Agency Information Collection Activities: Proposed Collection; Comment Request, 47216-47217 [05-15977]
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47216
Federal Register / Vol. 70, No. 155 / Friday, August 12, 2005 / Notices
and Not-for-profit institutions; Number
of Respondents: 2600; Total Annual
Responses: 2600; Total Annual Hours:
100.
CMS is requesting OMB review and
approval of these collections by
September 16, 2005, with a 180-day
approval period. Written comments and
recommendation will be considered
from the public if received by the
individuals designated below by
September 12, 2005.
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/
regulations/pra 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.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
mailed to the designees referenced
below by September 12, 2005:
Centers for Medicare & Medicaid
Services, Office of Strategic Operations
and Regulatory Affairs, Room C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850, Attn: William N. Parham,
III, and, OMB Human Resources and
Housing Branch, Attention: Christopher
Martin, New Executive Office Building,
Room 10235, Washington, DC 20503.
Dated: August 5, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–15975 Filed 8–11–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–29/30, CMS–
10150, CMS–381, CMS–10161, CMS–10134,
CMS–R–137]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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
AGENCY:
VerDate jul<14>2003
17:14 Aug 11, 2005
Jkt 205001
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: Request for
Certification as Rural Health Clinic and
Rural Health Clinic Survey Report Form
and Supporting Regulations in 42 CFR
491.1–491.11; Form No.: CMS–29 and
CMS–30 (OMB #0938–0074); Use: The
form CMS–29 is utilized as an
application to be completed by
suppliers of Rural Health Clinic (RHC)
services requesting participation in the
Medicare/Medicaid programs. This form
initiates the process of obtaining a
decision as to whether the conditions
for certification are met as a supplier of
RHC services. It also promotes data
reduction or introduction to and
retrieval from the Online Survey and
Certification and Reporting System
(OSCAR) by CMS Regional Offices (RO).
The Form CMS–30 is an instrument
used by the State survey agency to
record data collected in order to
determine RHC compliance with
individual conditions of participation
and to report it to the Federal
government. The form is primarily a
coding worksheet designed to facilitate
data reduction (keypunching) and
retrieval into OSCAR at the CMS ROs.
The form includes basic information on
compliance (i.e., met, not met and
explanatory statements) and does not
require any descriptive information
regarding the survey activity itself;
Frequency: Reporting—Annually;
Affected Public: State, Local or Tribal
Government; Number of Respondents:
698; Total Annual Responses: 698; Total
Annual Hours: 1,222.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Collection of
Drug Pricing and Network Pharmacy
Data from Medicare Prescription Drug
Plans (PDPs and MA–PDs) and
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Supporting Regulations in 42 CFR
423.48; Form No.: CMS–10150 (OMB
#0938–0951); Use: Both stand alone
prescription drug plans (PDPs) and
Medicare Advantage Prescription Drug
(MA–PDs) plans will be required to
submit drug pricing and pharmacy
network data to CMS. These data will be
made publicly available to Medicare
beneficiaries through the new Medicare
prescription drug plan finder tool that
will be launched in the fall of 2005 on
https://www.medicare.gov. The purpose
of the data is to enable beneficiaries to
compare, learn, select and enroll in a
plan that best meets their needs;
Frequency: Reporting—Weekly;
Affected Public: Business or other forprofit; Number of Respondents: 350;
Total Annual Responses: 18,200; Total
Annual Hours: 36,400.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Identification of
Extension Units of Outpatient Physical
Therapy/Outpatient Speech Pathology
(OPT/OSP) Providers and Supporting
Regulations in 42 CFR Sections
485.701–485.729; Form No.: CMS–381
(OMB #0938–0273); Use: Medicare
provides OPT/OSP providers to be
surveyed to determine compliance with
Federal regulations. All locations where
OPT/OSP providers furnish services
must meet these requirements. The
CMS–381 is the form used to identify all
the OPT/OSP locations. Frequency:
Reporting—Annually; Affected Public:
Business or other for-profit; Number of
Respondents: 2960; Total Annual
Responses: 2960; Total Annual Hours:
740.
4. Type of Information Collection
Request: New Collection; Title of
Information Collection: New Freedom
Initiative—Web-based Reporting System
for Grantees; Form No.: CMS–10161
(OMB #0938–NEW); Use: CMS currently
awards competitive grants to States and
other eligible entities for the purpose of
designing and implementing effective
and enduring improvements in
community-based long-term services
and supporting systems. We currently
require grantees to report quarterly,
semi-annual, and or annually,
depending on the grant type. CMS
requires the information obtained
through Web-based grantee reporting for
two reasons: (1) in order to effectively
monitor the grants, and; (2) to report to
Congress and other interested
stakeholders the progress and obstacles
experienced by the grantees. The
grantees are the respondents to the Webbased reporting system; Frequency:
Reporting—Quarterly, Semi-annually,
E:\FR\FM\12AUN1.SGM
12AUN1
Federal Register / Vol. 70, No. 155 / Friday, August 12, 2005 / Notices
and Annually; Affected Public: State,
Local or Tribal Government and Not-forprofit institutions; Number of
Respondents: 298; Total Annual
Responses: 836; Total Annual Hours:
6,440.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Physician Group
Practice (PGP) Standardized
Ambulatory Care Quality Measure
Collection Initiative; Use: The Benefits
Improvement & Protection Act of 2000
mandated the Physician Group Practice
(PGP) Demonstration and gave the
Secretary discretion to use quality
measures to assess physician
performance in order to reward them for
improvements in the quality and
efficiency of health care. This
demonstration is intended to strengthen
the Medicare program by offering
innovative models to beneficiaries that
improve quality and access and lower
costs. As a result, Medicare beneficiaries
will directly benefit from these
innovative models. The demonstration
represents the first pay for performance
project for physician group practices
and will enable comparisons across
groups and geography; Form Number:
CMS–10134 (OMB #0938–0942);
Frequency: Annually; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 10; Total Annual
Responses: 10; Total Annual Hours:
790.
6. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Internal
Revenue Service/Social Security
Administration/Centers for Medicare
and Medicaid Services Data Match and
Supporting Regulations in 42 CFR
411.20–491.206; Form No.: CMS–R–137
(OMB #0938–0565); Use: The Data
Match project and information
collection activity provides a ‘‘check
and balance’’ against the Medicare
program relying solely on a single
information collection system. It gives
CMS the opportunity to pursue
collection of identified mistaken
payments (within legal constraints) and
to update incorrect status indicators to
prevent further incorrect suspensions or
mistaken payment or denial. Employers
identified through a match of IRS, SSA,
and Medicare records will be contacted
concerning group health plan coverage
of identified individuals to ensure
compliance with Medicare Secondary
Payer provisions found at 42 U.S.C.
1395y(b); Frequency: Reporting—
Annually; Affected Public: Business or
VerDate jul<14>2003
17:14 Aug 11, 2005
Jkt 205001
other for-profit, Not-for-profit
institutions, Farms, Federal, State, Local
or Tribal Government; Number of
Respondents: 341,065; Total Annual
Responses: 341,065; Total Annual
Hours: 1,986,810.
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/
regulations/pra/, 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.
Written comments and
recommendations for the proposed
information collections must be mailed
within 60 days of this notice to the
address below: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Melissa Musotto, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Dated: August 5, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–15977 Filed 8–11–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D–0835]
Draft Guidance for Industry on
Conjugated Estrogens, USP–LC–MS
Method for Both Qualitative Chemical
Characterization and Documentation of
Qualitative Pharmaceutical
Equivalence; Withdrawal of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Frm 00050
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
David J. Cummings, Center for Drug
Evaluation and Research (HFD–357),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–443–5187.
SUPPLEMENTARY INFORMATION: FDA is
announcing the withdrawal of a draft
guidance for industry entitled
‘‘Conjugated Estrogens, USP–LC–MS
Method for Both Qualitative Chemical
Characterization and Documentation of
Qualitative Pharmaceutical
Equivalence.’’ The agency announced
the availability of the guidance in the
Federal Register of March 9, 2000 (65
FR 12556). The draft guidance was
originally intended to provide
recommendations to applicants on how
to use the liquid chromatography mass
spectrometry (LC–MS) method to
address both qualitative chemical
characterization and qualitative
pharmaceutical equivalence for natural
source conjugated estrogens. FDA is
withdrawing the guidance because
advances in technology allow for the
possibility of using different
methodologies. FDA does not want to
inhibit companies from using a
methodology that might provide
additional scientific data to support
characterization and pharmaceutical
equivalence for conjugated estrogens in
the future. If submitted, these data
would be evaluated to determine
applicability of the method before an
application could be approved.
Dated: August 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16019 Filed 8–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–22049]
Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of a draft guidance for
industry entitled ‘‘Conjugated Estrogens,
USP–LC–MS Method for Both
Qualitative Chemical Characterization
and Documentation of Qualitative
Pharmaceutical Equivalence.’’ FDA is
withdrawing the draft guidance because
the published methodology limits the
submission of scientifically valid
information to the agency that may be
based on different methodologies. FDA
does not want to dictate the scientific
approach for developing adequate
methods.
PO 00000
47217
Collection of Information Under
Review by Office of Management and
Budget (OMB): OMB Control Numbers:
1625–0035 and 1625–0051
Coast Guard, DHS.
Request for comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, the
Coast Guard intends to seek the
approval of OMB for the renewal of two
Information Collection Requests (ICRs).
The ICRs are for 1625–0035, Title 46
CFR Subchapter Q: Lifesaving,
Electrical, and Engineering Equipment,
Construction and Materials & Marine
E:\FR\FM\12AUN1.SGM
12AUN1
Agencies
[Federal Register Volume 70, Number 155 (Friday, August 12, 2005)]
[Notices]
[Pages 47216-47217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15977]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-29/30, CMS-10150, CMS-381, CMS-10161, CMS-
10134, CMS-R-137]
Agency Information Collection Activities: Proposed Collection;
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) 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: Request for
Certification as Rural Health Clinic and Rural Health Clinic Survey
Report Form and Supporting Regulations in 42 CFR 491.1-491.11; Form
No.: CMS-29 and CMS-30 (OMB 0938-0074); Use: The form CMS-29
is utilized as an application to be completed by suppliers of Rural
Health Clinic (RHC) services requesting participation in the Medicare/
Medicaid programs. This form initiates the process of obtaining a
decision as to whether the conditions for certification are met as a
supplier of RHC services. It also promotes data reduction or
introduction to and retrieval from the Online Survey and Certification
and Reporting System (OSCAR) by CMS Regional Offices (RO). The Form
CMS-30 is an instrument used by the State survey agency to record data
collected in order to determine RHC compliance with individual
conditions of participation and to report it to the Federal government.
The form is primarily a coding worksheet designed to facilitate data
reduction (keypunching) and retrieval into OSCAR at the CMS ROs. The
form includes basic information on compliance (i.e., met, not met and
explanatory statements) and does not require any descriptive
information regarding the survey activity itself; Frequency:
Reporting--Annually; Affected Public: State, Local or Tribal
Government; Number of Respondents: 698; Total Annual Responses: 698;
Total Annual Hours: 1,222.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Collection of
Drug Pricing and Network Pharmacy Data from Medicare Prescription Drug
Plans (PDPs and MA-PDs) and Supporting Regulations in 42 CFR 423.48;
Form No.: CMS-10150 (OMB 0938-0951); Use: Both stand alone
prescription drug plans (PDPs) and Medicare Advantage Prescription Drug
(MA-PDs) plans will be required to submit drug pricing and pharmacy
network data to CMS. These data will be made publicly available to
Medicare beneficiaries through the new Medicare prescription drug plan
finder tool that will be launched in the fall of 2005 on https://
www.medicare.gov. The purpose of the data is to enable beneficiaries to
compare, learn, select and enroll in a plan that best meets their
needs; Frequency: Reporting--Weekly; Affected Public: Business or other
for-profit; Number of Respondents: 350; Total Annual Responses: 18,200;
Total Annual Hours: 36,400.
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Identification of
Extension Units of Outpatient Physical Therapy/Outpatient Speech
Pathology (OPT/OSP) Providers and Supporting Regulations in 42 CFR
Sections 485.701-485.729; Form No.: CMS-381 (OMB 0938-0273);
Use: Medicare provides OPT/OSP providers to be surveyed to determine
compliance with Federal regulations. All locations where OPT/OSP
providers furnish services must meet these requirements. The CMS-381 is
the form used to identify all the OPT/OSP locations. Frequency:
Reporting--Annually; Affected Public: Business or other for-profit;
Number of Respondents: 2960; Total Annual Responses: 2960; Total Annual
Hours: 740.
4. Type of Information Collection Request: New Collection; Title of
Information Collection: New Freedom Initiative--Web-based Reporting
System for Grantees; Form No.: CMS-10161 (OMB 0938-NEW); Use:
CMS currently awards competitive grants to States and other eligible
entities for the purpose of designing and implementing effective and
enduring improvements in community-based long-term services and
supporting systems. We currently require grantees to report quarterly,
semi-annual, and or annually, depending on the grant type. CMS requires
the information obtained through Web-based grantee reporting for two
reasons: (1) in order to effectively monitor the grants, and; (2) to
report to Congress and other interested stakeholders the progress and
obstacles experienced by the grantees. The grantees are the respondents
to the Web-based reporting system; Frequency: Reporting--Quarterly,
Semi-annually,
[[Page 47217]]
and Annually; Affected Public: State, Local or Tribal Government and
Not-for-profit institutions; Number of Respondents: 298; Total Annual
Responses: 836; Total Annual Hours: 6,440.
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Physician Group
Practice (PGP) Standardized Ambulatory Care Quality Measure Collection
Initiative; Use: The Benefits Improvement & Protection Act of 2000
mandated the Physician Group Practice (PGP) Demonstration and gave the
Secretary discretion to use quality measures to assess physician
performance in order to reward them for improvements in the quality and
efficiency of health care. This demonstration is intended to strengthen
the Medicare program by offering innovative models to beneficiaries
that improve quality and access and lower costs. As a result, Medicare
beneficiaries will directly benefit from these innovative models. The
demonstration represents the first pay for performance project for
physician group practices and will enable comparisons across groups and
geography; Form Number: CMS-10134 (OMB 0938-0942); Frequency:
Annually; Affected Public: Business or other for-profit and Not-for-
profit institutions; Number of Respondents: 10; Total Annual Responses:
10; Total Annual Hours: 790.
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Internal Revenue
Service/Social Security Administration/Centers for Medicare and
Medicaid Services Data Match and Supporting Regulations in 42 CFR
411.20-491.206; Form No.: CMS-R-137 (OMB 0938-0565); Use: The
Data Match project and information collection activity provides a
``check and balance'' against the Medicare program relying solely on a
single information collection system. It gives CMS the opportunity to
pursue collection of identified mistaken payments (within legal
constraints) and to update incorrect status indicators to prevent
further incorrect suspensions or mistaken payment or denial. Employers
identified through a match of IRS, SSA, and Medicare records will be
contacted concerning group health plan coverage of identified
individuals to ensure compliance with Medicare Secondary Payer
provisions found at 42 U.S.C. 1395y(b); Frequency: Reporting--Annually;
Affected Public: Business or other for-profit, Not-for-profit
institutions, Farms, Federal, State, Local or Tribal Government; Number
of Respondents: 341,065; Total Annual Responses: 341,065; Total Annual
Hours: 1,986,810.
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/regulations/pra/, 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.
Written comments and recommendations for the proposed information
collections must be mailed within 60 days of this notice to the address
below: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Melissa Musotto, Room
C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Dated: August 5, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 05-15977 Filed 8-11-05; 8:45 am]
BILLING CODE 4120-01-P