Department of Health and Human Services December 18, 2014 – Federal Register Recent Federal Regulation Documents

Caring for Our Children Basics; Comment Request
Document Number: 2014-29649
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
As authorized by the 2014 Omnibus Act, ACF is requesting public comment on a voluntary set of minimum health and safety standards for early care and education settings titled, ``Caring for Our Children Basics.''
World Trade Center Health Program; Petition 006-Primary Biliary Cirrhosis; Finding of Insufficient Evidence
Document Number: 2014-29647
Type: Proposed Rule
Date: 2014-12-18
Agency: Department of Health and Human Services
On October 20, 2014, the Administrator of the World Trade Center (WTC) Health Program received a petition to add primary biliary cirrhosis (Petition 006) to the List of WTC-Related Health Conditions (List). The Administrator has not found sufficient scientific evidence to conduct an analysis of whether to add primary biliary cirrhosis to the List. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Proposed Information Collection Activity; Comment Request
Document Number: 2014-29641
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-29627
Type: Notice
Date: 2014-12-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development
Document Number: 2014-29612
Type: Notice
Date: 2014-12-18
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; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Document Number: 2014-29611
Type: Notice
Date: 2014-12-18
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.
Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2014-29609
Type: Notice
Date: 2014-12-18
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 ``Providing Regulatory Submissions in Electronic FormatSubmissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.'' The guidance announced in this notice sets forth FDA's interpretation of the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be submitted in electronic format, beginning no earlier than 24 months after issuance of a final version of a guidance document specifying the format for such electronic submissions. This guidance describes how FDA interprets and plans to implement the electronic submission requirements and finalizes the draft guidance that was issued on February 6, 2014.
Providing Regulatory Submissions in Electronic Format-Standardized Study Data; Guidance for Industry; Availability
Document Number: 2014-29608
Type: Notice
Date: 2014-12-18
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 ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data.'' The guidance announced in this document is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). This finalizes the revised draft guidance that was issued on February 6, 2014.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review
Document Number: 2014-29607
Type: Notice
Date: 2014-12-18
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.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2014-29573
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Multivalent Vaccines for Rabies Virus and Ebola and Marburg (Filoviruses)
Document Number: 2014-29572
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: E-032-2011/0, Blaney et al., ``Multivalent Vaccines for Rabies Virus and Filoviruses'', U.S. Patent Application Number 61/439,046, filed on February 3, 2011, PCT Application Number PCT/US2012/23575, filed on February 2, 2012, U.S. Patent Application Number 13/983,545, filed on August 2, 2013, European Patent Application Number 12702953.6, filed on February 2, 2012, and Canadian Patent Application Number 2826594, filed on February 2, 2012, to Exxell BIO, Inc., having a place of business in Shoreview, Minnesota, United States of America. The patent rights in these inventions have been assigned to the United States of America and Thomas Jefferson University.
National Center for Complementary & Alternative Medicine; Notice of Meeting
Document Number: 2014-29571
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD); Notice of Meeting
Document Number: 2014-29570
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
Document Number: 2014-29522
Type: Proposed Rule
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.