Agency Information Collection Activities: Proposed Collection; Comment Request, 41142-41143 [E9-19539]
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mstockstill on DSKH9S0YB1PROD with NOTICES
41142
Federal Register / Vol. 74, No. 156 / Friday, August 14, 2009 / Notices
Information Collection: National
Medicare & You Education Program
(NMEP) Survey of Medicare
Beneficiaries Use: The Centers for
Medicare and Medicaid Services is
requesting a reinstatement of this
information collection request to
continue to collect information from
Medicare beneficiaries, caregivers,
health care providers, and health
information providers. The collection of
information was inadvertently
discontinued in December 2008;
however, as stated earlier, we are
currently seeking a reinstatement with
change as we have revised the collection
instrument. It is critical for this agency
to obtain feedback from the
aforementioned groups so that the
agency can accurately assess the needs
of the Medicare audience. Using random
digit dial and/or an administrative
sample, members of the Medicare
audience will be called and asked to
complete the survey via telephone. The
results of this survey will be compiled
and studied so that communication may
be amended to benefit Medicare’s
audience. The survey has the following
objectives: to assess satisfaction with
and knowledge of the Medicare
program; to gather information on
health behaviors and quality of health
care; to determine the most used source
for Medicare information; and to gather
information from health care provider
and health information providers. Form
Number: CMS–R–254 (OMB# 0938–
0738); Frequency: Once; Affected
Public: Individuals and Households,
Private Sector—Business or other forprofits; Number of Respondents: 7,000;
Total Annual Responses: 7,000; Total
Annual Hours: 1,750.
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.
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 September 14, 2009: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, E-mail:
OIRA_submission@omb.eop.gov.
VerDate Nov<24>2008
16:27 Aug 13, 2009
Jkt 217001
Dated: August 7, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–19537 Filed 8–13–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–284 and
CMS–10190]
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 without change of a
currently approved collection; Title of
Information Collection: Medicaid
Statistical Information System; Use:
State data are reported by the Federally
mandated electronic process, known as
(MSIS) Medical Statistical Information
System. These data are the basis of
actuarial forecasts for Medicaid service
utilization and costs; of analysis and
cost savings estimates required for
legislative initiatives relating to
Medicaid and for responding to requests
for information from CMS components,
the Department, Congress and other
customers.
Form Number: CMS–R–284 (OMB#:
0938–0345); Frequency: Reporting—
Quarterly; Affected Public: State, Local,
or Tribal Governments; Number of
Respondents: 51; Total Annual
Responses: 204; Total Annual Hours:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
2,040. (For policy questions regarding
this collection contact Denise Franz
410–786–6117. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Section 1901 of
the Act (42 U.S.C. 1396) requires that
States must establish a State plan for
medical assistance that are approved by
the Secretary to carry out the purposes
of title XIX. The DRA provides States
with numerous flexibilities in operating
their State Medicaid programs. The
intent of these flexibilities is to provide
States with program alternatives that
allow them to provide the most
appropriate health care coverage that
meets beneficiary needs, while at the
same time curtailing State and Federal
spending. Except for the documentation
of citizenship requirements, States can
submit SPAs to CMS to effectuate these
changes to their Medicaid programs.
CMS provided State Medicaid Directors
letters providing guidance on these
provisions and the implementation of
the DRA and associated SPA templates
for use by States to modify their
Medicaid State plans if they choose to
implement these flexibilities. Under this
process, the end result is the State
burden will be reduced significantly. To
implement these flexibilities, a
collection of information to effectuate
these changes is required. Therefore,
State Medicaid agencies will complete
the templates to effectuate the changes.
CMS will review the information to
determine if the State has met all of the
requirements of the DRA provisions the
States choose to implement. If the
requirements are met, CMS will approve
the amendments to the State’s Title XIX
plan giving the State the authority to
implement the flexibilities. For a State
to receive Medicaid Title XIX funding,
there must be an approved Title XIX
State plan. Five templates were created
to assist States in effectuating these
flexibilities through modifications to the
State plan. The Children’s Health
Insurance Program Reauthorization Act
(CHIPRA) of 2009, enacted on February
4, 2009, corrected language in section
6044 (Alternative Benefit Packages) of
the DRA as if these amendments were
included in the DRA, and subsequently
amended section 1937 ‘‘State Flexibility
for Medicaid Benefit Packages.’’ We
have modified the preprints to reflect
these statutory changes. Form Number:
CMS–10190 (OMB#: 0938–0993);
Frequency: Reporting—Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 16; Total
E:\FR\FM\14AUN1.SGM
14AUN1
Federal Register / Vol. 74, No. 156 / Friday, August 14, 2009 / Notices
Annual Hours: 699. (For policy
questions regarding this collection
contact Fran Crystal at 410–786–1195.
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 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 October 13, 2009:
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 (CMS–R–284 and
CMS–10190), Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: August 7, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–19539 Filed 8–13–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
[Docket No. FDA–2009–D–0342]
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 10 on
Polyacrylamide Gel Electrophoresis
General Chapter; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Nov<24>2008
16:27 Aug 13, 2009
Jkt 217001
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions; Annex 10: Polyacrylamide
Gel Electrophoresis General Chapter.’’
The draft guidance was prepared under
the auspices of the International
Conference on Harmonisation of
Technical Requirements for Registration
of Pharmaceuticals for Human Use
(ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the
Polyacrylamide Gel Electrophoresis
General Chapter harmonized text from
each of the three pharmacopoeias
(United States, European, and Japanese)
represented by the Pharmacopoeial
Discussion Group (PDG). The draft
guidance conveys recognition of the
three pharmacopoeial methods by the
three ICH regulatory regions and
provides specific information regarding
the recognition. The draft guidance is
intended to recognize the
interchangeability between the local
regional pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. This draft guidance is the tenth
annex to the core Q4B guidance, which
was made available in the Federal
Register of February 21, 2008 (73 FR
9575).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by October 13, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002; or the Office of
Communication and Development
(HFM–40), Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448. The guidance may also be
obtained by mail by calling the Center
for Biologics Evaluation and Research at
1–800–835–4709 or 301–827–1800.
Send two self-addressed adhesive labels
to assist the office in processing your
requests. Submit written comments on
the draft guidance 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://
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
41143
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H.
King, Sr., Center for Drug
Evaluation and Research (HFD–
003), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993–0002,
301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–25), Food and Drug
Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD
20852–1448, 301–827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 74, Number 156 (Friday, August 14, 2009)]
[Notices]
[Pages 41142-41143]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19539]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-284 and CMS-10190]
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 without change
of a currently approved collection; Title of Information Collection:
Medicaid Statistical Information System; Use: State data are reported
by the Federally mandated electronic process, known as (MSIS) Medical
Statistical Information System. These data are the basis of actuarial
forecasts for Medicaid service utilization and costs; of analysis and
cost savings estimates required for legislative initiatives relating to
Medicaid and for responding to requests for information from CMS
components, the Department, Congress and other customers.
Form Number: CMS-R-284 (OMB: 0938-0345); Frequency:
Reporting--Quarterly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 51; Total Annual Responses: 204;
Total Annual Hours: 2,040. (For policy questions regarding this
collection contact Denise Franz 410-786-6117. For all other issues call
410-786-1326.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Section 1901 of
the Act (42 U.S.C. 1396) requires that States must establish a State
plan for medical assistance that are approved by the Secretary to carry
out the purposes of title XIX. The DRA provides States with numerous
flexibilities in operating their State Medicaid programs. The intent of
these flexibilities is to provide States with program alternatives that
allow them to provide the most appropriate health care coverage that
meets beneficiary needs, while at the same time curtailing State and
Federal spending. Except for the documentation of citizenship
requirements, States can submit SPAs to CMS to effectuate these changes
to their Medicaid programs. CMS provided State Medicaid Directors
letters providing guidance on these provisions and the implementation
of the DRA and associated SPA templates for use by States to modify
their Medicaid State plans if they choose to implement these
flexibilities. Under this process, the end result is the State burden
will be reduced significantly. To implement these flexibilities, a
collection of information to effectuate these changes is required.
Therefore, State Medicaid agencies will complete the templates to
effectuate the changes. CMS will review the information to determine if
the State has met all of the requirements of the DRA provisions the
States choose to implement. If the requirements are met, CMS will
approve the amendments to the State's Title XIX plan giving the State
the authority to implement the flexibilities. For a State to receive
Medicaid Title XIX funding, there must be an approved Title XIX State
plan. Five templates were created to assist States in effectuating
these flexibilities through modifications to the State plan. The
Children's Health Insurance Program Reauthorization Act (CHIPRA) of
2009, enacted on February 4, 2009, corrected language in section 6044
(Alternative Benefit Packages) of the DRA as if these amendments were
included in the DRA, and subsequently amended section 1937 ``State
Flexibility for Medicaid Benefit Packages.'' We have modified the
preprints to reflect these statutory changes. Form Number: CMS-10190
(OMB: 0938-0993); Frequency: Reporting--Yearly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 56;
Total Annual Responses: 16; Total
[[Page 41143]]
Annual Hours: 699. (For policy questions regarding this collection
contact Fran Crystal at 410-786-1195. 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 October 13, 2009:
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 (CMS-R-284 and CMS-10190), Room C4-26-05, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850.
Dated: August 7, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-19539 Filed 8-13-09; 8:45 am]
BILLING CODE 4120-01-P
