Department of Health and Human Services April 2018 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 277
Meeting of the Tick-Borne Disease Working Group
The Department of Health and Human Services (HHS) announces the fourth ``on-line'' meeting of the Tick-Borne Disease Working Group (Working Group) on May 10, 2018, from 8:30 a.m. to 6:30 p.m., Eastern Time. For this fourth meeting, the Working Group will focus on the findings and basis for the draft reports from the work of the six Subcommittee Working Groups that were established on December 12, 2017. These subcommittees were established to assist the Working Group with the development of the report to Congress and the HHS Secretary as required by the 21st Century Cures Act. The subcommittees are: 1. Disease Vectors, Surveillance and Prevention (includes epidemiology of tick-borne diseases); 2. Pathogenesis, Transmission, and Treatment; 3. Testing and Diagnostics (including laboratory-based diagnoses and clinical-diagnoses); 4. Access to Care Services and Support to Patients; 5. Vaccine and Therapeutics; and 6. Other Tick-Borne Diseases and Co-infections.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; NURSE Corps Loan Repayment Program, OMB #0915-0140-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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Telehealth Resource Center Performance Measurement Tool, OMB No. 0915-0361, Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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 reporting requirements contained in existing FDA regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients.
Aker BioMarine; Filing of Color Additive Petition
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by Aker BioMarine, proposing that the color additive regulations be amended to provide for the safe use of Antarctic krill meal which is composed of the ground and dried tissue of Euphausia superba, for use in the feed of salmonid fish. The use would enhance the color of the salmonid fish flesh.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
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; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
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.
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.'' This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.'' This draft guidance addresses FDA's current thinking about the relevant age groups to study and how early in the drug development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request
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; Announcement of Office of Management and Budget Approvals
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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.
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board advises the Agency on keeping pace with technical and scientific developments, including in regulatory science; provides input into the Agency's research agenda; and advises on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public.
The National Institutes of Health (NIH) Sexual & Gender Minority Research Office Request for Letters of Intent for Inaugural Investigator Award Program
The National Institutes of Health (NIH) Sexual & Gender Minority Research Office (SGMRO) is requesting letters of intent for an inaugural Investigator Award Program. The NIH Sexual and Gender Minority (SGM) Investigator Award Program was developed to recognize early-stage investigators who have made substantial, outstanding research contributions in areas related to SGM health and who are poised to become future leaders or are already leading the field of SGM health research. The NIH SGMRO is currently soliciting nominations for the 2018 NIH SGM Investigator Awards.
Notice of Meeting
The Agency for Healthcare Research and Quality (AHRQ) announces the Special Emphasis Panel (SEP) meeting on Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute Learning Health Systems Mentored Career Development Program (K12). Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/iccvamforum- 2018.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. Attendance is limited only by room seating available, (add number of seats that will be available in the room). The public is also welcome to listen to the meeting via teleconference; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt of written public comment is May 3, 2018. All requests must contain the name, address, and organizational affiliation of the speaker, as well as the topic being addressed. Written comments should not exceed one single-spaced typed page in length and delivered in 3 minutes or less. Members of the public who wish to provide public comments should plan to attend the public comment session at the start time listed. Please note that the public comment period may end before the time indicated, following the last call for comments. Written comments received in advance of the meeting will be included in the official record of the meeting. Registration is required to attend in person or on the phone. Interested parties may register at www.cdc.gov/ hicpac.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH website to register (https://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397-9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely. This meeting is open to the public, limited only by the space available. The public is welcome to participate during the public comment period, 12:30 p.m. to 12:45 p.m. EDT May 15, 2018. Please note that the public comment period ends at the time indicated above. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: https://www.cdc.gov/niosh/bsc/contact.html.
Solicitation of Nominations for Appointment to the Advisory Committee on Immunization Practices (ACIP).
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACIP. The ACIP consists of 15 experts in fields associated with immunization practices and public health, have expertise in the use of vaccines and other immunobiologic agents in clinical practice or preventive medicine, have expertise with clinical or laboratory vaccine research, or have expertise in assessment of vaccine efficacy and safety. The committee shall include a person or persons knowledgeable about consumer perspectives and/or social and community aspects of immunization programs. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population of the United States. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ACIP objectives https://www.cdc.gov/vaccines/acip/committee/charter.html.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
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.
Exposure-Response Analysis in Drug Development and Regulatory Decision Making; Establishment of a Public Docket; Request for Comments
The Prescription Drug User Fee Act of 2017 (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA, highlights the goal of advancing model-informed drug development (MIDD). Exposure-response analysis is a MIDD strategy that has been used in drug development and regulatory decision making. The Food and Drug Administration (FDA or Agency) is opening a docket to receive public comments on experience leveraging exposure-response analysis since publishing the guidance for industry (GFI) entitled ``Exposure-Response RelationshipsStudy Design, Data Analysis, and Regulatory Applications,'' which was announced in the Federal Register on May 6, 2003. Specifically, the Agency wants to identify areas of scientific policy that may need further clarity or elaboration, as well as any obstacles that prevent use of exposure-response analyses in drug development and regulatory review.
Advisory Commission on Childhood Vaccines
HRSA is requesting nominations to fill vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), and advises the Secretary of HHS (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS. HRSA is seeking nominations of qualified candidates to fill up to three positions on the Committee.
Agency For Healthcare Research And Quality; Notice Of Meeting
The Agency for Healthcare Research and Quality (AHRQ) announces the Special Emphasis Panel (SEP) meeting on AHRQ-HS-17-012, Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute Learning Health Systems Mentored Career Development Program (K12). Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
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 October, November, and December 2017. FDA is 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 changes of sponsorship of applications and a change of a sponsor's name and address.
Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.'' This guidance document finalizes the revised draft of the same name that published on October 30, 2015. This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs), reviewed by the Center for Drug Evaluation and Research (CDER).
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting is open to the public and will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss ISMICC member relationship to implementation workgroups, establishing the prevalence of SMI and SED, communication with non-federal organizations to engage non-federal support for ISMICC, and future meetings. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee.
Tribal Consultation Meetings
Pursuant to the Improving Head Start for School Readiness Act of 2007, notice is hereby given of six 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Head Start (OHS) leadership and the leadership of tribal governments operating Head Start (including Early Head Start) programs. The purpose of these consultation sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations.
Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management and support of the NVAC and its activities are the responsibility of the NVPO. The NVAC serves an advisory role, providing recommendations to the Assistant Secretary for Health in his/her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
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.
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
