Centers for Medicare & Medicaid Services; Agency Information Collection Activities: Submission for OMB Review; Comment Request, 25266-25267 [2010-10622]
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25266
Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices
Written comments and
recommendations concerning the
proposed information collection should
be sent by June 7, 2010 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–6974.
Dated: April 28, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–10907 Filed 5–6–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–901A and 901D]
jlentini on DSKJ8SOYB1PROD with NOTICES
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
Request: Extension of a currently
approved collection; Title of
Information Collection: Federal
Qualification Application (42 CFR
417.140) and Medicare Health Care
Prepayment Plan Application (42 CFR
417.800); Use: The application is the
collection form used to obtain
information to determine if an applicant
meets the regulatory requirements to
enter into a contract with CMS as a
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19:19 May 06, 2010
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Federal Qualified health maintenance
organization (HMO) or to provide health
benefits to Medicare beneficiaries as a
Medicare Health Care Prepayment Plan
contractor. Form Number: CMS–901A &
901D (OMB#: 0938–0470); Frequency:
Once; Affected Public: Business or other
for-profits and Not-for-profit
institutions; Number of Respondents:
20; Total Annual Responses: 20; Total
Annual Hours: 800 (For policy
questions regarding this collection
contact Heidi Arndt at 410–786–1607.
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
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.
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 July 6, 2010:
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.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–10623 Filed 5–6–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: CMS–10293]
Centers for Medicare & Medicaid
Services; Agency Information
Collection Activities: Submission for
OMB Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
PO 00000
Frm 00082
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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), 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: New Collection; Title of
Information Collection: Tribal
Consultation State Plan Amendment
Template; Use: Effective July 1, 2009,
section 5006 of the American Recovery
and Reinvestment Act of 2009 (Recovery
Act) amended section 1902(a)(73) of the
Act to require that certain States utilize
a process for the State to seek advice on
a regular, ongoing basis from designees
of the Indian Health Service (IHS) and
Urban Indian Organizations concerning
Medicaid and Children’s Health
Insurance Program (CHIP) matters
having a direct effect on them. The
consultation process is required for the
37 States in which 1 or more Indian
Health Programs or Urban Indian
Organizations furnish health care
services. The State Medicaid agency for
each of these States will complete the
template page and submit it for approval
as part of a State plan amendment, to
document how it meets the
requirements for tribal consultation.
Form Number: CMS–10293 (OMB#:
0938–NEW); Frequency: Reporting—
Once and occasionally; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 37; Total
Annual Responses: 37; Total Annual
Hours: 37. (For policy questions
regarding this collection contact Lane
Terwilliger at 410–786–2059. 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
E:\FR\FM\07MYN1.SGM
07MYN1
Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices
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 7, 2010.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–10622 Filed 5–6–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0074]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: 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
(the PRA).
DATES: Fax written comments on the
collection of information by June 7,
2010.
ADDRESSES: 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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0650. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
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19:19 May 06, 2010
Jkt 220001
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products—(OMB Control Number 0910–
0650)—Extension
On June 22, 2009, the President
signed The Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Public Law 111–31) into
law. The Tobacco Control Act amended
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 301 et seq.) by,
among other things, adding a new
chapter granting FDA important new
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect the public health
generally and to reduce tobacco use by
minors. Section 905(b) of the act (21
U.S.C. 395(b)), as amended by the
Tobacco Control Act, requires that
‘‘every person who owns or operates any
establishment in any State engaged in
the manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products
* * *’’ register with FDA the name,
places of business, and all
establishments owned or operated by
that person. Every person must register
by December 31 of each year. Section
905(i)(1) of the act, as amended by the
Tobacco Control Act, requires that all
registrants ‘‘shall, at the time of
registration under any such subsection,
file with [FDA] a list of all tobacco
products which are being manufactured,
prepared, compounded, or processed by
that person for commercial
distribution,’’ along with certain
accompanying consumer information,
such as all labeling and a representative
sampling of advertisements. Section
904(a)(1) of the act, as amended by the
Tobacco Control Act, requires each
tobacco product manufacturer or
importer, or agent thereof, to submit ‘‘a
listing of all ingredients, including
tobacco, substances, compounds, and
additives that are * * * added by the
manufacturer to the tobacco, paper,
filter, or other part of each tobacco
product by brand and by quantity in
each brand and subbrand.’’ Since the
Tobacco Control Act was enacted on
June 22, 2009, the information required
under section 904(a)(1) of the act must
be submitted to FDA by December 22,
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25267
2009, and include the ingredients added
as of the date of submission. Section
904(c) of the act also requires
submission of information whenever
additives, or the quantities of additives,
are changed.
FDA issued guidance documents on
both (1) Registration and Product Listing
for Owners and Operators of Domestic
Tobacco Product Establishments
(November 12, 2009, 74 FR 58298) and
(2) Listing of Ingredients in Tobacco
Products (December 1, 2009, 74 FR
62795) to assist persons making such
submissions to FDA under the Tobacco
Control Act. While electronic
submission of registration and product
listing information and ingredient
listing information are not required,
FDA is strongly encouraging electronic
submission to facilitate efficiency and
timeliness of data management and
collection. To that end, FDA designed
the eSubmitter application to streamline
the data entry process for registration
and product listing and for ingredient
listing. This tool allows for importation
of large quantities of structured data,
attachments of files (e.g., in portable
document format (PDFs) and certain
media files), and automatic
acknowledgement of FDA’s receipt of
submissions. FDA also developed paper
forms (FDA Form 3742—Registration
and Listing for Owners and Operators of
Domestic Tobacco Product
Establishments and FDA Form 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool. Both the eSubmitter application
and the paper forms can be accessed at
https://www.fda.gov/tobacco.
In the Federal Register of September
1, 2009 (74 FR 45219), FDA published
a notice announcing that a proposed
collection of information had been
submitted to OMB for emergency
processing under the PRA. In the
Federal Register of September 15, 2009
(74 FR 47257), FDA published a notice
correcting the length of the comment
period, keeping it open until October 1,
2009. In the Federal Register of October
13, 2009 (74 FR 52495), FDA published
a notice reopening the comment period
until October 26, 2009. Based on
comments indicating that the burden
estimates were too low, FDA has
adjusted its original burden estimates.
FDA has adjusted its burden estimate
for registration and product listing for
owners and operators of domestic
establishments under section 905 of the
act from 0.75 hours per response to 3.75
hours per response. FDA has adjusted
its burden estimate for listing of
ingredients under section 904 of the act
from 0.75 hours per response to 3.0
hours per response. FDA also decreased
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Agencies
[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25266-25267]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10622]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: CMS-10293]
Centers for Medicare & Medicaid Services; 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
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: New Collection; Title of
Information Collection: Tribal Consultation State Plan Amendment
Template; Use: Effective July 1, 2009, section 5006 of the American
Recovery and Reinvestment Act of 2009 (Recovery Act) amended section
1902(a)(73) of the Act to require that certain States utilize a process
for the State to seek advice on a regular, ongoing basis from designees
of the Indian Health Service (IHS) and Urban Indian Organizations
concerning Medicaid and Children's Health Insurance Program (CHIP)
matters having a direct effect on them. The consultation process is
required for the 37 States in which 1 or more Indian Health Programs or
Urban Indian Organizations furnish health care services. The State
Medicaid agency for each of these States will complete the template
page and submit it for approval as part of a State plan amendment, to
document how it meets the requirements for tribal consultation. Form
Number: CMS-10293 (OMB: 0938-NEW); Frequency: Reporting--Once
and occasionally; Affected Public: State, Local, or Tribal Governments;
Number of Respondents: 37; Total Annual Responses: 37; Total Annual
Hours: 37. (For policy questions regarding this collection contact Lane
Terwilliger at 410-786-2059. 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
[[Page 25267]]
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 7, 2010.
OMB, Office of Information and Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395-6974, E-mail: OIRA_submission@omb.eop.gov.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2010-10622 Filed 5-6-10; 8:45 am]
BILLING CODE 4120-01-P