Department of Health and Human Services 2014 – Federal Register Recent Federal Regulation Documents
Results 351 - 400 of 3,620
Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Rare Pediatric Disease Priority Review Vouchers.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section. These vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. These vouchers can be sold or transferred for use to another sponsor any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases.
Flexibility, Efficiency, and Modernization in Child Support Enforcement Programs
This NPRM is intended to carry out the President's directives in Executive Order 13563: Improving Regulation and Regulatory Review. The NPRM proposes revisions to make Child Support Enforcement program operations and enforcement procedures more flexible, more effective, and more efficient by recognizing the strength of existing state enforcement programs, advancements in technology that can enable improved collection rates, and the move toward electronic communication and document management. This NPRM proposes to improve and simplify program operations, and remove outmoded limitations to program innovations to better serve families. In addition, changes are proposed to clarify and correct technical provisions in existing regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates
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 information collection requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
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 procedure by which a manufacturer or distributor of a new dietary ingredient or of a dietary supplement containing a new dietary ingredient is to submit to FDA information upon which it has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. The notice also invites comments on two new forms FDA is developing to allow manufacturers and distributors to submit this information electronically via FDA's Unified Registration and Listing System (FURLS).
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2014
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2014, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Medicare Program; Prior Authorization of Repetitive Scheduled Nonemergent Ambulance Transports
This notice announces a 3-year Medicare Prior Authorization model for repetitive scheduled nonemergent ambulance transport in the states of New Jersey, Pennsylvania, and South Carolina where there have been high incidences of improper payments for these services.
Blood Products Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Blood Products Advisory Committee. This meeting was announced in the Federal Register of October 22, 2014. The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.
Agency Information Collection Activities; Proposed Collection; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer (DTC) Prescription Drug Advertisements.'' This study will examine differences between consumers viewing prescription drug ads with a spouse or partner versus alone through empirical research.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
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 information collection in the regulations on the Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements.
Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment
The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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
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.
Food Advisory Committee; Notice of Meeting; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Food Advisory Committee. This meeting was announced in the Federal Register of August 19, 2014. The amendment is being made to add an ADDRESSES section and to reflect a change in the Agenda. There are no other changes.
Science Board to the Food and Drug Administration Advisory Committee Meeting; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. This meeting was announced in the Federal Register of October 8, 2014. The amendment is being made to reflect changes in URL for the Webcast. There are no other changes.
Notice of Intent To Award Ebola Response Outbreak Funding to the International Association of National Public Health Institutes (IANPHI)
This notice provides public announcement of CDC's intent to award Ebola appropriations to the International Association of National Public Health Institutes (IANPHI) for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1419 ``Advancing National Public Health Institutes Globally''. IANPHI is uniquely positioned, in terms of authority, ability, track record, infrastructure, and credibility to engage its member institutes to respond to the Ebola outbreak in West Africa. Furthermore, these activities to increase eligible governments' capacity to respond to the Ebola outbreak are directly aligned with the current activities that IANPHI is conducting under this FOA to strengthen and expand national public health institute capabilities and support global health security.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015
This major final rule with comment period addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. See the Table of Contents for a listing of the specific issues addressed in this rule.
Submission for OMB Review; 30-Day Comment Request; HIV Study in Blood Donors From Five Chinese Regions (NHLBI)
Under the provisions of Section 3507(a)(1)(D) 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 in Volume 79, June 12, 2014 on page 33764 and allowed 60-days for public comment. One public comment was received that was a personal opinion regarding conducting research about the Chinese blood donation system. 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
The National Institute of Mental Health (NIMH) Draft Strategic Plan; Request for Comments
NIMH is revising its 2008 Strategic Plan to guide the Institute's research efforts and priorities over the next five years (2015-2020). The purpose of this Notice is to seek input from the public about the draft NIMH 2015 Strategic Plan. The draft plan will be publicly available through the NIMH Draft Strategic Plan Web page (https://www.nimh.nih.gov/about/strategic-planning-reports/rev iew-the- draft-2015-nimh-strategic-plan.shtml) for a 30-day period beginning on the publication date of this Notice. The public is invited to provide comments via the email address or postal address provided in this Notice and on the NIMH Draft Strategic Plan Web page.
Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems
The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls); require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the dynamic stabilization systems, currently a subtype of pedicle screws, regardless of the indication for use; and clarify the device identification of pedicle screw spinal systems, to more clearly delineate between rigid pedicle screw systems and dynamic stabilization systems. FDA is proposing this action based on new information pertaining to the device type. This proposed action implements certain statutory requirements.
Nominations to the Presidential Advisory Council on HIV/AIDS
The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four-year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature.
DSM Nutritional Products; Food Additive Petition (Animal Use); Ethoxyquin; Environmental Assessment
The Food and Drug Administration (FDA) is announcing the availability of an environmental assessment filed by DSM Nutritional Products in support of their petition proposing that the food additive regulations be amended to provide for the safe use of ethoxyquin in vitamin D formulations, including 25-hydroxyvitamin D3, used in animal food.
Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads.'' This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads.
Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Molecular Diagnostic Instruments with Combined Functions.'' This guidance document provides industry and Agency staff with FDA's current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions.
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC reviews and evaluates medical literature and technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.
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