Proposed Information Collection Activity; Comment Request, 23266-23267 [2012-9337]
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Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices
Information Collection: Post Clinical
Laboratory Survey Questionnaire and
Supporting Regulations in 42 CFR
493.1771, 493.1773, and 493.1777. Use:
Form CMS–668B is used by a Clinical
Laboratory Improvement Amendments
(CLIA) laboratory to express its
satisfaction with the survey process and
to make recommendations for
improvement. Surveyors furnish this
form to all laboratories that receive
either an onsite survey or the Alternate
Quality Assessment Survey (i.e., paper
survey of quality indicators). CMS
Central Office performs an overview
evaluation of the completed forms. Each
calendar year, a summary of the
information collected is sent to the State
and CMS Regional Office. Form
Number: CMS–668B (OCN 0938–0653).
Frequency: Biennially; Affected Public:
Business or other for-profits and not-forprofit institutions. State, Local, or Tribal
Government, Federal Government.
Number of Respondents: 21,000. Total
Annual Responses: 10,500. Total
Annual Hours: 2,625. (For policy
questions regarding this collection
contact Kathleen Todd at 410–786–
3385. For all other issues call 410–786–
1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection. Title of
Information Collection: Survey Report
Form for Clinical Laboratory
Improvement Amendments (CLIA) and
Supporting Regulations in 42 CFR
493.1–493.2001. Use: CMS 1557 is used
to report surveyor findings during a
CLIA survey. For each type of survey
conducted (i.e., initial certification,
recertification, validation, complaint,
addition/deletion of specialty/
subspecialty, transfusion fatality
investigation, or revisit inspections) the
Survey Report Form incorporates the
requirements specified in the CLIA
regulations. Form Number: CMS–1557
(OCN 0938–0544). Frequency:
Biennially. Affected Public: Business or
other for-profit, Not-for-profit
institutions, State, Local or Tribal
Governments and Federal Government.
Number of Respondents: 21,000. Total
Annual Responses: 10,500. Total
Annual Hours: 5,248. (For policy
questions regarding this collection
contact Kathleen Todd at 410–786–
3385. For all other issues call 410–786–
1326.)
3. Type of Information Collection
Request: New collection; Title of
Information Collection: Analysis of
Transportation Barriers to Utilization of
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Medicare Services by American Indian
and Alaska Native Medicare
Beneficiaries; Use: The purpose of the
proposed study is to identify and
analyze transportation barriers
associated with the utilization of
Medicare services by American Indian
and Alaska Native (AI/AN)
beneficiaries, to identify and analyze the
health outcomes resulting from those
barriers, and ultimately to identify
potential solutions that could help
mitigate the problem and produce
meaningful improvements in health care
use and health outcomes for this
population. Specifically, the
information that will be collected
through the use of instruments and the
study developed under the Analysis of
Transportation Barriers to Utilization of
Medicare Services by American Indian
and Alaska Native Medicare
Beneficiaries Project has not been
collected or evaluated previously by any
agency or individual, so data on the
extent of transportation barriers for rural
AI/AN beneficiaries to Medicare
services by AI/AN Medicare
beneficiaries are not available except
from the proposed data collection
activity.
The information gathered as part of
the project—through the use of survey,
interview, and focus group
instruments—will be used by CMS to
identify transportation barriers to
Medicare services for AI/AN Medicare
beneficiaries. It will provide the first
ever complete evaluation of
transportation barriers to health care for
this population.
The information collection request
has been revised since the publication
of the 60-day Federal Register notice.
Several questions were added in
response to public comments. In
addition to new questions, several
clarifying edits were made as well. Form
Number: CMS–10399 (OMB # 0938–
NEW); Frequency: Occasionally;
Affected Public: Individuals and
Households, Private Sector; Number of
Respondents: 3,418; Total Annual
Responses: 3,418; Total Annual Hours:
2,544. (For policy questions regarding
this collection contact Roger Goodacre
at 410–786–3209. For all other issues
call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
PO 00000
Frm 00046
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address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on May 18, 2012.
OMB, Office of Information and
Regulatory Affairs,
Attention: CMS Desk Officer,
Fax Number: (202) 395–6974,
Email: OIRA_submission@omb.eop.gov.
Dated: April 12, 2012.
Martique Jones,
Director, Regulations Development Group,
Division-B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–9259 Filed 4–17–12; 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: National Youth in Transition
Database and Youth Outcome Survey.
OMB No.: 0970–0340.
Description: The Foster Care
Independence Act of 1999 (42 U.S.C.
1305 et seq.) as amended by Public Law
106–169 requires State child welfare
agencies to collect and report to the
Administration on Children and
Families (ACF) data on the
characteristics of youth receiving
independent living services and
information regarding their outcomes.
The regulation implementing the
National Youth in Transition Database,
listed in 45 CFR 1356.80, contains
standard data collection and reporting
requirements for States to meet the law’s
requirements. ACF will use the
information collected under the
regulation to track independent living
services, assess the collective outcomes
of youth, and potentially to evaluate
State performance with regard to those
outcomes consistent with the law’s
mandate.
Respondents: State agencies that
administer the John H. Chafee Foster
Care Independence Program.
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Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices
ANNUAL BURDEN ESTIMATES
Youth Outcome Survey ...................................................................
Data File ..........................................................................................
Estimated Total Annual Burden
Hours: 132,571.
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. 2012–9337 Filed 4–17–12; 8:45 am]
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Number of
responses per
respondent
Number of
respondents
Instrument
15,334
52
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0324]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry, FDA Staff, and Foreign
Governments: Fiscal Year 2012
Medical Device User Fee Small
Business Qualification and
Certification
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
Form FDA 3602 and Form FDA 3602A,
which will allow domestic and foreign
applicants to certify that they qualify as
a ‘‘small business’’ and pay certain
medical device user fees at reduced
rates.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by June 18, 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–
DATES:
PO 00000
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Average
burden hours
per response
1
2
0.50
1,201
Total
burden
hours
7,667
124,904
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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry, FDA Staff, and
Foreign Governments: Fiscal Year 2012
Medical Device User Fee Small
Business Qualification and
Certification—(OMB Control Number
0910–0508)—Extension
Section 101 of the Medical Device
User Fee and Modernization Act
(MDUFMA) amends the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
to provide for user fees for certain
medical device applications. FDA
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[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23266-23267]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9337]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: National Youth in Transition Database and Youth Outcome
Survey.
OMB No.: 0970-0340.
Description: The Foster Care Independence Act of 1999 (42 U.S.C.
1305 et seq.) as amended by Public Law 106-169 requires State child
welfare agencies to collect and report to the Administration on
Children and Families (ACF) data on the characteristics of youth
receiving independent living services and information regarding their
outcomes. The regulation implementing the National Youth in Transition
Database, listed in 45 CFR 1356.80, contains standard data collection
and reporting requirements for States to meet the law's requirements.
ACF will use the information collected under the regulation to track
independent living services, assess the collective outcomes of youth,
and potentially to evaluate State performance with regard to those
outcomes consistent with the law's mandate.
Respondents: State agencies that administer the John H. Chafee
Foster Care Independence Program.
[[Page 23267]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Youth Outcome Survey.................... 15,334 1 0.50 7,667
Data File............................... 52 2 1,201 124,904
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 132,571.
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. 2012-9337 Filed 4-17-12; 8:45 am]
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