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

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is publishing this notice requesting public comment on the draft National Public Health Action Plan for the Detection, Prevention, and Management of Infertility. The draft plan can be found at https://www.regulations.gov Docket No. CDC-2012-0004. Also found in the docket is a supporting document for reference, the Outline for a National Action Plan for the Prevention, Detection, and Management of Infertility, which was subsequently developed into the present Plan.

This final rule amends the regulations implementing medical loss ratio (MLR) standards for health insurance issuers under the Public Health Service Act in order to establish notice requirements for issuers in the group and individual markets that meet or exceed the applicable MLR standard in the 2011 MLR reporting year.

This final rule identifies reforms in Medicare and Medicaid regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This rule increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care. This is one of several rules that we are finalizing to achieve regulatory reforms under Executive Order 13563 on Improving Regulation and Regulatory Review and the Department's Plan for Retrospective Review of Existing Rules.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time.

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 Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002.

The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Daphne I. Panagotacos and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Panagotacos 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 Panagotacos was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Panagotacos's debarment, FDA has considered the relevant factors listed in the FD&C Act. Panagotacos has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 31, 2012, is canceled. This meeting was announced in the Federal Register of March 23, 2012 (77 FR 17078). The meeting is being canceled because the Agency no longer needs to discuss the issues that were originally under consideration in the review of the application. The sponsor of the new drug application (NDA) submitted new information which negated the necessity for the planned meeting. The Agency intends to continue evaluating NDA 200-436 and, as needed, may schedule an Advisory Committee meeting in the future.

The Food and Drug Administration (FDA) has determined the regulatory review period for PROLIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) has determined the regulatory review period for EQUIDONE GEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for JEVTANA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for EGRIFTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

This notice announces that a public meeting of the Medicare Economic Index Technical Advisory Panel (``the Panel'') will be held on Monday, May 21, 2012. The purpose of the Panel is to review all aspects of the Medicare Economic Index (MEI). This first meeting will focus on MEI inputs and input weights. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

The Food and Drug Administration (FDA) has determined the regulatory review period for HALAVEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for PRADAXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for LASTACAFT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

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 grant funds for the support of the Joint Institute for Food Safety and Applied Nutrition (JIFSAN). FDA believes that University of Maryland, College Park (UMCP)-JIFSAN is a sound investment to protect and promote public health. FDA faces an increasing number of critical and complex food safety and public health issues associated with the products that FDA regulates. These complex issues can be addressed most efficiently by expanding the scientific base through the development of collaborative partnerships. FDA believes that partnering with UMCP-JIFSAN will enhance FDA's ability to address safety and other public health issues related to foods, cosmetics, and animal health and continue to stimulate the integration of applied research, education, and outreach programs.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.'' The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients' and health care providers' knowledge about the risks of drugs marketed with an approved Risk Evaluation and Mitigation Strategy (REMS). The input from this workshop will be used to develop guidance for industry describing the best practices for conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug's risk(s). To assist in the workshop discussion and the ultimate development of the guidance, FDA is making available an issue paper that discusses our experience with knowledge assessments for REMS and contains specific questions we hope to receive input on. FDA is also opening a public docket to receive written comments. Date and Time: The public workshop will be held on June 7, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Participants are encouraged to arrive early to ensure time for parking and security screening before the workshop. Contact Person: Colleen O'Malley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4305, Silver Spring, MD 20993-0002, 301-796-1786, FAX: 301-796- 9832, email: colleen.omalley@fda.hhs.gov. Registration and Requests for Oral Presentations: There is no fee to attend the workshop, and attendees who do not wish to make a formal presentation do not need to register. Seating will be on a first-come, first-served basis. Individuals who wish to make a presentation at the public workshop must register and provide an abstract of your presentation by 5 p.m. on May 21, 2012. Submit electronic registration requests to make a presentation to KnowledgeAssessmentWorkshop@fda.hhs.gov. Submit written registration requests to make a presentation to Colleen O'Malley (see Contact Person). Please provide your name, title, business affiliation (if applicable), address, telephone, FAX number, and email address. Identify the Panel number(s) for the question(s) you will discuss in your presentation (see section IV of this document). FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Persons registered to make a formal presentation should check in before the workshop. Time will be allowed during the scheduled agenda for attendees to ask questions of the panelists. In addition, we strongly encourage electronic or written comments to the docket. FDA has developed an issue paper entitled ``Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge'' that discusses our experience with knowledge assessments for REMS. The issue paper also contains a number of specific questions that we hope to receive input on. The issue paper can be found on the Internet at https://www.fda.gov/Drugs/NewsEvents/ ucm292337.htm. Background information on the public workshop, registration information, the agenda, and other relevant information will be posted on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm as it becomes available. If you need special accommodations due to a disability, please contact Colleen O'Malley (see Contact Person) at least 7 days before the workshop. Comments: FDA is opening a docket to allow for public comments to be submitted to the Agency on the issues and questions presented in the issue paper or at the workshop. Regardless of attendance at the public workshop, interested persons may submit to the Division of Dockets Management either electronic or written comments by July 7, 2012, to receive consideration. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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 amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2012. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.

The Department of Health and Human Services (DHHS) is seeking to identify interest and obtain information relevant to the design, deployment, operations, maintenance, and future enhancement of a centralized, secure, flexible data reporting system to streamline the collection, processing, and sharing of programmatic, funding, and other data reported to DHHS Operating Divisions (OpDivs) by grantees funded to provide HIV prevention, treatment, and care services.

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, exclusive license (excluding the nonexclusively licensed field of use entitled ``Use of P4 as either a carrier and/or immunoenhancer in a polysaccharide vaccine conjugate for prevention of Streptococcus pneumonia infection in humans'') to practice the inventions embodied in the patent application referred to below to Viper Therapeutics, having a place of business in Atlanta, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent(s) to be licensed are:

The Food and Drug Administration (FDA) has determined the regulatory review period for KALBITOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) has determined the regulatory review period for Alair Bronchial Thermoplasty System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

This Federal Register Notice solicits comments on Parts A through F of the Ryan White HIV/AIDS Program. Comments are solicited to inform the 2013 reauthorization of the Program, which was most recently reauthorized under Title XXVI of the Public Health Service Act (PHS), as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White HIV/AIDS Program). Stakeholders will be invited to share written comments regarding reauthorization of the Ryan White HIV/AIDS Program through the Web portal at www.regulations.gov. HRSA's HIV/AIDS Bureau will also host listening sessions in the form of teleconferences or webinars to engage stakeholders across the U.S. At least four listening sessions will be conducted, each targeting different geographic areas. The listening sessions will offer stakeholders the opportunity to discuss reauthorization of the Ryan White HIV/AIDS Program. Listening sessions will be announced as dates are determined. Dates will be announced at https://hab.hrsa.gov/reauthorization/.

The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

AHRQ has accepted a notification of voluntary relinquishment from the Surgical Safety Institute of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PS0s.

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).

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: ``American Recovery and Reinvestment Act ``Developing a Registry of Registries''.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 23, 2012 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.

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for OFORTA (fludarabine phosphate) Tablets held by sanofi-aventis, U.S., LLC (sanofi-aventis), 55 Corporate Dr., Bridgewater, NJ 08807-0977. Sanofi-aventis has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of chronic venous ulcer treatment medical devices. Scientific information is being solicited to inform our Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities report, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.