Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 56898-56899 [2013-22517]
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56898
Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices
or other forms of information
technology to minimize the information
collection burden.
Darius Taylor,
Deputy Information Collection Clearance
Officer.
[FR Doc. 2013–22450 Filed 9–13–13; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier: CMS–10371]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Center for Medicare and
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare and Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review.
This is necessary to ensure compliance
with an initiative of the Administration.
We are requesting an emergency review
under 5 CFR Part 1320(a)(2)(i) because
public harm is reasonably likely to
result if the normal clearance
procedures are followed. The approval
of the data collection tools for outcomes
and operational metrics is essential to
ensuring that State-based Marketplaces
provide substantive operational and
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
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17:46 Sep 13, 2013
Jkt 229001
monitoring data to CMS in a uniform
format from the beginning of the
enrollment period, October 1, 2013.
Without an emergency clearance
process, systematic data collection
would not begin until well into the open
enrollment period, and states would
have to delay critical steps to integrating
this reporting into their information
systems. Without consistent data, we
will be limited in our ability to
effectively track states’ progress and
identify problems during this crucial
early implementation period.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Cooperative
Agreement to Support Establishment of
State-Operated Health Insurance
Exchanges; Use: All States (including
the 50 States, consortia of States,
Territories, and the District of Columbia
herein referred to as States) that
received a State Planning and
Establishment Grant for Affordable Care
Act’s (ACA) Exchanges are eligible for
the Cooperative Agreement to Support
Establishment of State Operated
Insurance Exchanges. Section 1311 of
the Affordable Care Act offers the
opportunity for each State to establish
an Exchange [now referred to as
Marketplace], and provides for grants to
States for the planning and
establishment of these Exchanges. Given
the innovative nature of Exchanges and
the statutorily-prescribed relationship
between the Secretary and States in
their development and operation, it is
critical that the Secretary work closely
with States to provide necessary
guidance and technical assistance to
ensure that States can meet the
prescribed timelines, Federal
requirements, and goals of the statute.
In order to provide appropriate and
timely guidance and technical
assistance, the Secretary must have
access to timely, periodic information
regarding State progress. Consequently,
the information collection associated
with these grants is essential to
facilitating reasonable and appropriate
federal monitoring of funds, providing
statutorily-mandated assistance to States
to implement Exchanges in accordance
with Federal requirements, and to
ensure that States have all necessary
information required to proceed, such
that retrospective corrective action can
be minimized.
The submitted revision adds lists and
suggested data reporting formats for
Outcomes and Operational Metrics to
states’ data collection requirements; we
will use the resulting data to evaluate
Marketplace performance and overall
effectiveness of the ACA. Key areas of
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
measurement are the effectiveness of
eligibility determination and enrollment
processes, impact on affordability for
consumers, and the effect of
Marketplace participation on health
insurances markets. Furthermore, these
metrics facilitate actionable feedback
and technical assistance to States for
quality improvement efforts during the
critical early period of operations. This
funding opportunity was first released
on January 20, 2011. Form Number:
CMS–10371(OCN: 0938–1121);
Frequency: Occasionally; Affected
Public: State, Local or Tribal
governments; Number of Respondents:
40; Total Annual Responses: 1,475;
Total Annual Hours: 64,695. (For policy
questions regarding this collection
contact Christina Daw at 301–492–
4181.)
We are requesting OMB review and
approval of this collection by September
23, 2013, with a 180-day approval
period. Written comments and
recommendation will be considered
from the public if received by the
individuals designated below by the
noted deadline below.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’s Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995 or Email
your request, including your address,
phone number, OMB number, and CMS
document identifier, to Paperwork@
cms.hhs.gov, or call the Reports
Clearance Office on (410) 786–1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by September 23, 2013:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier (CMS–10371),
Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland
21244–1850 and,
OMB Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, New Executive Office
Building, Room 10235, Washington,
E:\FR\FM\16SEN1.SGM
16SEN1
Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices
DC 20503, Fax Number: (202) 395–
6974.
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 0910–0607. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Dated: September 12, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–22517 Filed 9–13–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2013–N–0514]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requests for
Clinical Laboratory Improvement
Amendments Categorization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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. Requests for
Clinical Laboratory Improvement
Amendments of 1988 (CLIA)
Categorization—42 CFR 493.17 (OMB
Control Number 0910–0607)—
Extension.
A guidance document entitled
‘‘Guidance for Administrative
Procedures for CLIA Categorization’’
was released on May 7, 2008. The
document describes procedures FDA
uses to assign the complexity category
to a device. Typically, FDA assigns
complexity categorizations to devices at
the time of clearance or approval of the
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
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 October 16,
2013.
SUMMARY:
56899
device. In this way, no additional
burden is incurred by the manufacturer
because the labeling (including
operating instructions) is included in
the premarket notification (510(k)) or
premarket approval application (PMA).
In some cases, however, a manufacturer
may request CLIA categorization even if
FDA is not simultaneously reviewing a
510(k) or PMA. One example is when a
manufacturer requests that FDA assign
CLIA categorization to a previously
cleared device that has changed names
since the original CLIA categorization.
Another example is when a device is
exempt from premarket review. In such
cases, the guidance recommends that
manufacturers provide FDA with a copy
of the package insert for the device and
a cover letter indicating why the
manufacturer is requesting a
categorization (e.g. name change,
exempt from 510(k) review). The
guidance recommends that in the
correspondence to FDA the
manufacturer should identify the
product code and classification as well
as reference to the original 510(k) when
this is available. In the Federal Register
of May 22, 2013 (78 FR 30312), FDA
published a 60-day notice requesting
public comment on the proposed
collection of information. No comments
were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN ACTIVITY 1
Activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Operating and
maintenance
costs
Request for CLIA categorization ..............
60
15
900
1
900
$46,800
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
are no capital costs associated with this collection of information.
The number of respondents is
approximately 60. On average, each
respondent will request categorizations
(independent of a 510(k) or PMA) 15
times per year. The cost, not including
personnel, is estimated at $52 per hour
(52 × 900), totaling $46,800. This
includes the cost of copying and mailing
copies of package inserts and a cover
letter, which includes a statement of the
reason for the request and reference to
the original 510(k) numbers, including
regulation numbers and product codes.
The burden hours are based on FDA
familiarity with the types of
documentation typically included in a
sponsor’s categorization requests, and
costs for basic office supplies (e.g.
paper).
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17:46 Sep 13, 2013
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Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22443 Filed 9–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00044
Fmt 4703
Sfmt 4703
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
Agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on November 1, 2013, from 8 a.m. to 4:30
p.m.
Location: FDA Fishers Lane Building, 5630
Fishers Lane, rm. 1066, Rockville, MD 20857.
For those unable to attend in person, the
meeting will also be Web cast. The Web cast
will be available at the following link: https://
fda.yorkcast.com/webcast/Viewer/?peid=
18390c01dfff405681afa644b1837e5a1d.
Contact Person: Bryan Emery or Pearline
Muckelvene, Center for Biologics Evaluation
E:\FR\FM\16SEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56898-56899]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22517]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier: CMS-10371]
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
AGENCY: Center for Medicare and Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections for public comment.
Interested persons are invited to send comments regarding this burden
estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
We are, however, requesting an emergency review of the information
collection referenced below. In compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have
submitted to the Office of Management and Budget (OMB) the following
requirements for emergency review. This is necessary to ensure
compliance with an initiative of the Administration. We are requesting
an emergency review under 5 CFR Part 1320(a)(2)(i) because public harm
is reasonably likely to result if the normal clearance procedures are
followed. The approval of the data collection tools for outcomes and
operational metrics is essential to ensuring that State-based
Marketplaces provide substantive operational and monitoring data to CMS
in a uniform format from the beginning of the enrollment period,
October 1, 2013. Without an emergency clearance process, systematic
data collection would not begin until well into the open enrollment
period, and states would have to delay critical steps to integrating
this reporting into their information systems. Without consistent data,
we will be limited in our ability to effectively track states' progress
and identify problems during this crucial early implementation period.
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Cooperative
Agreement to Support Establishment of State-Operated Health Insurance
Exchanges; Use: All States (including the 50 States, consortia of
States, Territories, and the District of Columbia herein referred to as
States) that received a State Planning and Establishment Grant for
Affordable Care Act's (ACA) Exchanges are eligible for the Cooperative
Agreement to Support Establishment of State Operated Insurance
Exchanges. Section 1311 of the Affordable Care Act offers the
opportunity for each State to establish an Exchange [now referred to as
Marketplace], and provides for grants to States for the planning and
establishment of these Exchanges. Given the innovative nature of
Exchanges and the statutorily-prescribed relationship between the
Secretary and States in their development and operation, it is critical
that the Secretary work closely with States to provide necessary
guidance and technical assistance to ensure that States can meet the
prescribed timelines, Federal requirements, and goals of the statute.
In order to provide appropriate and timely guidance and technical
assistance, the Secretary must have access to timely, periodic
information regarding State progress. Consequently, the information
collection associated with these grants is essential to facilitating
reasonable and appropriate federal monitoring of funds, providing
statutorily-mandated assistance to States to implement Exchanges in
accordance with Federal requirements, and to ensure that States have
all necessary information required to proceed, such that retrospective
corrective action can be minimized.
The submitted revision adds lists and suggested data reporting
formats for Outcomes and Operational Metrics to states' data collection
requirements; we will use the resulting data to evaluate Marketplace
performance and overall effectiveness of the ACA. Key areas of
measurement are the effectiveness of eligibility determination and
enrollment processes, impact on affordability for consumers, and the
effect of Marketplace participation on health insurances markets.
Furthermore, these metrics facilitate actionable feedback and technical
assistance to States for quality improvement efforts during the
critical early period of operations. This funding opportunity was first
released on January 20, 2011. Form Number: CMS-10371(OCN: 0938-1121);
Frequency: Occasionally; Affected Public: State, Local or Tribal
governments; Number of Respondents: 40; Total Annual Responses: 1,475;
Total Annual Hours: 64,695. (For policy questions regarding this
collection contact Christina Daw at 301-492-4181.)
We are requesting OMB review and approval of this collection by
September 23, 2013, with a 180-day approval period. Written comments
and recommendation will be considered from the public if received by
the individuals designated below by the noted deadline below.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS's
Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995
or Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by September 23, 2013:
1. Electronically. You may submit your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) accepting comments.
2. By regular mail. You may mail written comments to the following
address:
CMS, Office of Strategic Operations and Regulatory Affairs, Division of
Regulations Development, Attention: Document Identifier (CMS-10371),
Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850
and,
OMB Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, New Executive Office Building, Room 10235, Washington,
[[Page 56899]]
DC 20503, Fax Number: (202) 395-6974.
Dated: September 12, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-22517 Filed 9-13-13; 8:45 am]
BILLING CODE 4120-01-P
