Department of Health and Human Services January 14, 2015 – Federal Register Recent Federal Regulation Documents

Draft Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Notice for Public Meeting on Draft Environmental Impact Statement
Document Number: 2015-00564
Type: Proposed Rule
Date: 2015-01-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) has made available for public review and comment the Draft Environmental Impact Statement (EIS) for the proposed rule establishing standards for the growing, harvesting, packing, and holding of produce for human consumption. The document is available in Docket No. FDA-2014-N-2244. FDA is also announcing a public meeting to discuss the Draft EIS. The purpose of the public meeting is to inform the public of the findings in the Draft EIS, to provide information about the EIS process (including how to submit comments, data, and other information to the docket), to solicit oral stakeholder and public comments on the Draft EIS, and to provide clarification, as needed, about the contents of the Draft EIS.
CHEMBIOMED, LTD., Opportunity for a Hearing on a Proposal To Revoke U.S. License No. 0916
Document Number: 2015-00442
Type: Notice
Date: 2015-01-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on a proposal to revoke the biologics license (U.S. License No. 0916) issued to CHEMBIOMED, LTD. (CHEMBIOMED), for the manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\ (Murine Monoclonal) and Anti-Le\b\ (Murine Monoclonal). The proposed revocation is based on information that the firm is no longer in operation and the manufacture of its licensed products has been discontinued.
Payment for Physician and Other Health Care Professional Services Purchased by Indian Health Programs and Medical Charges Associated With Non-Hospital-Based Care
Document Number: 2015-00400
Type: Proposed Rule
Date: 2015-01-14
Agency: Department of Health and Human Services, Indian Health Service
This document extends the comment period for the Payment for Physician and Other Health Care Professional Services Purchased by Indian Health Programs and Medical Charges Associated with Non- Hospital-Based Care proposed rule, which was published in the Federal Register on December 5, 2014. The comment period for the proposed rule, which would have ended on January 20, 2015, is extended to February 4, 2015.
Determining Mental Health Professional Shortage Areas of Greatest Need
Document Number: 2015-00398
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of section 333A(b)(1) of the Public Health Service (PHS) Act, as amended by the Health Care Safety Net Amendments of 2002, 42 U.S.C. 254f-1(b)(1), the Secretary of HHS shall establish the criteria which she will use to make determinations under section 333A(a)(1)(A) of the HPSAs with the greatest shortages. This notice sets forth revised criteria for determining mental health HPSAs with the greatest shortage. This updates the previous criteria published on May 30, 2003.
Announcement of Requirements and Registration for: “Innovations in Measuring and Managing Addiction Treatment Quality” Challenge
Document Number: 2015-00394
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Through the ``Innovations in Measuring and Managing Addiction Treatment Quality'' Challenge (the ``Challenge''), the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), challenges the general public to make concrete advances toward improving the quality of addiction treatment. Specifically, through this Challenge, NIDA hopes to incentivize the development of innovative concepts for quality measurement and quality management systems based on the latest science of addiction and its treatment and of quality measurement and management. These new concepts would be game-changing because they would go beyond current performance measurement concepts in that they would not be limited by the data commonly available in current provider and payer data systems. Instead, they would (a) more directly reflect the clinical effects that can and should be expected from high-quality addiction treatment; (b) capture what clinicians and provider organizations need to measure to help them provide high-quality addiction treatment; and (c) provide a solid basis for measuring clinician and provider performance that may be used by patients and other purchasers to select and incent high-quality treatment. NIDA believes that the development of such quality measures and management systems has the potential to meaningfully improve the quality of addiction treatment both by giving clinicians and providers the information they need to assess and improve the quality of the care they provide and by providing tools patients and purchasers can use to shop for the highest quality providers, allowing market forces to provide another incentive for improvement.
Submission for OMB Review; 30-day Comment Request Progress Reports for Center for Global Health's Low and Mid-Income Countries (LMICs) Global Health Collaborations (NCI)
Document Number: 2015-00393
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 July 28, 2014, Vol. 79, P. 43755 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-00374
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-00347
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2015-00346
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2015-00345
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2015-00081
Type: Notice
Date: 2015-01-14
Agency: Department of Health and Human Services, Administration for Children and Families
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