Department of Health and Human Services April 17, 2013 – Federal Register Recent Federal Regulation Documents

Reimbursement Rates for Calendar Year 2013
Document Number: 2013-09030
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Indian Health Service
Notice is given that the Director of the Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2013 for Medicare and Medicaid beneficiaries, and beneficiaries of other Federal programs, and for recoveries under the Federal Medical Care Recovery Act (42 U.S.C. 2651-2653). The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment shall be available to the extent that those services are provided.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-09029
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-09026
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Advisory Council on Migrant Health; Notice of Meeting
Document Number: 2013-09025
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Advisory Council on Nurse Education and Practice; Notice of Meeting
Document Number: 2013-09023
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
World Trade Center Health Program; Certification of Breast Cancer in WTC Responders and Survivors Exposed to PCBs
Document Number: 2013-09003
Type: Rule
Date: 2013-04-17
Agency: Department of Health and Human Services
On September 12, 2012, HHS published a final rule in the Federal Register adding certain types of cancer to the List of World Trade Center (WTC)-Related Health Conditions (List) established in the WTC Health Program regulation. Breast cancer was included on the List, although only individuals experiencing nighttime sleep disruption as a result of response and cleanup activities involving shiftwork are currently considered to have experienced exposure relevant for certification. A recent publication in The Lancet Oncology by the International Agency for Research on Cancer (IARC) concludes that there is limited evidence that polychlorinated biphenyls (PCBs) cause breast cancer in humans. As described below, the WTC Program Administrator (Administrator) has found that PCBs were present in WTC dust in the New York City disaster area and, accordingly, the Program will now certify breast cancer in eligible WTC responders and survivors who were exposed to either shiftwork/nighttime sleep disruption or PCBs as a result of the 9/11 attacks.
Proposed Collection; 60-day Comment Request: Topic-based Studies for the Population Assessment of Tobacco and Health (PATH) Study
Document Number: 2013-08954
Type: Notice
Date: 2013-04-17
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 Institute on Drug Abuse (NIDA), 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 on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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 and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact Kevin P. Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, 6001 Executive Blvd., Room 5185; Rockville, MD 20852, or call non-toll free number (301) 443-8755 or Email your request, including your address to: PATHprojectofficer@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
National Institute of Nursing Research; Notice of Meeting
Document Number: 2013-08945
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-08944
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2013-08943
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2013-08942
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International Center; Notice of Closed Meeting
Document Number: 2013-08941
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-08940
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-08939
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-08938
Type: Notice
Date: 2013-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-Contamination; Availability
Document Number: 2013-08913
Type: Notice
Date: 2013-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Non-Penicillin Beta- Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.'' This guidance describes the importance of implementing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and non-penicillin beta-lactams), beta-lactamase inhibitors, and beta-lactam intermediates and derivatives. Finally, this guidance clarifies that manufacturers should generally utilize separate facilities for manufacture of non- penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-08912
Type: Notice
Date: 2013-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-08911
Type: Notice
Date: 2013-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents
Document Number: 2013-08906
Type: Notice
Date: 2013-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
AHRQ Standing Workgroup for Quality Indicator Measure Specification
Document Number: 2013-08834
Type: Notice
Date: 2013-04-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for both a time-limited workgroup and a standing workgroup to be convened by an AHRQ contractor. The workgroups shall be comprised of individuals with knowledge of the AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues. The overarching goals of each group are to provide feedback to AHRQ regarding refinements to the QIs. The time-limited workgroup is more restricted to specific clinical or methodological issues, while the standing workgroup addresses broader issues related to the measurement cycle. Because AHRQ did not get a set of candidates with anticipated breadth of diversity of experience as required in response to our notice (https://www.federalregister.gov/articles/2013/01/28/2013-013 48/ ahrq-standing-workgroup-for-quality-indicator-measure-specifi cation) published on January 28, 2013, Volume 78, No. 18, page numbers: 5810 & 5811, AHRQ resubmits the same notice to give opportunity to those interested in this objective.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-08833
Type: Notice
Date: 2013-04-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Applying Novel Methods to Better Understand the Relationship between Health IT and Ambulatory Care Workflow Redesign.'' 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 January 28th, 2013 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.