Energy Policy and New Uses Office, Agriculture Department September 11, 2015 – Federal Register Recent Federal Regulation Documents

Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications; Public Meeting
Document Number: 2015-22949
Type: Notice
Date: 2015-09-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications'' and an opportunity for public comment on the topic of drug interactions with hormonal contraceptives (HCs). The goal of this public meeting is to provide an opportunity for FDA to seek input from experts on the public health concerns associated with use of HCs and interacting drugs that might affect efficacy and safety, pharmacokinetic (PK)/pharmacodynamic (PD) considerations in designing drug interaction studies with HCs during drug development, and approaches to translating the results of drug interaction information into informative labeling and communication. The input received may be used to refine FDA's thinking on HC drug interaction study design and interpretation, and labeling communication on drug interaction risk.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-22944
Type: Notice
Date: 2015-09-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (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.
Center for Scientific Review Notice of Closed Meetings
Document Number: 2015-22938
Type: Notice
Date: 2015-09-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Document Number: 2015-22920
Type: Notice
Date: 2015-09-11
Agency: Energy Policy and New Uses Office, Agriculture Department
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (the Advisory Council) is scheduled for September 29, 2015, from 9:00 a.m. to 5:00 p.m. ET. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should email CARB@hhs.gov. Registration information is available on the Web site https:// www.hhs.gov/ash/ carb/ and must be completed by September 21, 2015; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/ash/carb/.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-22886
Type: Notice
Date: 2015-09-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
World Trade Center Health Program; Addition of New-Onset Chronic Obstructive Pulmonary Disease and Acute Traumatic Injury to the List of WTC-Related Health Conditions
Document Number: 2015-22599
Type: Proposed Rule
Date: 2015-09-11
Agency: Energy Policy and New Uses Office, Agriculture Department
The World Trade Center (WTC) Health Program, at the direction of the Administrator, conducted a review of published studies regarding potential evidence of chronic obstructive pulmonary disease (COPD) and acute traumatic injury among individuals who were responders to or survivors of the September 11, 2001, terrorist attacks. The Administrator of the WTC Health Program found that these studies provided substantial support for a causal relationship between the health conditions and 9/11 exposures. As a result, the Administrator has determined to publish a proposed rule to add new- onset COPD and to add acute traumatic injury to the List of WTC-Related Health Conditions eligible for treatment coverage in the WTC Health Program.
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