Department of Health and Human Services September 30, 2011 – Federal Register Recent Federal Regulation Documents

Announcement of Requirements and Registration for “Million Hearts Challenge”
Document Number: 2011-25296
Type: Notice
Date: 2011-09-30
Agency: Department of Health and Human Services
The ``Million Hearts Challenge'' is a multidisciplinary call to innovators and developers to create an application that activates and empowers patients to take charge of their cardiovascular disease. Winning entries have the potential to help patients combat the nation's leading cause of death through medication adherence, a healthier diet, and a more active lifestyle while promoting the goals of the Million Hearts campaign. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. No. 111-358).
Announcement of Requirements and Registration for “popHealth Tools Development Challenge”
Document Number: 2011-25295
Type: Notice
Date: 2011-09-30
Agency: Department of Health and Human Services
The ``popHealth Tools Development Challenge'' tasks developers with creating applications that leverage the popHealth open source framework, existing functionality, standards, and sample datasets to improve patient care and provide greater insight into patient populations. Winning entries will extend the capabilities of popHealth, increasing its value to healthcare providers and EHR vendors. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Meeting of the Advisory Committee on Minority Health
Document Number: 2011-25294
Type: Notice
Date: 2011-09-30
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-25274
Type: Notice
Date: 2011-09-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-25271
Type: Notice
Date: 2011-09-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2011-25245
Type: Notice
Date: 2011-09-30
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin
Document Number: 2011-25220
Type: Rule
Date: 2011-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of melengestrol acetate and monensin in two-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Proposed Information Collection Activity; Comment Request
Document Number: 2011-25210
Type: Notice
Date: 2011-09-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans, and Standards Related to Reinsurance, Risk Corridors and Risk Adjustment; Extension of Comment Period
Document Number: 2011-25202
Type: Proposed Rule
Date: 2011-09-30
Agency: Department of Health and Human Services
This document extends the comment period for two proposed rules published in the Federal Register on July 15, 2011. One proposed rule would implement the new 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. The other proposed rule would implement standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with Title I of the Affordable Care Act. The comment period for both proposed rules, which would have ended on September 28, 2011, is extended to October 31, 2011.
Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability
Document Number: 2011-25196
Type: Notice
Date: 2011-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' This draft guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2011-25152
Type: Notice
Date: 2011-09-30
Agency: Department of Health and Human Services
National Mammography Quality Assurance Advisory Committee; Notice of Meeting
Document Number: 2011-25148
Type: Notice
Date: 2011-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
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