Proposed Information Collection Activity; Comment Request, 33745-33746 [2012-13812]
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Federal Register / Vol. 77, No. 110 / Thursday, June 7, 2012 / Notices
Human Subjects—FDA
Clinical Trials: https://www.fda.gov/
ScienceResearch/SpecialTopics/
RunningClinicalTrials/default.htm.
Office of Good Clinical Practice: https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
OfficeofScienceandHealthCoordination/
ucm2018191.
comments should be received within 30
days of this notice.
Proposed Project
Data collection for the residential care
facility and adult day service center
components of the National Study of
Long-Term Care Providers—NEW—
National Center for Health Statistics
(NCHS), Centers for Disease Control and
Prevention (CDC).
Consumer Protection—FTC
Bureau of Consumer Protection: https://
business.ftc.gov/privacy-and-security.
Authority: 15 U.S.C. 3719.
Dated: May 31, 2012.
Farzad Mostashari,
National Coordinator for Health Information
Technology.
[FR Doc. 2012–13834 Filed 6–6–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day 12–12BZ]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, ‘‘shall collect
statistics on health resources * * *
[and] utilization of health care,
including extended care facilities, and
other institutions.’’
NCHS seeks approval to collect data
for the residential care facility (RCF)
and adult day services center (ADSC)
components of a planned new survey,
the National Study of Long-Term Care
Providers (NSLTCP). A one year
clearance is requested.
As background here are some details
on the plans for the whole study, of
which this data collection is two
components. The entire NSLTCP is
being designed to (1) Broaden NCHS’
ongoing coverage of paid, regulated
long-term care (LTC) providers; (2)
merge with existing administrative data
on LTC providers (i.e. Centers for
Medicare and Medicaid Services (CMS)
data on nursing home, home health, and
hospice care); (3) update data more
frequently on LTC providers for which
nationally representative administrative
data do not exist; and (4) enable
comparisons across LTC provider types
and monitor the supply and use of these
providers.
The data will be collected in the 50
states and the District of Columbia from
two types of LTC facilities: 11,701 RCFs
and 5,000 ADSCs. The data to be
collected from RCCs and ADSCs include
basic characteristics, services offered,
staffing, and practices of providers, as
well as distributions of the
demographics, physical functioning,
and cognitive functioning of users (RCC
residents and ADSC participants)
aggregated to the RCC/ADSC level.
Expected users of data from this
collection effort include, but are not
limited to CDC; other Department of
Health and Human Services (DHHS)
agencies, such as the Office of the
Assistant Secretary for Planning and
Evaluation and the Agency for
Healthcare Research and Quality;
provider associations, such as
LeadingAge (formerly the American
Association of Homes and Services for
the Aging), National Center for Assisted
Living, American Seniors Housing
Association, Assisted Living Federation
of America, and National Adult Day
Services Association; universities;
foundations; and other private sector
organizations, such as AARP.
Expected burden from data collection
is 30 minutes for respondents. We
estimate that 10% of RCC and ADSC
directors will be called for 15 minutes
of data retrieval when there are errors or
omissions in their returned surveys.
There is no cost to respondents other
than their time to participate. The total
estimate of annualized burden is 8,769
hours.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Form name
RCC Director ...................................................
ADSC Director ................................................
RCC and ADSC Directors ..............................
RCC Questionnaire ........................................
ADSC Questionnaire ......................................
Data Retrieval ................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Kimberly S. Lane,
Deputy Director, Office of Science Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012–13795 Filed 6–6–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Native Employment Works
(NEW) Program Plan Guidance and
Report Requirements.
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Average
burden/
response
(in hours)
Number of
responses/
respondent
11,701
5,000
1,670
1
1
1
30/60
30/60
15/60
OMB No.: 0970–0174.
Description
The Native Employment Works
(NEW) program plan is the application
for NEW program funding. As approved
by the Department of Health and Human
Services (HHS), it documents how the
grantee will carry out its NEW program.
The NEW program plan guidance
provides instructions for preparing a
NEW program plan and explains the
process for plan submission every third
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33746
Federal Register / Vol. 77, No. 110 / Thursday, June 7, 2012 / Notices
year. The NEW program report provides
information on the activities and
accomplishments of grantees’ NEW
programs. The NEW program report and
instructions specify the program data
that NEW grantees report annually.
Respondents
Federally recognized Indian Tribes
and Tribal organizations that are NEW
program grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
NEW program plan guidance ..........................................................................
NEW program report .......................................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 1,474.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is 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)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–13812 Filed 6–6–12; 8:45 am]
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48
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0110]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Reporting: Manufacturer, Importer,
User Facility, and Distributor Reporting
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
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 9,
2012.
SUMMARY:
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0437. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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Number of
responses per
respondent
1
1
Average
burden hours
per response
29
15
Total burden
hours
754
720
Medical Device Reporting:
Manufacturer, Importer, User Facility,
and Distributor Reporting—21 CFR Part
803 (OMB Control Number 0910–
0437)—Extension
Section 519(a)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360i(a)(1)) requires every
manufacturer or importer to report
‘‘whenever the manufacturer or
importer receives or otherwise becomes
aware of information that reasonably
suggests that one of its marketed
devices: (A) May have caused or
contributed to a death or serious injury,
or (B) has malfunctioned and that such
device or a similar device marketed by
the manufacturer or importer would be
likely to cause or contribute to a death
or serious injury if the malfunction were
to recur.’’
Section 519(b)(1)(A) of the FD&C Act
requires ‘‘whenever a device user
facility receives or otherwise becomes
aware of information that reasonably
suggests that a device has or may have
caused or contributed to the death or
serious illness, of a patient of the
facility, the facility shall, as soon as
practicable but not later than 10
working days after becoming aware of
the information, report the information
to the Secretary and, if the identity of
the manufacturer is known, to the
manufacturer of the device.’’
Section 519(b)(1)(B) of the FD&C Act
requires ‘‘whenever a device user
facility receives or otherwise becomes
aware of: (i) Information that reasonably
suggests that a device has or may have
caused or contributed to the serious
illness of, or serious injury to, a patient
of the facility * * *, shall, as soon as
practicable but not later than 10
working days after becoming aware of
the information, report the information
to the manufacturer of the device or to
the Secretary if the identity of the
manufacturer is not known.’’
Complete, accurate, and timely
adverse event information is necessary
for the identification of emerging device
problems. Information from these
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[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)]
[Notices]
[Pages 33745-33746]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13812]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Native Employment Works (NEW) Program Plan Guidance and
Report Requirements.
OMB No.: 0970-0174.
Description
The Native Employment Works (NEW) program plan is the application
for NEW program funding. As approved by the Department of Health and
Human Services (HHS), it documents how the grantee will carry out its
NEW program. The NEW program plan guidance provides instructions for
preparing a NEW program plan and explains the process for plan
submission every third
[[Page 33746]]
year. The NEW program report provides information on the activities and
accomplishments of grantees' NEW programs. The NEW program report and
instructions specify the program data that NEW grantees report
annually.
Respondents
Federally recognized Indian Tribes and Tribal organizations that
are NEW program grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
NEW program plan guidance....................... 26 1 29 754
NEW program report.............................. 48 1 15 720
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,474.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is 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) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden 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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-13812 Filed 6-6-12; 8:45 am]
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