Department of Health and Human Services April 2010 – Federal Register Recent Federal Regulation Documents

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 document is a request for comments regarding Section 1003 of the Patient Protection and Affordable Care Act (PPACA), Pub. L. 111- 148, which added Section 2794 to the Public Health Service Act (the PHS Act). Section 2794 of the PHS Act requires the Secretary to work with States to establish an annual review of unreasonable rate increases, to monitor premium increases and to award grants to States to carry out their rate review process. The Department of Health and Human Services (HHS) invites public comments in advance of future rulemaking.

This notice is to request comments from interested parties regarding criteria for grants issued under NASPER (42 U.S.C. 280g-3). NASPER establishes a formula grant program for States to establish or improve State controlled substance monitoring systems (``prescription monitoring programs,'' or ``PMPs''). Under NASPER, the Secretary will award grants to qualifying States, defined in the legislation as the 50 States and the District of Columbia (42 U.S.C. 280g-3(m)(8)). This notice is required under NASPER and comments received in response to this notice will be evaluated and as appropriate, included in public announcements for grants under this law.

The Food and Drug Administration (FDA) has determined the regulatory review period for SAVELLA 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 patents which claim that human drug product.

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), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA- regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil as products that do not release ODSs, and therefore they will no longer be essential uses of ODSs as of the effective dates of this rule. MDIs for these active moieties containing an ODS may not be marketed after the relevant effective date.

The Food and Drug Administration (FDA) has determined the regulatory review period for AFINITOR 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.

In accordance with the requirements of the Privacy Act, OMH proposes to establish a new system of records entitled, ``Minority Health Information Service.'' Under provisions of 42 U.S.C. sec. 300u- 6, the Office of Minority Health (OMH) is charged with maintaining a national minority health resource center to (1) Facilitate exchange of and access to information related to health information, promotion, services and education; (2) assist in analysis of issues and problems with regard to such matters; and (3) provide technical assistance with regard to the exchange of such information. The primary purpose of this system is to collect and facilitate distribution of minority health information to public and professional audiences. In support of this purpose, this system maintains individually identifiable information concerning individuals voluntarily participating in OMH health campaigns and technical assistance programs, and concerning information requested by individually identifiable customers that is maintained to facilitate order tracking and customer service.

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:

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH Steering Committee and Expert Working Group Meetings in Tallinn, Estonia'' to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Tallinn, Estonia. The topics to be discussed are the topics for discussion at the forthcoming ICH 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 Tallinn, Estonia, June 5 through 10, 2010, at which discussion of the topics underway and the future of ICH will continue.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and TransportationSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of July 9, 2009, and is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation. Elsewhere in this issue of the Federal Register, FDA is amending its July 9, 2009, regulation to correct the date by which producers must register their farm with FDA,

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``FDA/NHLBI/NSF Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models.'' The workshop will include a smaller, optional session entitled ``Microstructure Modeling Session.'' FDA is cosponsoring the workshop with the National Heart Lung and Blood Institute of the National Institutes of Health and the National Science Foundation. The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors.'' 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 professionals, and others from the general public about the design of drug and therapeutic biologic container labels, carton labeling, and product packaging, and practices to develop proprietary names to reduce medication errors. The input from this workshop will be used to develop draft guidance for industry on practices for naming, labeling, and packaging of drugs and biologics to reduce the potential for medication errors. FDA is also opening a public docket to receive comments on this topic to assist in the development of draft guidance.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (208) entitled ``Draft Guidance for Industry on Guidances for the Validation of Analytical Methods Used in Residue Depletion Studies,'' (VICH GL49). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide a general description of the criteria that has been found to be acceptable to the European Union (EU), Japan, the United States, Australia, New Zealand, and Canada for the validation of analytical methods used in veterinary drug residue studies.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (205) entitled ``Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK),'' VICH GL46. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommendations for internationally harmonized test procedures to study the quantity and nature of residues of veterinary drugs in food-producing animals.

The Food and Drug Administration (FDA) has determined the regulatory review period for MOZOBIL 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) Baltimore District, in co-sponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public educational forum entitled ``Drugs & Medical Device Supplier Management Forum.'' This 2-day public educational forum, a component of AFDO's Annual Educational Conference, is intended to provide information about FDA drug and device regulation to the regulated industry.

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 requests for exemption from the food additive listing regulation requirements that are submitted under part 170 (21 CFR part 170).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Kevin Xu 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 Mr. Xu was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Mr. Xu was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 23, 2009, Mr. Xu has failed to respond. Mr. Xu's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of the remaining portion of a color additive petition (CAP 8C0262) proposing an amendment of the color additive regulations to provide for the safe use of composite pigments prepared from synthetic iron oxide, mica, and titanium dioxide to color food.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to substantially revise ``Public Health Service (PHS) and National Health Service Corps (NHSC) Scholarship/Loan Repayment Participants Records System, HHS/HRSA/BPHC,'' HRSA Systems of Records No. 09-15-0037, to reflect organizational and physical location changes, and to update the categories of individuals and records covered by the system. HRSA is also proposing to (a) delete the Nursing Student Education Direct Loan Program, which is not administered by HRSA; (b) add records pertaining to the Nursing Scholarship Program and the Student/Resident Experiences and Rotations in Community Health (SEARCH) Program; and (c) incorporate the Faculty Loan Repayment Program and the Physician Shortage Area Scholarship Program, which previously had their own System of Records Notices (09-15-0058, and 09- 15-0042 respectively). These changes will require renaming the system of records and expanding the Authority to maintain the system. HRSA has updated the section on maintenance and storage of records to reflect current technologies, as well as Purpose(s), Safeguards, Retention and Disposal (of records), Notification Procedures, and Records source categories to detail current operations. HRSA is proposing to delete routine uses that are obsolete and to add new routine uses that cover disclosures of information needed for effective program operations.

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 Ames Laboratory, Ames, Iowa, 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 National Cancer Institute, Division of Cancer Treatment and Diagnosis, is seeking comments on a proposed revision to its policy on intellectual property agreements with certain funding recipients, entitled the Cancer Therapy Evaluation Program (CTEP) INTELLECTUAL PROPERTY OPTION. The proposed policy, if finalized, would establish that potential applicants for CTEP funding should include an assurance of agreement with the recommended Intellectual Property Option and Institution Notification if they wish to be considered for funding support to carry out any CTEP-sponsored clinical trial for which CTEP holds the investigational new drug (IND) application.

The Food and Drug Administration (FDA) has determined the regulatory review period for FANAPT 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 providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, U.S. Department of Health and Human Services and the National Alliance for Hispanic Health. The purpose of the MOU is to establish the terms for collaboration to enhance the diversity pool of candidates and to promote shared interests in increasing science and public health internship opportunities for socio-economically disadvantaged students.

The Food and Drug Administration (FDA) is announcing the availability of draft special controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft special controls guidance document for each of the 11 devices. These draft guidance documents describe a means by which these devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate special controls for each of these devices and would exempt six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the act). These draft guidance documents are not final nor are they in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Tablet Friability General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

The Food and Drug Administration (FDA) is announcing the availability of five documents related to FDA's continuing assessment of Bisphenol A (BPA) and soliciting public comments on the four documents prepared by FDA's Center for Food Safety and Applied Nutrition (CFSAN). These documents do not represent an agency opinion or position on BPA, on which an interim update was recently provided. (See https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm ). Rather, these documents provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA for food contact applications.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the then Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 Influenza) that affects or has significant potential to affect national security. On the basis of this determination, on April 26 and April 27, 2009, the then Acting Secretary declared emergencies justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb- 3(a). The then Acting Secretary also specified that these declarations are declarations of emergency as defined by former Secretary Michael O. Leavitt in the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antivirals Oseltamivir Phosphate and Zanamavir, as amended, and the December 17, 2008 Declaration under the PREP Act for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices. The Secretary renewed the then Acting Secretary's determination that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009 H1N1 Influenza) on July 24, October 1, and December 28, 2009, and March 26, 2010. Also on March 26, 2010, the Secretary renewed the then Acting Secretary's declarations of emergency justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a).

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

This notice announces a meeting to discuss the technical specifications for AHRQ's common definitions and reporting formats (Common Formats) Version 1.1 that allow for reporting of patient safety information to Patient Safety Organizations (PSOs). The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. 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 the Common Formats that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. More information on the Common Formats Version 1.1, including the technical specifications, can be obtained through AHRQ's PSO Web site: https://www.PSO.AHRQ.gov/.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Bavarian Nordic Immunotherapeutics (``BNIT'') located in Mountain View, CA, USA.

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Administration for Children and Families (ACF), Office of Human Services Emergency Preparedness and Response (OHSEPR) intends to submit notice in the Federal Register for comments on the ACF Disaster Case Management Implementation Guide, dated December 2009.

The Food and Drug Administration (FDA) is amending certain medical device regulations to correct statutory and regulatory references to ensure accuracy, consistency, and clarity in the agency's regulations.

The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organization change in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

The Food and Drug Administration (FDA) is amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of a suspension containing orbifloxacin, mometasone furoate monohydrate, and posaconazole for the treatment of otitis externa in dogs.