Department of Health and Human Services May 2017 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 277
Solicitation of Nominations for Appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
The U.S. Department of Health and Human Services (HHS) is soliciting nominations of individuals who are interested in being considered for appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council) as a non- voting liaison representative member from an organization and/or interest group. Nominations from qualified individuals who wish to be considered for appointment to this member category of the Advisory Council are currently being accepted.
Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.'' This guidance is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations.
Request for Nominations of Candidates To Serve as Members of the Community Preventive Services Task Force (CPSTF)
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the opening of the nomination period for individuals qualified to serve as members of the Community Preventive Services Task Force (CPSTF) to serve 5-year terms starting in 2018 or 2019.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This publication corrects a notice that was published in the Federal Register on May 4, 2017, Volume 82, No. 85, page 20895. The meeting time and date should read as follows: Time and Date: 8:00 a.m.-6:00 p.m., EST, June 14, 2017 (Closed). Contact Person for More Information: Oscar Tarrag[oacute], M.D., M.P.H., Scientific Review Officer, CDC, 4770 Buford Highway NE., Mailstop F63, Atlanta, Georgia 30341, Telephone: (770) 488-3492. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Organ Procurement and Transplantation Network, OMB No. 0915-0184-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
World Trade Center Health Program; Petition 015-Neuropathy; Finding of Insufficient Evidence
On November 25, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 015) to add neuropathy to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add neuropathy to the List. 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.
Request for Nominations to the Advisory Council on Alzheimer's Research, Care, and Services
The Secretary of HHS established the Advisory Council to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for seven (7) new non-Federal members of the Advisory Council to replace the seven members whose terms will end September 30th, 2017. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 (PRA), federal agencies are required 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 required 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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures
The Secretary is issuing a declaration pursuant to section 319F-3 of the Public Health Service Act to provide liability protections consistent with that authority for medical countermeasures against nerve agents and organophosphorus insecticides that result in organophosphorus poisoning and carbamate insecticides that result in carbamate poisoning.
Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft revisions to the ``FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics'' (Blueprint). The Blueprint is part of the FDA-approved risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). FDA is seeking comment on the draft revisions to the Blueprint and has added sections of draft revised Blueprint to the background materials for the public workshop scheduled for May 9-10, 2017. Although the draft revisions to the Blueprint will not be a discussion topic at the workshop, FDA expects the draft revisions to provide important context for discussions during the workshop.
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.
Meeting of the National Advisory Council on Migrant Health
In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the National Advisory Council on Migrant Health (NACMH/Council). This meeting will be open to the public. The agenda for the NACMH meeting can be obtained by contacting the Designated Federal Officer (DFO) or accessing the Council Web site: https://bphc.hrsa.gov/qualityimprovement/ strategicpartnerships/nacmh/.
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