Department of Health and Human Services April 1, 2016 – Federal Register Recent Federal Regulation Documents

New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Document Number: C1-2016-07135
Type: Rule
Date: 2016-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-07424
Type: Notice
Date: 2016-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-07423
Type: Notice
Date: 2016-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 require; 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.
Temporary Reassignment of State, Tribal, and Local Personnel During a Public Health Emergency
Document Number: 2016-07404
Type: Notice
Date: 2016-04-01
Agency: Department of Health and Human Services
The Department of Health and Human Services, Office of the Secretary is announcing the availability of a final guidance entitled ``Guidance for Temporary Reassignment of State, Tribal, and Local Personnel during a Public Health Emergency.'' Section 201 of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Law 113-5, amends section 319 of the Public Health Service (PHS) Act to allow the Secretary of HHS, when she declares a public health emergency under section 319 of the PHS Act, to authorize, upon request by a state or tribal organization or their designee, the temporary reassignment of state, tribal, and local personnel funded through programs authorized under the PHS Act to immediately address a public health emergency in the state or Indian tribe. This final guidance addresses that provision.
Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
Document Number: 2016-07369
Type: Notice
Date: 2016-04-01
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 notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.
Notice of Availability of the Final Environmental Assessment (Final EA) and a Finding of No Significant Impact (FONSI) for HHS/CDC Fort Collins Campus Proposed Improvements
Document Number: 2016-07368
Type: Notice
Date: 2016-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this notice to advise the public that HHS/CDC has prepared and approved on March 22, 2016, a Finding of No Significant Impact (FONSI) based on the Final Environmental Assessment for proposed improvements on the HHS/CDC Fort Collins Campus. HHS/CDC prepared the Final EA in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR parts 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000. HHS/CDC has determined that the proposed action would not have a significant impact on the human or natural environment and therefore, the preparation of an Environmental Impact Statement is not required.
Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications
Document Number: 2016-07365
Type: Notice
Date: 2016-04-01
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 notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
Document Number: 2016-07364
Type: Notice
Date: 2016-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2016-07363
Type: Notice
Date: 2016-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Advisory Committee; Arthritis Advisory Committee, Renewal
Document Number: 2016-07362
Type: Notice
Date: 2016-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Arthritis Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Arthritis Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 5, 2018.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-07361
Type: Notice
Date: 2016-04-01
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2016-07359
Type: Notice
Date: 2016-04-01
Agency: Department of Health and Human Services, Administration for Children and Families
Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2016-07321
Type: Notice
Date: 2016-04-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2016-07319
Type: Notice
Date: 2016-04-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.