Department of Health and Human Services November 14, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
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.
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