Agency Information Collection Activities: Proposed Data Collection; Comment Request

SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of  Management and Budget (OMB) approve the proposed information collection  project: ``Pilot Test of the Proposed Pharmacy Survey on Patient Safety Culture.'' In accordance with the Paperwork Reduction Act, 44 U.S.C.3501-3521, A1-IRQ invites the public to comment on this proposed information collection.

DATES: Comments on this notice must be received by May 10, 2011.

ADDRESSES: Written comments should be submitted to: 

Doris Lefkowitz, Reports Clearance Officer, AHRQ, by e-mail at 
doris.lefkowitz@AHRQ.hhs.gov.

    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by e-mail at

 doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Pilot Test of the Proposed Pharmacy Survey on Patient 
Safety Culture

    As the baby boomer population ages, the general U.S. population 
continues to grow, and as drug therapies for the treatment of chronic 
diseases become more efficacious, the expected increase in the number 
of prescriptions and demand for pharmaceutical products is likely to 
increase the potential for medication errors in community/retail 
pharmacies. In 2007, there were about 56,000 community/retail 
pharmacies, including about 22,000 traditional chain pharmacy 
companies, nearly 17,000 independent drug stores, about 9,300 
supermarket pharmacies, and about 7,700 mass merchant pharmacies. 
Numerous reports substantiate the presence of medication errors in 
pharmacies. For example, one national observational study of 
prescription dispensing accuracy and safety in 50 pharmacies in the 
U.S. found a rate of about 4 errors per day in a pharmacy filling 250 
prescriptions daily. This error rate translates to an estimated 51.5 
million errors occurring during the filling of 3 billion prescriptions 
each year.

    Given the widespread impact of pharmacies on patient safety, the 
new Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) will 
measure pharmacy staff perceptions about what is important in their 
organization and what attitudes and behaviors related to patient safety 
are supported, rewarded, and expected. The survey will help community/
retail pharmacies to identify and discuss strengths and weaknesses of 
patient safety culture within their individual pharmacies. They can 
then use that knowledge to develop appropriate action plans to improve 
their practices and their culture of patient safety. This survey is 
designed for use in community/retail pharmacies, which includes chain 
drugstores (e.g., Walgreens and CVS), supermarket pharmacies, 
independently owned pharmacies, and mass merchant pharmacies (e.g., 
Wal-Mart, Costco, Target), not for use in hospital pharmacies.

    This research has the following goals:
    (1) Cognitively test and modify as necessary the Pharmacy Survey              on Patient Safety Culture Questionnaire;
    (2) Pretest and modify the questionnaire as necessary;
    (3) Make the final questionnaire available to the public.

    This study is being conducted by AHRQ through its contractor, 
Westat, pursuant to AHRQ's statutory authority to conduct and support 
research on healthcare and on systems for the delivery of such care, 
including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of healthcare services and with 
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) 
and (2).

Full Federal Register Announcement

American Community Survey - Comment Request

SUMMARY: The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

Abstract

Given the rapid demographic changes experienced in recent years and the strong expectation that such changes will continue and accelerate, the once-a-decade detailed data collection as part of a decennial census is no longer acceptable for producing much of the data required by the Federal government, states, municipalities, and tribal governments. To meet the needs and expectations of the country, the Census Bureau developed the American Community Survey (ACS). This survey collects detailed population and housing data every month and provides tabulations of these data on a yearly basis. In the past, the long-form data were collected only at the time of each decennial census. After years of development and testing, the ACS began full implementation in households in January 2005 and in group quarters (GQs) in January 2006.

Collecting long-form data during the decade through the ACS has had a profound effect on the census design plan. The collection of long- form data had added substantial burden and complexity to past decennial censuses. Implementing the ACS means that the Decennial Census can focus on its constitutional mandate to accurately count the population to apportion the House of Representatives. The ACS--supported by a complete and accurate address system--has simplified the census design, resulting in improvements in both coverage and data quality, while providing current data on detailed population, social, economic, and housing characteristics.

The ACS provides more timely information for critical economic planning by governments and the private sector. In the current information-based economy, federal, state, tribal, and local decision makers, as well as private business and non-governmental organizations, need current, reliable, and comparable socioeconomic data to chart the future. In 2006, the ACS began publishing up-to-date profiles of American communities every year, providing policymakers, planners, and service providers in the public and private sectors this information every year--not just every ten years.

The ACS released estimates of population and housing characteristics for geographic areas of all sizes in December 2010. These data products, used by federal agencies and others, are similar in scope to the Summary File 3 tables from Census 2000. The 2010 Census did not include these detailed characteristics, leaving the ACS as the source of data for uses previously associated with the decennial census long form.

The Census Bureau presently plans to resubmit the ACS to the Office of Management and Budget (OMB) for extended clearance. The current ACS content has been reviewed by the Census Bureau, in conjunction with Federal agency stakeholders, to determine potential areas for improved item response and/or data quality.

DATES: To ensure consideration, written comments must be submitted on or before May 9, 2011.


ADDRESSES: Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at dHynek@doc.gov).

FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to James Treat, U.S. Census Bureau, American Community Survey Office, Washington, DC 20233, by FAX to (301) 763-8070 or via the Internet at james.b.treat@census.gov.

Full Announcement 

Assessment of the Sustainability and Impact of Community Coalitions Once Federal Funding Has Expired

The Office of the Assistant Secretary for Planning and Evaluation (ASPE) is requesting Office of Management and Budget (OMB)approval on a new collection to conduct a survey of community coalitions formerly funded by the Community Access Program (CAP)/Healthy Communities Access Program (HCAP) to learn about their sustainability and impact post-federal funding. ASPE will use the CAP/HCAP experience to examine the long-term sustainability of coalitions that successfully completed for grant funding from the Department of Health and Human Services (DHHS).

As part of the study, a one-time,self-administered survey will be administered to the 260 coalitions funded through CAP/HCAP, providing a unique set of data to assess coalition sustainability and the factors that enable and hinder sustainability. The survey will focus on CAP/HCAP coalitions'structure, funding, activities, impact, and outcomes post-funding. The survey design and content is informed by a review of the literature on community coalitions including coalition organization, functions, impact, and sustainability. Results from the survey will also inform the selection of sites for key informant interviews and site visits. Specifically, telephone interviews will occur with a subset of 20 CAP/HCAP coalitions that have been sustained as well as 20 CAP/HCAP coalitions that have not been sustained. The key informant interviews will utilize a structured instrument tailored to the coalitions' experiences. Site visits will be conducted with seven coalitions that were sustained post-funding. Data collection activities will be completed within 18 months of OMB Clearance.

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Pilot for Volunteer Management ROI Measurement System. OMB Number: None

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The Corporation is seeking approval of a pilot version of a tool designed to measure the return on investment for recruiting and managing community volunteers. The Corporation has entered into a cooperative agreement with the National Council on Aging (NCOA) to adapt its SMART (Strategic Metrics and Results Tracking) system for use by Corporation grantees and subgrantees. The goal is to develop and pilot a system that all Corporation projects can use to calculate the return on investment for the time and resources they devote to recruiting and managing volunteers.

Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in this Federal Register:
(1) By fax to: (202) 395-6974, Attention: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service; and
(2) Electronically by e-mail to: smar@omb.eop.gov.

National Survey of Public Attitudes Towards People With Disabilities

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This survey will assess public attitudes towards people with disabilities with a focus on workplace relations. The survey will inform ODEP's policies to promote the employment of people with disabilities as it assesses the attitudes of individuals and develops ways of changing those attitudes to improve the employment rate and overall well-being of people with disabilities in the workplace. The study will also provide direction for the development of intervention programs that can be adopted in a corporate environment to promote acceptance and integration of people with disabilities in the workplace. For additional information, see related notice published in the Federal Register on January 14, 2010 (75 FR page 2162).

The Department of Labor (DOL) hereby announces the submission of this public information collection request (ICR) to the http:// www.reginfo.gov/public/do/PRAMain or by contacting Darrin King on 202- 693-4129 (this is not a toll-free number), e-mail: DOL_PRA_ PUBLIC@dol.gov. Interested parties are encouraged to send comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor--Office of Disability Employment Policy (ODEP), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202-395-7316/Fax: 202-395-5806 (these are not toll-free numbers), E-mail: OIRA_submission@omb.eop.gov within 30 days from the date of this publication in the Federal Register. In order to ensure the appropriate consideration, comments should reference the OMB Control Number"Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of this ICR, with applicable supporting documentation including, among other things, a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site at http:// www.reginfo.gov/public/do/PRAMain or by contacting Darrin King on 202- 693-4129 (this is not a toll-free number), e-mail: DOL_PRA_ PUBLIC@dol.gov.

Interested parties are encouraged to send comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor--Office of Disability Employment Policy (ODEP), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202-395-7316/Fax: 202-395-5806 (these are not toll-free numbers), E-mail: OIRA_submission@omb.eop.gov within 30 days from the date of this publication in the Federal Register. In order to ensure the appropriate consideration, comments should reference the OMB Control Number.
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Evaluation of Reaching the Underserved Elderly and Working Poor in SNAP

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In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This is a new collection for the contract Evaluation of Reaching the Underserved Elderly and Working Poor in SNAP.

DATES: Written comments must be received on or before June 21, 2010.

Less than one-third of eligible elderly (age 60 and older) persons and less than three-fifths of persons in eligible households with someone working participate in the Supplemental Nutrition Assistance Program (SNAP), according to the latest (2007) U.S. Department of Agriculture (USDA) estimates. These participation rates suggest that many people in these two groups who may need nutrition assistance are not receiving SNAP benefits. Without SNAP, elderly individuals may not be able to meet their nutritional needs or may forgo medicine for food; working people may not be able to adequately feed their families, despite their work efforts. The Food and Nutrition Service (FNS), responding to a Congressional request, has funded six State demonstration projects to increase SNAP access to eligible households with either persons over age 60 or with adult members who are working or looking for work. FNS is conducting an evaluation of the demonstration projects. By evaluating these demonstrations, FNS will be able to advise Federal policymakers and State administrators on the best approaches to increasing SNAP access for these two populations.

The evaluation of the demonstration projects has several objectives. The evaluation will describe each demonstration project and the implementation process; assess the impact on SNAP participation in the target groups, application barriers, client satisfaction, household benefits, administrative costs, and payment errors; and assess the sustainability and replicability of each demonstration project. To meet these objectives, FNS will collect information from the pilot and comparison sites before, during, and after the intervention. FNS will collect and analyze administrative data in each demonstration State and will conduct site visits to each demonstration project and conduct focus groups with SNAP applicants.

SAMHSA Transformation Accountability (TRAC) Reporting System --(OMB No. 0930-0285)--Revision

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SAMHSA's CMHS is requesting approval for a revision to the National Outcome Measures (NOMs) for Consumers Receiving Mental Health Services. The name of this data collection effort is revised to the Transformation Accountability (TRAC) Reporting System (hereafter referred to as TRAC) to enable SAMHSA CMHS to consolidate its performance reporting activities within one package. This request includes a revision of the currently approved client-level data collection effort for programs providing direct services; additional questions will enable CMHS to more fully explain grantee performance in relation to Agency and/or program objectives. This request also includes the addition of data collection from Project Directors of grants engaged in infrastructure development, prevention, and mental health promotion activities. These new instruments will enable SAMHSA CMHS to capture a standardized set of performance indicators using a uniform reporting method.

These proposed data activities are intended to promote the use of consistent measures among CMHS grantees and technical assistance contractors. These common measures recommended by CMHS are a result of extensive examination and recommendations, using consistent criteria, by panels of staff, experts, and grantees. Wherever feasible, the proposed measures are consistent with or build upon previous data development efforts within CMHS. These data collection activities will be organized to reflect and support the domains specified for SAMHSA's NOMs for programs providing direct services, and the categories developed by CMHS to specify infrastructure development, prevention,
and mental health promotion activities.

Client-Level Data Collection

The currently approved data collection effort for the SAMHSA CMHS programs that provide direct services to consumers includes separate data collection forms that are parallel in design for use in interviewing adults and children (or their caregivers for children under the age of 11 years old). These SAMHSA TRAC data will be collected at baseline, at six month reassessments for as long as the consumer receives services, and at discharge. The proposed data collection encompasses eight of the ten SAMHSA NOMs domains.

Written comments and recommendations concerning the proposed information collection should be sent by April 23, 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.
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Common Formats for Patient Safety Data Collection and Event Reporting

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The Patient Safety Act (at 42 U.S.C. 299b–23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3(Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731–70814. As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The initial release of the formats,Version 0.1 Beta, was announced in thevFederal Register on August 29, 2008: 73 FR 50974–50976. The purpose of this notice is to announce the availability of the expanded and enhanced Common Formats Version 1.0 and the process for their continued development and refinement.

DATES: Ongoing public input.

ADDRESSES: The Common Formats can be accessed electronically at the following HHS Web site: http://www.pso.ahrq.gov/index.html.

FOR FURTHER INFORMATION CONTACT:
Susan Grinder, Center for Quality Improvement and Patient Safety, AHRQ,
540 Gaither Road, Rockville, MD 20850;
Telephone (toll free): (866) 403–3697;
Telephone (local): (301) 427–1111; TTY
(toll free): (866) 438–7231; TTY (local):
(301) 427–1130;
E-mail: pso@ahrq.hhs.gov.
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Standards for Privacy of Individually Identifiable Health Information

Agency Information Collection Request. 30-Day Public Comment Request The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The final regulation requires covered entities (as defined in the regulation) to maintain strong protections for the privacy of individually identifiable health information; to use or disclose this information only as required or permitted by the Rule or with the express written authorization of the individual; to provide a notice of the entity’s privacy practices; and to document compliance with the Rule. Read More

SMP (Formerly Senior Medicare Patrol) Program Outcome Measurement

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Submit written comments on the collection of information by August 24,2009. ADDRESSES: Submit written comments on the collection of information by fax 202.395.6974 to the OMB Desk Officer for AoA, Office of Information and Regulatory Affairs, OMB. FOR FURTHER INFORMATION CONTACT: Doris Summey, telephone (202) 357–3533; e-mail: doris.summey@aoa.hhs.gov.

CMS: Medicare Advantage Data Collection

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage and Prescription Drug Program: Final Marketing Provisions CFR 422.111(a)(3) and 423.128(a)(3) Use: Medicare Advantage (MA) plans must provide notice to plan members of impending changes to plan benefits, premiums and copays in the coming year so that members will be in the best position to make an informed choice on continued enrollment or disenrollment from that plan at least 15 days before the Annual Election Period (AEP). Beginning 2009, organizations will be required to notify plan members of the coming year changes using a combined standardized document at the time of enrollment and annually thereafter.

Survey of Evidence-Based Practices in State Medicaid Plans

Proposed Project Survey of Evidence-Based Practices in State Medicaid Plans: Coverage Structures, Access and Challenges--NEW The Substance Abuse and Mental Health Services Administration (SAMHSA) is conducting a survey to gather information about current and planned State Medicaid activities and policies related to six mental health/substance abuse evidence-based practices (EBPs). This survey is part of a five-year project to increase attention to and understanding of Medicaid mental health and substance abuse service issues among State Medicaid and Mental Health/Substance Abuse Directors, as well as improve the effectiveness of State Medicaid mental health services. The purpose of the survey is to determine the overall management and delivery of mental health and substance abuse services within Medicaid and the use of six specific evidence-based practices. The information provided through the survey will be vital to increasing awareness and understanding of Medicaid mental health/substance abuse evidence-based practice activities. This information will also be used to develop numerous products to help State Medicaid and Mental Health/ Substance Abuse Directors adopt, deliver, and refine existing policies about mental health and substance abuse EBPs. Full Notice

Medical Expenditure Panel Survey

SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component through 2012.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on May 6th 2009 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by August 13, 2009.

Census Bureau Annual Social & Economic Supplement

The Census Bureau plans to request clearance for the collection of 
data concerning the Annual Social and Economic Supplement (ASEC) to be 
conducted in conjunction with the February, March, and April Current 
Population Survey (CPS). The Census Bureau has conducted this 
supplement annually for over 50 years. The Census Bureau, the Bureau of 
Labor Statistics, and the Department of Health and Human Services 
sponsor this supplement.

In the ASEC, the Census Bureau collects information on work experience,
personal income, noncash benefits, health insurance coverage, and migration.
The work experience items in the ASEC provide a unique measure of the 
dynamic nature of the labor force as viewed over a one-year period. 
These items produce statistics that show movements in and out of the 
labor force by measuring the number of periods of unemployment 
experienced by people, the number of different employers worked for 
during the year, the principal reasons for unemployment, and part-/
full-time attachment to the labor force. We can make indirect 
measurements of discouraged workers and others with a casual attachment 
to the labor market.

The income data from the ASEC are used by social planners, 
economists, government officials, and market researchers to gauge the 
economic well-being of the country as a whole and selected population 
groups of interest. Government planners and researchers use these data 
to monitor and evaluate the effectiveness of various assistance 
programs. Market researchers use these data to identify and isolate 
potential customers. Social planners use these data to forecast 
economic conditions and to identify special groups that seem to be 
especially sensitive to economic fluctuations. Economists use ASEC 
data to determine the effects of various economic forces, such 
as inflation, recession, recovery, and so on, and their differential
 effects on various population groups.

A prime statistic of interest is the classification of people in 
poverty and how this measurement has changed over time for various 
groups. Researchers evaluate ASEC income data not only to determine 
poverty levels but also to determine whether government programs are 
reaching eligible households.

New questions are proposed for the ASEC, beginning in 2010. The 
questions are related to: 
(1) Medical expenditures; 
(2) presence and cost of a mortgage on property; 
(3) child support payments; and 
(4) amount of child care assistance received. 

These questions will enable analysts and policymakers to obtain
better estimates of family and household income, and to gauge 
poverty status more precisely. To offset respondent burden, 
some questions will be removed from the ASEC. Those removed 
include questions on transportation assistance, child care 
services, and questions on receipt of government assistance 
related to welfare reform.

Full Announcement

Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments

The information collection is for pre-award, post-award,
and subsequent reporting and recordkeeping requirements for grants and
cooperative agreements. The information collected is necessary to
award, monitor, close out and manage grant programs, ensure minimum
fiscal control and accountability for Federal funds and deter fraud,
waste, and abuse. HHS needs this information to meet its Federal
stewardship responsibilities. The authorization for the collection of
information is under the Department of Health and Human Services
regulation 45 CFR part 92, ``Uniform Administrative Requirements for
Grants and Cooperative Agreements to State and Local Governments.'' The
requested extension is for 3 years. Respondents are State, local and
tribal governments.

To obtain copies of the supporting statement and any related forms for
the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above e-mail
address within 60-days.

Ambulatory Surgical Center Conditions for Coverage

Type of Information Collection Request: New collection; Title of Information Collection: Ambulatory Surgical Center Conditions for Coverage; Form Number: CMS-10279 (OMB: 0938-New); Use: The Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs) focus on a patient-centered, outcome-oriented, and transparent processes that promote quality patient care. The CfCs are designed to ensure that each facility has properly trained staff to provide the appropriate type and level of care for that facility and provide a safe physical environment for patients. The CfCs are used by Federal or State surveyors as a basis for determining whether an ASC qualifies for approval or re- approval under Medicare. CMS and the healthcare industry believe that the availability to the facility of the type of records and general content of records, which this regulation specifies, is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. Frequency: Recordkeeping and Reporting--One time; Affected Public: Business or other for-profit, Not-for-profit institutions; Number of Respondents: 5,100; Total Annual Responses: 5,100; Total Annual Hours: 193,800. (For policy questions regarding this collection contact Jacqueline Morgan at 410-786-4282. For all other issues call 410-786- 1326.)

CMS Real-time Eligibility Agreement and Access Request

Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: CMS Real-time Eligibility Agreement and Access Request; Form Number: CMS-10157 (OMB: 0938-0960); Use: Federal law requires that CMS take precautions to minimize the security risk to Federal information systems. Accordingly, CMS is requiring that trading partners who wish to conduct the eligibility transaction on a real-time basis to access Medicare beneficiary information provide certain assurances as a condition of receiving access to the Medicare database for the purpose of conducting eligibility verification. Health care providers, clearinghouses, and health plans that wish access to the Medicare database are required to complete this form. The information will be used to assure that those entities that access the Medicare database are aware of applicable provisions and penalties. Frequency: Recordkeeping and Reporting--One time; Affected Public: Business or other for-profit, Not-for-profit institutions; Number of Respondents: 2000; Total Annual Responses: 500; Total Annual Hours: 500. (For policy questions regarding this collection contact Vivian Rogers at 410-786- 8142. For all other issues call 410-786-1326.)

NIH: Women's Health Initiative Observational Study

This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women.

Medicare and Medicaid Programs: Quarterly Listing of Program Issuances

This notice lists CMS Medicare and Medicaid programs:

• manual instructions,
• substantive and interpretive regulations, and
• other Federal Register notices that were published from July 2008 through September 2008.

This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare.

Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare.

This notice also includes listings of:

• all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and
• a list of Medicare-approved carotid stent facilities.

Included in this notice is:

• a list of the American College of Cardiology's National Cardiovascular Data registry sites,
• active CMS coverage-related guidance documents, and
• special one-time notices regarding national coverage provisions.

Also included in this notice is a list of:

• National Oncologic Positron Emissions Tomography Registry sites,
• Medicare-approved ventricular assist device (destination therapy) facilities,
• Medicare-approved lung volume reduction surgery facilities,
• Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and
• Medicare-approved bariatric surgery facilities.

Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

SSA: Revision of Medicare Part D Forms

Request for Comments The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. Therefore, your comments would be most helpful if you submit them to SSA within 60 days from the date of this publication. Individuals can obtain copies of these collection instruments by calling the SSA Reports Clearance Officer at 410-965-0454 or by writing to the e-mail address listed above. 1. Application for EXTRA Help with Medicare Prescription Drug Plan Costs--20 CFR 418.3101--0960-0696. The Medicare Modernization Act of 2003 mandated the creation of the Medicare Part D prescription drug coverage program and provided for certain subsidies for eligible Medicare beneficiaries to help pay for the costs of prescription drugs. SSA uses Form SSA-1020 (and the i1020, its electronic counterpart), the Application for Extra Help with Medicare Prescription Drug Plan Costs, to collect information to make Part D subsidy eligibility determinations. In compliance with Public Law 110-275, beginning in January 2010, SSA will use a new version of Form SSA-1020. In this new version, SSA will eliminate questions about the value of life insurance policies and in-kind support and maintenance, and we will ask applicants about their interest in applying for the Medicare Savings Program. This information collection request (ICR) is for the new version we will use in 2010. The respondents are Medicare beneficiaries who are applying for the Medicare Part D subsidy. 2. Medicare Subsidy Quality Review Forms--20 CFR 418(b)(5)--0960-0707. The Medicare Modernization Act of 2003 mandated the creation of the Medicare Part D prescription drug coverage program and provided for certain subsidies for eligible Medicare beneficiaries to help pay for the costs of prescription drugs. As part of its stewardship duties of the Medicare Part D subsidy program, SSA must conduct periodic quality review checks of the information Medicare beneficiaries report on their subsidy applications (Form SSA-1020). SSA uses the Medicare Quality Review program to conduct these checks. Beginning in January 2010, SSA will revise the Medicare Quality Review system to comply with Public Law 110-275. Specifically, we will: (1) Eliminate the use of Form SSA-9309, the Life Insurance Verification form; and (2) remove any questions about life insurance policy values and in-kind support and maintenance from the other forms in the collection. This ICR is for the revised Medicare Quality Review System, which we will not use until January 2010. The respondents are applicants for the Medicare Part D subsidy whom we have chosen to undergo a Quality Review. 3. Redetermination of Eligibility for Help with Medicare Prescription Drug Plan Costs--0960-0723. As required by the Medicare Modernization Act of 2003 (Pub. L. 108-173), SSA conducts low-income subsidy eligibility redeterminations for Medicare beneficiaries who filed for the subsidy and were determined by SSA to be eligible. SSA will conduct subsidy eligibility redeterminations under two circumstances: (1) When an individual completes Form SSA-1026-OCR-SM-SCE to report a subsidy-changing event (marriage, separation from a spouse, separated spouses resume living together, divorce, annulment, or death); and (2) When SSA uses Form SSA-1026-OCR-SM-REDE to conduct an annual review of individuals who became entitled during the prior 12 months, an annual review of a percentage of individuals who are eligible for more than 12 months, and a review of individuals who report a change in income, resources, or household size that may affect the subsidy amount. In compliance with Public Law 110-275, SSA will use a new version of Form SSA-1026 beginning in January 2010. In this new version, SSA will eliminate questions about the value of life insurance policies and in-kind support and maintenance. The respondents are current recipients of the Medicare Part D low-income subsidy who will undergo an eligibility redetermination for one of the reasons mentioned above.