System (HPBS) Transmission File
Layouts for HPBS Work Measures.
ANNUAL BURDEN ESTIMATES
srobinson on DSK4SPTVN1PROD with NOTICES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
State High Performance Bonus System (HPBS) Transmission File Layouts
for HPBS Work Measures ............................................................................
42
2
12
1,008
Estimated Total Annual Burden
Hours: 1,008
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Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
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Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
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Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Fax: (202)
395–7285, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–28510 Filed 11–2–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0755]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Implementation of
the Food and Drug Administration
Amendments Act of 2007
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 requirement established by Title II
of the Food and Drug Administration
Amendments Act of 2007 (FDAAA)
(Pub. L. 110–85) that device
establishments must submit registration
and listing information by electronic
means, using FDA Form 3673, unless
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
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Jkt 226001
the Secretary of the Department of
Health and Human Services (the
Secretary) grants them a waiver from the
electronic submission requirement.
DATES: Submit either written or
electronic comments on the collection
of information by January 3, 2012.
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
5156, Daniel.Gittleson@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
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68195
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Implementation of Sections 222, 223,
and 224 of the Food and Drug
Administration Amendments Act of
2007 (OMB Control Number 0910–
0625)—Extension
Sections 222, 223, and 224 of FDAAA,
which were in effect on October 1, 2007,
require that device establishment
registrations and listings under section
510 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360), including the submission of
updated information, be submitted to
the Secretary by electronic means,
unless the Secretary grants a request for
waiver of the requirement because the
use of electronic means is not
reasonable for the person requesting the
waiver. There are approximately 24,000
establishments that are electronically
registered as of September 2011.
Section 222 of FDAAA amends
sections 510(b) of the FD&C Act to
require domestic establishments to
register annually during the period
beginning October 1 and ending
December 31 of each year. Section 222
of FDAAA also amends section 510(i)(1)
of the FD&C Act to require foreign
establishments to register immediately
upon first engaging in one of the
covered device activities described
under the statute, and in addition, they
must also register annually during the
time period beginning October 1 and
ending December 31 of each year.
Further, section 223 of FDAAA amends
section 510(j)(2) of the FD&C Act to
require establishments to list their
devices with FDA annually, during the
time period beginning October 1 and
ending December 31 of each year.
Under FDAAA, device establishment
owners and operators are required to
keep their registration and device listing
information up-to-date using the
Agency’s new electronic system.
Owners and operators of new device
establishments must use the electronic
system to create new accounts, new
registration records, and new device
listings. Section 224 of FDAAA amends
section 510(p) of the FD&C Act by
allowing an affected person to request a
waiver from the requirement to register
electronically when the ‘‘use of
electronic means’’ is not reasonable for
the person.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Notices]
[Pages 68194-68195]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28510]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: State High Performance Bonus System (HPBS) Transmission File
Layouts for HPBS Work Measures.
OMB No.: 0970-0230.
Description: There is no longer a High Performance Bonus associated
with this information collection. The Deficit Reduction Act of 2005
(Pub. L. 109-171) eliminated the funding for the High Performance Bonus
(HPB), but we are still requesting that States continue to submit data
necessary to calculate the work measures previously reported under the
HPB.
Specifically, The TANF program was reauthorized under the Deficit
Reduction Act of 2005. The statute eliminated the funding for the HPB
under section 403(a)(4). Nevertheless the Department is required under
section 413(d) to annually rank State performance in moving TANF
recipients into private sector employment. We are, therefore,
requesting that States continue to transmit monthly files of adult TANF
recipients necessary to calculate the work measures performance data.
To the extent States do not provide the requested information, we will
extract the matching information from the TANF Data Report. This may
result in calculation of the work performance measures based on sample
data, which would provide us less precise information on States'
performance.
The Transmission File Layouts form provides the format that States
will continue to use for the quarterly electronic transmission of
monthly data on TANF adult recipients. States that have separate TANF-
MOE files on these programs are also requested to transmit similar
files. We are not requesting any changes to the Transmission File
Layouts form.
Respondents: Respondents may include any of the 50 States, the
District of Columbia, Guam, Puerto Rico, and the Virgin Islands.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
State High Performance Bonus System (HPBS) 42 2 12 1,008
Transmission File Layouts for HPBS Work
Measures...................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,008
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade
SW., Washington,
[[Page 68195]]
DC 20447, Attn: ACF Reports Clearance Officer. All requests should be
identified by the title of the information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following:
Office of Management and Budget, Paperwork Reduction Project, Fax:
(202) 395-7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer
for the Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-28510 Filed 11-2-11; 8:45 am]
BILLING CODE 4184-01-P
