Department of Health and Human Services June 2009 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public teleconference. The meeting is open to the public.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 29, 2009. The document requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDs). The document was published with an incorrect Analysis of Impacts section and omitted a reference from the reference section of the final rule. The document was also published with an error in the codified text regarding the introductory sentence to the stomach bleeding warning for NSAIDs. This document replaces the incorrect Analysis of Impacts section with the correct Analysis of Impacts section, adds a reference to the reference section of the final rule, and corrects the codified text.

HHS gives notice of a decision to designate a class of employees for the Standard Oil Development Company in Linden, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

This rule finalizes our proposal to delay enforcement of certain clarifications regarding standards for determining hold harmless arrangements in the final rule entitled, ``Medicaid Program; Health Care-Related Taxes'' from the expiration of a Congressional moratorium on enforcement from July 1, 2009 to June 30, 2010.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality Subcommittee on Quality Measures for Children's Healthcare in Medicaid and Children's Health Insurance Programs (CHIP).

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: ``Building an Implementation Toolset for E-Prescribing.'' 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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for

The President's Advisory Council for Faith-based and Neighborhood Partnerships will hold a Council meeting. Topics to be discussed include updates from Council subcommittees on Reform of the Office, Economic Recovery, Fatherhood and Healthy Families, Inter- religious Dialogue and Cooperation, Environment and Climate Change and Global Poverty and Development.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the supplemental approval of a new animal drug application (NADA) filed by Dechra, Ltd. The supplemental NADA provides for the addition of a 10-milligram capsule size of trilostane, used in dogs for treatment of hyperadrenocorticism.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Complementary and Alternative Medicine (NCCAM), at the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible U.S. Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members issued on October 3, 2008, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Health and Human Services (HHS). Following issuance of FDA's October 3, 2008, Authorization letter, on February 19, 2009, BARDA submitted a request on behalf of ASPR, to amend the Authorization. In response to BARDA's request, FDA amended the Authorization letter and reissued the Authorization letter in its entirety on February 25, 2009. The Authorization, as amended and reissued in its entirety, is reprinted in this document.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2009 through March 2009, relating to the Medicare and Medicaid programs. 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, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Friday, May 29, 2009 (74 FR 25651). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request information from (1) small- and medium-sized practices about how they study or redesign their workflow, including information on the use of tools and methods for studying workflow, and (2) others (e.g., experts, vendors, professional associations) that have developed, implemented and used tools and methods for studying workflow in the context of health IT implementation and use. Workflow is defined as the way work is performed and patient-related information is communicated within small- and medium-sized practices and between those practices and external organizations such as community pharmacies and local hospitals. It is our understanding that there is currently no standard description of workflows for care processes that can be used to guide decisions of where and how to incorporate health information technology. This Request for Information is part of a three-pronged effort to scan the environment, the literature and knowledgeable and interested parties to produce a useful list of resources that may assist small- and medium- sized medical practices and clinics to consider the utility and potential effectiveness of incorporating health IT into the way they practice and communicate patient information. The responses to this request for information will be considered for reference and possible incorporation into an electronic toolkit to be made available on the Internet to assist small- and medium-sized practices in analyzing or redesigning workflow either before or after implementation of one or more health IT applications. All responses to this request for information are voluntary.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a neutral, independent institution and/or organization that proposes appropriate methods and processes for convening a broad range of stakeholders with relevant expertise to manage and support conferences and meetings. The focus of

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

This notice announces an administrative hearing to be held on August 4, 2009, at the CMS Seattle Regional Office, 2201 Sixth Avenue, MS/RX-43, Seattle, Washington 98121, to reconsider CMS' decision to disapprove Washington SPA 08-019.

The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients (Corps Personnel, Corps members) during the period July 1, 2009, through June 30, 2010, is posted on the NHSC Web site at https:// nhscjobs.hrsa.gov/. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program. A separate Federal Register Notice pertaining to sites eligible to receive NHSC Loan Repayment Program participants and non-obligated individuals was published on May 28, 2009 (74 FR 25568). Please note that not all vacancies associated with sites on the list described below will be for Corps members, but could be for NHSC Scholarship Program participants serving their obligation through the Private Practice Option.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to preventing the onset and reducing the progression of mental illness, substance abuse, and substance-related problems among all individuals. As part of this effort, SAMHSA has expanded and refined the agency's National Registry of Evidence-based Programs and Practices (NREPP). Two previous notices announcing these changes have been published in the Federal Register (70 FR 50381, Aug. 26, 2005; 71 FR 13133, Mar. 14, 2006). Since 2006, SAMHSA has held two open submission periods during which interventions could be submitted for potential review and inclusion on the NREPP Web site (71 FR 37590, June 30, 2006; 72 FR 30814, June 4, 2007). This notice announces the open submission period for fiscal year 2010, explains how submissions will be screened and selected, and provides guidance on the submission process for individuals and organizations seeking to have an intervention reviewed and listed on the NREPP Web site. Potential applicants should be aware that this notice includes new information relating to the eligibility of interventions and the review process that supersedes guidance provided in earlier Federal Register notices.

This advance notice of proposed rulemaking announces the intention of CMS to publish proposed amendments to the regulations implementing Medicaid home and community-based services waivers under section 1915(c) of the Social Security Act and solicits advance public comments on the merits of providing States the option to combine or eliminate the existing three permitted waiver targeting groups, and on the most effective means to define home and community.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to- Consumer (DTC) Television and Print Advertisements for Prescription Drugs. This study is designed to communicate quantitative information about product benefits in DTC print and television ads.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. app. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

This notice finalizes an amendment to the eligibility guidelines proposed on March 4, 2009 in the Federal Register (74 FR 9407). The purpose of this notice was to solicit comments on the amendment to the Program Eligibility Guidelines proposed by HRSA concerning the Reimbursement of Travel and Subsistence Expenses Program follow-up period.

This proposed rule amends the Federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products approved by FDA for opioid dependence and used in federally certified and registered opioid treatment programs. Opioid treatment programs that use these products in the treatment of opioid dependence will adhere to all other Federal treatment standards established for methadone.

This notice invites comments, within ten (10) days of the June 16, 2009, HIT Policy Committee (the ``Committee'') meeting, on the Committee's discussions of and draft recommendations for the term ``meaningful use'' available at https://healthit.hhs.gov. Comments will be received by the Committee for consideration and further recommendations to the National Coordinator of Health Information Technology on the elements and measures of Meaningful Use of a certified EHR.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Lake Ontario Ordnance Works, Niagara Falls, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to Emergency review and approve the information collection by July 1, 2009. Given the long term nature of this project and the Recovery Act timelines, the NCI has requested approval to conduct emergency processing of information collections pursuant to 5 CFR 1320.13. NIH cannot reasonably comply with the normal clearance procedures for information collection, because the use of regular procedures would delay the collection and hinder the agency in accomplishing its mission and meeting new statutory requirements, to the detriment of the public good. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and prevention (CDC), will conduct a public meeting to discuss current respirator standards development projects for Supplied Air Respirators (SAR); Air Fed Ensembles; and Total Inward Leakage (TIL) for respirators other than filtering facepieces and halfmasks. There will be an opportunity for discussion following NIOSH's presentations and an accompanying poster session.

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: ``CAHPS Field Test of Proposed Health Information Technology Questions and Methodology.'' 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.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). This notice solicits comments on the proposed collection of information associated with the draft guidance document entitled ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.'' The draft guidance, when finalized, will assist the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Dr. Mary E. Sawaya a.k.a. Marty Sawaya (Dr. Sawaya) from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Sawaya was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Sawaya failed to request a hearing. Dr. Sawaya's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Dr. Allyn M. Norman for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Norman was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of drug products under the act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Norman failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.'' The draft guidance, when finalized, will assist the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA is also announcing a further delay in the implementation of the Reportable Food Registry (the Registry) of FDAAA until September 8, 2009, to consider any comments received on the draft guidance and through the agency's planned outreach initiatives, and to allow for further testing of the electronic portal for reportable foods.