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Federal Register / Vol. 72, No.

158 / Thursday, August 16, 2007 / Notices 46085

Dated: August 10, 2007. Comments are invited on: (a) Whether Early Detection Program (NBCCEDP)
Maryam Daneshvar, the proposed collection of information framework. A subset of the women
Acting Reports Clearance Officer, Centers for is necessary for the proper performance (those who are 40–64 years of age) who
Disease Control and Prevention. of the functions of the agency, including participate in NBCCEDP may also
[FR Doc. E7–16119 Filed 8–15–07; 8:45 am] whether the information shall have participate in WISEWOMAN.
BILLING CODE 4163–18–P practical utility; (b) the accuracy of the Addressing risk factors such as elevated
agency’s estimate of the burden of the cholesterol, high blood pressure,
proposed collection of information; (c) obesity, sedentary lifestyle, poor diet,
DEPARTMENT OF HEALTH AND ways to enhance the quality, utility, and diabetes, and smoking can help reduce
HUMAN SERVICES clarity of the information to be a woman’s risk of cardiovascular
collected; and (d) ways to minimize the
Centers for Disease Control and disease-related illness and death.
burden of the collection of information
Prevention on respondents, including through the The Division for Heart Disease and
[60Day–07–0679] use of automated collection techniques Stroke Division Management
or other forms of information Information System will collect in
Proposed Data Collections Submitted technology. Written comments should electronic format: (a) Data needed to
for Public Comment and be received within 60 days of this measure progress by State Heart Disease
Recommendations notice. and Stroke Prevention and
Proposed Project WISEWOMAN Programs toward, or
In compliance with the requirement
of section 3506(c)(2)(A) of the achievement of, program performance
Implementation of an Automated measures. The respondent population
Paperwork Reduction Act of 1995 for Management Information System (MIS)
opportunity for public comment on will consist of State Health Department
for the Division for Heart Disease and
proposed data collection projects, the Heart Disease and Stroke Prevention
Stroke Prevention—REVSION—National
Centers for Disease Control and Center for Chronic Disease Prevention Program Managers and WISEWOMEN
Prevention (CDC) will publish periodic and Health Promotion (NCCDPHP), Program Managers.
summaries of proposed projects. To Centers for Disease Control and There are no costs to respondents
request more information on the Prevention (CDC). except their time to participate in the
proposed projects or to obtain a copy of survey. Thirty-four respondents from
the data collection plans and Background and Brief Description
HDSP program and 15 respondents from
instruments, call 404–639–5960 and In 1993, the U.S. Congress authorized the WISEWOMAN program will provide
send comments to Maryam I. Daneshvar, the Centers for Disease Control and input into the proposed system.
CDC Acting Reports Clearance Officer, Prevention (CDC) to establish the Respondents reside in each of 39 States,
1600 Clifton Road, MS–D74, Atlanta, WISEWOMAN demonstration program
two Tribal organizations, and the
GA 30333 or send an e-mail to to extend the services provided within
District of Columbia. the National Breast and Cervical Cancer


Average bur-
Number of re-
Number of re- den per re- Total burden
Respondents sponses per
spondents sponse (in hours)
respondent (in hours)

State Health Officials ........................................................................................ 49 2 6 588

Dated: August 10, 2007. DEPARTMENT OF HEALTH AND collections for public comment.
Maryam I. Daneshvar, HUMAN SERVICES Interested persons are invited to send
Acting Reports Clearance Officer, Centers for comments regarding this burden
Disease Control and Prevention. Centers for Medicare & Medicaid estimate or any other aspect of this
[FR Doc. E7–16120 Filed 8–15–07; 8:45 am]
Services collection of information, including any
of the following subjects: (1) The
BILLING CODE 4163–18–P [Document Identifier: CMS–R–308, CMS– necessity and utility of the proposed
116, CMS–1561/1561A, CMS–417, CMS– information collection for the proper
10227, CMS–437, CMS–724, CMS–10116,
performance of the Agency’s function;
CMS–10142, and CMS–10225]
(2) the accuracy of the estimated
Agency Information Collection burden; (3) ways to enhance the quality,
Activities: Submission for OMB utility, and clarity of the information to
Review; Comment Request be collected; and (4) the use of
automated collection techniques or
AGENCY: Centers for Medicare & other forms of information technology to
Medicaid Services, HHS. minimize the information collection
In compliance with the requirement burden.
of section 3506(c)(2)(A) of the 1. Type of Information Collection
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Paperwork Reduction Act of 1995, the Request: Extension of a currently

Centers for Medicare & Medicaid approved collection; Title of
Services (CMS), Department of Health Information Collection: State Children’s
and Human Services, is publishing the Health Insurance Program and
following summary of proposed Supporting Regulations in 42 CFR

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46086 Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Notices

431.636, 457.50, 457.60, 457.70, 1561 and 1561A are essential for CMS CMS is seeking OMB approval to use
457.340, 457.350, 457.431, 457.440, to ensure that applicants are in Enclosures #3, 4, 5, 6 and 7. The
457.525, 457.560, 457.570, 457.740, compliance with the requirements. information is used by CMS to affirm
457.750, 457.810, 457.940, 457.945, Applicants will be required to sign the that the State elects to offer PACE an
457.965, 457.985, 457.1005, 457.1015, completed form and provide operational optional State plan service and the
and 457.1180; Form Number: CMS–R– information to CMS to assure that they specifications of eligibility, payment
308 (OMB#: 0938–0841) Use: States are continue to meet the requirements after and enrollment for the program.
required to submit title XXI plans and approval; Frequency: Reporting—Other: Frequency: Reporting—Once; Affected
amendments for approval by the All new applicants must complete; Public: State, Local or Tribal
Secretary pursuant to section 2102 of Affected Public: State, Local or Tribal Governments; Number of Respondents:
the Social Security Act in order to Governments, Business or Other for- 56; Total Annual Responses: 56 possible
receive funds for initiating and profits and Not-for-profit institutions; responses but we have only received 20
expanding health insurance coverage for Number of Respondents: 3,300; Total thus far; Total Annual Hours: 1,120.
uninsured children. States are also Annual Responses: 3,300; Total Annual 6. Type of Information Collection
required to submit State expenditure Hours: 275. Request: Reinstatement with change of a
and statistical reports, annual reports 4. Type of Information Collection previously approved collection; Title of
and State evaluations to the Secretary as Request: Extension of a currently Information Collection: Psychiatric Unit
outlined in title XXI of the Social approved collection; Title of Criteria Worksheet and Supporting
Security Act. Frequency: Yearly and Information Collection: Hospice Request Regulations at 42 CFR 412.25 and
Quarterly; Affected Public: State, Local for Certification in the Medicare 412.27. Form Number: CMS–437 (OMB#
or Tribal governments; Number of Program; Form Number: CMS–417 0938–0358); Use: The psychiatric unit
Respondents: 56; Total Annual (OMB#: 0938–0313); Use: The Hospice criteria worksheets are necessary to
Responses: 1,454,601; Total Annual Request for Certification Form is the verify that these units comply and
Hours: 864,933. identification and screening form used remain in compliance with the
2. Type of Information Collection to initiate the certification process and exclusion criteria for the Medicare
Request: Revision of a currently to determine if the provider has prospective payment system. Frequency:
approved collection. In this revision, a sufficient personnel to participate in the Reporting—Annually; Affected Public:
number of changes were made to the Medicare program; Frequency: Business or other for-profit, Not-for-
form and accompanying instructions to Reporting—Yearly; Affected Public: profit institutions, and State, Local and
facilitate the completion and data entry Private Sector: Business or other for- Tribal Government; Number of
of the form. Specifically, the profits; Number of Respondents: 2,286; Respondents: 1,333; Total Annual
enumeration of individuals involved in Total Annual Responses: 2,286; Total Responses: 1,333; Total Annual Hours:
laboratory testing was eliminated, and Annual Hours: 572. 333.
the reporting of hours of laboratory 5. Type of Information Collection 7. Type of Information Collection
operations was streamlined. Some fields Request: Existing collection in use Request: Extension of a currently
were expanded to reflect changes in without an OMB Control Number; Title approved collection; Title of
laboratory demographics (added prison of Information Collection: PACE State Information Collection: Psychiatric
and assisted living facility to location of Plan Amendment Pre-print; Form Hospital Survey Data and Supporting
laboratory testing) and to collect Number: CMS–10227 (OMB#: 0938– Regulations at 42 CFR 482.60, 482.61,
complete information on the number of NEW); Use: The Balanced Budget Act of and 482.62; Form Number: CMS–724
tests performed in laboratories. There 1997 created section 1934 of the Social (OMB#: 0938–0378); Use: The
are no program changes; Title of Security Act that established the Medicare/Medicaid Psychiatric Hospital
Information Collection: Clinical Program for the All-Inclusive Care for Survey is used to collect data that is not
Laboratory Improvement Amendments the Elderly (PACE). The legislation collected elsewhere and assists CMS in
Application Form and Supporting established the PACE program as a program planning and evaluation of
Regulations at 42 CFR 493.1–.2001; Medicaid State plan option serving the survey needs. In addition, the survey
Form Number: CMS–116 (OMB#: 0938– frail and elderly in the home and assists CMS in maintaining an accurate
0581); Use: The application must be community. In accordance with the rule data base on providers participating in
completed by entities performing published in the November 24, 1999 the Medicare psychiatric hospital
laboratory testing specimens for Federal Register (64 FR 66271), if a program; Frequency: Reporting—Yearly;
diagnostic or treatment purposes. This State elects to offer PACE as an optional Affected Public: Private Sector: Business
information is vital to the certification Medicaid benefit, it must complete a or other for-profits; Number of
process. Frequency: Reporting— State Plan Amendment described as Respondents: 420; Total Annual
Biennially; Affected Public: Business or Enclosures #3, 4, 5, 6 and 7. In State Responses: 200; Total Annual Hours:
other for-profit and Not-for-profit Medicaid Director letters dated March 100.
institutions; Number of Respondents: 23, 1998 and November 9, 2000, CMS 8. Type of Information Collection
187,000; Total Annual Responses: advised States that it had provided a Request: Extension of a currently
17,960; Total Annual Hours: 22,450. suggested pre-print and supplemental approved collection; Title of
3. Type of Information Collection pages for a State to express its intention Information Collection: Medicare
Request: Extension without change of a to elect PACE as an option to its State Program; Conditions of Payment of
currently approved collection; Title of plans. As pre-print packet Enclosures Power Mobility Devices, Including
Information Collection: Health #3–7 were suggested and not required, Power Wheelchairs and Power-Operated
Insurance Benefit Agreement and CMS did not believe at the time that a Vehicles (CMS–3017–F); Form
Supporting Regulations at 42 CFR 489; suggested form required clearance from Numbers: CMS–10116 (OMB#: 0938–
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Form Numbers: CMS–1561 and 1561A OMB. The PACE regulation 42 CFR Part 0971); Use: The CMS is seeking the
(OMB#: 0938–0832); Use: Applicants to 460 was first published in the Federal reapproval of the collection
the Medicare program are required to Register as an interim final rule on requirements associated with the final
agree to provide services in accordance November 24, 1999. The final PACE rule rule, CMS–3017–F (71 FR 17021), which
with Federal requirements. The CMS– was published on December 8, 2006. was published on April 5, 2006, and

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Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Notices 46087

became effective on June 5, 2006. Prescription Drug, Improvement, and 21024) for this information collection
Specifically, we are seeking OMB Modernization (MMA), Medicare request, we revised our burden
approval for the following terms of Advantage organizations (MAO) and estimates to include the burden
clearance identified in the Notice of Prescription Drug Plans (PDP) are associated with the physician-
Action dated October 16, 2006, of which required to submit an actuarial pricing ownership disclosure and
OMB has requested CMS to monitor the ‘‘bid’’ for each plan offered to Medicare recordkeeping requirement for
paperwork burden required of providers beneficiaries. CMS requires that MAOs outpatient visits. In addition, we revised
and suppliers to determine if the and PDPs complete the BPT as part of the burden associated with the
paperwork requirements impose any the annual bidding process. During this disclosure requirement for critical
unnecessary burden on the industry process, organizations prepare their access hospitals that may not have a
and/or need to be revised in order to proposed actuarial bid pricing for the physician on-site at all times to account
improve the utility of the information. upcoming contract year and submit for outpatient visits as well. Frequency:
After analyzing the documentation them to CMS for review and approval. Reporting—On occasion; Affected
requirements burden, CMS does not The purpose of the BPT is to collect the Public: Business or for-profits, Not-for-
believe that the documentation actuarial pricing information for each profit institutions; Number of
requirements impose any additional plan. The BPT calculates the plan’s bid, Respondents: 2,679; Total Annual
unnecessary burden on the durable enrollee premiums, and payment rates. Responses: 52,984,510; Total Annual
medical equipment (DME) Industry. We Form Number: CMS–10142 (OMB#: Hours: 839,599.
believe that most physicians are already 0938–0944); Frequency: Yearly; Affected To obtain copies of the supporting
conducting a face-to-face examination Public: Business or other for-profit and statement and any related forms for the
before prescribing a wheelchair. Given Not-for-profit institutions; Number of proposed paperwork collections
that physicians and treating Respondents: 550 Total Annual referenced above, access CMS Web site
practitioners can now prescribe power- Responses: 6,050; Total Annual Hours: address at
operated vehicles (POVs), thereby 42,350. PaperworkReductionActof1995, or e-
removing the requirement that a 10. Type of Information Collection mail your request, including your
specialist can order a POV, CMS Request: New collection; Title of address, phone number, OMB number,
believes that the increased burden of Information Collection: Disclosures to and CMS document identifier, to
48,600 hours for physicians and treating Patients by Certain Hospitals and, or call the
practitioners is based on the Critical Access Hospitals; Form Reports Clearance Office on (410) 786–
Congressional decision to allow a Numbers: CMS–10225 (OMB#: 0938– 1326.
broader range of physicians and treating New); Use: There is no Medicare Written comments and
practitioners to prescribe POVs. This prohibition against physician recommendations for the proposed
increased burden is offset by the new investment in a hospital or critical information collections must be mailed
payments implemented in connection access hospital (CAH). Likewise, there is or faxed within 30 days of this notice
with the Final Rule, which is no Medicare requirement that a hospital directly to the OMB desk officer:
demonstrated by the shift in or CAH have a physician on-site at all OMB Human Resources and Housing
prescriptions from one class of times, although there is a requirement Branch, Attention: Carolyn Lovett, New
equipment, power wheelchairs, to that they be able to provide basic Executive Office Building, Room 10235,
another class of equipment, POVs. elements of emergency care to their Washington, DC 20503, Fax Number:
In addition, CMS believes that with patients. Medicare quality and safety (202) 395–6974.
the recent coverage decision on Mobility standards are designed to provide a
Dated: August 9, 2007.
Assistive Equipment, the implementing national framework that is sufficiently
details in the Final Rule (e.g., improved Michelle Shortt,
flexible to apply simultaneously to
documentation for suppliers; physician hospitals of varying sizes, offering Director, Regulations Development Group,
and treating practitioner payments; Office of Strategic Operations and Regulatory
varying ranges of services in differing
improved classification of mobility settings across the Nation. At the same
equipment; the elimination of the [FR Doc. E7–16160 Filed 8–15–07; 8:45 am]
time, however, patients might consider
certificate of medical necessity (CMN)), BILLING CODE 4120–01–P
an ownership interest by their referring
and the provider outreach and physician and/or the presence of a
education provided by CMS, the DME physician on-site to be important factors
program safeguard contractors (PSCs) DEPARTMENT OF HEALTH AND
in their decisions about where to seek
and DME Medicare administrative HUMAN SERVICES
hospital care. A well-educated
contractors (MACs), the needs of consumer is essential to improving the Food and Drug Administration
mobility-impaired beneficiaries and the quality and efficiency of the healthcare
needs of suppliers have been better met. system. Accordingly, patients should be [Docket No. 2007N–0306]
Frequency: Recordkeeping—On made aware of the physician ownership
occasion; Affected Public: Business or of a hospital, whether or not a physician Agency Information Collection
for-profits, Not-for-profit institutions, is present in the hospital at all times, Activities; Proposed Collection;
and State, Local or Tribal governments; and the hospital’s plans to address Comment Request; Current Good
Number of Respondents: 38,000; Total patients’ emergency medical conditions Manufacturing Practice Regulations for
Annual Responses: 243,000; Total when a physician is not present. The Type A Medicated Articles
Annual Hours: 48,600. intent of the proposed disclosures are AGENCY: Food and Drug Administration,
9. Type of Information Collection increase the transparency of the HHS.
Request: Extension of a currently hospital’s ownership and operations to
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ACTION: Notice.
approved collection; Title of patients as they make decisions about
Information Collection: Bid Pricing Tool receiving care at the hospital. SUMMARY: The Food and Drug
(BPT) for Medicare Advantage (MA) Based on public comments received Administration (FDA) is announcing an
Plans and Prescription Drug Plans during the 60-day comment period for opportunity for public comment on the
(PDPs); Use: Under the Medicare the Federal Register notice (72 FR proposed collection of certain

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