Agency Information Collection Activities: Submission for OMB Review; Comment Request, 24013-24014 [E9-11939]
Download as PDF
<![CDATA[
24013
Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–12023 Filed 5–21–09; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0299]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Agency Information Collection
Request. 60-Day Public Comment
Request.
AGENCY:
ACTION:
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
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. To obtain copies of
the supporting statement and any
related forms for the proposed
paperwork collections referenced above,
e-mail your request, including your
address, phone number, OMB number,
and OS document identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above e-mail address within 60days.
Proposed Project: Adolescent Family
Life Care and Prevention End of Year
Report Templates (Revision) OMB No.
0990–0299, Office of Adolescent
Pregnancy Programs (OAPP).
Abstract: OAPP is proposing to revise
the current OMB approved Adolescent
Family Life Care and Prevention End of
Year Report Templates. The current
OMB approval is applicable through
May 31, 2009. All AFL grantees are
required by their Notice of Grant
Awards to submit an end of year report
once per year. The current End of Year
Report templates provide a degree of
standardization across the AFL grantees,
allowing for more complete data
collection by OAPP for program
assessment.
OAPP is also proposing to consolidate
0990–0300–AFL Prevention Project End
of Year Report Template ICR and 0990–
0299–AFL Care and Prevention End of
Year Report Templates ICR. After the
approval by OMB on 0990–0299 ICR,
OAPP will eliminate 0990–0300. This
action will reduce the redundancy
across ICRs and lessen the number of
burden hours reported by including
both templates under one ICR (0990–
0299).
The original title will be changed to
Adolescent Family Life End of the Year
Report Template.
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
(if necessary)
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
End of Year Report Templates (program and evaluation for prevention and
care grants) ..................................................................................................
65
1
65
4,225
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–12014 Filed 5–21–09; 8:45 am]
BILLING CODE 4150–30–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for Occupational
Safety and Health; Decision To
Evaluate a Petition To Designate a
Class of Employees for the University
of Rochester in Rochester, NY, To Be
Included in the Special Exposure
Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
erowe on PROD1PC63 with NOTICES
AGENCY:
HHS gives notice as required
by 42 CFR 83.12(e) of a decision to
evaluate a petition to designate a class
SUMMARY:
VerDate Nov<24>2008
14:18 May 21, 2009
Jkt 217001
of employees for the University of
Rochester in Rochester, New York, to be
included in the Special Exposure Cohort
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. The initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: University of Rochester.
Location: Rochester, New York.
Job Titles and/or Job Duties:
Laboratory Technicians who worked in
the University of Rochester Atomic
Energy Project laboratory building.
Period of Employment: September 1,
1943 through June 19, 1945.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
Christine M. Branche,
Acting Director, National Institute for
Occupational Safety and Health.
[FR Doc. E9–12007 Filed 5–21–09; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10185 and
CMS–10141]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
E:\FR\FM\22MYN1.SGM
22MYN1
erowe on PROD1PC63 with NOTICES
24014
Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices
Paperwork Reduction Act of 1995, the
Centers for Medicare & 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 function;
(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
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Part D
Reporting Requirements and Supporting
Regulations under 42 CFR 423.505;
Form Number: CMS–10185 (OMB#:
0938–0992); Use: Title I, Part 423,
§ 423.514 describes CMS’ regulatory
authority to establish requirements for
Part D sponsors. It is noted that each
Part D plan sponsor must have an
effective procedure to develop, compile,
evaluate, and report to CMS, its
enrollees, and the general public, at the
times and in the manner that CMS
requires, statistics in the following
areas: (1) The cost of its operations; (2)
The availability of utilization of its
services; (3) The availability,
accessibility; and acceptability of its
services; (4) Information demonstrating
that the Part D plan sponsor has a
fiscally sound operation; and (5) other
matters that CMS may require.
Subsection 423.505 of the Medicare
Prescription Drug Modernization and
Modernization Act establishes as a
contract provision that Part D Sponsors
must comply with the reporting
requirements for submitting drug claims
and related information to CMS. Data
collected via Medicare Part D Reporting
Requirements will be an integral
resource for oversight, monitoring,
compliance and auditing activities
necessary to ensure quality provision of
the Medicare Prescription Drug Benefit
to beneficiaries. Please see the
supporting documentation, ‘‘Revisions
to 2nd Draft of CY 2010 Part D
Reporting Requirements’’ document to
view a list of current changes.
Frequency: Reporting—yearly, quarterly
and semi-annually; Affected Public:
Business or other for-profit; Number of
VerDate Nov<24>2008
14:18 May 21, 2009
Jkt 217001
Respondents: 4,526; Total Annual
Responses: 380,184; Total Annual
Hours: 157,450. (For policy questions
regarding this collection contact Alice
Lee-Martin at 410–786–4578. For all
other issues call 410–786–1103.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Prescription Drug Benefit Plan Program:
Use: Part D plans use the information
discussed to comply with the eligibility
and associated Part D participating
requirements. CMS will use this
information to approve contract
applications, monitor compliance with
contract requirements, make proper
payment to plans, and to ensure that
correct information is disclosed to
enrollees, both potential and current
enrollees. Form Number: CMS–10141
(OMB#: 0938–0964); Frequency:
Reporting—quarterly, semi-annually
and yearly; Affected Public: Business or
other for-profits and Individuals or
households; Number of Respondents:
19,937,772; Total Annual Responses:
38,152,764; Total Annual Hours:
34,730,676. (For policy questions
regarding this collection contact
Eugenia Mattison-Gibson at 410–786–
2564. 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
E-mail 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.
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 June 22, 2009: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, E-mail:
OIRA_submission@omb.eop.gov.
Dated: May 15, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–11939 Filed 5–21–09; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0307]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; INTELENCE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
INTELENCE and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 74, Number 98 (Friday, May 22, 2009)]
[Notices]
[Pages 24013-24014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11939]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10185 and CMS-10141]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
In compliance with the requirement of section 3506(c)(2)(A) of the
[[Page 24014]]
Paperwork Reduction Act of 1995, the Centers for Medicare & 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 function; (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 Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Part D
Reporting Requirements and Supporting Regulations under 42 CFR 423.505;
Form Number: CMS-10185 (OMB: 0938-0992); Use: Title I, Part
423, Sec. 423.514 describes CMS' regulatory authority to establish
requirements for Part D sponsors. It is noted that each Part D plan
sponsor must have an effective procedure to develop, compile, evaluate,
and report to CMS, its enrollees, and the general public, at the times
and in the manner that CMS requires, statistics in the following areas:
(1) The cost of its operations; (2) The availability of utilization of
its services; (3) The availability, accessibility; and acceptability of
its services; (4) Information demonstrating that the Part D plan
sponsor has a fiscally sound operation; and (5) other matters that CMS
may require. Subsection 423.505 of the Medicare Prescription Drug
Modernization and Modernization Act establishes as a contract provision
that Part D Sponsors must comply with the reporting requirements for
submitting drug claims and related information to CMS. Data collected
via Medicare Part D Reporting Requirements will be an integral resource
for oversight, monitoring, compliance and auditing activities necessary
to ensure quality provision of the Medicare Prescription Drug Benefit
to beneficiaries. Please see the supporting documentation, ``Revisions
to 2nd Draft of CY 2010 Part D Reporting Requirements'' document to
view a list of current changes. Frequency: Reporting--yearly, quarterly
and semi-annually; Affected Public: Business or other for-profit;
Number of Respondents: 4,526; Total Annual Responses: 380,184; Total
Annual Hours: 157,450. (For policy questions regarding this collection
contact Alice Lee-Martin at 410-786-4578. For all other issues call
410-786-1103.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare
Prescription Drug Benefit Plan Program: Use: Part D plans use the
information discussed to comply with the eligibility and associated
Part D participating requirements. CMS will use this information to
approve contract applications, monitor compliance with contract
requirements, make proper payment to plans, and to ensure that correct
information is disclosed to enrollees, both potential and current
enrollees. Form Number: CMS-10141 (OMB: 0938-0964); Frequency:
Reporting--quarterly, semi-annually and yearly; Affected Public:
Business or other for-profits and Individuals or households; Number of
Respondents: 19,937,772; Total Annual Responses: 38,152,764; Total
Annual Hours: 34,730,676. (For policy questions regarding this
collection contact Eugenia Mattison-Gibson at 410-786-2564. 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
E-mail 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.
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 June 22, 2009:
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-6974, E-mail: OIRA_submission@omb.eop.gov.
Dated: May 15, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-11939 Filed 5-21-09; 8:45 am]
BILLING CODE 4120-01-P
