Department of Health and Human Services April 23, 2014 – Federal Register Recent Federal Regulation Documents

Request for Information on Adoption of Career Pathways Approaches for the Delivery of Education, Training, Employment, and Human Services
Document Number: 2014-09274
Type: Notice
Date: 2014-04-23
Agency: Department of Education, Department of Health and Human Services, Department of Labor
Through this Request for Information (RFI), the Departments of Education (ED), Health and Human Services (HHS), and Labor (DOL) (the Departments) seek to further support the development of high-quality career pathways systems by jointly soliciting information and recommendations from a broad array of stakeholders in the public and private sectors, as well as in State, regional, tribal, and local areas. The Departments will analyze the career pathways information collected from the RFI to: (1) Inform and coordinate policy development, strategic investments, and technical assistance activities; and (2) improve coordination of Federal policy development with investments at the State, tribal and local levels.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2014-09224
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2014-09223
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2014-09222
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-09221
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Guidance for Industry on Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations; Availability
Document Number: 2014-09220
Type: Notice
Date: 2014-04-23
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 ``Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations.'' The purpose of this guidance is to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations.
Excentials B.V.; Filing of Food Additive Petition (Animal Use)
Document Number: 2014-09216
Type: Proposed Rule
Date: 2014-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Excentials B.V. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of L- selenomethionine as a dietary source of selenium in feed for poultry, swine, and ruminants.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Cover Sheet
Document Number: 2014-09202
Type: Notice
Date: 2014-04-23
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; Animal Generic Drug User Fee Act Cover Sheet
Document Number: 2014-09201
Type: Notice
Date: 2014-04-23
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; Color Additive Certification Requests and Recordkeeping
Document Number: 2014-09200
Type: Notice
Date: 2014-04-23
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.
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-09190
Type: Notice
Date: 2014-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the draft guidance entitled ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.'' This draft guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process. This draft guidance is not final nor is it in effect at this time.
Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-09189
Type: Notice
Date: 2014-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the draft guidance entitled ``Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions.'' This draft guidance outlines FDA's proposal for a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMA). FDA believes that the Expedited Access PMA (EAP) program will help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval, consistent with the Agency's mission to protect and promote public health. The document also discusses how the EAP program approaches the balance of premarket and postmarket data collection and incorporates a benefit-risk framework. This draft guidance is not final nor is it in effect at this time.
Food and Drug Administration Transparency Initiative: Increasing Public Access to the Food and Drug Administration's Compliance and Enforcement Data; Availability
Document Number: 2014-09188
Type: Notice
Date: 2014-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
As part of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``Food and Drug Administration Transparency Initiative: Increasing Public Access to FDA's Compliance and Enforcement Data.'' This report summarizes findings and recommendations from eight FDA working groups established to enhance the transparency and public accessibility of the Agency's compliance and enforcement data.
Notice of Meeting
Document Number: 2014-09175
Type: Notice
Date: 2014-04-23
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-007, Patient-Centered Outcomes Research (PCOR) for Deliberative Approaches: Patient and Consumer Input for Implementing Evidence-Based Health Care (R21)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-09172
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-09150
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-09149
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-09148
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-09147
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Interagency Committee on Smoking and Health (ICSH)
Document Number: 2014-09146
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statewide Data Indicators and National Standards for Child and Family Services Reviews
Document Number: 2014-09001
Type: Proposed Rule
Date: 2014-04-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Children's Bureau reviews a state's substantial conformity with titles IV-B and IV-E of the Social Security Act through the Child and Family Services Reviews (CFSRs). Statewide data indicators are used to inform the Children's Bureau's determination of a state's substantial conformity relative to certain safety and permanency outcomes. This document advises the public of the Children's Bureau's plan to replace the statewide data indicators and the methods for calculating associated national standards on those indicators. We invite the public to comment on these indicators and methods before their use in CFSRs scheduled for Federal Fiscal Years (FFY) 2015 through FY 2018.