Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents

In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice announces our proposal to renew the Medicare Advantage ``deeming authority'' of the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) for Health Maintenance Organizations and Preferred Provider Organizations for a term of 6 years. This new term of approval would begin July 11, 2012, and end July 10, 2018. This notice announces a 30-day period for public comments on the renewal of the application.

Under the provisions of Section (3507(a)(1)(D)) of the Paperwork Reduction Act of 1995, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 2, 2011, pages 24497-24498, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health 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. Proposed Collection: Title: Neuropsychosocial Formative Research Methodological Studies for the National Children's Study (NCS). Type of Information Request: NEW. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

This notice announces our intention to establish a Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will discuss the Draft National Plan to Address Alzheimer's Disease, and, as appropriate, make recommendations to the Secretary of HHS. Meeting Date: April 17, 2012 from 9 a.m. to 4:15 p.m. EDT.

The Administration on Aging is announcing the availability of expansion funds for the support of the Senior Medicare Patrol (SMP) Program. This additional funding opportunity will be used to expand the reach of the SMP program with the explicit purpose of expanding current program capacity to recruit, train, and support the SMP volunteer network. In addition, this funding opportunity will increase targeted collaborative efforts with the Centers for Medicare and Medicaid Services, Office of Inspector General and other law enforcement entities in identified high fraud states. Funding Opportunity Title/Program Name: Health Care Fraud Prevention Program Expansion and SMP Capacity Building Grants. Announcement Type: Health Care Fraud Prevention Program Expansion Capacity. Funding Opportunity Number: Program Announcement No. HHS-2012-AoA- SM-1208.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for iron sucrose injection.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.'' This guidance is intended to provide greater clarity on FDA's decisionmaking process with regard to benefit-risk determinations in the premarket review of medical devices in the premarket approval and de novo pathways.

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: ``Adapting Best Practices for Medicaid Readmissions.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. The meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.

NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Winchester Engineering and Analytical Center in Winchester, Massachusetts, 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: Facility: Winchester Engineering and Analytical Center. Location: Winchester, Massachusetts. Job Titles and/or Job Duties: All employees of the Department of Energy, its predecessor agencies, and its contractors and subcontractors. Period of Employment: October 1, 1952 to December 31, 1961.

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, including each proposed extension of an existing 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 Graphic Cigarette Warning Labels that is being conducted in support of the graphic label provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).

This final rule will implement the new Affordable Insurance Exchanges (``Exchanges''), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.

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.

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 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.

This direct final rule makes technical changes that will update a requirement that many of our written agreements and memoranda of understanding (MOUs) with other departments, Agencies, and organizations be published in the Federal Register. Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This direct final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents. We are proceeding in accordance with our direct final rule procedures. We are publishing a companion proposed rule under our usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event we receive any significant adverse comments and withdraw this direct final rule. The companion proposed rule and this direct final rule are substantively identical.

The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.

This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

This final rule implements standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These programs will mitigate the impact of potential adverse selection and stabilize premiums in the individual and small group markets as insurance reforms and the Affordable Insurance Exchanges (``Exchanges'') are implemented, starting in 2014. The transitional State-based reinsurance program serves to reduce uncertainty by sharing risk in the individual market through making payments for high claims costs for enrollees. The temporary Federally administered risk corridors program serves to protect against uncertainty in rate setting by qualified health plans sharing risk in losses and gains with the Federal government. The permanent State-based risk adjustment program provides payments to health insurance issuers that disproportionately attract high-risk populations (such as individuals with chronic conditions).

This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accreditation program for rural health clinics (RHCs) seeking to participate in the Medicare or Medicaid programs.

This notice establishes a timeframe by which plan sponsors participating in the Early Retiree Reinsurance Program (ERRP) are expected to use ERRP reimbursement funds. Sponsors are expected to use such funds as soon as possible, but not later than December 31, 2014.

This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines ``student health insurance coverage'' as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.

The Food and Drug Administration (FDA) is withdrawing approval of 35 new drug applications (NDAs) and 64 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Pegasus Laboratories, Inc. The NADA provides for the veterinary prescription use of phenylpropanolamine hydrochloride chewable tablets for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.'' This guidance document is intended to provide information on the implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance document describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this provision of the law. The Pilot Program will be effective June 5, 2012.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Savannah River Site in Aiken, South Carolina, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 2, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

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 Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

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 Institute of Child Health and Human Development (NICHD), 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. Proposed Collection: Title: Child Health Disparities Substudy for the National Children's Study (NCS). Type of Information Collection Request: NEW. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

The Department of Health and Human Services (HHS) is seeking to identify interest and obtain information relevant to the design of a pilot operational study (or studies) on alternative donor deferral criteria that would permit blood and plasma donations (subsequently termed ``blood donations'') by men who have had sex with other men (MSM). Based upon documented higher levels of certain transfusion- transmissible infections (e.g. Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV)) in some groups of men who have had sex with men, all men with a history of this behavior since 1977 are currently deferred from donating blood. However, the increased effectiveness of donor testing for HIV, HBV, syphilis and other infectious agents has greatly enhanced blood safety. As a result, questions have been raised about the need to continue an indefinite deferral of all MSM and whether there could be blood donation by MSM who may not be at increased risk. In June 2010, HHS sought advice from its Advisory Committee for Blood Safety and Availability (ACBSA) on the issue of the current MSM deferral policy. The Advisory Committee noted that the existing policy is suboptimal, but recommended that the policy should be retained pending the completion of targeted research studies that might support a safe alternative policy. HHS and the agencies responsible for blood safety are committed to efforts to maintain and enhance the safety of the nation's blood supply, taking into account all new and emerging scientific information. Consistent with the June 2010 recommendations of the ACBSA, HHS seeks to determine through appropriate studies whether blood safety can be maintained or enhanced under revised blood donor screening criteria that would permit donation by some MSM. This request for information (RFI) is being issued in recognition of the challenges of designing such studies. This RFI seeks information from interested parties regarding the design, logistics and feasibility of a pilot operational study (or studies) to assess alternative blood donor eligibility criteria for MSM. Responses to this RFI will inform HHS on the design, logistics and feasibility of such a study, which, if feasible, could result in identifying potential pathways toward future alternate policies that will maintain or enhance the current very high levels of blood safety. The concept is to conduct a pilot operational study, in which MSM who meet specified criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients during the course of the study. Data would be gathered to assess the effectiveness of the specified criteria to select low risk donors among MSM. Upon completing all data collection activities, there will be a transparent and evidence-based evaluation of current and possible future MSM blood donation policies. This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of HHS. HHS does not intend to award a grant or contract to pay for the preparation of any information submitted or for the use of such information by HHS. Whereas all responses to this notice will be carefully considered, acknowledgment of receipt of responses will not be made, nor will respondents be notified of the evaluation by HHS of the information received. No basis for claims against HHS shall arise as a result of a response to this request for information or to the use of such information by HHS as either part of our evaluation process or in developing specifications for any subsequent announcement.

The Food and Drug Administration (FDA) has determined that the DURANEST (etidocaine hydrochloride) drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these drug products if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Cooperative Manufacturing Arrangements for Licensed Biologics'' has been approved by the Office of Management and Budget (OMB) 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 National Institute of Child Health and Human Development (NICHD), 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. Proposed Collection: Title: Environmental Science Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Collection Request: Generic Clearance. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Web-Based Assessment of the Clinical Studies Support Center (CSSC). Type of Information Collection Request: New. Need and Use of Information Collection: Over the past decade Data Safety Monitoring Boards (DSMBs), Observational Safety Monitoring Boards (OSMBs), and Protocol Review Committees (PRCs) have become an important quality standard in clinical trials and research involving human subjects. The National Heart, Lung, and Blood Institute (NHLBI) alone currently has approximately 60 active review Committees. These include DSMBs, OSMBs, and PRCs which are independent groups convened to review study protocols developed under NHLBI funded Clinical Trial Networks. These committees are composed of members with expertise in biostatistics, clinical trials, bioethics, and other specific scientific and research areas. The NHLBI is charged with ensuring the highest quality of each Institute-funded clinical research project and compliance with Department of Health and Human Services (DHHS)/National Institutes of Health (NIH)/NHLBI regulations regarding human subject protections and safety monitoring. To carry out this responsibility, the NHLBI program staff instituted a new methodology for supporting the administration of NHLBI-appointed Committees in 2009. The new methodology included the establishment of the Clinical Studies Support Center (CSSC) under the direction of Westat, Inc. The CSSC is a pilot program to support the operations of NHLBI's DSMBs, Observational OSMBs, and PRCs for the Division of Blood Diseases and Resources. Utilizing Executive Secretaries to support each NHLBI safety monitoring board, the CSSC is responsible for documenting standardized operating procedures related to the administration of monitoring committees and the support center in a CSSC Manual of Operations and Procedures (MOP); coordinating meeting space and logistics for in-person meetings, Web conferences, and teleconferences; managing distribution of adverse event notifications to DSMB chairs and members, new protocols, and proposed amendments; and providing Executive Secretaries who provide scientific and administrative support to document board recommendations related to the safety and efficacy of trial interventions and the quality and completeness of clinical research study data. To move forward with full knowledge of current Committee operations and to monitor the effect of newly established procedures, Westat is required, as part of this contract, to conduct an assessment of the efficiency and effectiveness of NHLBI CSSC committee operations. As part of this assessment, the NHLBI requires feedback and advice regarding the support provided by the CSSC for monitoring board operations. To this end, a Web-based questionnaire will be administered to Chairs and members of monitoring boards to learn about their opinions about specific CSSC activities and their satisfaction with the performance of CSSC staff. Frequency of Response: Once; Affected Public: Individuals; Type of Respondents: Monitoring board members. The annual reporting burden is as follows: Estimated Number of Respondents: 90; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.33 and Estimated Total Annual Burden Hours Requested: 30.36. The annualized cost to respondents is estimated at: $3.036 (based on $100 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA advisory committee members, and FDA staff, entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' We are issuing the guidance to help the public, FDA advisory committee members, and FDA staff to understand the public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The guidance provides additional transparency to FDA's advisory committee process beyond current guidance. This guidance finalizes the draft guidance of the same title dated March 2010 and replaces the guidance of the same title dated August 2008.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)-Preparation for ICCR-6 Meeting in Rockville, Maryland'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Rockville, MD. The topics to be discussed are the topics for discussion at the forthcoming ICCR Steering Committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Rockville, MD on July10 to 13, 2012. Date and Time: The meeting will be held on May 15, 2012, from 2 to 4 p.m. Location: The meeting will be held in the Washington Theater Room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: All participants must register with Kimberly Franklin, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, by email: Kimberly.Franklin@fda.hhs.gov or FAX: 301-595-7937. Registration and Requests for Oral Presentations: Send registration information (including: Name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentation, to the contact person by May 9, 2012. If you need special accommodations due to a disability, please contact Kimberly Franklin (see Contact Person) at least 7 days in advance. Interested persons may present data, information, or views orally or in writing, on issues pending at the public meeting. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person by May 9, 2012, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses, telephone number, FAX and email of the proposed participants, and an indication of the approximate time requested to make their presentation. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg. Rockville, MD 20857.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.'' This guidance document describes a means by which norovirus serological reagents may comply with the requirement of special controls for class II devices. This guidance document is to be implemented immediately as the special control for norovirus serological reagents.

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: ``Demonstration of a Health Literacy Universal Precautions Toolkit.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, 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 review and clearance under the Paperwork Reduction Act of 1995 (the PRA).