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

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2013 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program. We are continuing the electronic reporting pilot for the Electronic Health Record (EHR) Incentive Program, and revising the various regulations governing Quality Improvement Organizations (QIOs), including the secure transmittal of electronic medical information, beneficiary complaint resolution and notification processes, and technical changes. The technical changes to the QIO regulations reflect CMS' commitment to the general principles of the President's Executive Order on Regulatory Reform, Executive Order 13563 (January 18, 2011).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 23, 2012 (Volume 77, Number 36) 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, to correct the omission of the peers survey in the previous notice, and to correct the errant data that appeared in Table 1 and Table 2 of the notice. The data in Table 1 and Table 2 of this notice are correct. 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.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. This proposed information collection project was previously published in the Federal Register (77 FR 52748) on August 30, 2012, and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917- 0034, ``Indian Health Service (IHS) Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form.'' Type of Information Collection Request: Extension without revision of the currently approved information collection, 0917-0034, ``IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form,'' which was previously approved under the title ``Director's 3 Initiative Best Practice, Promising Practice, and Local Efforts Form.'' Although the name of the form has changed, the contents of the form remain the same. Forms: 0917-0034, ``IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form.'' Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/ AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and to provide the product/service to IHS, Tribal, and Urban (I/T/U) programs, the Office of Preventive and Clinical Services' program divisions (i.e., Behavioral Health, Health Promotion/Disease Prevention, Nursing, and Dental) have developed a centralized program database of best practices, promising Practices and local efforts and resources. This database was previously referred as OSCAR, but the name will be changed to BPPPLE to reflect the revised name of the form. The purpose of this collection is to develop a database of BPPPLE and resources to be published on the IHS.gov Web site which will be a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities. All information submitted is on a voluntary basis; no legal requirement exists for collection of this information. The information collected will enable the Indian Health systems to: (a) Identify evidence based approaches to prevention programs among the I/T/Us when no system is currently in place, and (b) Allow the program managers to review BPPPLE occurring among the I/T/Us when considering program planning for their communities. Affected Public: Individuals. Type of Respondents: I/T/U programs' staff. The table below provides: Types of data collection instruments, Number of respondents, Responses per respondent, Average burden hour per response, and Total annual burden hour(s).

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Administration (ODASA). This reorganization establishes the Office of Diversity Management and Equal Employment Opportunity (ODME). In addition, it realigns the acquisition oversight function to the Ethics Team in the Immediate Office of the Deputy Assistant Secretary for Administration.

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 quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasures in vitro nucleic acid based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time.

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 Battelle Laboratories King Avenue facility in Columbus, OH, 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: Battelle Laboratories King Avenue Location: Columbus, Ohio. Job Titles and/or Job Duties: All Atomic Weapons Employees who worked at the King Avenue facility in Columbus, Ohio. Period of Employment: April 16, 1943 through June 30, 1956.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft Compliance Policy Guide entitled ``Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee ProductsHypoglycin A Toxin (the draft CPG).'' The draft CPG, when finalized, will provide guidance for FDA staff on our enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain hypoglycin A.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on 15 August 2012 on page 48993 and allowed 60-days for public comment. 1 public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer. Type of Information Collection Request: Revision. Need and Use of Information Collection: This is to continue the Phase II follow-up of the Sister Study a study of genetic and environmental risk factors for the development of breast cancer in a high-risk cohort of sisters of women who have had breast cancer. The etiology of breast cancer is complex, with both genetic and environmental factors likely playing a role. Environmental risk factors, however, have been difficult to identify. By focusing on genetically susceptible subgroups, more precise estimates of the contribution of environmental and other non- genetic factors to disease risk may be possible. Sisters of women with breast cancer are one group at increased risk for breast cancer; we would expect at least 2 times as many breast cancers to accrue in a cohort of sisters as would accrue in a cohort identified through random sampling or other means. In addition, a cohort of sisters should be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect gene-environment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonally- mediated diseases. From August 2003 through July 2009, we enrolled a cohort of 50,884 women who had not had breast cancer. We estimated that after the cohort was fully enrolled, approximately 300 new cases of breast cancer will be diagnosed during each year of follow-up. Thus far 1,634 participants have reported being diagnosed with breast cancer. Frequency of Response: For the remainder of the study, women will be contacted once each year (when not scheduled for ``triennial'') to update contact information and health status (10 minutes per response); and asked to complete short (75 minutes per response) follow-up interviews or questionnaires (``triennial'') every three years. Follow- up and validation of reported incident breast cancer and other health outcomes is conducted under Clinical Exemption CE 2009-09-004. Affected Public: Study participants, next-of-kin/proxies. Type of Respondents: Participants enrolled in high-risk cohort study of risk factors for breast cancer; next-of-kin/proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 50,884 study participants or next-of-kin/proxies. Estimated Number of Responses per Respondent: See annualized table below:

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co-sponsoring this public workshop together with the Board of Regents of the University System of Georgia by and on behalf of the Georgia Institute of Technology's Translational Research Institute for Biomedical Engineering and Science (TRIBES). The purpose of this public workshop is to bring together a wide variety of stakeholders to discuss key topics relating to minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related procedures in order to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design. Date and Time: The public workshop will be held on November 27, 2012, from 7:45 a.m. to 5:30 p.m., and on November 28, 2012, from 7:45 a.m. to 1 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, on November 27, 2012 (Day 1), and Building 66, Atrium, on November 28, 2012 (Day 2). Entrance for the public workshop participants (non-FDA employees) is through Building 1 on Day 1 and Building 66 on Day 2, 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.ht m. Contact Person: Faisal Mirza, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1558, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6910 or 6311, FAX: 301-847-8117, email: faisal.mirza@fda.hhs.gov. Registration: TRIBES will charge a registration fee for non-federal employees to cover its share of the expenses associated with the workshop. The registration fee is $230 for non-federal employees. Registration is available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 13, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on Day 1 of the public workshop will be provided beginning at 6:45 a.m. The onsite registration fee is $275. If you need special accommodations due to a disability, please contact Joyce Raines at 301-796-5709, email: joyce.raines@fda.hhs.gov no later than November 13, 2012. To register for the public workshop, please visit the Georgia Institute of Technology's TRIBES Web site at https:// www.tribes.gatech.edu/mcid-conf-2012. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. For more information on the public workshop, please see FDA's Medical Devices News & EventsWorkshops and Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list.) Streaming Webcast of the Public Workshop: This public workshop will also be available as a Webcast for registrants only. Persons interested in viewing the Webcast must register online by November 13, 2012. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 13, 2012. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_ test.htm. To get a quick overview of the Connect Pro program, please visit: https://www.adobe.com/go/connectprooverview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 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, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list).