Agency Information Collection Activities: Proposed Collection; Comment Request, 38601-38602 [E7-13412]
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Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
coordinates, and evaluates extramural
research activities in cooperation with
centers, divisions, and offices within the
Coordinating Center for Health
Promotion. In carrying out its mission,
the ERPO: (1) Coordinates, monitors,
and directs the extramural research
program which is designed to address
center priorities; (2) provides scientific
leadership in the processes supporting
extramural research of the center; (3)
works with National Centers to prepare
and promote initiatives to stimulate
extramural research in relevant priority
areas; (4) coordinates and conducts indepth external peer review and
secondary program relevance review of
extramural research applications by use
of consultant expert panels; (5) makes
recommendations to the center directors
on award selections on the basis of
secondary reviews; (6) staff members
serve as the program officials and work
with CDC grants management officers,
and the Procurement and Grants Office
to implement and monitor the scientific,
technical, and administrative aspects of
awards; (7) facilitates scientific
collaborations between external and
internal investigators; (8) evaluates
extramural research progress and impact
and disseminates findings; and (9)
assists Office of the Chief Science
Officer, CDC, in developing extramural
research policies and oversees the
implementation of those policies within
the center.
Dated: June 28, 2007.
William H. Gimson,
Chief Operating Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 07–3427 Filed 7–12–07; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10137, CMS–
10237 and 10214, CMS–10242, CMS–379
and CMS–10102]
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.
Interested persons are invited to send
comments regarding this burden
pwalker on PROD1PC71 with NOTICES
AGENCY:
VerDate Aug<31>2005
19:05 Jul 12, 2007
Jkt 211001
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: Revision of a currently
approved collection; Title of
Information Collection: Application for
Prescription Drug Plans (PDP);
Application for Medicare Advantage
Prescription Drug (MA–PD);
Application for Cost Plans to Offer
Qualified Prescription Drug Coverage;
Application for Employer Group Waiver
Plans to Offer Prescription Drug
Coverage; Service Area Expansion
Application for Prescription Drug
Coverage; Use: Collection of this
information is mandated in Part D of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003. The application requirements are
codified in Subpart K of 42 CFR 423.
Coverage for the prescription drug
benefit is provided through prescription
drug plans (PDPs) that offer drug-only
coverage, or through Medicare
Advantage (MA) organizations that offer
integrated prescription drug and health
care coverage (MA–PD plans). PDPs
must offer a basic drug benefit.
Medicare Advantage Coordinated Care
Plans (MA–CCPs) must offer either a
basic benefit or may offer broader
coverage for no additional cost.
Medicare Advantage Private Fee for
Service Plans (MA–PFFS) may choose to
offer a Part D benefit. Cost Plans that are
regulated under Section 1876 of the
Social Security Act, and Employer
Group Plans may also provide a Part D
benefit. If any of the contracting
organizations meet basic requirements,
they may also offer supplemental
benefits through enhanced alternative
coverage for an additional premium.
The information will be collected
under the solicitation of proposals from
PDP, MA–PD, Cost Plan, and Employer
Group Waiver Plans applicants. The
collected information will be used by
CMS to: (1) Insure that applicants meet
CMS requirements, and (2) support the
determination of contract awards.
Refer to the ‘‘High-Level Summary of
Changes in Employer Group Waiver
Plan Part D Applications’’ and ‘‘HighLevel Summary of All Part D
Application Revisions from 2008
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
38601
Solicitation for the 2009 Solicitation’’
documents to review changes from 2008
to 2009; Form Number: CMS–10137
(OMB#: 0938–0936); Frequency:
Reporting: Once; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 455; Total Annual
Responses: 455; Total Annual Hours:
11,890.
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Advantage (MA) Applications—Part C;
Use: An entity seeking a contract as an
MA organization must be able to
provide Medicare’s basic benefits plus
meet the organizational requirements set
out in regulations at 42 CFR part 422.
An applicant must demonstrate that it
can meet the benefit and other
requirements within the specific
geographic area it is requesting. The
application forms are designed to give
CMS the information they need about
the health plan to determine compliance
with Federal regulations at 42 CFR part
422 in an efficient manner. The cited
regulations outline the MA application
process that begins with submission of
an application in the form and manner
that the Secretary provides. The MA
application forms will be used by CMS
to determine whether an entity is
eligible to enter into a contract to
provide services to Medicare
beneficiaries. Refer to the ‘‘2009
Medicare Advantage Application
Changes’’ document to review a list of
the 2009 changes. Form Number: CMS–
10237 and 10214 (OMB#: 0938–0935);
Frequency: Reporting: Yearly; Affected
Public: Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 241; Total Annual
Responses: 241; Total Annual Hours:
5,858.
3. Type of Information Collection
Request: New collection; Title of
Information Collection: Revisions to
Payment Policies Under the Physician
Fee Schedule, Other Changes to
Payment Under Part B, and Revisions to
Payment Policies for Ambulance
Services for CY 2008 (42 CFR 424.36—
Signature Requirements); Use: 42 CFR
424.33(a)(3) states that all claims must
be signed by the beneficiary or the
beneficiary’s representative (in
accordance with 42 CFR 424.36(b)). 42
CFR 424.36(a) states that the
beneficiary’s signature is required on a
claim unless the beneficiary has died or
the provisions of § 424.36(b), (c), or (d)
apply. The statutory authority requiring
a beneficiary’s signature on a claim
submitted by a provider is located in
section 1835(a) and in 1814(a) of the
E:\FR\FM\13JYN1.SGM
13JYN1
pwalker on PROD1PC71 with NOTICES
38602
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
Social Security Act (the Act), for Part B
and Part A services, respectively. The
authority requiring a beneficiary’s
signature for supplier claims is implicit
in sections 1842(b)(3)(B)(ii) and in
1848(g)(4) of the Act. Because it is very
difficult to obtain a beneficiary’s
signature (or the signature of a person
authorized to sign on behalf of the
beneficiary) on a claim when the
beneficiary is being transported by
ambulance in emergency situations,
CMS is proposing that, for emergency
ambulance transport services, an
ambulance provider or supplier may
submit the claim without a beneficiary’s
signature, as long as certain
documentation requirements are met.
The information collected will be used
by CMS contractors (both, fiscal
intermediaries and carriers) that process
and pay emergency ambulance transport
claims. Form Number: CMS–10242
(OMB#: 0938–New); Frequency:
Reporting: Hourly, Daily, Weekly,
Monthly and Yearly; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 9,000; Total Annual
Responses: 6,500,000; Total Annual
Hours: 541,667.
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Financial
Statement of Debtor and Supporting
Regulations in 42 CFR 405.376; Use: 42
CFR 405.376(g) requires that, ‘‘* * * In
determining whether a claim will be
compromised, or collection action
terminated, CMS will consider the
following factors: * * * age and health
of the debtor, present and potential
income, inheritance prospects, possible
concealment or fraudulent transfer of
assets * * *’’ Sections 1842(a)(1)(B) and
(C) of the Social Security Act and 42
CFR 405.376(g) provide the authority for
collection of this information.
In some instances a physician/
supplier who is notified of a debt may
allege inability to immediately repay the
debt in full and may request an
extended repayment schedule.
Alternatively, the debtor may request a
compromise settlement for less than the
full amount due. Before establishing an
extended repayment schedule or
compromise settlement, the CMS’s
Regional Offices and the carrier must
evaluate the provider’s capacity to pay
the debt. Accordingly, the provider is
requested to complete a ‘‘Financial
Statement of Debtor’’ form, CMS–379.
Form Number: CMS–379 (OMB#: 0938–
0270); Frequency: Reporting: Yearly;
Affected Public: Business or other forprofit; Number of Respondents: 500;
VerDate Aug<31>2005
19:05 Jul 12, 2007
Jkt 211001
Total Annual Responses: 500; Total
Annual Hours: 1000.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: National
Implementation of Hospital Consumer
Assessment of Health Providers and
Systems (HCAHPS); Use: The intent of
the HCAHPS initiative is to provide a
standardized survey instrument and
data collection methodology for
measuring patients’ perspectives on
hospital care. While many hospitals
collect information on patient
satisfaction, there is no national
standard for collecting or publicly
reporting this information that would
enable valid comparisons to be made
across all hospitals. In order to make
‘‘apples to apples’’ comparisons to
support consumer choice, it is necessary
to introduce a standard measurement
approach. Hospital Consumer
Assessment of Healthcare Providers and
Systems, also known as the CAHPS
Hospital Survey (HCAHPS) can be
viewed as a core set of questions that
hospitals can combine with their
customized items. HCAHPS was
developed and is being implemented
under the auspices of the Hospital
Quality Alliance, a private/public
partnership that includes hospital
associations, consumer groups, payors
and government agencies that share a
common interest in reporting on
hospital quality.
Beginning in July 2007, participation
in HCAHPS can affect the annual
payment update for the inpatient
prospective payment system (IPPS)
hospitals participating in the Reporting
Hospital Quality Data Annual Payment
Update (RHQDAPU) program; Form
Number: CMS–10102 (OMB#: 0938–
0981); Frequency: Reporting: Monthly;
Affected Public: Individuals or
households; Number of Respondents:
2,820,000; Total Annual Responses:
2,820,000; Total Annual Hours: 329,940.
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 at the address below, no
later than 5 p.m. on September 11, 2007.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—C,Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: July 3, 2007.
Michelle Shortt,
Director, Regulations Development
Group,Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. E7–13412 Filed 7–12–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0265]
Global Harmonization Task Force,
Study Groups 1 and 5; New Proposed
and Final Documents; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of several proposed and
final documents that have been
prepared by Study Groups 1 and 5 of the
Global Harmonization Task Force
(GHTF). These documents represent a
harmonized proposal and
recommendation from the GHTF Study
Groups that may be used by
governments developing and updating
their regulatory requirements for
medical devices. These documents are
intended to provide information only
and do not describe current regulatory
requirements; elements of these
documents may not be consistent with
current U.S. regulatory requirements.
FDA is requesting comments on these
documents.
DATES: Submit written or electronic
comments by October 11, 2007. After
the 90 day period, written comments or
electronic comments may be submitted
at any time to the contact persons listed
in this document.
ADDRESSES: Submit written requests for
single copies of the guidance documents
to the Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–443–8818. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
E:\FR\FM\13JYN1.SGM
13JYN1
Agencies
[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38601-38602]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13412]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10137, CMS-10237 and 10214, CMS-10242, CMS-
379 and CMS-10102]
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: Revision of a currently
approved collection; Title of Information Collection: Application for
Prescription Drug Plans (PDP); Application for Medicare Advantage
Prescription Drug (MA-PD); Application for Cost Plans to Offer
Qualified Prescription Drug Coverage; Application for Employer Group
Waiver Plans to Offer Prescription Drug Coverage; Service Area
Expansion Application for Prescription Drug Coverage; Use: Collection
of this information is mandated in Part D of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003. The application
requirements are codified in Subpart K of 42 CFR 423. Coverage for the
prescription drug benefit is provided through prescription drug plans
(PDPs) that offer drug-only coverage, or through Medicare Advantage
(MA) organizations that offer integrated prescription drug and health
care coverage (MA-PD plans). PDPs must offer a basic drug benefit.
Medicare Advantage Coordinated Care Plans (MA-CCPs) must offer either a
basic benefit or may offer broader coverage for no additional cost.
Medicare Advantage Private Fee for Service Plans (MA-PFFS) may choose
to offer a Part D benefit. Cost Plans that are regulated under Section
1876 of the Social Security Act, and Employer Group Plans may also
provide a Part D benefit. If any of the contracting organizations meet
basic requirements, they may also offer supplemental benefits through
enhanced alternative coverage for an additional premium.
The information will be collected under the solicitation of
proposals from PDP, MA-PD, Cost Plan, and Employer Group Waiver Plans
applicants. The collected information will be used by CMS to: (1)
Insure that applicants meet CMS requirements, and (2) support the
determination of contract awards.
Refer to the ``High-Level Summary of Changes in Employer Group
Waiver Plan Part D Applications'' and ``High-Level Summary of All Part
D Application Revisions from 2008 Solicitation for the 2009
Solicitation'' documents to review changes from 2008 to 2009; Form
Number: CMS-10137 (OMB: 0938-0936); Frequency: Reporting:
Once; Affected Public: Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 455; Total Annual Responses: 455;
Total Annual Hours: 11,890.
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare
Advantage (MA) Applications--Part C; Use: An entity seeking a contract
as an MA organization must be able to provide Medicare's basic benefits
plus meet the organizational requirements set out in regulations at 42
CFR part 422. An applicant must demonstrate that it can meet the
benefit and other requirements within the specific geographic area it
is requesting. The application forms are designed to give CMS the
information they need about the health plan to determine compliance
with Federal regulations at 42 CFR part 422 in an efficient manner. The
cited regulations outline the MA application process that begins with
submission of an application in the form and manner that the Secretary
provides. The MA application forms will be used by CMS to determine
whether an entity is eligible to enter into a contract to provide
services to Medicare beneficiaries. Refer to the ``2009 Medicare
Advantage Application Changes'' document to review a list of the 2009
changes. Form Number: CMS-10237 and 10214 (OMB: 0938-0935);
Frequency: Reporting: Yearly; Affected Public: Business or other for-
profit and Not-for-profit institutions; Number of Respondents: 241;
Total Annual Responses: 241; Total Annual Hours: 5,858.
3. Type of Information Collection Request: New collection; Title of
Information Collection: Revisions to Payment Policies Under the
Physician Fee Schedule, Other Changes to Payment Under Part B, and
Revisions to Payment Policies for Ambulance Services for CY 2008 (42
CFR 424.36--Signature Requirements); Use: 42 CFR 424.33(a)(3) states
that all claims must be signed by the beneficiary or the beneficiary's
representative (in accordance with 42 CFR 424.36(b)). 42 CFR 424.36(a)
states that the beneficiary's signature is required on a claim unless
the beneficiary has died or the provisions of Sec. 424.36(b), (c), or
(d) apply. The statutory authority requiring a beneficiary's signature
on a claim submitted by a provider is located in section 1835(a) and in
1814(a) of the
[[Page 38602]]
Social Security Act (the Act), for Part B and Part A services,
respectively. The authority requiring a beneficiary's signature for
supplier claims is implicit in sections 1842(b)(3)(B)(ii) and in
1848(g)(4) of the Act. Because it is very difficult to obtain a
beneficiary's signature (or the signature of a person authorized to
sign on behalf of the beneficiary) on a claim when the beneficiary is
being transported by ambulance in emergency situations, CMS is
proposing that, for emergency ambulance transport services, an
ambulance provider or supplier may submit the claim without a
beneficiary's signature, as long as certain documentation requirements
are met. The information collected will be used by CMS contractors
(both, fiscal intermediaries and carriers) that process and pay
emergency ambulance transport claims. Form Number: CMS-10242
(OMB: 0938-New); Frequency: Reporting: Hourly, Daily, Weekly,
Monthly and Yearly; Affected Public: Business or other for-profit and
Not-for-profit institutions; Number of Respondents: 9,000; Total Annual
Responses: 6,500,000; Total Annual Hours: 541,667.
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Financial
Statement of Debtor and Supporting Regulations in 42 CFR 405.376; Use:
42 CFR 405.376(g) requires that, ``* * * In determining whether a claim
will be compromised, or collection action terminated, CMS will consider
the following factors: * * * age and health of the debtor, present and
potential income, inheritance prospects, possible concealment or
fraudulent transfer of assets * * *'' Sections 1842(a)(1)(B) and (C) of
the Social Security Act and 42 CFR 405.376(g) provide the authority for
collection of this information.
In some instances a physician/supplier who is notified of a debt
may allege inability to immediately repay the debt in full and may
request an extended repayment schedule. Alternatively, the debtor may
request a compromise settlement for less than the full amount due.
Before establishing an extended repayment schedule or compromise
settlement, the CMS's Regional Offices and the carrier must evaluate
the provider's capacity to pay the debt. Accordingly, the provider is
requested to complete a ``Financial Statement of Debtor'' form, CMS-
379. Form Number: CMS-379 (OMB: 0938-0270); Frequency:
Reporting: Yearly; Affected Public: Business or other for-profit;
Number of Respondents: 500; Total Annual Responses: 500; Total Annual
Hours: 1000.
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: National
Implementation of Hospital Consumer Assessment of Health Providers and
Systems (HCAHPS); Use: The intent of the HCAHPS initiative is to
provide a standardized survey instrument and data collection
methodology for measuring patients' perspectives on hospital care.
While many hospitals collect information on patient satisfaction, there
is no national standard for collecting or publicly reporting this
information that would enable valid comparisons to be made across all
hospitals. In order to make ``apples to apples'' comparisons to support
consumer choice, it is necessary to introduce a standard measurement
approach. Hospital Consumer Assessment of Healthcare Providers and
Systems, also known as the CAHPS Hospital Survey (HCAHPS) can be viewed
as a core set of questions that hospitals can combine with their
customized items. HCAHPS was developed and is being implemented under
the auspices of the Hospital Quality Alliance, a private/public
partnership that includes hospital associations, consumer groups,
payors and government agencies that share a common interest in
reporting on hospital quality.
Beginning in July 2007, participation in HCAHPS can affect the
annual payment update for the inpatient prospective payment system
(IPPS) hospitals participating in the Reporting Hospital Quality Data
Annual Payment Update (RHQDAPU) program; Form Number: CMS-10102
(OMB: 0938-0981); Frequency: Reporting: Monthly; Affected
Public: Individuals or households; Number of Respondents: 2,820,000;
Total Annual Responses: 2,820,000; Total Annual Hours: 329,940.
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 at the address below,
no later than 5 p.m. on September 11, 2007.
CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development--C,Attention: Bonnie L Harkless,
Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Dated: July 3, 2007.
Michelle Shortt,
Director, Regulations Development Group,Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E7-13412 Filed 7-12-07; 8:45 am]
BILLING CODE 4120-01-P