Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition)
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Fifth Edition).'' The guidance provides updated information pertaining to registration of human and animal food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA) on January 4, 2011.
Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities; Availability
The Food and Drug Administration (FDA) is announcing the availability of an updated guidance for industry entitled ``What You Need To Know About Registration of Food FacilitiesSmall Entity Compliance Guide.'' FDA has prepared this guidance to restate the legal requirements pertaining to registration of food facilities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). Previously, this guidance restated the legal requirements of FDA's food facility registration regulation. This document also served as FDA's Small Entity Compliance Guide for FDA's food facility registration regulation in accordance with the Small Business Regulatory Enforcement Fairness Act. FDA is revising this document to provide guidance intended to help any entity comply with the requirements pertaining to registration of food facilities in the FD&C Act, including the amendments made by FSMA. This document continues to serve as FDA's Small Entity Compliance Guide for FDA's food facility registration regulation. Further, this guidance is intended to set forth in plain language the requirements for registration of food facilities and help small businesses understand the requirements.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice To Extend Expiration Date
The Food and Drug Administration (FDA) is extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2014.
Notice of Intent To Prepare an Environmental Impact Statement, Public Scoping Meeting, and Request for Comments; 2015-2025 Facilities Master Plan for Edward R. Roybal Campus in Atlanta, GA
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces its intent to prepare an Environmental Impact Statement (EIS) for the proposed 2015-2025 Facilities Master Plan for HHS/CDC's Edward R. Roybal Campus located at 1600 Clifton Road NE., in Atlanta, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR Part 1500-1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting 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 revision 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 to accompany humanitarian device exemption (HDE) applications and the collection of information regarding the annual distribution number (ADN).
Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials.
Ag-Mark, Incorporated, et al.; Proposal To Withdraw Approval of New Animal Drug Applications; Opportunity for a Hearing
The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of 19 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required periodic reports for these applications.
Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket
The Food and Drug Administration (FDA or we) is establishing a docket to obtain comments relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens as defined in the Food Allergen Labeling and Consumer Protection Act of 2004.
Medicaid Program; Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under the Vaccines for Children Program; Correction
This document corrects technical errors that appeared in the final rule published in the November 6, 2012 Federal Register entitled ``Medicaid Program; Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration under the Vaccines for Children Program.''
Availability of Final Toxicological Profiles
This notice announces the availability of ten final toxicological profiles of priority hazardous substances prepared by ATSDR.
Issuance of Final Guidance Publication
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: NIOSH Alert entitled ``Preventing Occupational Respiratory Disease from Exposures Caused by Dampness in Office Buildings, Schools, and Other Nonindustrial Buildings'' [2013-102].
Request for Information on Edel-Kindwall Caisson Tables for Preventing Decompression Illness in Construction Workers
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) invites comments and information on decompression tables used for protecting tunneling (caisson) workers from developing decompression illnesses. Public Comment Period: Comments must be received by March 29, 2013.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products
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.
Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application (e.g., monograph) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products.
Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. This draft guidance is not final nor is it in effect at this time.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, December 7, 2012 (77 FR 73034). The product name in the document was incorrect. This document corrects that error.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a conference call. The call will be open to the public.
Office of Child Support Enforcement; Privacy Act of 1974; Computer Matching Agreement
In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Unemployment Compensation (UC) program.
Office of Child Support Enforcement; Privacy Act of 1974; Computer Matching Agreement
In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program.
Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
This document corrects a technical error in the notice [Document Identifier: CMS-10451] entitled ``Evaluation and Development of Outcome Measures for Quality Assessment in Medicare Advantage and Special Needs Plans'' that was published in the October 26, 2012 (77 FR 65391) Federal Register.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study: Disease Information in Branded Promotional Material
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study: Disease Information in Branded Promotional Material'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.
Submission for OMB Review; Comment Request
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center, 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 on July 13, 2012, page 41431 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health 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. Proposed Collection: Title: The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research. Type of Information Collection Request: Reinstatement with Change; OMB Control Number: 0925-0602; Need and Use of Information Collection: This study will assess the value of the training programs administered by the Office of Clinical Research Training and Medical Education. The primary objective of the survey is to determine if training programs have had an impact on whether the trainees are performing clinical research, hold an academic appointment, have National Institutes of Health funding sources as well as to obtain information from the trainees as to what part of the National Institutes of Health medical education program they feel could be improved upon, the quality of the mentoring program, and how their National Institutes of Health training has contributed to their current clinical competence. Frequency of Response: On occasion. Affected Public: Individuals and businesses. Type of Respondents: Physicians and dentists, Ph.D. medical scientists, medical students, dental students, post-baccalaureate students, graduate students, post-doctoral students, and other health care professionals. The estimated annualized burden hours are as follows:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff
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.
Susan F. Knott; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Susan F. Knott and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Knott for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Knott was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Knott's debarment, FDA has considered the relevant factors listed in the FD&C Act. Knott has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.
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