Department of Health and Human Services June 30, 2015 – Federal Register Recent Federal Regulation Documents

Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-16028
Type: Notice
Date: 2015-06-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Healthcare Safety Network (NHSN). NHSN is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-16027
Type: Notice
Date: 2015-06-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Prevent Hepatitis Transmission among Persons Who Inject Drugs''. The purpose of this study is to address the high prevalence of HCV infection by developing an integrated approach for detection, prevention, care and treatment of infection among persons aged 18-30 years who reside in non-urban counties.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration Regulated Products
Document Number: 2015-16023
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Export Certificates for FDA Regulated Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives
Document Number: 2015-16022
Type: Notice
Date: 2015-06-30
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; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults
Document Number: 2015-16020
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Evaluation of FDA's Multicultural Youth Tobacco Prevention Campaigns.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2015-16013
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-16011
Type: Notice
Date: 2015-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.'' FDA is issuing this draft guidance to describe the Agency's premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. This draft guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to describe gowns has evolved, including by industry, the standards community, and health care professionals. This draft guidance is not final nor is it in effect at this time.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-15946
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-15945
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-15944
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2015-15943
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke Notice of Closed Meetings
Document Number: 2015-15942
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-15941
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2015-15925
Type: Notice
Date: 2015-06-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health Study
Document Number: 2015-15844
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirements of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request; Population Sciences Biospecimen Catalog
Document Number: 2015-15842
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirements of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; 30-Day Comment Request; The Effectiveness of Donor Notification, HIV Counseling, and Linkage of HIV Positive Donors to Health Care in Brazil
Document Number: 2015-15841
Type: Notice
Date: 2015-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 8, 2015, page 18853 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health (NIH) may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
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