Department of Health and Human Services February 1, 2013 – Federal Register Recent Federal Regulation Documents

Medicare Program: Notice of Two Membership Appointments to the Advisory Panel on Hospital Outpatient Payment
Document Number: 2013-02193
Type: Notice
Date: 2013-02-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces two new membership appointments to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). The two new appointments to the Panel will each serve a 4-year period. The new members will have terms that begin on February 1, 2013 and continue through January 31, 2017. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their relative payment weights. The Panel also addresses and makes recommendations regarding supervision of outpatient services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-02155
Type: Notice
Date: 2013-02-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-02153
Type: Notice
Date: 2013-02-01
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Development of Human Monoclonal Antibodies Against DR4
Document Number: 2013-02152
Type: Notice
Date: 2013-02-01
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions embodied in PCT Patent Application No. PCT/US2011/040750 and foreign equivalents thereof entitled ``Agonistic Human Monoclonal Antibodies Against DR4'' (HHS Ref. No. E-158-2010/0) to Customized Biosciences, Inc., which is located in Pasadena, CA. The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive commercial license territory may be worldwide and the field of use may be limited to ``use of the Licensed Patent Rights to develop therapeutic agents for the treatment of lymphomas, leukemias, hepatocellular cancer, colorectal cancer, ovarian cancer, lung cancer, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis, and Alzheimer's disease''.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Contract Health Services Report
Document Number: 2013-02140
Type: Notice
Date: 2013-02-01
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3507(a)(1)(D) 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 69865) on November 21, 2012, and allowed 60 days for public comment, as required by 3506(c)(2)(A). 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: 0917-0002, ``IHS Contract Health Service Report.'' Type of Information Collection Request: Extension, without change, of a currently approved information collection, 0917- 0002, ``IHS Contract Health Service Report.'' While there were minor text changes (i.e., updating of statute/regulatory citations), there were no significant changes to the form. Form: IHS 843-1A. ``Order for Health Services.'' Need and Use of Information Collection: The IHS Contract Health Service (CHS) Program, located in the Office of Resource Access and Partnerships, needs this information to certify that the health care services requested and authorized by the IHS have been performed by the CHS provider(s) to have providers validate services provided; to process payments for health care services performed by such providers; and to serve as a legal document for health and medical care authorized by IHS and rendered by health care providers under contract with the IHS. Affected Public: Patients, health and medical care providers or Tribal Governments. Type of Respondents: Health and medical care providers. Burden Hours: The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hours.
Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions
Document Number: 2013-02139
Type: Proposed Rule
Date: 2013-02-01
Agency: Department of Health and Human Services
This proposed rule would implement certain functions of the 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. These specific statutory functions include determining eligibility for and granting certificates of exemption from the shared responsibility payment for not maintaining minimum essential coverage as described in section 5000A of the Internal Revenue Code. Additionally, this proposed rule implements the responsibility of the Secretary of Health and Human Services, in coordination with the Secretary of the Treasury, to designate other health benefits coverage as minimum essential coverage by providing that certain coverage be designated as minimum essential coverage. It also outlines substantive and procedural requirements that other types of individual coverage must fulfill in order to be certified as minimum essential coverage under the Internal Revenue Code.
Submission for OMB Review; Comment Request
Document Number: 2013-02137
Type: Notice
Date: 2013-02-01
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organization, Functions and Delegations of Authority
Document Number: 2013-02124
Type: Notice
Date: 2013-02-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP) Database (NCI)
Document Number: 2013-02123
Type: Notice
Date: 2013-02-01
Agency: Department of Health and Human Services, National Institutes of Health
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 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. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To submit comments in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact: Jose Galvez, Office of the Director, National Cancer Institute, 2115 East Jefferson Street, Rockville, MD 20852 or call non-toll-free number 301-443-6141 or Email your request, including your address to: jose.galvez@nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600, Expiration Date 3/31/2013EXTENSION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research. The designees can electronically access the CTRP Web site to complete the initial trial registration. Subsequent to registration, four amendments and four study subject accrual updates occur per trial annually. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 38,500.
Submission for OMB Review; Comment Request
Document Number: 2013-02115
Type: Notice
Date: 2013-02-01
Agency: Department of Health and Human Services, Administration for Children and Families