Department of Health and Human Services June 19, 2017 – Federal Register Recent Federal Regulation Documents

Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-12736
Type: Notice
Date: 2017-06-19
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 a proposed information collection entitled ``Evaluation of Medication-Assisted Treatment (MAT) for Opioid use disorder.'' CDC will use the collection to conduct an epidemiologic study to assess the type of MAT (methadone maintenance; buprenorphine; naltrexone; or, counseling, no MAT), and the contextual, provider, and individual factors that influence implementation and improved patient wellbeing over a two-year follow up period.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-12691
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, Administration for Children and Families
Reallotment of Fiscal Year 2016 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
Document Number: 2017-12675
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2016 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that received FY 2017 direct LIHEAP grants. No subgrantees or other entities may apply for these funds.
Announcement of the Award of Six Single-Source Program Expansion Supplement Grants Under the Unaccompanied Children's Program
Document Number: 2017-12627
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families, Office of Refugee Resettlement (ORR), announces the award of six single-source program expansion supplement grants for a total of $14,821,314 under the UC Program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Drug Medicinal Product Designation
Document Number: 2017-12620
Type: Notice
Date: 2017-06-19
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 Common European Medicines Agency (EMA)/FDA Application Form for Orphan Drug Medicinal Product Designation (Form FDA 3671).
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
Document Number: 2017-12619
Type: Notice
Date: 2017-06-19
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 (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 requirements governing the acceptance of electronic records and electronic signatures.
National Institute of Environmental Health Sciences; Amended Notice of Meeting
Document Number: 2017-12616
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2017-12615
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submission
Document Number: 2017-12604
Type: Notice
Date: 2017-06-19
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; Data To Support Drug Product Communications as Used by the Food and Drug Administration
Document Number: 2017-12601
Type: Notice
Date: 2017-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 a generic clearance to collect information to support communications used by FDA about drug products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads
Document Number: 2017-12600
Type: Notice
Date: 2017-06-19
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 (PRA), Federal Agencies are required to publish 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 research entitled ``Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads.'' This study will examine how repetition and overwarning apply to the presentation of risks in the context of direct-to-consumer print advertising.
Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
Document Number: 2017-12599
Type: Notice
Date: 2017-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish 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 research entitled ``Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion.''
National Institute of Mental Health; Notice of Meeting
Document Number: 2017-12595
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2017-12594
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences Amended; Notice of Meeting
Document Number: 2017-12593
Type: Notice
Date: 2017-06-19
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: 2017-12592
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-12591
Type: Notice
Date: 2017-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Changes in Permit Application To Import a Dog Inadequately Immunized Against Rabies
Document Number: 2017-12439
Type: Notice
Date: 2017-06-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces changes in the application process to import a dog inadequately immunized against rabies. As a result of these changes, at least 10 business days before arriving into the United States with an inadequately immunized dog, an importer must apply online at https://www.cdc.gov/importation/ for a Permit to Import a Dog Inadequately Immunized against Rabies. Permit applications to import an inadequately immunized dog will not be available at the port of entry and no permits will be issued at the port of entry. Inadequately immunized dogs arriving at a port of entry without an approved permit will be denied entry into the United States and exported to its country of origin at the owner's expense.
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