Agency Information Collection Activities: Proposed Collection; Comment Request, 71801-71802 [2012-29243]
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71801
Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices
these forms to (1) grant public health
professionals the continuing education
(CE) they need to maintain professional
licenses and certifications, (2) create a
transcript or summary of training at the
participant’s request, (3) generate
management reports, and (4) maintain
training statistics; and a revision that
will allow CDC to comply with new
continuing education accreditation
organization requirements for collection
of additional profession-specific data.
CDC is accredited by six different
continuing education (CE) organizations
to award CE: (1) The International
Association for Continuing Education
and Training (IACET) to provide
Continuing Education Units (CEUs), (2)
the Accreditation Council for
Continuing Medical Education
(ACCME) to provide Continuing
Medical Education credits (CME), (3)
the American Nurses Credentialing
Center (ANNC) to provide Continuing
course. CDC uses the email address to
verify the participant’s electronic
request for transcripts, verify course
certificates, and send confirmation that
a participant is registered for a course.
Tracking course attendance and
meeting accrediting organizations’
standards for reporting, require uniform
standardized training application forms.
The standardized data these forms
request for laboratory training,
classroom study, online training, and
distance learning are not requested
elsewhere. In other words, these forms
do not duplicate requests for
information from participants. Data are
collected only once per course or once
per new registration. The annual burden
table has been updated to reflect an
increase in distance learning to 6,792
burden hours; that is an average burden
of 5 minutes per respondent. There is no
cost to respondents other than their
time.
Nurse Education credits (CNE), (4) the
National Commission for Health
Education Credentialing (NCHEC) to
award CHES credit, (5) the
Accreditation Council for Pharmacy
Education (ACPE) to provide continuing
pharmacy credit, and (6) the American
Association of Veterinary State Boards
to award Registry of Approved
Continuing Education (RACE) credit.
The accrediting organizations require a
method of tracking participants who
complete an educational activity and
demographic data allows CDC to do so.
Also, several of the organizations
require a permanent record that
includes the participant’s name,
address, and phone number, to facilitate
retrieval of historical information about
when a participant completed a course
or several courses during a time period.
This information provides the basis for
a transcript or for determining whether
a person is enrolled in more than one
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
responses per
respondent
No. of
respondents
Avg. burden
per response
(in hrs)
Total burden
(in hrs)
Type of respondents
Form name
Health Professionals .........................
Training and Continuing Education
Online New Participant Registration Form (36.5).
National Laboratory Training Network Registration Form (32.1).
75,000
1
5/60
6,250
6,500
1
5/60
542
...........................................................
........................
........................
........................
6,792
Laboratorians ....................................
Total ...........................................
Dated: November 26, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012–29174 Filed 12–3–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10418]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
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 & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
mstockstill on DSK4VPTVN1PROD with
AGENCY:
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17:31 Dec 03, 2012
Jkt 229001
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.
1. Type of Information Collection:
Revision of a currently approved
collection; Title of Information
Collection: Annual MLR and Rebate
Calculation Report and MLR Rebate
Notices; Use: Under Section 2718 of the
Affordable Care Act and implementing
regulation at 45 CFR part 158, a health
insurance issuer (issuer) offering group
or individual health insurance coverage
must submit a report to the Secretary
concerning the amount the issuer
spends each year on claims, quality
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
improvement expenses, non-claims
costs, federal and state taxes and
licensing and regulatory fees, and the
amount of earned premium. An issuer
must provide an annual rebate if the
amount it spends on certain costs
compared to its premium revenue
(excluding federal and states taxes and
licensing and regulatory fees) does not
meet a certain ratio, referred to as the
medical loss ratio (MLR). An interim
final rule (IFR) implementing the MLR
was published on December 1, 2010 (75
FR 74865) and modified by technical
corrections on December 30, 2010 (75
FR 82277), which added part 158 to
Title 45 of the Code of Federal
Regulations. The IFR was effective
January 1, 2011. A final rule regarding
selected provisions of the IFR was
published on December 7, 2011 (76 FR
76574, CMS–9998–FC) and an interim
final rule regarding an issue not
included in issuers’ reporting
obligations (disbursement of rebates by
non-federal governmental plans) was
also published December 7, 2011 (76 FR
76596, CMS–9998–IFC2) Both rules
published on December 7, 2011 and
E:\FR\FM\04DEN1.SGM
04DEN1
mstockstill on DSK4VPTVN1PROD with
71802
Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices
were effective January 1, 2012. Each
issuer is required to submit annually
MLR data, including information about
any rebates it must provide, on a form
prescribed by CMS, for each state in
which the issuer conducts business.
Each issuer is also required to provide
a rebate notice to each policyholder that
is owed a rebate and each subscriber of
policyholders that are owed a rebate for
any given MLR reporting year.
Additionally, each issuer is required to
maintain for a period of seven years all
documents, records and other evidence
that support the data included in each
issuer’s annual report to the Secretary.
Based upon HHS’ experience in the
MLR data collection and evaluation
process, HHS is updating its annual
burden hour estimates to reflect the
actual numbers of submissions, rebates
and rebate notices. In addition, the
notice requirement for issuers that do
not owe rebates applied only to the 2011
reporting year, and does not apply to
2012 and subsequent MLR reporting
years.
We have simplified the format of the
reporting form and the method by
which issuers submit their data. For the
2012 MLR reporting year, when
submitting data to CMS, issuers will
have the option to use either a Microsoft
Excel (.xls) or a Comma Separated Value
(.csv) file format. This will allow issuers
flexibility and reduce the burden in
submitting the MLR report. The new
method will no longer include precalculated fields which will reduce the
burden as well as the possibility of
error.
The 2012 MLR Reporting Form and
instructions also reflect changes for the
2012 reporting year and beyond that are
set forth in the December 2011 Final
Rule as to whether certain already
reported expenditures such as ICD–10
conversion costs are taken into account
in calculating an issuer’s MLR.
HHS has created and published a host
of electronic training tools to assist
issuers with the preparation and
submission of MLR data forms and
Rebate calculations. Consequently the
agency is reducing its current burden
hours from 354,570 to 311,302. Form
Number: CMS–10418 (OCN: 0938–
1164); Frequency: Annual submission
for each respondent; Affected Public:
Private Sector, Business or other forprofits and not-for-profit institutions;
Number of Respondents: 502; Number
of Responses: 3,085; Total Annual
Hours: 311,302. (For policy questions
regarding this collection, contact Carol
Jimenez at (301) 492–4457. For all other
issues, call (410) 786–1326.)
To obtain copies of the supporting
statement and any related forms for the
VerDate Mar<15>2010
17:31 Dec 03, 2012
Jkt 229001
proposed paperwork collections
referenced above, access CMS’ 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 February 4, 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/OMB
Control Number llll, Room C4–26–
05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Dated: November 29, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–29243 Filed 12–3–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0081]
Guidance on Investigational New Drug
Applications for Positron Emission
Tomography Drugs; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Investigational New Drug Applications
for Positron Emission Tomography
(PET) Drugs.’’ The guidance is intended
to assist manufacturers of PET drugs in
submitting investigational new drug
applications (INDs).
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kyong (Kaye) Kang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2352,
Silver Spring, MD 20993–0002, 301–
796–2050.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance entitled ‘‘Investigational
New Drug Applications for Positron
Emission Tomography (PET) Drugs.’’
The guidance summarizes the IND
process for PET drugs, makes
recommendations for how to submit an
IND, provides advice on expanded
access options for investigational PET
drugs, and describes the process for
requesting permission to charge for an
investigational PET drug.
A draft guidance of the same title was
announced in the Federal Register on
February 14, 2012 (77 FR 8262), and
Docket No. FDA–2012–D–0081 was
open for comments until May 14, 2012.
We received comments from industry
and professional societies. We have
carefully considered, and where
appropriate, we have made corrections,
added information, or clarified the
information in this guidance in response
to the comments or on our own
initiative.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the submission of
INDs for PET drugs. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
E:\FR\FM\04DEN1.SGM
04DEN1
Agencies
[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71801-71802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10418]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & 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 & Medicaid
Services (CMS) 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.
1. Type of Information Collection: Revision of a currently approved
collection; Title of Information Collection: Annual MLR and Rebate
Calculation Report and MLR Rebate Notices; Use: Under Section 2718 of
the Affordable Care Act and implementing regulation at 45 CFR part 158,
a health insurance issuer (issuer) offering group or individual health
insurance coverage must submit a report to the Secretary concerning the
amount the issuer spends each year on claims, quality improvement
expenses, non-claims costs, federal and state taxes and licensing and
regulatory fees, and the amount of earned premium. An issuer must
provide an annual rebate if the amount it spends on certain costs
compared to its premium revenue (excluding federal and states taxes and
licensing and regulatory fees) does not meet a certain ratio, referred
to as the medical loss ratio (MLR). An interim final rule (IFR)
implementing the MLR was published on December 1, 2010 (75 FR 74865)
and modified by technical corrections on December 30, 2010 (75 FR
82277), which added part 158 to Title 45 of the Code of Federal
Regulations. The IFR was effective January 1, 2011. A final rule
regarding selected provisions of the IFR was published on December 7,
2011 (76 FR 76574, CMS-9998-FC) and an interim final rule regarding an
issue not included in issuers' reporting obligations (disbursement of
rebates by non-federal governmental plans) was also published December
7, 2011 (76 FR 76596, CMS-9998-IFC2) Both rules published on December
7, 2011 and
[[Page 71802]]
were effective January 1, 2012. Each issuer is required to submit
annually MLR data, including information about any rebates it must
provide, on a form prescribed by CMS, for each state in which the
issuer conducts business. Each issuer is also required to provide a
rebate notice to each policyholder that is owed a rebate and each
subscriber of policyholders that are owed a rebate for any given MLR
reporting year. Additionally, each issuer is required to maintain for a
period of seven years all documents, records and other evidence that
support the data included in each issuer's annual report to the
Secretary.
Based upon HHS' experience in the MLR data collection and
evaluation process, HHS is updating its annual burden hour estimates to
reflect the actual numbers of submissions, rebates and rebate notices.
In addition, the notice requirement for issuers that do not owe rebates
applied only to the 2011 reporting year, and does not apply to 2012 and
subsequent MLR reporting years.
We have simplified the format of the reporting form and the method
by which issuers submit their data. For the 2012 MLR reporting year,
when submitting data to CMS, issuers will have the option to use either
a Microsoft Excel (.xls) or a Comma Separated Value (.csv) file format.
This will allow issuers flexibility and reduce the burden in submitting
the MLR report. The new method will no longer include pre-calculated
fields which will reduce the burden as well as the possibility of
error.
The 2012 MLR Reporting Form and instructions also reflect changes
for the 2012 reporting year and beyond that are set forth in the
December 2011 Final Rule as to whether certain already reported
expenditures such as ICD-10 conversion costs are taken into account in
calculating an issuer's MLR.
HHS has created and published a host of electronic training tools
to assist issuers with the preparation and submission of MLR data forms
and Rebate calculations. Consequently the agency is reducing its
current burden hours from 354,570 to 311,302. Form Number: CMS-10418
(OCN: 0938-1164); Frequency: Annual submission for each respondent;
Affected Public: Private Sector, Business or other for-profits and not-
for-profit institutions; Number of Respondents: 502; Number of
Responses: 3,085; Total Annual Hours: 311,302. (For policy questions
regarding this collection, contact Carol Jimenez at (301) 492-4457. 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 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 February 4, 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/OMB
Control Number --------, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
Dated: November 29, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-29243 Filed 12-3-12; 8:45 am]
BILLING CODE 4120-01-P