Department of Health and Human Services October 22, 2014 – Federal Register Recent Federal Regulation Documents

Notice of Intent To Award Ebola Response Outbreak Funding to Eligible Ministries of Health and Their Bona Fide Agents
Document Number: 2014-25133
Type: Notice
Date: 2014-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This notice provides public announcement of CDC's intent to award Ebola appropriations to select Ministries of Health and their bona fide agents for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1418, ``Protecting and Strengthening Public Health Impact, Systems, Capacity, and Security.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Document Number: 2014-25106
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations
Document Number: 2014-25105
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-25095
Type: Notice
Date: 2014-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-25094
Type: Notice
Date: 2014-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Colorcon, Inc.; Filing of Color Additive Petition
Document Number: 2014-25089
Type: Proposed Rule
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.
National Eye Institute Meeting
Document Number: 2014-25068
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Eye Institute will host a meeting to enable public discussion of the Institute's proposal to rename its Division of Extramural Research to the Division of Extramural Science and establish a new Division of Extramural Activities. The proposal seeks to clearly delineate functions and streamline the services provided by adding focus to scientific programs and extramural operations. This proposed change aligns NEI with the structure of other NIH Institutes and Centers.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2014-25067
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
Seventh Annual Sentinel Initiative; Public Workshop
Document Number: 2014-25053
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance
Document Number: 2014-25049
Type: Rule
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Migraine: Developing Drugs for Acute Treatment; Draft Guidance for Industry; Availability
Document Number: 2014-25048
Type: Notice
Date: 2014-10-22
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 for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine. This guidance is intended to serve as a focus for continued discussions among the Division of Neurology Products, pharmaceutical sponsors, the academic community, and the public.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2014-25046
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-25045
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2014-25044
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2014-25043
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-25042
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-25041
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 2014-25040
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-25039
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 2014-25038
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-25037
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-25036
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability
Document Number: 2014-25033
Type: Notice
Date: 2014-10-22
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 ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Determination of Regulatory Review Period for Purposes of Patent Extension; CARBON DIOXIDE LASER
Document Number: 2014-25032
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for CARBON DIOXIDE LASER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the United States Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that food additive.
Office of the Director, Program on Biosecurity and Biosafety Policy; Notice of Meeting
Document Number: 2014-25030
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health