Department of Health and Human Services April 3, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments,'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Residual Solvents in Animal Drug Products; Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers.'' The questions and answers guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and non-compendial drug products. This document answers questions regarding the Center for Veterinary Medicine's (CVM) implementation of USP Residual Solvents.
Identifying Potential Biomarkers for Qualification and Describing Contexts of Use To Address Areas Important to Drug Development; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the notice entitled ``Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development; Request for Comments'' that appeared in the Federal Register of February 13, 2015 (80 FR 8089). In the notice, FDA requested comments on identifying potential biomarkers for qualification and describing contexts of use to address areas important to drug development. The Agency is taking this action for an extension to allow interested persons additional time to submit comments.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 revision of the information collection entitled Possession, Use, and Transfer of Select Agents and Toxins (OMB Control No. 0920-0576). CDC is requesting Office of Management and Budget (OMB) approval to continue to collect information under the select agent regulations through the use of five forms: (1) Application for Registration for Possession. Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1); (2) Request to Transfer Select Agents or Toxins (APHIS/CDC Form 2); (3) Incident Form to Report Potential Theft, Loss, Release, or Occupational Exposure (APHIS/CDC Form 3); (4) Report of Identification of Select Agent or Toxin from Clinical/Diagnostic Specimen, Proficiency Testing, or Seizure by Federal Law Enforcement (APHIS/CDC Form 4); and (5) Request for Exemption of Select Agents and Toxins for an Investigational Product (APHIS/CDC Form 5).
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through September 30, 2015.
Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure the accuracy of the Agency's regulations.
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